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CDC endorses Pfizer’s COVID-19 vaccine for young kids
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
– meaning the shots are now available for immediate use.
The Nov. 2 decision came mere hours after experts that advise the CDC on vaccinations strongly recommended the vaccine for this age group.
“Together, with science leading the charge, we have taken another important step forward in our nation’s fight against the virus that causes COVID-19. We know millions of parents are eager to get their children vaccinated and with this decision, we now have recommended that about 28 million children receive a COVID-19 vaccine. As a mom, I encourage parents with questions to talk to their pediatrician, school nurse, or local pharmacist to learn more about the vaccine and the importance of getting their children vaccinated,” Dr. Walensky said in a prepared statement.
President Joe Biden applauded Dr. Walensky’s endorsement: “Today, we have reached a turning point in our battle against COVID-19: authorization of a safe, effective vaccine for children age 5 to 11. It will allow parents to end months of anxious worrying about their kids, and reduce the extent to which children spread the virus to others. It is a major step forward for our nation in our fight to defeat the virus,” he said in a statement.
The 14 members of the Advisory Committee on Immunization Practices (ACIP) voted unanimously earlier in the day to recommend the vaccine for kids.
“I feel like I have a responsibility to make this vaccine available to children and their parents,” said committee member Beth Bell, MD, MPH, a clinical professor at the University of Washington in Seattle. Bell noted that all evidence the committee had reviewed pointed to a vaccine that was safe and effective for younger children.
“If I had a grandchild, I would certainly get that grandchild vaccinated as soon as possible,” she said.
Their recommendations follow the U.S. Food and Drug Administration’s emergency authorization of Pfizer-BioNTech’s vaccine for this same age group last week.
“I’m voting for this because I think it could have a huge positive impact on [kids’] health and their social and emotional wellbeing,” said Grace Lee, MD, a professor of pediatrics at Stanford University School of Medicine, who chairs the CDC’s ACIP.
She noted that, though masks are available to reduce the risk for kids, they aren’t perfect and transmission still occurs.
“Vaccines are really the only consistent and reliable way to provide that protection,” Lee said.
The vaccine for children is two doses given 3 weeks apart. Each dose is 10 micrograms, which is one-third of the dose used in adults and teens.
To avoid confusion, the smaller dose for kids will come in bottles with orange labels and orange tops. The vaccine for adults is packaged in purple.
The CDC also addressed the question of kids who are close to age 12 when they get their first dose.
In general, pediatricians allow for a 4-day grace period around birthdays to determine which dose is needed. That will be the same with the COVID-19 vaccine.
For kids who are 11 when they start the series, they should get another 10-microgram dose after they turn 12 a few weeks later.
COVID-19 cases in this age group have climbed sharply over the summer and into the fall as schools have fully reopened, sometimes without the benefit of masks.
In the first week of October, roughly 10% of all COVID-19 cases recorded in the United States were among children ages 5 through 11. Since the start of pandemic, about 1.9 million children in this age group have been infected, though that’s almost certainly an undercount. More than 8,300 have been hospitalized, and 94 children have died.
Children of color have been disproportionately impacted. More than two-thirds of hospitalized children have been black or Hispanic.
Weighing benefits and risks
In clinical trials that included more than 4,600 children, the most common adverse events were pain and swelling at the injection site. They could also have side effects like fevers, fatigue, headache, chills, and sometimes swollen lymph nodes.
These kinds of side effects appear to be less common in children ages 5 to 11 than they have been in teens and adults, and they were temporary.
No cases of myocarditis or pericarditis were seen in the studies, but myocarditis is a very rare side effect, and the studies were too small to pick up these cases.
Still, doctors say they’re watching for it. In general, the greatest risk for myocarditis after vaccination has been seen in younger males between the ages of 12 and 30.
Even without COVID-19 or vaccines in the mix, doctors expect to see as many as two cases of myocarditis for every million people over the course of a week. The risk for myocarditis jumps up to about 11 cases for every million doses of mRNA vaccine given to men ages 25 to 30. It’s between 37 and 69 cases per million doses in boys between the ages of 12 and 24.
Still, experts say the possibility of this rare risk shouldn’t deter parents from vaccinating younger children.
Here’s why: The risk for myocarditis is higher after COVID-19 infection than after vaccination. Younger children have a lower risk for myocarditis than teens and young adults, suggesting that this side effect may be less frequent in this age group, although that remains to be seen.
Additionally, the smaller dose authorized for children is expected to minimize the risk for myocarditis even further.
The CDC says parents should call their doctor if a child develops pain in their chest, has trouble breathing, or feels like they have a beating or fluttering heart after vaccination.
What about benefits?
Models looking at the impact of vaccines in this age group predict that, nationally, cases would drop by about 8% if children are vaccinated.
