Immunology

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images

A version of this article first appeared on Medscape.com.

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images

A version of this article first appeared on Medscape.com.

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images

A version of this article first appeared on Medscape.com.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

Endocrine-disrupting chemicals linked to a variety of health problems are abundant in fast foods sold in the United States, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.

Digital Vision./Thinkstock

The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.

“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.

“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.

A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.

Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.

“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”

The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
 

Fast foods containing meat had highest concentrations of chemicals

Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.

Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.

The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).

Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.

“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.

The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.

Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.

“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”

Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.

“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”

The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Endocrine-disrupting chemicals linked to a variety of health problems are abundant in fast foods sold in the United States, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.

Digital Vision./Thinkstock

The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.

“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.

“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.

A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.

Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.

“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”

The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
 

Fast foods containing meat had highest concentrations of chemicals

Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.

Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.

The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).

Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.

“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.

The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.

Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.

“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”

Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.

“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”

The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Endocrine-disrupting chemicals linked to a variety of health problems are abundant in fast foods sold in the United States, such as chicken nuggets, hamburgers, and cheese pizza, new research suggests.

Digital Vision./Thinkstock

The first-of-its-kind study, which measured concentrations of chemicals such as phthalates in foods and gloves from U.S. fast food chains, is also the first to detect the plasticizer DEHT in fast foods.

“We knew from prior research that fast food consumption is linked to higher levels of phthalates in people’s bodies, but our study was novel because we actually collected these food items from fast food places and measured them,” said study author Lariah Edwards, PhD, a postdoctoral research scientist at the Milken Institute School of Public Health, George Washington University, Washington.

“Our research added an additional piece of information to the puzzle,” Dr. Edwards said in an interview.

A class of chemicals used in food packaging and food processing equipment, phthalates such as DEHP and DnBP, can leach out of these items and interfere with hormone production, Dr. Edwards said. They are linked with a wide variety of reproductive, developmental, brain, and immune effects, as well as with childhood obesity, asthma, cancer, and cardiovascular problems.

Meanwhile, nonphthalate or replacement plasticizers have been used in place of phthalates, some of which have been banned in certain products. But these plasticizers aren’t well studied, Dr. Edwards said, making the detection of DEHT in fast foods particularly concerning.

“There’s very limited research out there to understand the human health effects” of DEHT in food, she said, “so we’re being exposed before we understand what it’s doing to our health. It’s almost like we’re setting ourselves up for a big experiment.”

The study was recently published in the Journal of Exposure Science & Environmental Epidemiology .
 

Fast foods containing meat had highest concentrations of chemicals

Dr. Edwards and colleagues obtained 64 food samples, including hamburgers, fries, chicken nuggets, chicken burritos, and cheese pizza, as well as three pairs of unused gloves from six different fast food restaurants in San Antonio.

Using gas chromatography–mass spectrometry, they analyzed the samples for 11 chemicals, including eight phthalates and three replacement plasticizers.

The researchers detected 10 of the 11 chemicals in fast food samples: 81% of foods contained DnBP (di-n-butyl phthalate), and 70% contained DEHP (di(2-ethylhexyl phthalate)). Meanwhile 86% of samples contained replacement plasticizer DEHT (di(2-ethylhexyl terephthalate)).

Overall, fast food samples containing meat — including chicken nuggets, chicken burritos, and hamburgers — contained higher levels of these chemicals, Dr. Edwards noted.

“We know fast food is not the most nutritious, and now we’re seeing these chemicals in it we shouldn’t be exposed to,” she said.

The results also create implications for health equity, Dr. Edwards said, as Black people in the United States report eating more fast foods than other racial and ethnic groups for many reasons, such as longstanding residential segregation.

Many advocacy groups are pushing for stronger regulations on phthalates in foods, she said, and the study can be used to fuel those efforts.

“We’re hoping our findings help people understand what they’re eating and what’s in food,” Dr. Edwards said. “If they want to reduce exposure to phthalates in fast food, they can choose foods without meat in them. But not everyone has the option of reducing fast food consumption — personal choice is important, but policy is what’s going to protect us.”

Dr. Edwards noted that the research was limited by small sample sizes gathered in one U.S. city. Limitations in extraction methods also meant the researchers were able to detect chemicals in gloves only at high concentrations.

“That being said, I do think our results are fairly generalizable,” she added, “because the way fast foods are prepared at these restaurants is fairly consistent.”

The study was funded by the Passport Foundation, Forsythia Foundation, and Marisla Foundation. Dr. Edwards has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Early trials are under way to test medicinal mushrooms and Chinese herbs to treat COVID-19 patients with mild to moderate symptoms.

The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.

The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.

The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA  described the trials.

The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.

“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.

For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.

D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.

“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”

Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.

“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.

Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.

“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”

“Not a crazy concept”

Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.

“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”

Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.

“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.

Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.

“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.

As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.

Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.

He gave the example of St. John’s Wort, which has been problematic in HIV treatment.

“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.

Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”

He, too, pointed out that many traditional medicines were discovered from plants.

“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.

He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»

A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.

Early trials are under way to test medicinal mushrooms and Chinese herbs to treat COVID-19 patients with mild to moderate symptoms.

The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.

The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.

The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA  described the trials.

The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.

“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.

For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.

D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.

“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”

Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.

“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.

Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.

“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”

“Not a crazy concept”

Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.

“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”

Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.

“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.

Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.

“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.

As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.

Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.

He gave the example of St. John’s Wort, which has been problematic in HIV treatment.

“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.

Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”

He, too, pointed out that many traditional medicines were discovered from plants.

“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.

He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»

A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.

Early trials are under way to test medicinal mushrooms and Chinese herbs to treat COVID-19 patients with mild to moderate symptoms.

The U.S. Food and Drug Administration (FDA) approved the MACH-19 trials (the acronym for Mushrooms and Chinese Herbs for COVID-19) after researchers applied for approval in April.

The first two phase 1 randomized, double-blind, placebo-controlled trials have begun at UCLA and the University of California San Diego to treat COVID-19 patients quarantining at home with mild to moderate symptoms. A third trial is investigating the use of medicinal mushrooms as an adjuvant to COVID-19 vaccines.

The researchers have also launched a fourth trial testing the mushrooms against placebo as an adjunct to a COVID booster shot. It looks at the effect in people who have comorbidities that would reduce their vaccine response. An article in JAMA  described the trials.

The two mushroom varieties being tested — turkey tail and agarikon — are available as over-the-counter supplements, according to the report. They are a separate class from hallucinogenic or “magic” mushrooms being tested for other uses in medicine.

“They are not even as psychoactive as a cup of tea,” Gordon Saxe, MD, PhD, MPH, principal investigator for the MACH-19 trials, told this news organization.

For each of the MACH-19 treatment trials, researchers plan to recruit 66 people who are quarantined at home with mild to moderate COVID-19 symptoms. Participants will be randomly assigned either to receive the mushroom combination, the Chinese herbs, or a placebo for 2 weeks, according to the JAMA paper.

D. Craig Hopp, PhD, deputy director of the division of extramural research at the National Center for Complementary and Integrative Health (NCCIH), told JAMA in an interview that he was “mildly concerned” about using mushrooms to treat people with active SARS-CoV-2 infection.

“We know that a cytokine storm poses the greatest risk of COVID mortality, not the virus itself,” Dr. Hopp said. “The danger is that an immune-stimulating agent like mushrooms might supercharge an individual’s immune response, leading to a cytokine storm.”

Stephen Wilson, PhD, an immunologist who consulted on the trials when he was chief operating officer of the La Jolla Institute for Immunology, says in the JAMA article that a cytokine storm is unlikely for these patients because the mushroom components “don’t mimic inflammatory cytokines.” Dr. Wilson is now chief innovations officer at Statera Biopharma.

“We think the mushrooms increase the number of immunologic opportunities to better see and respond to a specific threat. In the doses used, the mushrooms perturb the immune system in a good way but fall far short of driving hyper or sustained inflammation,” Dr. Wilson said.

Dr. Saxe said the FDA process was extensive and rigorous and FDA investigators also asked about potential cytokine storms before approving the trials. Cytokine storm is not an issue with a healthy response, Dr. Saxe pointed out. It’s a response that’s not balanced or modulated.

“Mushrooms are immunomodulatory,” he said. “In some ways they very specifically enhance immunity. In other ways they calm down overimmunity.” Dr. Saxe noted that they did a sentinel study for the storm potential “and we didn’t see any evidence for it.”

“Not a crazy concept”

Dr. Saxe pointed out that one of the mushrooms in the combo they use — agarikon — was used to treat pulmonary infections 2,300 years ago.

“Hippocrates, the father of western medicine, used mushrooms,” he said. “Penicillin comes from fungi. It’s not a crazy concept. Most people who oppose this or are skeptics — to some extent, it’s a lack of information.”

Dr. Saxe explained that there are receptors on human cells that bind specific mushroom polysaccharides.

“There’s a hand-in-glove fit there,” Dr. Saxe said, and that’s one way mushrooms can modulate immune cell behavior, which could have an effect against SARS-CoV-2.

Daniel Kuritzkes, MD, chief of the division of infectious diseases at Brigham and Women’s Hospital in Boston, who was not part of the study, told this news organization that he wasn’t surprised the FDA approved moving forward with the trials.

“As long as you can demonstrate that there is a rationale for doing the trial and that you have some safety data or a plan to collect safety data, they are fairly liberal about doing early-phase studies. It would be a much different issue, I think, if they were proposing to do a study for actual licensing or approval of a drug,” Dr. Kuritzkes said.

