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ACIP plans flu review for older adults
according to data presented at a meeting of the Centers for Disease Control and Prevention’s ACIP.
Lynette Brammer of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) presented a surveillance update of the flu season in the United States so far. Overall, the influenza A(H3N2) viruses are predominant, although dominance varies in different regions of the country, and it is too soon to predict what strain will dominate later in the season.
“While two of the four vaccine components were updated for the Southern Hemisphere, the components selected for the 2019-2020 Northern Hemisphere vaccine, at this time, look appropriate for the season,” she said.
In other flu news, Lisa Groskopf, MD, of the NCIRD discussed the influenza work group’s plans for a meta-analysis to assess the relative benefit of different vaccines for older adults, in light of the growing variety of products available.
Currently, no preferential recommendations have been made for a specific vaccine for a particular age group. “There’s a dearth of data comparing these vaccines to one another,” said Dr. Groskopf. She added that, because vaccine effectiveness varies by season, the generalizability of effectiveness data is another challenge.
The work group’s systematic review and meta-analysis is designed to compare the high-dose inactivated influenza vaccine (HD-IIV), the adjuvanted inactivated influenza vaccine (aIIV), and the recombinant influenza vaccine (RIV). The study will include adults aged 65 years and older who receive trivalent or quadrivalent HD-IIV, aIIV, or RIV, compared with those who receive another influenza vaccine, a noninfluenza control vaccine, placebo, or no vaccine. The outcomes will include data on safety and effectiveness of the vaccines, Dr. Groskopf said.
In addition to safety and effectiveness, manufacturers such as Sanofi Pasteur continue to collect data on the success of available vaccines and develop new ones. Lee-Jah Chang, MD, of Sanofi Pasteur presented results of a noninferiority study of the company’s investigational high-dose quadrivalent influenza vaccine (QIV-HD; including two prevailing B viruses) versus the high-dose trivalent influenza vaccine (TID-HD). The study was conducted at 35 sites in the United States and included 2,670 adults aged 65 years and older.
Overall, the reactogenicity profile for patients given QIV-HD was similar to that of TID-HD, and approximately 5% of patients in the QIV group reported an immediate adverse event, Dr. Chang said. However, no related deaths or related adverse events of special interest occurred in any of the study groups.
Sanofi plans to pursue licensure of the QIV-HD vaccine, with a Center for Biologics Evaluation and Research action date of Nov. 4, 2019, said Dr. Chang. If the vaccine is licensed, it should be available for purchase by health care providers in the first quarter of 2020.
The ACIP members had no financial conflicts to disclose.
according to data presented at a meeting of the Centers for Disease Control and Prevention’s ACIP.
Lynette Brammer of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) presented a surveillance update of the flu season in the United States so far. Overall, the influenza A(H3N2) viruses are predominant, although dominance varies in different regions of the country, and it is too soon to predict what strain will dominate later in the season.
“While two of the four vaccine components were updated for the Southern Hemisphere, the components selected for the 2019-2020 Northern Hemisphere vaccine, at this time, look appropriate for the season,” she said.
In other flu news, Lisa Groskopf, MD, of the NCIRD discussed the influenza work group’s plans for a meta-analysis to assess the relative benefit of different vaccines for older adults, in light of the growing variety of products available.
Currently, no preferential recommendations have been made for a specific vaccine for a particular age group. “There’s a dearth of data comparing these vaccines to one another,” said Dr. Groskopf. She added that, because vaccine effectiveness varies by season, the generalizability of effectiveness data is another challenge.
The work group’s systematic review and meta-analysis is designed to compare the high-dose inactivated influenza vaccine (HD-IIV), the adjuvanted inactivated influenza vaccine (aIIV), and the recombinant influenza vaccine (RIV). The study will include adults aged 65 years and older who receive trivalent or quadrivalent HD-IIV, aIIV, or RIV, compared with those who receive another influenza vaccine, a noninfluenza control vaccine, placebo, or no vaccine. The outcomes will include data on safety and effectiveness of the vaccines, Dr. Groskopf said.
In addition to safety and effectiveness, manufacturers such as Sanofi Pasteur continue to collect data on the success of available vaccines and develop new ones. Lee-Jah Chang, MD, of Sanofi Pasteur presented results of a noninferiority study of the company’s investigational high-dose quadrivalent influenza vaccine (QIV-HD; including two prevailing B viruses) versus the high-dose trivalent influenza vaccine (TID-HD). The study was conducted at 35 sites in the United States and included 2,670 adults aged 65 years and older.
Overall, the reactogenicity profile for patients given QIV-HD was similar to that of TID-HD, and approximately 5% of patients in the QIV group reported an immediate adverse event, Dr. Chang said. However, no related deaths or related adverse events of special interest occurred in any of the study groups.
Sanofi plans to pursue licensure of the QIV-HD vaccine, with a Center for Biologics Evaluation and Research action date of Nov. 4, 2019, said Dr. Chang. If the vaccine is licensed, it should be available for purchase by health care providers in the first quarter of 2020.
The ACIP members had no financial conflicts to disclose.
according to data presented at a meeting of the Centers for Disease Control and Prevention’s ACIP.