The models also suggested that vaccination of kids this age would slow — but not stop — the emergence of new variants.
For every million doses, the CDC’s modeling predicts that more than 56,000 COVID-19 infections would be prevented in this age group, along with dozens of hospitalizations, and post-COVID conditions like multisystem inflammatory syndrome in children.
CDC experts estimate that just 10 kids would need to be vaccinated over 6 months to prevent a single case of COVID-19.
The CDC pointed out that vaccinating kids may help slow transmission of the virus and would give parents and other caregivers greater confidence in participating in school and extracurricular activities.
CDC experts said they would use a variety of systems, including hospital networks, the open Vaccines and Adverse Events Reporting System (VAERS) database, the cell-phone based V-SAFE app, and insurance claims databases to keep an eye out for any rare adverse events related to the vaccines in children.
This article, a version of which first appeared on Medscape.com, was updated on Nov. 3, 2021.
Children and COVID: A look at the pace of vaccination
With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?
Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and according to data from the CDC.
(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)
The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.
That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.
So where does that put the 5- to 11-year-olds?
The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”
Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.
“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.
With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?
Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and according to data from the CDC.
(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)
The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.
That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.
So where does that put the 5- to 11-year-olds?
The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”
Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.
“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.
With children aged 5-11 years about to enter the battle-of-the-COVID-vaccine phase of the war on COVID, there are many questions. MDedge takes a look at one: How long will it take to get 5- to 11-year-olds vaccinated?
Previous experience may provide some guidance. The vaccine was approved by the Centers for Disease Control and Prevention for the closest group in age, 12- to 15-year-olds, on May 12, 2021, and according to data from the CDC.
(Use of the 5% figure acknowledges the uneven start after approval – the vaccine became available to different age groups at different times, even though it had been approved for all adults aged 18 years and older.)
The 16- to 17-year-olds, despite being a smaller group of less than 7.6 million individuals, took 120 days to go from 5% to 50% coverage. For those aged 18-24 years, the corresponding time was 132 days, while the 24- to 36-year-olds took longer than any other age group, 135 days, to reach the 50%-with-at-least-one-dose milestone. The time, in turn, decreased for each group as age increased, with those aged 75 and older taking just 41 days to get at least one dose in 50% of individuals, the CDC data show.
That trend also applies to full vaccination, for the most part. The oldest group, 75 and older, had the shortest time to 50% being fully vaccinated at 69 days, and the 25- to 39-year-olds had the longest time at 206 days, with the length rising as age decreased and dropping for groups younger than 25-39. Except for the 12- to 15-year-olds. It has been 160 days (as of Nov. 2) since the 5% mark was reached on May 17, but only 47.4% of the group is fully vaccinated, making it unlikely that the 50% mark will be reached earlier than the 169 days it took the 16- to 17-year-olds.
So where does that put the 5- to 11-year-olds?
The White House said on Nov. 1 that vaccinations could start the first week of November, pending approval from the CDC’s Advisory Committee on Immunization Practices, which meets on Nov. 2. “This is an important step forward in our nation’s fight against the virus,” Jeff Zients, the White House COVID-19 Response Coordinator, said in a briefing. “As we await the CDC decision, we are not waiting on the operations and logistics. In fact, we’ve been preparing for weeks.”
Availability, of course, is not the only factor involved. In a survey conducted Oct. 14-24, the Kaiser Family Foundation found that only 27% of parents of children aged 5-11 years are planning to have them vaccinated against COVID-19 “right away” once the vaccine is available, and that 33% would “wait and see” how the vaccine works.
“Parents of 5-11 year-olds cite a range of concerns when it comes to vaccinating their children for COVID-19, with safety issues topping off the list,” and “two-thirds say they are concerned the vaccine may negatively impact their child’s fertility in the future,” Kaiser said.
COVID-19 vaccines provide 5 times the protection of natural immunity, CDC study says
, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
, according to a new study published recently in the CDC’s Morbidity and Mortality Weekly Report.
The research team concluded that vaccination can provide a higher, stronger, and more consistent level of immunity against COVID-19 hospitalization than infection alone for at least six months.
“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” Rochelle Walensky, MD, director of the CDC, said in a statement.
“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19,” she said. “The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing and staying home when sick.”
Researchers looked at data from the VISION Network, which included more than 201,000 hospitalizations for COVID-like illness at 187 hospitals across nine states between Jan. 1 to Sept. 2. Among those, more than 94,000 had rapid testing for the coronavirus, and 7,300 had a lab-confirmed test for COVID-19.
The research team found that unvaccinated people with a prior infection within 3 to 6 months were about 5-1/2 times more likely to have laboratory-confirmed COVID-19 than those who were fully vaccinated within 3 to 6 months with the Pfizer or Moderna shots. They found similar results when looking at the months that the Delta variant was the dominant strain of the coronavirus.