As yet unanswered, he noted, is which component of the mushrooms or herbs is having the effect. It will be a challenge, he said, to know from one batch of the compound to the next that you have the same amount of material and that it’s going to have the same potency among lots.

Another challenge is how the mushrooms and herbs might interact with other therapies, Dr. Kuritzkes said.

He gave the example of St. John’s Wort, which has been problematic in HIV treatment.

“If someone is on certain HIV medicines and they also are taking St. John’s Wort, they basically are causing the liver to eat up the HIV drug and they don’t get adequate levels of the drug,” he said.

Though there are many challenges ahead, Dr. Kuritzkes acknowledged, but added that “this is a great starting point.”

He, too, pointed out that many traditional medicines were discovered from plants.

“The most famous of these is quinine, which came from cinchona bark that was used to treat malaria.” Dr. Kuritzkes said. Digitalis, often used to treat heart failure, comes from the fox glove plant, he added.

He said it’s important to remember that “people shouldn’t be seeking experimental therapies in place of proven therapies, they should be thinking of them in addition to proven therapies.»

A co-author reports an investment in the dietary supplement company Mycomedica Life Sciences, for which he also serves as an unpaid scientific adviser. Another co-author is a medical consultant for Evergreen Herbs and Medical Supplies. Dr. Hopp, Dr. Saxe, and Dr. Wilson have disclosed no relevant financial relationships. Dr. Kuritzkes consults for Merck, Gilead, and GlaxoSmithKline.

It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.

The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.

“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”

Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.

Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.

The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.

Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.

The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.

“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.

“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.

The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.

“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.

Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.

The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.

None of the researchers or commentators had financial disclosures.

It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.

The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.

“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”

Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.

Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.

The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.

Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.

The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.

“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.

“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.

The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.

“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.

Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.

The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.

None of the researchers or commentators had financial disclosures.

It’s rare for mothers with COVID-19 to transfer the infection to their newborns, according to a new small study.

The research, published in JAMA Network Open, found that newborns of mothers infected with the COVID-19 virus were able to develop their own immune defenses via their mother’s breast milk. Researchers detected antibodies in the infants’ saliva.

“It is the first time that this mechanism has been demonstrated,” said study author Rita Carsetti, MD, head of immunology diagnostics for Bambino Gesù Children’s Hospital in Rome. “We now know how breast milk can help babies develop their immune defenses. The system could work the same way for many other pathogens, which are present in the mother during breastfeeding.”

Dr. Carsetti and colleagues examined data from 28 pregnant women who tested positive for COVID-19 and who gave birth at Policlinico Umberto I in Rome between November 2020 and May 2021, and their newborns. They investigated the immune responses of the mothers and their newborns by detecting spike-specific antibodies in serum, and the mucosal immune response was assessed by measuring specific antibodies in maternal breast milk and infant saliva 48 hours after delivery and 2 months later.

Twenty-one mothers and their newborns completed the 2 months of follow-up. Researchers found that the majority of the mothers had mild symptoms of COVID-19, while only three of them were admitted for worsening condition. There was only one reported case of a possible vertical transmission – transmitted in utero – and one case of a horizontal infection through droplets or respiratory secretions, which occurred when the newborn was taken home.

The results of the study showed that antibodies specific to the virus were present in the mothers’ blood at 2 months after delivery, but not at 48 hours. However, in milk, specific antibodies were already present 48 hours after delivery.

Therefore, after 48 hours, the breastfed babies had specific mucosal antibodies against COVID-19 in their saliva that the other newborns did not have. Two months later, these antibodies continued to be present even though the mothers had stopped producing them.

The findings suggest that breast milk offers protection by transferring the antibodies produced by the mother to the baby, but also by helping them to produce their own immune defenses.

“I am not surprised that infants of mothers who had COVID-19 infection in the peripartum period pass anti-spike protein IgA to their infants,” J. Howard Smart, MD, FAAP, who was not involved with the study, said in an interview. “This confirmation is good news for breastfeeding mothers.

“I wonder whether we really know these infants did not become infected, and produce their own antibodies,” said Dr. Smart, chairman of the department of pediatrics at Sharp Rees-Stealy Medical Group in San Diego.

The American College of Obstetricians and Gynecologists said having COVID-19 should not stop mothers from giving their children breast milk. The organization also said that the chance of COVID-19 passing through the breast milk and causing infection in the newborn infant is slim.

“Breast milk also helps protect babies from infections, including infections of the ears, lungs, and digestive system. For these reasons, having COVID-19 should not stop you from giving your baby breast milk,” according to ACOG’s website.

Similar studies on mothers who received the COVID-19 vaccination rather than being infected would be interesting, Dr. Smart added.

The authors of the current study plan to broaden their research by evaluating the response of pregnant mothers vaccinated against SARS-CoV-2 for the presence of antibodies in the milk and the immunity of their newborns. Dr. Carsetti said her team plans to expand the study to other infections, such as cytomegalovirus and respiratory syncytial virus.

None of the researchers or commentators had financial disclosures.

Four years after new infant feeding guidelines were issued to prevent allergies to peanut and other foods, 70% of surveyed parents and caregivers in the United States said they had never heard about the new recommendation.

Food allergies in developed countries have doubled in each of the last decades and now affect 7.6% of U.S. children. About 1 in 50 are allergic to peanut. Data from the 2015 LEAP study and other research has convincingly shown that early, sustained feeding of peanuts, eggs, and other allergens can prevent babies from developing allergies to these foods.

Based on those findings, the National Institute of Allergy and Infectious Diseases (NIAID) updated its feeding guidelines in 2017, urging parents to introduce these foods to babies around 4-6 months of age rather than wait until 1-3 years of age, as previously recommended. The American Academy of Pediatrics approved those guidelines too, and in 2019 changed its own feeding recommendations.

To assess awareness of this new guidance and to what extent these recommendations are being translated into clinical practice, researchers surveyed a demographically representative U.S. sample of 3,062 parents and caregivers with children between 7 months and 3½ years old. The survey was conducted in English and Spanish over the web or by phone.

More than one-third reported that their child’s primary care physician never discussed when to start feeding peanut-containing foods. And among those whose doctors did offer guidance, fewer than 1 in 4 specifically recommended introducing peanut by 6 months of age.

These data show that “despite strong evidence that early introduction of peanut within the first year of life can prevent the development of peanut allergy, this evidence is simply not making its way to parents of infants,” said Christopher Warren, PhD, assistant professor of preventive medicine at the Northwestern University Feinberg School of Medicine, Chicago. Dr. Warren led the study and presented the findings on a poster at this year’s American College of Allergy, Asthma & Immunology annual meeting in New Orleans.

In addition to caregivers, the Northwestern team surveyed U.S. allergists and pediatricians about the new feeding guidelines. Uptake was fairly good among allergists, with 65% reporting full implementation. On the other hand, while most pediatricians seemed familiar with the 2017 recommendations, fewer than one-third said they were following them.

“What’s unique about this challenge is that it’s not just a guideline change – it’s a guideline reversal,” said Wendy Sue Swanson, MD, chief medical officer for SpoonfulONE, a company that makes mix-ins and other products for multi-allergen feeding. After telling families for years to avoid these allergens in early life because food allergies were rising, “it’s harder advice to say, actually, we were wrong. Not only should you not wait, you should get peanut in while your baby’s immune system has this critical moment to learn and develop, and you should keep getting it in,” Dr. Swanson said in an interview.

Making matters worse, pediatricians are time pressed. Typically, at 4- to 6-month-old well-check visits, “they’re talking about sleep and development and feeding and milestones,” said Ruchi Gupta, MD, MPH, professor of pediatrics and medicine at Northwestern Feinberg, who led the allergist and pediatrician analyses.

Another challenge: Guidelines differ depending on the child’s level of food allergy risk, so it’s hard to explain them clearly and quickly. Babies at highest risk – as judged by having severe eczema, egg allergy, or both – should get peanut IgE blood testing and, if negative, begin regular consumption of peanut by 4-6 months. Intermediate-risk babies who have mild-to-moderate eczema are recommended to start peanut-containing foods by 6 months. And for low-risk babies with no eczema or known food allergies, the guidance is simply to introduce peanut-containing foods “in accordance with family preferences and cultural practices.”

As for pediatricians who say it’s hard to distinguish mild-to-moderate from severe eczema, “any eczema puts you at some risk,” Dr. Gupta told this news organization. “If they’ve required steroid creams to clear up their skin, or if you look at their skin, and you think it’s severe, don’t hesitate. Go ahead and draw the IgE and send them to an allergist.”

Australia, which has the highest rate of confirmed food allergy, has had more success implementing early feeding guidelines, said Dr. Swanson. Unlike the United States’ tiered approach, she said, they “had a national guideline that very crisply, years ago, told parents what to do.” Australia also has nurse educators that follow up with new moms to make sure they understand and follow the recommendations.

Dr. Gupta receives research support from the National Institutes of Health, Food Allergy Research and Education, the Melchiorre Family Foundation, the Sunshine Charitable Foundation, the Walder Foundation, the UnitedHealth Group, Thermo Fisher Scientific, and Genentech. She serves as a medical consultant/advisor for Genentech, Novartis, and Food Allergy Research and Education. Dr. Swanson serves as chief medical officer for SpoonfulONE.