Protection from the Moderna vaccine “appeared to be higher” than for the Pfizer vaccine, the study authors wrote. The boost in protection also “trended higher” among older adults, as compared to those under age 65.
Importantly, the research team noted, these estimates may change over time as immunity wanes. Future studies should consider infection-induced and vaccine-induced immunity as time passes during the pandemic, they wrote.
Additional research is also needed for the Johnson & Johnson vaccine, they wrote. Those who have received the Johnson & Johnson vaccine are currently recommended to receive a booster shot at least two months after the first shot.
Overall, “all eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected,” the research team concluded.
A version of this article first appeared on WebMD.com.
FDA panel votes to approve Pfizer’s vaccine for children
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
FDA approves first nasal spray for dry eye
The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.
Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.
“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.
The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.
The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.
Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.
“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”
The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.
Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.
The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.
In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.
The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.
Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.
A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.
“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.
Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.
A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.
ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.
Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.
“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.
The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.
The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.
Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.
“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”
The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.
Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.
The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.
In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.
The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.
Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.
A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.
“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.
Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.
A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.
ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The first nasal spray to treat dry eye disease has won approval from the Food and Drug Administration.
Sprayed twice daily into the nostrils, 0.03-mg varenicline solution (Tyrvaya) improves signs and symptoms of dry eye disease. It provides an alternative to the immunomodulators currently available as prescription treatments, according to Marian Macsai, MD, chief medical officer for the drug’s maker, Oyster Point Pharma.
“We’re super excited to bring a new treatment for dry eye disease to patients and eye care practitioners,” she told this news organization.
The company plans to make the drug available to wholesalers in November in cartons containing two multidose nasal spray bottles. Each bottle supplies treatment for 15 days. Samples will be made available to eye care practitioners.
The company is working with payers on reimbursement codes and will supply the drug for $10 or less to patients who are not insured, said Dr. Macsai.
Varenicline can be prescribed for anyone with dry eye disease who has not gotten relief from artificial tears or who needs to use artificial tears “more than three or four times a day,” she said.
“In our pivotal trials, we enrolled patients with mild, moderate, and severe disease,” said Dr. Macsai. “And in each subgroup, we reached statistical significance. So with this new route of administration and a new mechanism of action, I’m hopeful that this will provide relief to many of the dry eye patients out there that are currently suffering.”
The causes of dry eye disease are multifactorial, and it can prove difficult to treat. Varenicline appears to work by stimulating the trigeminal nerve, causing natural tears to form.
Marketed as the oral drug Chantix by Pfizer, varenicline is prescribed to reduce cigarette cravings. Administered as a nasal spray for dry eye, much less of it enters the bloodstream, according to Michael Raizman, MD, an associate professor of ophthalmology at Tufts University, Boston, who was an investigator in the phase 3 ONSET-2 trial of the drug.
The spray acts in as little as 14 days, rather than the 3-6 months required for prescription immunomodulators, and it doesn’t irritate the eyes, he said.
In the ONSET-2 trial, basal tear production and symptoms were assessed. Schirmer test scores increased by10 mm or more for 47% of the patients treated with varenicline vs. 28% of patients treated with placebo.
The mean change from baseline in Eye Dryness Score at week 4 was –10.3 mm for varenicline-treated patients, compared with –7.4 mm for vehicle-treated patients. The difference was not statistically significant. However, that test was disrupted by COVID-19 precautions, Dr. Macsai said. The phase 2b ONSET-1 trial showed a statistically significant advantage in Eye Dryness Score for patients treated with varenicline in comparison with those treated with placebo.
Almost everyone who took varenicline sneezed, but only about 12% experienced any ocular adverse events, which was similar to the placebo group. No one reported burning or stinging in the eyes.
A few patients coughed or felt throat or nose irritation. In the group that received 1.2 mg/mL, eight people discontinued the drug because of adverse reactions, compared with five in the group that received 0.6 mg/mL and four in the placebo group.
“This approval is exciting for the ophthalmic community, as it gives us a new therapeutic agent that can be used alone or in combination with existing therapies to treat individuals who fall under the umbrella term ‘dry eye,’ “ said Anat Galor, MD, MSPH, clinical spokesperson for the American Academy of Ophthalmology and associate professor at University of Miami.
Some idea of what to expect from Tyrvaya comes from TrueTear, a device made by Allergan that caused tearing by electrically stimulating the anterior ethmoidal nerve through the nasal passage. It provided benefit to some patients who had not gotten relief through medication, but was expensive and was eventually discontinued, Dr. Galor said.
A new device, the iTear100, from Olympic Ophthalmics, stimulates the anterior ethmoidal nerve through the side of the nose. It received FDA clearance last year.
ONSET-2 was funded by Oyster Point Pharma. Dr. Macsai is an employee of Oyster Point. Dr. Raizman is a consultant to Oyster Point Pharma. Dr. Galor reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
ACIP recommends Shingrix for younger immunocompromised adults; updates pneumococcal vaccine guidance
The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.
Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.
The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.
According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”
For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.
During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.
These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.
A version of this article first appeared on Medscape.com.
The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.
Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.
The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.
According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”
For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.
During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.
These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.
A version of this article first appeared on Medscape.com.
The U.S. Centers for Disease Control and Prevention Advisory Committee of Immunization Practices has voted to recommend Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention of shingles in immunodeficient or immunosuppressed adults aged 19 or older. The recommendation was approved Oct. 20 by a unanimous vote.
Shingles is a reactivation of varicella zoster virus (VZV), the virus that causes chickenpox. There are about 1 million cases of shingles in the United States every year, according to CDC estimates, and one in three Americans will develop shingles over their lifetime. While adults older than 50 are one of the most vulnerable groups to reinfection – with about 99% having been infected with VZV – a weakened immune system is another common risk factor.
The Food and Drug Administration originally approved Shingrix in 2017 for the prevention of shingles in adults over 50; in July of this year, the vaccine was approved for immunodeficient adults aged 18 or older. The approval and subsequent recommendation by ACIP were based on clinical studies of Shingrix in adults being treated for hematologic malignancies or those who had undergone an autologous hematopoietic stem cell transplant.
According to a press statement from the FDA, “Further safety and immunogenicity data were generated in adults who were, or were anticipated to be, immunodeficient or immunosuppressed due to known disease or therapy, including patients with HIV, solid tumors, and renal transplants.”
For adults with functional immune systems, Shingrix is administered in two doses, 2-6 months apart. For immunocompromised individuals, the second dose can be given 1-2 months after the first dose.
During the same meeting, ACIP also voted to recommend pneumococcal vaccines for routine use in adults older than 65 and in adults aged 19-64 with chronic conditions such as diabetes, chronic heart disease, chronic liver disease, and HIV, and disease risk factors like smoking and alcoholism. The recommendation only applies to those who have not received a pneumococcal conjugate vaccine or whose vaccination history is unknown. The recommendation states that qualifying adults should be vaccinated with the 15-valent pneumococcal conjugate vaccine Vaxneuvance followed by Pneumovax23, or a single dose of the 20-valent pneumococcal conjugate vaccine Prevnar 20.
These ACIP recommendations will now be sent to the directors of the CDC and the U.S. Department of Health & Human Services for review and approval. If approved, the recommendations are considered finalized and will be published in a future Morbidity and Mortality Weekly Report.
A version of this article first appeared on Medscape.com.
CDC panel backs COVID-19 boosters for nearly all adults
Editor’s note: This story was updated with the CDC director’s endorsement.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.
The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.
“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.
She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.
The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.
Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.
They are:
- Anyone over age 65.
- Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
- Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.
These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.
There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
Questions, concerns
Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.
“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.
She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.
“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.
The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.
But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.
On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.
Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.
The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.
Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.
The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.
These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
“Real world” recommendations
In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.
“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.
Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.
The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.
Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.
Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.
Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.
The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.
In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.
Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.
“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
A version of this article first appeared on WebMD.com.
Editor’s note: This story was updated with the CDC director’s endorsement.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.
The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.
“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.
She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.
The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.
Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.
They are:
- Anyone over age 65.
- Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
- Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.
These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.
There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
Questions, concerns
Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.
“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.
She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.
“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.
The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.
But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.
On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.
Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.
The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.
Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.
The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.
These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
“Real world” recommendations
In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.
“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.
Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.
The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.
Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.
Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.
Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.
The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.
In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.
Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.
“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
A version of this article first appeared on WebMD.com.
Editor’s note: This story was updated with the CDC director’s endorsement.
Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, has signed off on an advisory panel’s earlier unanimous vote to recommend boosters for the Moderna and Johnson and Johnson COVID vaccines.
The decision now means that millions of Americans are eligible to get a booster shot for either the Pfizer, Moderna, or J&J COVID vaccines.
“The evidence shows that all three COVID-19 vaccines authorized in the United States are safe – as demonstrated by the over 400 million vaccine doses already given. And, they are all highly effective in reducing the risk of severe disease, hospitalization, and death, even in the midst of the widely circulating Delta variant,” Dr. Walensky said in a CDC news release.
She also signed off on the panel’s suggestion that individuals can mix or match the booster from any one of the three available COVID-19 vaccines.
The Advisory Committee on Immunization Practices (ACIP) recommended in a late afternoon 15-0 vote that everyone over age 18 who are at least 2 months past their Johnson & Johnson vaccine should get a booster, an endorsement that affects an estimated 13 million Americans.