A version of this article first appeared on Medscape.com.

Four years after new infant feeding guidelines were issued to prevent allergies to peanut and other foods, 70% of surveyed parents and caregivers in the United States said they had never heard about the new recommendation.

Food allergies in developed countries have doubled in each of the last decades and now affect 7.6% of U.S. children. About 1 in 50 are allergic to peanut. Data from the 2015 LEAP study and other research has convincingly shown that early, sustained feeding of peanuts, eggs, and other allergens can prevent babies from developing allergies to these foods.

Based on those findings, the National Institute of Allergy and Infectious Diseases (NIAID) updated its feeding guidelines in 2017, urging parents to introduce these foods to babies around 4-6 months of age rather than wait until 1-3 years of age, as previously recommended. The American Academy of Pediatrics approved those guidelines too, and in 2019 changed its own feeding recommendations.

To assess awareness of this new guidance and to what extent these recommendations are being translated into clinical practice, researchers surveyed a demographically representative U.S. sample of 3,062 parents and caregivers with children between 7 months and 3½ years old. The survey was conducted in English and Spanish over the web or by phone.

More than one-third reported that their child’s primary care physician never discussed when to start feeding peanut-containing foods. And among those whose doctors did offer guidance, fewer than 1 in 4 specifically recommended introducing peanut by 6 months of age.

These data show that “despite strong evidence that early introduction of peanut within the first year of life can prevent the development of peanut allergy, this evidence is simply not making its way to parents of infants,” said Christopher Warren, PhD, assistant professor of preventive medicine at the Northwestern University Feinberg School of Medicine, Chicago. Dr. Warren led the study and presented the findings on a poster at this year’s American College of Allergy, Asthma & Immunology annual meeting in New Orleans.

In addition to caregivers, the Northwestern team surveyed U.S. allergists and pediatricians about the new feeding guidelines. Uptake was fairly good among allergists, with 65% reporting full implementation. On the other hand, while most pediatricians seemed familiar with the 2017 recommendations, fewer than one-third said they were following them.

“What’s unique about this challenge is that it’s not just a guideline change – it’s a guideline reversal,” said Wendy Sue Swanson, MD, chief medical officer for SpoonfulONE, a company that makes mix-ins and other products for multi-allergen feeding. After telling families for years to avoid these allergens in early life because food allergies were rising, “it’s harder advice to say, actually, we were wrong. Not only should you not wait, you should get peanut in while your baby’s immune system has this critical moment to learn and develop, and you should keep getting it in,” Dr. Swanson said in an interview.

Making matters worse, pediatricians are time pressed. Typically, at 4- to 6-month-old well-check visits, “they’re talking about sleep and development and feeding and milestones,” said Ruchi Gupta, MD, MPH, professor of pediatrics and medicine at Northwestern Feinberg, who led the allergist and pediatrician analyses.

Another challenge: Guidelines differ depending on the child’s level of food allergy risk, so it’s hard to explain them clearly and quickly. Babies at highest risk – as judged by having severe eczema, egg allergy, or both – should get peanut IgE blood testing and, if negative, begin regular consumption of peanut by 4-6 months. Intermediate-risk babies who have mild-to-moderate eczema are recommended to start peanut-containing foods by 6 months. And for low-risk babies with no eczema or known food allergies, the guidance is simply to introduce peanut-containing foods “in accordance with family preferences and cultural practices.”

As for pediatricians who say it’s hard to distinguish mild-to-moderate from severe eczema, “any eczema puts you at some risk,” Dr. Gupta told this news organization. “If they’ve required steroid creams to clear up their skin, or if you look at their skin, and you think it’s severe, don’t hesitate. Go ahead and draw the IgE and send them to an allergist.”

Australia, which has the highest rate of confirmed food allergy, has had more success implementing early feeding guidelines, said Dr. Swanson. Unlike the United States’ tiered approach, she said, they “had a national guideline that very crisply, years ago, told parents what to do.” Australia also has nurse educators that follow up with new moms to make sure they understand and follow the recommendations.

Dr. Gupta receives research support from the National Institutes of Health, Food Allergy Research and Education, the Melchiorre Family Foundation, the Sunshine Charitable Foundation, the Walder Foundation, the UnitedHealth Group, Thermo Fisher Scientific, and Genentech. She serves as a medical consultant/advisor for Genentech, Novartis, and Food Allergy Research and Education. Dr. Swanson serves as chief medical officer for SpoonfulONE.

A version of this article first appeared on Medscape.com.

Four years after new infant feeding guidelines were issued to prevent allergies to peanut and other foods, 70% of surveyed parents and caregivers in the United States said they had never heard about the new recommendation.

Food allergies in developed countries have doubled in each of the last decades and now affect 7.6% of U.S. children. About 1 in 50 are allergic to peanut. Data from the 2015 LEAP study and other research has convincingly shown that early, sustained feeding of peanuts, eggs, and other allergens can prevent babies from developing allergies to these foods.

Based on those findings, the National Institute of Allergy and Infectious Diseases (NIAID) updated its feeding guidelines in 2017, urging parents to introduce these foods to babies around 4-6 months of age rather than wait until 1-3 years of age, as previously recommended. The American Academy of Pediatrics approved those guidelines too, and in 2019 changed its own feeding recommendations.

To assess awareness of this new guidance and to what extent these recommendations are being translated into clinical practice, researchers surveyed a demographically representative U.S. sample of 3,062 parents and caregivers with children between 7 months and 3½ years old. The survey was conducted in English and Spanish over the web or by phone.

More than one-third reported that their child’s primary care physician never discussed when to start feeding peanut-containing foods. And among those whose doctors did offer guidance, fewer than 1 in 4 specifically recommended introducing peanut by 6 months of age.

These data show that “despite strong evidence that early introduction of peanut within the first year of life can prevent the development of peanut allergy, this evidence is simply not making its way to parents of infants,” said Christopher Warren, PhD, assistant professor of preventive medicine at the Northwestern University Feinberg School of Medicine, Chicago. Dr. Warren led the study and presented the findings on a poster at this year’s American College of Allergy, Asthma & Immunology annual meeting in New Orleans.

In addition to caregivers, the Northwestern team surveyed U.S. allergists and pediatricians about the new feeding guidelines. Uptake was fairly good among allergists, with 65% reporting full implementation. On the other hand, while most pediatricians seemed familiar with the 2017 recommendations, fewer than one-third said they were following them.

“What’s unique about this challenge is that it’s not just a guideline change – it’s a guideline reversal,” said Wendy Sue Swanson, MD, chief medical officer for SpoonfulONE, a company that makes mix-ins and other products for multi-allergen feeding. After telling families for years to avoid these allergens in early life because food allergies were rising, “it’s harder advice to say, actually, we were wrong. Not only should you not wait, you should get peanut in while your baby’s immune system has this critical moment to learn and develop, and you should keep getting it in,” Dr. Swanson said in an interview.

Making matters worse, pediatricians are time pressed. Typically, at 4- to 6-month-old well-check visits, “they’re talking about sleep and development and feeding and milestones,” said Ruchi Gupta, MD, MPH, professor of pediatrics and medicine at Northwestern Feinberg, who led the allergist and pediatrician analyses.

Another challenge: Guidelines differ depending on the child’s level of food allergy risk, so it’s hard to explain them clearly and quickly. Babies at highest risk – as judged by having severe eczema, egg allergy, or both – should get peanut IgE blood testing and, if negative, begin regular consumption of peanut by 4-6 months. Intermediate-risk babies who have mild-to-moderate eczema are recommended to start peanut-containing foods by 6 months. And for low-risk babies with no eczema or known food allergies, the guidance is simply to introduce peanut-containing foods “in accordance with family preferences and cultural practices.”

As for pediatricians who say it’s hard to distinguish mild-to-moderate from severe eczema, “any eczema puts you at some risk,” Dr. Gupta told this news organization. “If they’ve required steroid creams to clear up their skin, or if you look at their skin, and you think it’s severe, don’t hesitate. Go ahead and draw the IgE and send them to an allergist.”

Australia, which has the highest rate of confirmed food allergy, has had more success implementing early feeding guidelines, said Dr. Swanson. Unlike the United States’ tiered approach, she said, they “had a national guideline that very crisply, years ago, told parents what to do.” Australia also has nurse educators that follow up with new moms to make sure they understand and follow the recommendations.

Dr. Gupta receives research support from the National Institutes of Health, Food Allergy Research and Education, the Melchiorre Family Foundation, the Sunshine Charitable Foundation, the Walder Foundation, the UnitedHealth Group, Thermo Fisher Scientific, and Genentech. She serves as a medical consultant/advisor for Genentech, Novartis, and Food Allergy Research and Education. Dr. Swanson serves as chief medical officer for SpoonfulONE.

A version of this article first appeared on Medscape.com.

Alopecia areata (AA) has been linked to a significantly increased risk for dementia, new research shows.

After controlling for an array of potential confounders, investigators found a threefold higher risk of developing any form of dementia and a fourfold higher risk of developing Alzheimer’s disease (AD) in those with AA versus the controls.

“AA shares a similar inflammatory signature with dementia and has great psychological impacts that lead to poor social engagement,” lead author Cheng-Yuan Li, MD, MSc, of the department of dermatology, Taipei (Taiwan) Veterans General Hospital.

“Poor social engagement and shared inflammatory cytokines might both be important links between AA and dementia,” said Dr. Li, who is also affiliated with the School of Medicine and the Institute of Brain Science at National Yang Ming Chiao Tung University, Taipei.

The study was published online Oct. 26, 2021, in the Journal of Clinical Psychiatry (doi: 10.4088/JCP.21m13931).
 

Significant psychological impact

Patients with AA often experience anxiety and depression, possibly caused by the negative emotional and psychological impact of the hair loss and partial or even complete baldness associated with the disease, the authors noted.

However, AA is also associated with an array of other atopic and autoimmune diseases, including psoriasis and systemic lupus erythematosus (SLE).

Epidemiologic research has suggested a link between dementia and autoimmune diseases such as psoriasis and SLE, with some evidence suggesting that autoimmune and inflammatory mechanisms may “play a role” in the development of AD.

Dementia in general and AD in particular, “have been shown to include an inflammatory component” that may share some of the same mediators seen in AA (eg, IL-1 beta, IL-6, and tumor necrosis factor–alpha).

Moreover, “the great negative psychosocial impact of AA might result in poor social engagement, a typical risk factor for dementia,” said Dr. Li. The investigators sought to investigate whether patients with AA actually do have a higher dementia risk than individuals without AA.

The researchers used data from the Taiwan National Health Insurance Research Database, comparing 2,534 patients with AA against 25,340 controls matched for age, sex, residence, income, dementia-related comorbidities, systemic steroid use, and annual outpatient visits. Participants were enrolled between 1998 and 2011 and followed to the end of 2013.

The mean age of the cohort was 53.9 years, and a little over half (57.6%) were female. The most common comorbidity was hypertension (32.3%), followed by dyslipidemia (27%) and diabetes (15.4%).
 

Dual intervention

After adjusting for potential confounders, those with AA were more likely to develop dementia, AD, and unspecified dementia, compared with controls. They also had a numerically higher risk for vascular dementia, compared with controls, but it was not statistically significant.

When participants were stratified by age, investigators found a significant association between AA and higher risk for any dementia as well as unspecified dementia in individuals of all ages and an increased risk for AD in patients with dementia age at onset of 65 years and older.

The mean age of dementia diagnosis was considerably younger in patients with AA versus controls (73.4 vs. 78.9 years, P = .002). The risk for any dementia and unspecified dementia was higher in patients of both sexes, but the risk for AD was higher only in male patients.

Sensitivity analyses that excluded the first year or first 3 years of observation yielded similar and consistent findings.

“Intervention targeting poor social engagement and inflammatory cytokines may be beneficial to AA-associated dementia,” said Dr. Li.

“Physicians should be more aware of this possible association, help reduce disease discrimination among the public, and encourage more social engagement for AA patients,” he said.

“Further studies are needed to elucidate the underlying pathophysiology between AA and dementia risk,” he added.
 

No cause and effect

Commenting on the study, Heather M. Snyder, PhD, vice president of medical and scientific affairs, Alzheimer’s Association, said, “We continue to learn about and better understand factors that may increase or decrease a person’s risk of dementia.”

“While we know the immune system plays a role in Alzheimer’s and other dementia, we are still investigating links between, and impact of, autoimmune diseases – like alopecia areata, rheumatoid arthritis, and others – on our overall health and our brains, [which] may eventually give us important information on risk reduction strategies as well,” said Dr. Snyder, who was not involved in the research.

She cautioned that although the study did show a correlation between AA and dementia risk, this does not equate to a demonstration of cause and effect.

At present, “the message for clinicians is that when a patient comes to your office with complaints about their memory, they should, No. 1, be taken seriously; and, No. 2, receive a thorough evaluation that takes into account the many factors that may lead to cognitive decline,” Dr. Snyder said.

The study was supported by a grant from Taipei Veterans General Hospital and the Ministry of Science and Technology, Taiwan. Dr. Li, coauthors, and Dr. Snyder disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Alopecia areata (AA) has been linked to a significantly increased risk for dementia, new research shows.

After controlling for an array of potential confounders, investigators found a threefold higher risk of developing any form of dementia and a fourfold higher risk of developing Alzheimer’s disease (AD) in those with AA versus the controls.

“AA shares a similar inflammatory signature with dementia and has great psychological impacts that lead to poor social engagement,” lead author Cheng-Yuan Li, MD, MSc, of the department of dermatology, Taipei (Taiwan) Veterans General Hospital.

“Poor social engagement and shared inflammatory cytokines might both be important links between AA and dementia,” said Dr. Li, who is also affiliated with the School of Medicine and the Institute of Brain Science at National Yang Ming Chiao Tung University, Taipei.

The study was published online Oct. 26, 2021, in the Journal of Clinical Psychiatry (doi: 10.4088/JCP.21m13931).
 

Significant psychological impact

Patients with AA often experience anxiety and depression, possibly caused by the negative emotional and psychological impact of the hair loss and partial or even complete baldness associated with the disease, the authors noted.

However, AA is also associated with an array of other atopic and autoimmune diseases, including psoriasis and systemic lupus erythematosus (SLE).

Epidemiologic research has suggested a link between dementia and autoimmune diseases such as psoriasis and SLE, with some evidence suggesting that autoimmune and inflammatory mechanisms may “play a role” in the development of AD.

Dementia in general and AD in particular, “have been shown to include an inflammatory component” that may share some of the same mediators seen in AA (eg, IL-1 beta, IL-6, and tumor necrosis factor–alpha).

Moreover, “the great negative psychosocial impact of AA might result in poor social engagement, a typical risk factor for dementia,” said Dr. Li. The investigators sought to investigate whether patients with AA actually do have a higher dementia risk than individuals without AA.

The researchers used data from the Taiwan National Health Insurance Research Database, comparing 2,534 patients with AA against 25,340 controls matched for age, sex, residence, income, dementia-related comorbidities, systemic steroid use, and annual outpatient visits. Participants were enrolled between 1998 and 2011 and followed to the end of 2013.

The mean age of the cohort was 53.9 years, and a little over half (57.6%) were female. The most common comorbidity was hypertension (32.3%), followed by dyslipidemia (27%) and diabetes (15.4%).
 

Dual intervention

After adjusting for potential confounders, those with AA were more likely to develop dementia, AD, and unspecified dementia, compared with controls. They also had a numerically higher risk for vascular dementia, compared with controls, but it was not statistically significant.

When participants were stratified by age, investigators found a significant association between AA and higher risk for any dementia as well as unspecified dementia in individuals of all ages and an increased risk for AD in patients with dementia age at onset of 65 years and older.

The mean age of dementia diagnosis was considerably younger in patients with AA versus controls (73.4 vs. 78.9 years, P = .002). The risk for any dementia and unspecified dementia was higher in patients of both sexes, but the risk for AD was higher only in male patients.

Sensitivity analyses that excluded the first year or first 3 years of observation yielded similar and consistent findings.

“Intervention targeting poor social engagement and inflammatory cytokines may be beneficial to AA-associated dementia,” said Dr. Li.

“Physicians should be more aware of this possible association, help reduce disease discrimination among the public, and encourage more social engagement for AA patients,” he said.

“Further studies are needed to elucidate the underlying pathophysiology between AA and dementia risk,” he added.
 

No cause and effect

Commenting on the study, Heather M. Snyder, PhD, vice president of medical and scientific affairs, Alzheimer’s Association, said, “We continue to learn about and better understand factors that may increase or decrease a person’s risk of dementia.”

“While we know the immune system plays a role in Alzheimer’s and other dementia, we are still investigating links between, and impact of, autoimmune diseases – like alopecia areata, rheumatoid arthritis, and others – on our overall health and our brains, [which] may eventually give us important information on risk reduction strategies as well,” said Dr. Snyder, who was not involved in the research.

She cautioned that although the study did show a correlation between AA and dementia risk, this does not equate to a demonstration of cause and effect.

At present, “the message for clinicians is that when a patient comes to your office with complaints about their memory, they should, No. 1, be taken seriously; and, No. 2, receive a thorough evaluation that takes into account the many factors that may lead to cognitive decline,” Dr. Snyder said.

The study was supported by a grant from Taipei Veterans General Hospital and the Ministry of Science and Technology, Taiwan. Dr. Li, coauthors, and Dr. Snyder disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Alopecia areata (AA) has been linked to a significantly increased risk for dementia, new research shows.

After controlling for an array of potential confounders, investigators found a threefold higher risk of developing any form of dementia and a fourfold higher risk of developing Alzheimer’s disease (AD) in those with AA versus the controls.

“AA shares a similar inflammatory signature with dementia and has great psychological impacts that lead to poor social engagement,” lead author Cheng-Yuan Li, MD, MSc, of the department of dermatology, Taipei (Taiwan) Veterans General Hospital.

“Poor social engagement and shared inflammatory cytokines might both be important links between AA and dementia,” said Dr. Li, who is also affiliated with the School of Medicine and the Institute of Brain Science at National Yang Ming Chiao Tung University, Taipei.

The study was published online Oct. 26, 2021, in the Journal of Clinical Psychiatry (doi: 10.4088/JCP.21m13931).
 

Significant psychological impact

Patients with AA often experience anxiety and depression, possibly caused by the negative emotional and psychological impact of the hair loss and partial or even complete baldness associated with the disease, the authors noted.

However, AA is also associated with an array of other atopic and autoimmune diseases, including psoriasis and systemic lupus erythematosus (SLE).