Those eligible for a booster at least 6 months after their last Moderna shot are the same groups who can get a Pfizer booster.
They are:
- Anyone over age 65.
- Those over age 18 with an underlying health condition that puts them at risk of severe COVID-19.
- Those over age 18 who may be at higher risk of a COVID-19 infection because they live or work in a risky setting.
These recommendations are in line with the Food and Drug Administration’s Oct. 20 authorization of the boosters, along with the ability to mix-and-match vaccines.
There are an estimated 47 million Pfizer recipients and 39 million people vaccinated with Moderna who are now eligible for a booster dose, according to data presented by the CDC.
Questions, concerns
Before voting, some committee members expressed discomfort in broadly recommending boosters, stressing that there is very little evidence supporting the need for boosters in people younger than age 50.
“I can’t say that I am comfortable that anybody under 50 – an otherwise healthy individual – needs a booster vaccine at this time with either Moderna or Pfizer,” said ACIP member Sarah Long, MD, professor of pediatrics at Drexel University in Philadelphia.
She said she would try to mitigate any potential harm by having some kind of age restriction on the otherwise worried well.
“We don’t usually have the vaccines [for] the worried well. We give it because we have a need that’s worth the risk, and there’s a burden of severity of disease,” Dr. Long said.
The evidence to date shows that all the vaccines authorized for use in the U.S. continue to protect people well against severe COVID-19 outcomes, including hospitalization and death.
But breakthrough infections are on the rise, especially for people who initially received the Johnson and Johnson one-dose vaccine.
On Oct. 21, Pfizer released data from a study of more than 10,000 fully vaccinated people. Half were randomly assigned to get a booster of their Comirnaty vaccine, the other half were given a placebo.
Over the ensuing 2.5 months, there were 5 COVID-19 cases in the boosted group, and 109 in the group that got a placebo.
The data were posted in a press release and have not yet been peer reviewed, but are the first to show clinical effectiveness of boosters at preventing COVID-19 infections.
Data recently considered by the FDA and CDC for booster doses come from studies that were mostly shorter and smaller. These studies looked at biomarkers of immunity like the concentration of antibodies in a person’s blood and the percentage of study participants who saw a boost to those antibodies.
The studies demonstrated that boosters indeed restore high levels of antibodies, but unlike the newest Pfizer data they were not able to show that these antibodies prevented COVID-19.
These studies also weren’t powered to pick up on any less common safety problems that might arise after another dose of the shots.
“Real world” recommendations
In the end, however, the panel felt it was more important to be permissive in allowing boosters so that individuals and their doctors could be free to make their own decisions.
“The decision made by the FDA and the ACIP recommendations, I think, reflects the real world. The public is going to do what they feel driven to do. This at least adds a scientific review of the currently available data,” said Jay Varkey, MD, an infectious disease physician and associate professor at Emory University in Atlanta, who was not involved in the ACIP’s deliberations.
Dr. Varkey said he would recommend that anyone who is younger than 65, and who has no underlying medical conditions such as diabetes or obesity, speak with their doctor about their individual benefits and risks before getting a booster.
The CDC is planning to release a detailed suite of clinical considerations to help people weigh the risks and benefits of getting a booster.
Safety updates presented at the meeting show that serious adverse events after vaccination are extremely rare, but in some cases, they may rise above the risk for those problems generally seen in the population.
Those rare events include the disabling autoimmune condition Guillain-Barré syndrome and the platelet disorder thrombosis with thrombocytopenia (TTS), which causes blood clots along with the risk of excess bleeding because of a low platelet count.
Both can occur after the J&J vaccine. Out of 15.3 million doses of the vaccine given to date, there have been 47 cases of TTS and five deaths. These events are more common in younger women.
The mRNA vaccines, such as those from Pfizer and Moderna, can cause heart inflammation called myocarditis or pericarditis. This side effect is more common in men 18-24 years old. The reported rate of myocarditis after vaccination is 39 cases for every 1 million doses.
In voting to permit boosters, committee member Wilbur Chen, MD, professor at the University of Maryland’s Center for Vaccine Development, said he hoped boosters wouldn’t give Americans false confidence.
Dr. Chen stressed that ending the pandemic would depend on “a multilayered approach” that includes masking, social distancing, avoiding large crowds indoors, and convincing more Americans to take their first doses of the vaccines.
“We’re not just going to vaccinate ourselves out of this situation,” Dr. Chen said.
A version of this article first appeared on WebMD.com.
Children and COVID: Vaccinations lower than ever as cases continue to drop
As the COVID-19 vaccine heads toward approval for children under age 12 years, the number of older children receiving it dropped for the 10th consecutive week, based on data from the Centers for Disease Control and Prevention.