Epidemiologic research has suggested a link between dementia and autoimmune diseases such as psoriasis and SLE, with some evidence suggesting that autoimmune and inflammatory mechanisms may “play a role” in the development of AD.

Dementia in general and AD in particular, “have been shown to include an inflammatory component” that may share some of the same mediators seen in AA (eg, IL-1 beta, IL-6, and tumor necrosis factor–alpha).

Moreover, “the great negative psychosocial impact of AA might result in poor social engagement, a typical risk factor for dementia,” said Dr. Li. The investigators sought to investigate whether patients with AA actually do have a higher dementia risk than individuals without AA.

The researchers used data from the Taiwan National Health Insurance Research Database, comparing 2,534 patients with AA against 25,340 controls matched for age, sex, residence, income, dementia-related comorbidities, systemic steroid use, and annual outpatient visits. Participants were enrolled between 1998 and 2011 and followed to the end of 2013.

The mean age of the cohort was 53.9 years, and a little over half (57.6%) were female. The most common comorbidity was hypertension (32.3%), followed by dyslipidemia (27%) and diabetes (15.4%).
 

Dual intervention

After adjusting for potential confounders, those with AA were more likely to develop dementia, AD, and unspecified dementia, compared with controls. They also had a numerically higher risk for vascular dementia, compared with controls, but it was not statistically significant.

When participants were stratified by age, investigators found a significant association between AA and higher risk for any dementia as well as unspecified dementia in individuals of all ages and an increased risk for AD in patients with dementia age at onset of 65 years and older.

The mean age of dementia diagnosis was considerably younger in patients with AA versus controls (73.4 vs. 78.9 years, P = .002). The risk for any dementia and unspecified dementia was higher in patients of both sexes, but the risk for AD was higher only in male patients.

Sensitivity analyses that excluded the first year or first 3 years of observation yielded similar and consistent findings.

“Intervention targeting poor social engagement and inflammatory cytokines may be beneficial to AA-associated dementia,” said Dr. Li.

“Physicians should be more aware of this possible association, help reduce disease discrimination among the public, and encourage more social engagement for AA patients,” he said.

“Further studies are needed to elucidate the underlying pathophysiology between AA and dementia risk,” he added.
 

No cause and effect

Commenting on the study, Heather M. Snyder, PhD, vice president of medical and scientific affairs, Alzheimer’s Association, said, “We continue to learn about and better understand factors that may increase or decrease a person’s risk of dementia.”

“While we know the immune system plays a role in Alzheimer’s and other dementia, we are still investigating links between, and impact of, autoimmune diseases – like alopecia areata, rheumatoid arthritis, and others – on our overall health and our brains, [which] may eventually give us important information on risk reduction strategies as well,” said Dr. Snyder, who was not involved in the research.

She cautioned that although the study did show a correlation between AA and dementia risk, this does not equate to a demonstration of cause and effect.

At present, “the message for clinicians is that when a patient comes to your office with complaints about their memory, they should, No. 1, be taken seriously; and, No. 2, receive a thorough evaluation that takes into account the many factors that may lead to cognitive decline,” Dr. Snyder said.

The study was supported by a grant from Taipei Veterans General Hospital and the Ministry of Science and Technology, Taiwan. Dr. Li, coauthors, and Dr. Snyder disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

Baby formula trials are not reliable, and have an “almost universal lack of transparency” which could undermine breastfeeding, according to the results of a systematic review published in BMJ. The findings underscore the need for significant change in the way such trials are conducted and reported, concluded lead author Bartosz Helfer, PhD, of the National Heart and Lung Institute at Imperial College London and the University of Wroclaw (Poland) Institute of Psychology and his coauthors. Citing a high risk of bias, selective reporting, and “almost universally favourable conclusions,” the international team of investigators suggested “some trials might have a marketing aim and no robust scientific aim,” concluding “much of the recent information generated about formula products might be misleading.”

The review included a detailed evaluation of 125 trials published since 2015, that compared at least two formula products in 23,757 children less than 3 years of age. The trials were evaluated for how they were conducted and reported, with specific attention paid to their risk of bias and risk of undermining breastfeeding.

Using the Cochrane risk-of-bias assessment 2.0 (ROB2), the analysis found that risk of bias was high in 80% of trials “usually because of inappropriate exclusions of participants from the analysis, and selective reporting,” the investigators noted. “This lack of transparency was complemented by favourable conclusions in more than 90% of recent trials, and evidence of publication bias in recent superiority trials.”

When conflict of interest was assessed, the analysis showed 84% of the trials received support from the formula milk industry, and of these, 77% had at least one author affiliated with a formula company. Overall, only 14% of trials had a low level of conflicts of interest according to the investigators’ definition “that the main source of funding had no commercial interest in the outcome of the trial and all of the authors of the study declared no financial ties to an entity with a commercial interest in the outcome of the trial.”

The investigators also noted that, by providing free formula to parents of breastfed or mixed-fed infants, many of the trials may have contravened the International Code of Marketing of Breast-milk Substitutes – an international agreement used to protect breastfeeding and limit the marketing of formula. “Claims arising from formula trials can contribute to formula marketing by narrowing the perceived benefits of breast milk over formula for consumers,” they wrote, calling for “improved oversight, conduct, and reporting of formula trials to ensure they provide a rigorous evidence base to inform nutrition in infants and young children.”

Asked to comment, Jennifer L. Pomeranz, JD, MPH, who was not involved in the study, told this publication the findings are “very concerning.” Ms. Pomeranz of New York University’s School of Global Public Health, recently reported similar issues in an analysis of baby formula websites. “Infant formula labels in the U.S. are adorned with a plethora of unsupported health and nutrition-related claims, including unregulated structure/function claims and breast milk comparison claims,” she said. “Moreover, infant formula marketing uses these claims to convince new parents that infant formula is necessary and even better for their infants than breast milk. Our research indicates that parents believe the popular claims made by formula companies and some even believe that infant formula is better for their child’s development than breast milk. If these claims are based on trials with no robust scientific basis, as the study suggests might be the case, then they are certainly false, deceptive, unfair, and misleading.”

Ms. Pomeranz called for the Food and Drug Administration’s regulation of infant formula labels, adding that “Congress should grant the FDA the explicit authority to require evidence to support structure/function claims on infant formula and prohibit breast milk comparison claims. ... The Federal Trade Commission and state attorneys general should bring actions against infant formula manufacturers for false and deceptive claims made in marketing materials,” she added.

Jack Newman, MD, another expert not involved in the study told this publication that the findings show how most formula studies “are essentially another marketing tool of the formula companies and are aimed at a very susceptible audience – health care professionals.” According to Dr. Newman, chief pediatrician and founder of the Newman Breastfeeding Clinic in Toronto and a former UNICEF consultant for the Baby Friendly Hospital Initiative, “health care professionals often like to believe they are immune to formula company marketing – yet this study shows that, even if they believed they were relying on scientific evidence, they were in fact being influenced toward formula feeding by studies that are biased, unreliable, and designed to promote formula to begin with.”

However, Stewart Forsyth, MD, honorary professor in child health, at the University of Dundee (Scotland) and retired consultant pediatrician and medical director at NHS Tayside, Scotland, cautioned that this is a delicate issue on all sides of the debate. The possibility of bias “is a potential issue with all aspects of research but is heightened in relation to infant feeding research because of the longstanding conflict involving the World Health Organisation, breastfeeding activist groups, and the infant formula industry, and as a consequence, all three of these organisations frequently resort to overinterpreting the data to favour their arguments,” he told this publication. An example is the suggestion that formula trials might contravene the International Code of Marketing of Breastmilk Substitutes because they provide free formula to participants. “Since when do participants in a research study have to pay for the intervention that is being studied?” he asked.

Dr. Stewart advised three key considerations “to mitigate the damaging effects that this type of inappropriate and misleading information may have on policy, practice, and engagement with parents.” First, it must be acknowledged that there is need for “a product that will provide a safety net for infants who are not offered breast milk,” he said. “It has been argued that to determine optimum nutrient requirements in infants and young children collaboration with nutrition companies is required.” Second, “all researchers need to comply with regulations relating to scientific methods, ethical standards, and financial diligence.” And finally, “there needs to be more effective planning and coordination of research activities to ensure that lessons are learned from the many studies that have design and methodological deficiencies.”

The study was funded by Imperial Health Charity. Ms. Pomeranz and Dr. Newman reported no conflicts of interest. Dr. Forsyth has undertaken consultancy work with governments, health care institutions, academia, and industry and has received research grants and honoraria from governments, charitable organizations and industry, including infant formula companies.

Senior author Robert J. Boyle, MBChB, MRCP, PhD, received personal fees from Cochrane, DBV Technologies, and Prota Therapeutics, and from expert witness work in cases of food anaphylaxis and class actions related to infant formula health claims, outside the submitted work, and received personal fees from Public Health England as a member of the UK Nutrition and Health Claims Committee and the Maternal and Child Nutrition Subgroup of the Scientific Advisory Committee on Nutrition. Coauthor Jo Leonardi-Bee, MSc, PhD, received fees from Danone Nutricia Research and the Food Standards Agency, outside of the submitted work.