Over 47% of all children aged 12-17 years – that’s close to 12 million eligible individuals – have not received even one dose of COVID-19 vaccine, and less than 44% (about 11.1 million) were fully vaccinated as of Oct. 18, the CDC reported on its COVID Data Tracker.
, when eligibility expanded to include 12- to 15-year-olds, according to the CDC data, which also show that weekly vaccinations have never been lower.
Fortunately, the decline in new cases also continued, as the national total fell for a 6th straight week. There were more than 130,000 child cases reported during the week of Oct. 8-14, compared with 148,000 the previous week and the high of almost 252,000 in late August/early September, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
That brings the cumulative count to 6.18 million, with children accounting for 16.4% of all cases reported since the start of the pandemic. For the week of Oct. 8-14, children represented 25.5% of all COVID-19 cases in the 46 states with up-to-date online dashboards, the AAP and CHA said, noting that New York has never reported age ranges for cases and that Alabama, Nebraska, and Texas stopped reporting over the summer.
Current data indicate that child cases in California now exceed 671,000, more than any other state, followed by Florida with 439,000 (the state defines a child as someone aged 0-14 years) and Illinois with 301,000. Vermont has the highest proportion of COVID-19 cases occurring in children (24.3%), with Alaska (24.1%) and South Carolina (23.2%) just behind. The highest rate of cases – 15,569 per 100,000 children – can be found in South Carolina, while the lowest is in Hawaii (4,838 per 100,000), the AAP and CHA reported.
The total number of COVID-related deaths in children is 681 as of Oct. 18, according to the CDC, with the AAP/CHA reporting 558 as of Oct. 14, based on data from 45 states, New York City, Puerto Rico, and Guam. The CDC reports 65,655 admissions since Aug. 1, 2020, in children aged 0-17 years, and the AAP/CHA tally 23,582 since May 5, 2020, among children in 24 states and New York City.
As the COVID-19 vaccine heads toward approval for children under age 12 years, the number of older children receiving it dropped for the 10th consecutive week, based on data from the Centers for Disease Control and Prevention.
Over 47% of all children aged 12-17 years – that’s close to 12 million eligible individuals – have not received even one dose of COVID-19 vaccine, and less than 44% (about 11.1 million) were fully vaccinated as of Oct. 18, the CDC reported on its COVID Data Tracker.
, when eligibility expanded to include 12- to 15-year-olds, according to the CDC data, which also show that weekly vaccinations have never been lower.
Fortunately, the decline in new cases also continued, as the national total fell for a 6th straight week. There were more than 130,000 child cases reported during the week of Oct. 8-14, compared with 148,000 the previous week and the high of almost 252,000 in late August/early September, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
That brings the cumulative count to 6.18 million, with children accounting for 16.4% of all cases reported since the start of the pandemic. For the week of Oct. 8-14, children represented 25.5% of all COVID-19 cases in the 46 states with up-to-date online dashboards, the AAP and CHA said, noting that New York has never reported age ranges for cases and that Alabama, Nebraska, and Texas stopped reporting over the summer.
Current data indicate that child cases in California now exceed 671,000, more than any other state, followed by Florida with 439,000 (the state defines a child as someone aged 0-14 years) and Illinois with 301,000. Vermont has the highest proportion of COVID-19 cases occurring in children (24.3%), with Alaska (24.1%) and South Carolina (23.2%) just behind. The highest rate of cases – 15,569 per 100,000 children – can be found in South Carolina, while the lowest is in Hawaii (4,838 per 100,000), the AAP and CHA reported.
The total number of COVID-related deaths in children is 681 as of Oct. 18, according to the CDC, with the AAP/CHA reporting 558 as of Oct. 14, based on data from 45 states, New York City, Puerto Rico, and Guam. The CDC reports 65,655 admissions since Aug. 1, 2020, in children aged 0-17 years, and the AAP/CHA tally 23,582 since May 5, 2020, among children in 24 states and New York City.
As the COVID-19 vaccine heads toward approval for children under age 12 years, the number of older children receiving it dropped for the 10th consecutive week, based on data from the Centers for Disease Control and Prevention.
Over 47% of all children aged 12-17 years – that’s close to 12 million eligible individuals – have not received even one dose of COVID-19 vaccine, and less than 44% (about 11.1 million) were fully vaccinated as of Oct. 18, the CDC reported on its COVID Data Tracker.
, when eligibility expanded to include 12- to 15-year-olds, according to the CDC data, which also show that weekly vaccinations have never been lower.