During the 2020-2021 influenza season, fewer cases of influenza were reported than in any previous year since 1997, when data were first recorded.¹FIGURE 1² shows the dramatic decline in the number of influenza-positive clinical samples reported to the Centers for Disease Control and Prevention (CDC) during the 2020-2021 influenza season compared with the 2019-2020 season. There was only one pediatric death attributed to influenza in 2020-2021, compared with a mean of 177 per year in the previous 3 seasons.

Deaths attributed to pneumonia and influenza were recorded over a recent 5-year period, with COVID-19 added in early mid-2020 (FIGURE 2).¹ Total cumulative deaths for 2020-2021 were extremely high, mostly due to COVID-19. Of the relatively few influenza cases last season, 37.5% were caused by influenza A and 62.5% by influenza B. The extremely low incidence of influenza precludes determining influenza vaccine effectiveness for last season.¹

In addition, other common respiratory pathogens—parainfluenza, adenoviruses, rhinoviruses, enteroviruses, and common coronaviruses—circulated last winter at historic lows.³ All of these historic lows can be attributed to the measures taken to mitigate the effect of the COVID-19 pandemic, including masks, social distancing, closure of certain venues that normally attract large crowds, and the closure of schools with a resulting increase in schooling at home. With the anticipated relaxation of these measures in 2021-2022, we can expect more influenza and other respiratory ailments due to common pathogens.

Updates to influenza vaccine recommendations

At its June 2021 meeting, the Advisory Committee on Immunization Practices (ACIP) approved the influenza vaccine recommendations for the 2021-2022 season.⁴ The central recommendation is unchanged: Everyone ≥ 6 months of age should receive a vaccine unless they have a contraindication. Updates to the previous recommendations include the content of the 2021 vaccines, the specific vaccines that will be available for different age groups, the timing of vaccine administration, advice on co-administration with COVID-19 vaccines, and the list of contraindications and precautions based on vaccine type.⁴

Viral composition of US vaccines for the 2021-22 season

The antigens that will be included in the 2021-2022 influenza vaccines are listed in TABLE 1.⁴ The B strains are the same as last year; the A strains have been updated. The H3N2 strain is the same in all vaccines, but the H1N1 strain differs based on whether the vaccine is egg based or non-egg based. The advantage of non-egg-based vaccines is that the production process does not take as long and can be delayed in an attempt to better reflect the influenza stains in worldwide circulation.

The influenza vaccines expected to be available for the 2021-22 season

TABLE 2⁴ lists the influenza vaccines approved for use in the United States and the ages for which they are approved.⁴ All products for 2021-2022 will be quadrivalent, containing 2 type-A and 2 type-B antigens. The only change in age indications is that cell culture–based inactivated influenza vaccine (ccIIV4) (Flucelvax Quadrivalent) is now approved for use starting at age 2 years; previously it was approved starting at age 4 years.⁴

Timing of vaccination

The onsets and peaks of influenza disease occur at different times each year and can also vary by geographic location. An analysis of 36 influenza seasons starting in 1982 showed that peak activity occurred most frequently in February (15 seasons), followed by December (7 seasons), and January and March (6 seasons each).⁵ Only once did peak activity occur in October and once in November. This information, along with observational studies showing the waning of influenza vaccine effectiveness after 5 to 6 months, especially in the elderly, informed the ACIP decision to modify their recommendation on the timing of vaccination. The recommendation now states that vaccine should be administered by the end of October and that July and August would have been too early, especially for older adults.

Continue to: Children ages 6 months...

Children ages 6 months through 8 years who have not been vaccinated previously require 2 doses separated by at least 4 weeks, and the first dose should be administered early enough to allow for the second by the end of October.⁴ Children who require only 1 dose can also receive the vaccine as soon as it is available, as there is less evidence that vaccine effectiveness wanes in children.

Earlier administration is also recommended for pregnant women in their third trimester. Delaying vaccination in this group could result in postpartum administration of the vaccine, thereby depriving infants of protection against influenza illness during their first 6 months after birth.⁴

Co-administration of influenza and COVID-19 vaccines

Current guidance from the CDC states that COVID-19 vaccines can be co-administered with other vaccines including influenza vaccines.⁶ However, there are no data by which to judge the efficacy of each vaccine in coadministration or the potential for increased adverse reactions. ACIP advises caution on 2 points: (1) physicians should watch for updated guidance as more information becomes available, and (2) there is the potential for increased reactogenicity after co-administration, especially with the more reactogenic influenza vaccines: adjuvanted inactivated influenza vaccine (aIIV4) and high-dose inactivated influenza vaccine (HD-IIV4). Moreover, these vaccines and the co-administered COVID-19 vaccine should be injected into different limbs.

Contraindications and precautions

Serious allergic reactions to influenza vaccines are rare—about 1.3 incidents per million doses administered.⁷ However, a previous severe allergic reaction to a particular vaccine or to any component of the vaccine is a contraindication for use of that vaccine. In addition, a history of severe allergic reaction to any influenza vaccine is a contraindication for all egg-based vaccines.

There are 2 precautions for all influenza vaccines: a concurrent moderate or severe acute illness (with or without fever), and a history of Guillain-Barré syndrome within 6 weeks of receiving any influenza vaccine. An additional precaution for ccIIV4 and recombinant influenza vaccine (RIV4) is a history of severe allergic reaction after administration of any other influenza vaccine. Administration of RIV4 or ccIIV4 to someone with such a history should occur in a medical setting and be supervised by someone who can recognize and treat a severe reaction.

Continue to: Live attenuated influenza vaccine...

Live attenuated influenza vaccine (LAIV) continues to have a considerably longer list of contraindications, which can be found in the published recommendations for 2021-2022.⁸

Final advice

The upcoming influenza season has the potential to be clinically challenging with the possibility of co-existing high rates of both COVID-19 and influenza. Recommend both influenza and COVID-19 vaccination to patients. Also, be sure to encourage and practice other preventive measures such as masking in crowds, frequent hand washing, isolation when sick, respiratory hygiene, and (for physicians) selected prescribing of influenza antiviral medications and meticulous office-based infection control practices.⁹

During the 2020-2021 influenza season, fewer cases of influenza were reported than in any previous year since 1997, when data were first recorded.¹FIGURE 1² shows the dramatic decline in the number of influenza-positive clinical samples reported to the Centers for Disease Control and Prevention (CDC) during the 2020-2021 influenza season compared with the 2019-2020 season. There was only one pediatric death attributed to influenza in 2020-2021, compared with a mean of 177 per year in the previous 3 seasons.

Deaths attributed to pneumonia and influenza were recorded over a recent 5-year period, with COVID-19 added in early mid-2020 (FIGURE 2).¹ Total cumulative deaths for 2020-2021 were extremely high, mostly due to COVID-19. Of the relatively few influenza cases last season, 37.5% were caused by influenza A and 62.5% by influenza B. The extremely low incidence of influenza precludes determining influenza vaccine effectiveness for last season.¹

In addition, other common respiratory pathogens—parainfluenza, adenoviruses, rhinoviruses, enteroviruses, and common coronaviruses—circulated last winter at historic lows.³ All of these historic lows can be attributed to the measures taken to mitigate the effect of the COVID-19 pandemic, including masks, social distancing, closure of certain venues that normally attract large crowds, and the closure of schools with a resulting increase in schooling at home. With the anticipated relaxation of these measures in 2021-2022, we can expect more influenza and other respiratory ailments due to common pathogens.

Updates to influenza vaccine recommendations

At its June 2021 meeting, the Advisory Committee on Immunization Practices (ACIP) approved the influenza vaccine recommendations for the 2021-2022 season.⁴ The central recommendation is unchanged: Everyone ≥ 6 months of age should receive a vaccine unless they have a contraindication. Updates to the previous recommendations include the content of the 2021 vaccines, the specific vaccines that will be available for different age groups, the timing of vaccine administration, advice on co-administration with COVID-19 vaccines, and the list of contraindications and precautions based on vaccine type.⁴

Viral composition of US vaccines for the 2021-22 season

The antigens that will be included in the 2021-2022 influenza vaccines are listed in TABLE 1.⁴ The B strains are the same as last year; the A strains have been updated. The H3N2 strain is the same in all vaccines, but the H1N1 strain differs based on whether the vaccine is egg based or non-egg based. The advantage of non-egg-based vaccines is that the production process does not take as long and can be delayed in an attempt to better reflect the influenza stains in worldwide circulation.

The influenza vaccines expected to be available for the 2021-22 season

TABLE 2⁴ lists the influenza vaccines approved for use in the United States and the ages for which they are approved.⁴ All products for 2021-2022 will be quadrivalent, containing 2 type-A and 2 type-B antigens. The only change in age indications is that cell culture–based inactivated influenza vaccine (ccIIV4) (Flucelvax Quadrivalent) is now approved for use starting at age 2 years; previously it was approved starting at age 4 years.⁴

Timing of vaccination

The onsets and peaks of influenza disease occur at different times each year and can also vary by geographic location. An analysis of 36 influenza seasons starting in 1982 showed that peak activity occurred most frequently in February (15 seasons), followed by December (7 seasons), and January and March (6 seasons each).⁵ Only once did peak activity occur in October and once in November. This information, along with observational studies showing the waning of influenza vaccine effectiveness after 5 to 6 months, especially in the elderly, informed the ACIP decision to modify their recommendation on the timing of vaccination. The recommendation now states that vaccine should be administered by the end of October and that July and August would have been too early, especially for older adults.

Continue to: Children ages 6 months...