Fortunately, the decline in new cases also continued, as the national total fell for a 6th straight week. There were more than 130,000 child cases reported during the week of Oct. 8-14, compared with 148,000 the previous week and the high of almost 252,000 in late August/early September, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
That brings the cumulative count to 6.18 million, with children accounting for 16.4% of all cases reported since the start of the pandemic. For the week of Oct. 8-14, children represented 25.5% of all COVID-19 cases in the 46 states with up-to-date online dashboards, the AAP and CHA said, noting that New York has never reported age ranges for cases and that Alabama, Nebraska, and Texas stopped reporting over the summer.
Current data indicate that child cases in California now exceed 671,000, more than any other state, followed by Florida with 439,000 (the state defines a child as someone aged 0-14 years) and Illinois with 301,000. Vermont has the highest proportion of COVID-19 cases occurring in children (24.3%), with Alaska (24.1%) and South Carolina (23.2%) just behind. The highest rate of cases – 15,569 per 100,000 children – can be found in South Carolina, while the lowest is in Hawaii (4,838 per 100,000), the AAP and CHA reported.
The total number of COVID-related deaths in children is 681 as of Oct. 18, according to the CDC, with the AAP/CHA reporting 558 as of Oct. 14, based on data from 45 states, New York City, Puerto Rico, and Guam. The CDC reports 65,655 admissions since Aug. 1, 2020, in children aged 0-17 years, and the AAP/CHA tally 23,582 since May 5, 2020, among children in 24 states and New York City.
FDA expands use of HIV drug to young children
The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.
“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.
Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.
The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.
The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.
“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”
A version of this article first appeared on Medscape.com.
The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.
“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.
Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.
The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.
The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.
“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”
A version of this article first appeared on Medscape.com.
The new lower dose is approved for children weighing from at least 14 kg (30 pounds) to 25 kg (55 pounds) who are virologically suppressed or new to antiretroviral therapy.
“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, chief medical officer of Gilead Sciences, the company that produces Biktarvy, in a press release. “The New Drug Application approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world,” he said.
Although advances in treatment for pregnant women with HIV have lowered the likelihood of perinatal HIV transmission, pediatric HIV remains a global public health challenge. In 2020, about 1.7 million children younger than 15 years were living with HIV worldwide; 850 children become infected every day.
The approval, announced October 18, expands the use of Biktarvy to younger children. The medication was originally approved in February 2018 for treatment-naive or virologically suppressed adults. In June 2019, the FDA approved updating of the label to include pediatric patients weighing at least 25 kg. This new lower dose of Biktarvy is for a three-drug combo containing bictegravir 30 mg, emtricitabine 120 mg, and tenofovir alafenamide 15 mg. It is given once a day in tablet form.
The most recent expanded indication was based on data from an open-label, single-arm study that included 22 virologically suppressed children living with HIV. After switching to Biktarvy, 91% of participants (20 of 22) remained virologically suppressed at 24 weeks. HIV-1 RNA was not collected for two patients because of «pandemic-related study disruption,» the press release said.
“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, the division chief of pediatric infectious diseases at the University of South Florida, who was one of the study investigators. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”
A version of this article first appeared on Medscape.com.
States can reserve COVID shots for kids 5-11 this week
States can preorder COVID-19 vaccine doses for younger children this week as they begin to set up vaccination campaigns for ages 5-11.
Vaccine advisory groups for the FDA and CDC are scheduled to discuss and approve the Pfizer shot for kids in the next three weeks. To help states and cities prepare for the rollout, the CDC issued guidance on how to set up expanded vaccination programs.
Immunization program managers can begin ordering doses on Wednesday, according to the guidance. The vials won’t be delivered until the FDA and CDC authorize the shot, but registering now will help federal officials ship doses quickly once they’re available.
Pharmacies in every state will be able to give COVID-19 shots to children, but they can only use doses that are prepared specifically for children. Ages 5-11 will need a 10-microgram dose, which is one-third of the dose administered to ages 12 and older. The guidance warns that doctors should not try to split up or fraction the adult doses.
The CDC guidance also recommends that pediatricians and family practice doctors should serve as primary places to give shots to kids. The document mentions other options, such as vaccination clinics at schools, but doesn’t endorse them as the first choice for vaccinating kids.
The CDC hasn’t yet addressed questions around whether kids should be required to get vaccinated to attend school. The decision will likely be left to state and city officials.
Federal health officials aren’t yet sure how many parents and guardians will seek shots for their younger kids right away, the AP reported. Demand may be high at first for some families, but it may not be as high as when shots first became available for adults, Marcus Plescia, MD, chief medical officer of the Association of State and Territorial Health Officials, told The Associated Press.
“We’re going to have potentially a very busy, and perhaps modestly chaotic time,” he said.
When vaccines were first authorized for adults, hospitals and pharmacies received priority for ordering shots. Some doctors felt left out. This time, however, the CDC has said that pediatricians will receive higher priority and be able to receive shipments quickly.