Children ages 6 months through 8 years who have not been vaccinated previously require 2 doses separated by at least 4 weeks, and the first dose should be administered early enough to allow for the second by the end of October.⁴ Children who require only 1 dose can also receive the vaccine as soon as it is available, as there is less evidence that vaccine effectiveness wanes in children.

Earlier administration is also recommended for pregnant women in their third trimester. Delaying vaccination in this group could result in postpartum administration of the vaccine, thereby depriving infants of protection against influenza illness during their first 6 months after birth.⁴

Co-administration of influenza and COVID-19 vaccines

Current guidance from the CDC states that COVID-19 vaccines can be co-administered with other vaccines including influenza vaccines.⁶ However, there are no data by which to judge the efficacy of each vaccine in coadministration or the potential for increased adverse reactions. ACIP advises caution on 2 points: (1) physicians should watch for updated guidance as more information becomes available, and (2) there is the potential for increased reactogenicity after co-administration, especially with the more reactogenic influenza vaccines: adjuvanted inactivated influenza vaccine (aIIV4) and high-dose inactivated influenza vaccine (HD-IIV4). Moreover, these vaccines and the co-administered COVID-19 vaccine should be injected into different limbs.

Contraindications and precautions

Serious allergic reactions to influenza vaccines are rare—about 1.3 incidents per million doses administered.⁷ However, a previous severe allergic reaction to a particular vaccine or to any component of the vaccine is a contraindication for use of that vaccine. In addition, a history of severe allergic reaction to any influenza vaccine is a contraindication for all egg-based vaccines.

There are 2 precautions for all influenza vaccines: a concurrent moderate or severe acute illness (with or without fever), and a history of Guillain-Barré syndrome within 6 weeks of receiving any influenza vaccine. An additional precaution for ccIIV4 and recombinant influenza vaccine (RIV4) is a history of severe allergic reaction after administration of any other influenza vaccine. Administration of RIV4 or ccIIV4 to someone with such a history should occur in a medical setting and be supervised by someone who can recognize and treat a severe reaction.

Continue to: Live attenuated influenza vaccine...

Live attenuated influenza vaccine (LAIV) continues to have a considerably longer list of contraindications, which can be found in the published recommendations for 2021-2022.⁸

Final advice

The upcoming influenza season has the potential to be clinically challenging with the possibility of co-existing high rates of both COVID-19 and influenza. Recommend both influenza and COVID-19 vaccination to patients. Also, be sure to encourage and practice other preventive measures such as masking in crowds, frequent hand washing, isolation when sick, respiratory hygiene, and (for physicians) selected prescribing of influenza antiviral medications and meticulous office-based infection control practices.⁹

During the 2020-2021 influenza season, fewer cases of influenza were reported than in any previous year since 1997, when data were first recorded.¹FIGURE 1² shows the dramatic decline in the number of influenza-positive clinical samples reported to the Centers for Disease Control and Prevention (CDC) during the 2020-2021 influenza season compared with the 2019-2020 season. There was only one pediatric death attributed to influenza in 2020-2021, compared with a mean of 177 per year in the previous 3 seasons.

Deaths attributed to pneumonia and influenza were recorded over a recent 5-year period, with COVID-19 added in early mid-2020 (FIGURE 2).¹ Total cumulative deaths for 2020-2021 were extremely high, mostly due to COVID-19. Of the relatively few influenza cases last season, 37.5% were caused by influenza A and 62.5% by influenza B. The extremely low incidence of influenza precludes determining influenza vaccine effectiveness for last season.¹

In addition, other common respiratory pathogens—parainfluenza, adenoviruses, rhinoviruses, enteroviruses, and common coronaviruses—circulated last winter at historic lows.³ All of these historic lows can be attributed to the measures taken to mitigate the effect of the COVID-19 pandemic, including masks, social distancing, closure of certain venues that normally attract large crowds, and the closure of schools with a resulting increase in schooling at home. With the anticipated relaxation of these measures in 2021-2022, we can expect more influenza and other respiratory ailments due to common pathogens.

Updates to influenza vaccine recommendations

At its June 2021 meeting, the Advisory Committee on Immunization Practices (ACIP) approved the influenza vaccine recommendations for the 2021-2022 season.⁴ The central recommendation is unchanged: Everyone ≥ 6 months of age should receive a vaccine unless they have a contraindication. Updates to the previous recommendations include the content of the 2021 vaccines, the specific vaccines that will be available for different age groups, the timing of vaccine administration, advice on co-administration with COVID-19 vaccines, and the list of contraindications and precautions based on vaccine type.⁴

Viral composition of US vaccines for the 2021-22 season

The antigens that will be included in the 2021-2022 influenza vaccines are listed in TABLE 1.⁴ The B strains are the same as last year; the A strains have been updated. The H3N2 strain is the same in all vaccines, but the H1N1 strain differs based on whether the vaccine is egg based or non-egg based. The advantage of non-egg-based vaccines is that the production process does not take as long and can be delayed in an attempt to better reflect the influenza stains in worldwide circulation.

The influenza vaccines expected to be available for the 2021-22 season

TABLE 2⁴ lists the influenza vaccines approved for use in the United States and the ages for which they are approved.⁴ All products for 2021-2022 will be quadrivalent, containing 2 type-A and 2 type-B antigens. The only change in age indications is that cell culture–based inactivated influenza vaccine (ccIIV4) (Flucelvax Quadrivalent) is now approved for use starting at age 2 years; previously it was approved starting at age 4 years.⁴

Timing of vaccination

The onsets and peaks of influenza disease occur at different times each year and can also vary by geographic location. An analysis of 36 influenza seasons starting in 1982 showed that peak activity occurred most frequently in February (15 seasons), followed by December (7 seasons), and January and March (6 seasons each).⁵ Only once did peak activity occur in October and once in November. This information, along with observational studies showing the waning of influenza vaccine effectiveness after 5 to 6 months, especially in the elderly, informed the ACIP decision to modify their recommendation on the timing of vaccination. The recommendation now states that vaccine should be administered by the end of October and that July and August would have been too early, especially for older adults.

Continue to: Children ages 6 months...

Children ages 6 months through 8 years who have not been vaccinated previously require 2 doses separated by at least 4 weeks, and the first dose should be administered early enough to allow for the second by the end of October.⁴ Children who require only 1 dose can also receive the vaccine as soon as it is available, as there is less evidence that vaccine effectiveness wanes in children.

Earlier administration is also recommended for pregnant women in their third trimester. Delaying vaccination in this group could result in postpartum administration of the vaccine, thereby depriving infants of protection against influenza illness during their first 6 months after birth.⁴

Co-administration of influenza and COVID-19 vaccines

Current guidance from the CDC states that COVID-19 vaccines can be co-administered with other vaccines including influenza vaccines.⁶ However, there are no data by which to judge the efficacy of each vaccine in coadministration or the potential for increased adverse reactions. ACIP advises caution on 2 points: (1) physicians should watch for updated guidance as more information becomes available, and (2) there is the potential for increased reactogenicity after co-administration, especially with the more reactogenic influenza vaccines: adjuvanted inactivated influenza vaccine (aIIV4) and high-dose inactivated influenza vaccine (HD-IIV4). Moreover, these vaccines and the co-administered COVID-19 vaccine should be injected into different limbs.

Contraindications and precautions

Serious allergic reactions to influenza vaccines are rare—about 1.3 incidents per million doses administered.⁷ However, a previous severe allergic reaction to a particular vaccine or to any component of the vaccine is a contraindication for use of that vaccine. In addition, a history of severe allergic reaction to any influenza vaccine is a contraindication for all egg-based vaccines.

There are 2 precautions for all influenza vaccines: a concurrent moderate or severe acute illness (with or without fever), and a history of Guillain-Barré syndrome within 6 weeks of receiving any influenza vaccine. An additional precaution for ccIIV4 and recombinant influenza vaccine (RIV4) is a history of severe allergic reaction after administration of any other influenza vaccine. Administration of RIV4 or ccIIV4 to someone with such a history should occur in a medical setting and be supervised by someone who can recognize and treat a severe reaction.

Continue to: Live attenuated influenza vaccine...

Live attenuated influenza vaccine (LAIV) continues to have a considerably longer list of contraindications, which can be found in the published recommendations for 2021-2022.⁸

Final advice

The upcoming influenza season has the potential to be clinically challenging with the possibility of co-existing high rates of both COVID-19 and influenza. Recommend both influenza and COVID-19 vaccination to patients. Also, be sure to encourage and practice other preventive measures such as masking in crowds, frequent hand washing, isolation when sick, respiratory hygiene, and (for physicians) selected prescribing of influenza antiviral medications and meticulous office-based infection control practices.⁹

The chances that unvaccinated family members will be infected or hospitalized with COVID-19 drop sharply if even one family member is vaccinated. The chances are reduced even further with each additional vaccinated or otherwise immune family member, according to new data.

Lead author Peter Nordström, MD, PhD, with the unit of geriatric medicine, Umeå (Sweden) University, said in an interview the message is important for public health: “When you vaccinate, you do not just protect yourself but also your relatives.”

The findings were published online on Oct. 11, 2021, in JAMA Internal Medicine.

Researchers analyzed data from 1,789,728 individuals from 814,806 families from nationwide registries in Sweden. All individuals had acquired immunity either from previously being infected with SARS-CoV-2 or by being fully vaccinated (that is, having received two doses of the Moderna, Pfizer, or Oxford/AstraZeneca vaccines). Persons were considered for inclusion until May 26, 2021.