As the vaccine rollout begins, health officials should consider logistical concerns to address racial and economic disparities for younger kids, Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation and a former acting director of the CDC, told the AP.
If parents or guardians can’t leave work to take their kids to a pharmacy or doctor’s office, for instance, their kids may not receive a shot quickly – or at all.
“It’s really important that we recognize the barriers to vaccinations,” he said.
A version of this article first appeared on WebMD.com.
States can preorder COVID-19 vaccine doses for younger children this week as they begin to set up vaccination campaigns for ages 5-11.
Vaccine advisory groups for the FDA and CDC are scheduled to discuss and approve the Pfizer shot for kids in the next three weeks. To help states and cities prepare for the rollout, the CDC issued guidance on how to set up expanded vaccination programs.
Immunization program managers can begin ordering doses on Wednesday, according to the guidance. The vials won’t be delivered until the FDA and CDC authorize the shot, but registering now will help federal officials ship doses quickly once they’re available.
Pharmacies in every state will be able to give COVID-19 shots to children, but they can only use doses that are prepared specifically for children. Ages 5-11 will need a 10-microgram dose, which is one-third of the dose administered to ages 12 and older. The guidance warns that doctors should not try to split up or fraction the adult doses.
The CDC guidance also recommends that pediatricians and family practice doctors should serve as primary places to give shots to kids. The document mentions other options, such as vaccination clinics at schools, but doesn’t endorse them as the first choice for vaccinating kids.
The CDC hasn’t yet addressed questions around whether kids should be required to get vaccinated to attend school. The decision will likely be left to state and city officials.
Federal health officials aren’t yet sure how many parents and guardians will seek shots for their younger kids right away, the AP reported. Demand may be high at first for some families, but it may not be as high as when shots first became available for adults, Marcus Plescia, MD, chief medical officer of the Association of State and Territorial Health Officials, told The Associated Press.
“We’re going to have potentially a very busy, and perhaps modestly chaotic time,” he said.
When vaccines were first authorized for adults, hospitals and pharmacies received priority for ordering shots. Some doctors felt left out. This time, however, the CDC has said that pediatricians will receive higher priority and be able to receive shipments quickly.
As the vaccine rollout begins, health officials should consider logistical concerns to address racial and economic disparities for younger kids, Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation and a former acting director of the CDC, told the AP.
If parents or guardians can’t leave work to take their kids to a pharmacy or doctor’s office, for instance, their kids may not receive a shot quickly – or at all.
“It’s really important that we recognize the barriers to vaccinations,” he said.
A version of this article first appeared on WebMD.com.
States can preorder COVID-19 vaccine doses for younger children this week as they begin to set up vaccination campaigns for ages 5-11.
Vaccine advisory groups for the FDA and CDC are scheduled to discuss and approve the Pfizer shot for kids in the next three weeks. To help states and cities prepare for the rollout, the CDC issued guidance on how to set up expanded vaccination programs.
Immunization program managers can begin ordering doses on Wednesday, according to the guidance. The vials won’t be delivered until the FDA and CDC authorize the shot, but registering now will help federal officials ship doses quickly once they’re available.
Pharmacies in every state will be able to give COVID-19 shots to children, but they can only use doses that are prepared specifically for children. Ages 5-11 will need a 10-microgram dose, which is one-third of the dose administered to ages 12 and older. The guidance warns that doctors should not try to split up or fraction the adult doses.
The CDC guidance also recommends that pediatricians and family practice doctors should serve as primary places to give shots to kids. The document mentions other options, such as vaccination clinics at schools, but doesn’t endorse them as the first choice for vaccinating kids.
The CDC hasn’t yet addressed questions around whether kids should be required to get vaccinated to attend school. The decision will likely be left to state and city officials.
Federal health officials aren’t yet sure how many parents and guardians will seek shots for their younger kids right away, the AP reported. Demand may be high at first for some families, but it may not be as high as when shots first became available for adults, Marcus Plescia, MD, chief medical officer of the Association of State and Territorial Health Officials, told The Associated Press.
“We’re going to have potentially a very busy, and perhaps modestly chaotic time,” he said.
When vaccines were first authorized for adults, hospitals and pharmacies received priority for ordering shots. Some doctors felt left out. This time, however, the CDC has said that pediatricians will receive higher priority and be able to receive shipments quickly.
As the vaccine rollout begins, health officials should consider logistical concerns to address racial and economic disparities for younger kids, Richard Besser, MD, president and CEO of the Robert Wood Johnson Foundation and a former acting director of the CDC, told the AP.
If parents or guardians can’t leave work to take their kids to a pharmacy or doctor’s office, for instance, their kids may not receive a shot quickly – or at all.
“It’s really important that we recognize the barriers to vaccinations,” he said.
A version of this article first appeared on WebMD.com.