Each person with immunity was matched in a 1:1 ratio to a person without immunity from a cohort of individuals with families that had from two to five members. Families with more than five members were excluded because of small sample sizes.

Primarily nonimmune families in which there was one immune family member had a 45%-61% lower risk of contracting COVID-19 (hazard ratio, 0.39-0.55; 95% confidence interval, 0.37-0.61; P < .001).

The risk reduction increased to 75%-86% when two family members were immune (HR, 0.14-0.25; 95% CI, 0.11-0.27; P < .001).

It increased to 91%-94% when three family members were immune (HR, 0.06-0.09; 95% CI, 0.04-0.10; P < .001) and to 97% with four immune family members (HR, 0.03; 95% CI, 0.02-0.05; P < .001).

“The results were similar for the outcome of COVID-19 infection that was severe enough to warrant a hospital stay,” the authors wrote. They listed as an example that, in three-member families in which two members were immune, the remaining nonimmune family member had an 80% lower risk for hospitalization (HR, 0.20; 95% CI, 0.10-0.43; P < .001).
 

Global implications

Dr. Nordström said the team used the family setting because it was more easily identifiable as a cohort with the national registries and because COVID-19 is spread among people in close contact with each other. The findings have implications for other groups that spend large amounts of time together and for herd immunity, he added.

The findings may be particularly welcome in regions of the world where vaccination rates are very low. The authors noted that most of the global population has not yet been vaccinated and that “it is anticipated that most of the population in low-income countries will be unable to receive a vaccine in 2021, with current vaccination rates suggesting that completely inoculating 70%-85% of the global population may take up to 5 years.”

Jill Foster, MD, a pediatric infectious disease specialist at the University of Minnesota, Minneapolis, said in an interview she agrees that the news could encourage countries that have very low vaccination rates.

This study may help motivate areas with few resources to start small, she said: “Even one is better than zero.”

She added that this news could also help ease the minds of families that have immunocompromised members or in which there are children who are too young to be vaccinated.

With these data, she said, people can see there’s something they can do to help protect a family member.

Dr. Foster said that although it’s intuitive to think that the more vaccinated people there are in a family, the safer people are, “it’s really nice to see the data coming out of such a large dataset.”

The authors acknowledged that a limitation of the study is that, at the time the study was conducted, the Delta variant was uncommon in Sweden. It is therefore unclear whether the findings regarding immunity are still relevant in Sweden and elsewhere now that the Delta strain is dominant.

The authors reported no relevant financial relationships. Dr. Foster has received grant support from Moderna.

A version of this article first appeared on Medscape.com.

The chances that unvaccinated family members will be infected or hospitalized with COVID-19 drop sharply if even one family member is vaccinated. The chances are reduced even further with each additional vaccinated or otherwise immune family member, according to new data.

Lead author Peter Nordström, MD, PhD, with the unit of geriatric medicine, Umeå (Sweden) University, said in an interview the message is important for public health: “When you vaccinate, you do not just protect yourself but also your relatives.”

The findings were published online on Oct. 11, 2021, in JAMA Internal Medicine.

Researchers analyzed data from 1,789,728 individuals from 814,806 families from nationwide registries in Sweden. All individuals had acquired immunity either from previously being infected with SARS-CoV-2 or by being fully vaccinated (that is, having received two doses of the Moderna, Pfizer, or Oxford/AstraZeneca vaccines). Persons were considered for inclusion until May 26, 2021.

Each person with immunity was matched in a 1:1 ratio to a person without immunity from a cohort of individuals with families that had from two to five members. Families with more than five members were excluded because of small sample sizes.

Primarily nonimmune families in which there was one immune family member had a 45%-61% lower risk of contracting COVID-19 (hazard ratio, 0.39-0.55; 95% confidence interval, 0.37-0.61; P < .001).

The risk reduction increased to 75%-86% when two family members were immune (HR, 0.14-0.25; 95% CI, 0.11-0.27; P < .001).

It increased to 91%-94% when three family members were immune (HR, 0.06-0.09; 95% CI, 0.04-0.10; P < .001) and to 97% with four immune family members (HR, 0.03; 95% CI, 0.02-0.05; P < .001).

“The results were similar for the outcome of COVID-19 infection that was severe enough to warrant a hospital stay,” the authors wrote. They listed as an example that, in three-member families in which two members were immune, the remaining nonimmune family member had an 80% lower risk for hospitalization (HR, 0.20; 95% CI, 0.10-0.43; P < .001).
 

Global implications

Dr. Nordström said the team used the family setting because it was more easily identifiable as a cohort with the national registries and because COVID-19 is spread among people in close contact with each other. The findings have implications for other groups that spend large amounts of time together and for herd immunity, he added.

The findings may be particularly welcome in regions of the world where vaccination rates are very low. The authors noted that most of the global population has not yet been vaccinated and that “it is anticipated that most of the population in low-income countries will be unable to receive a vaccine in 2021, with current vaccination rates suggesting that completely inoculating 70%-85% of the global population may take up to 5 years.”

Jill Foster, MD, a pediatric infectious disease specialist at the University of Minnesota, Minneapolis, said in an interview she agrees that the news could encourage countries that have very low vaccination rates.

This study may help motivate areas with few resources to start small, she said: “Even one is better than zero.”

She added that this news could also help ease the minds of families that have immunocompromised members or in which there are children who are too young to be vaccinated.

With these data, she said, people can see there’s something they can do to help protect a family member.

Dr. Foster said that although it’s intuitive to think that the more vaccinated people there are in a family, the safer people are, “it’s really nice to see the data coming out of such a large dataset.”

The authors acknowledged that a limitation of the study is that, at the time the study was conducted, the Delta variant was uncommon in Sweden. It is therefore unclear whether the findings regarding immunity are still relevant in Sweden and elsewhere now that the Delta strain is dominant.

The authors reported no relevant financial relationships. Dr. Foster has received grant support from Moderna.

A version of this article first appeared on Medscape.com.

The chances that unvaccinated family members will be infected or hospitalized with COVID-19 drop sharply if even one family member is vaccinated. The chances are reduced even further with each additional vaccinated or otherwise immune family member, according to new data.

Lead author Peter Nordström, MD, PhD, with the unit of geriatric medicine, Umeå (Sweden) University, said in an interview the message is important for public health: “When you vaccinate, you do not just protect yourself but also your relatives.”

The findings were published online on Oct. 11, 2021, in JAMA Internal Medicine.

Researchers analyzed data from 1,789,728 individuals from 814,806 families from nationwide registries in Sweden. All individuals had acquired immunity either from previously being infected with SARS-CoV-2 or by being fully vaccinated (that is, having received two doses of the Moderna, Pfizer, or Oxford/AstraZeneca vaccines). Persons were considered for inclusion until May 26, 2021.

Each person with immunity was matched in a 1:1 ratio to a person without immunity from a cohort of individuals with families that had from two to five members. Families with more than five members were excluded because of small sample sizes.

Primarily nonimmune families in which there was one immune family member had a 45%-61% lower risk of contracting COVID-19 (hazard ratio, 0.39-0.55; 95% confidence interval, 0.37-0.61; P < .001).

The risk reduction increased to 75%-86% when two family members were immune (HR, 0.14-0.25; 95% CI, 0.11-0.27; P < .001).

It increased to 91%-94% when three family members were immune (HR, 0.06-0.09; 95% CI, 0.04-0.10; P < .001) and to 97% with four immune family members (HR, 0.03; 95% CI, 0.02-0.05; P < .001).

“The results were similar for the outcome of COVID-19 infection that was severe enough to warrant a hospital stay,” the authors wrote. They listed as an example that, in three-member families in which two members were immune, the remaining nonimmune family member had an 80% lower risk for hospitalization (HR, 0.20; 95% CI, 0.10-0.43; P < .001).
 

Global implications

Dr. Nordström said the team used the family setting because it was more easily identifiable as a cohort with the national registries and because COVID-19 is spread among people in close contact with each other. The findings have implications for other groups that spend large amounts of time together and for herd immunity, he added.

The findings may be particularly welcome in regions of the world where vaccination rates are very low. The authors noted that most of the global population has not yet been vaccinated and that “it is anticipated that most of the population in low-income countries will be unable to receive a vaccine in 2021, with current vaccination rates suggesting that completely inoculating 70%-85% of the global population may take up to 5 years.”

Jill Foster, MD, a pediatric infectious disease specialist at the University of Minnesota, Minneapolis, said in an interview she agrees that the news could encourage countries that have very low vaccination rates.

This study may help motivate areas with few resources to start small, she said: “Even one is better than zero.”

She added that this news could also help ease the minds of families that have immunocompromised members or in which there are children who are too young to be vaccinated.

With these data, she said, people can see there’s something they can do to help protect a family member.

Dr. Foster said that although it’s intuitive to think that the more vaccinated people there are in a family, the safer people are, “it’s really nice to see the data coming out of such a large dataset.”

The authors acknowledged that a limitation of the study is that, at the time the study was conducted, the Delta variant was uncommon in Sweden. It is therefore unclear whether the findings regarding immunity are still relevant in Sweden and elsewhere now that the Delta strain is dominant.

The authors reported no relevant financial relationships. Dr. Foster has received grant support from Moderna.

A version of this article first appeared on Medscape.com.