Lynette Brammer of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD) presented a surveillance update of the flu season in the United States so far. Overall, the influenza A(H3N2) viruses are predominant, although dominance varies in different regions of the country, and it is too soon to predict what strain will dominate later in the season.
“While two of the four vaccine components were updated for the Southern Hemisphere, the components selected for the 2019-2020 Northern Hemisphere vaccine, at this time, look appropriate for the season,” she said.
In other flu news, Lisa Groskopf, MD, of the NCIRD discussed the influenza work group’s plans for a meta-analysis to assess the relative benefit of different vaccines for older adults, in light of the growing variety of products available.
Currently, no preferential recommendations have been made for a specific vaccine for a particular age group. “There’s a dearth of data comparing these vaccines to one another,” said Dr. Groskopf. She added that, because vaccine effectiveness varies by season, the generalizability of effectiveness data is another challenge.
The work group’s systematic review and meta-analysis is designed to compare the high-dose inactivated influenza vaccine (HD-IIV), the adjuvanted inactivated influenza vaccine (aIIV), and the recombinant influenza vaccine (RIV). The study will include adults aged 65 years and older who receive trivalent or quadrivalent HD-IIV, aIIV, or RIV, compared with those who receive another influenza vaccine, a noninfluenza control vaccine, placebo, or no vaccine. The outcomes will include data on safety and effectiveness of the vaccines, Dr. Groskopf said.
In addition to safety and effectiveness, manufacturers such as Sanofi Pasteur continue to collect data on the success of available vaccines and develop new ones. Lee-Jah Chang, MD, of Sanofi Pasteur presented results of a noninferiority study of the company’s investigational high-dose quadrivalent influenza vaccine (QIV-HD; including two prevailing B viruses) versus the high-dose trivalent influenza vaccine (TID-HD). The study was conducted at 35 sites in the United States and included 2,670 adults aged 65 years and older.
Overall, the reactogenicity profile for patients given QIV-HD was similar to that of TID-HD, and approximately 5% of patients in the QIV group reported an immediate adverse event, Dr. Chang said. However, no related deaths or related adverse events of special interest occurred in any of the study groups.
Sanofi plans to pursue licensure of the QIV-HD vaccine, with a Center for Biologics Evaluation and Research action date of Nov. 4, 2019, said Dr. Chang. If the vaccine is licensed, it should be available for purchase by health care providers in the first quarter of 2020.
The ACIP members had no financial conflicts to disclose.
REPORTING FROM AN ACIP MEETING
CDC: Don’t vape, especially THC
Federal health officials once again are warning individuals to refrain from using all e-cigarette and vaping products, especially those containing tetrahydrocannabinol (THC).
The restated warning, issued by the Centers for Disease Control and Prevention, is based on a study of 83 patients with e-cigarette, or vaping, product use–associated lung injury (EVALI) in Utah, where researchers found several common characteristics, most strikingly the use of THC-containing products.
Fifty-three patients were interviewed by researchers. Of them, 49 (92%) reported use of THC-containing e-cigarette or vaping products during the 3 months preceding illness; 35 (66%) reported using nicotine-containing products; and 32 (60%) reported using both THC- and nicotine-containing products.
In addition, 17 (32%) patients reported exclusive use of THC-containing products, whereas only 3 (6%) reported exclusive use of nicotine-containing products. Non-medical THC use is illegal in Utah.
The median age of patients was 26 years, 3 years older than the national median; more than one-third were aged 30 years or older, according to the researchers.
Utah is seeing a higher-than-average rate of EVALI cases, with 26/million cases, compared with 4/million nationally.
Vitamin E acetate has been considered to have a suspect role in EVALI and was identified in the majority of THC cartridge samples tested in this study; however, those samples represented only six patients, according to the researchers. They added that testing of different THC cartridge samples by the Food and Drug Administration and other laboratories has shown vitamin E acetate concentrations of 31%-88% and lower-than-expected THC concentrations (14%-76% versus the typically advertised 75%-95%).
“The potential role of vitamin E acetate in lung injury remains unknown; however, the identification of vitamin E acetate among products collected from patients in Utah and elsewhere indicates that the outbreak might be associated with cutting agents or adulterants. Ascertaining the potential contribution of diluents to the current outbreak will require data from multiple states and analysis at the national level,” the researchers concluded.
The authors reported that they had no conflicts.
SOURCE: Lewis N et al. MMWR Morb Mortal Wkly Rep. Early Release. Oct. 22, 2019. 68:1-5.
Federal health officials once again are warning individuals to refrain from using all e-cigarette and vaping products, especially those containing tetrahydrocannabinol (THC).
The restated warning, issued by the Centers for Disease Control and Prevention, is based on a study of 83 patients with e-cigarette, or vaping, product use–associated lung injury (EVALI) in Utah, where researchers found several common characteristics, most strikingly the use of THC-containing products.
Fifty-three patients were interviewed by researchers. Of them, 49 (92%) reported use of THC-containing e-cigarette or vaping products during the 3 months preceding illness; 35 (66%) reported using nicotine-containing products; and 32 (60%) reported using both THC- and nicotine-containing products.
In addition, 17 (32%) patients reported exclusive use of THC-containing products, whereas only 3 (6%) reported exclusive use of nicotine-containing products. Non-medical THC use is illegal in Utah.
The median age of patients was 26 years, 3 years older than the national median; more than one-third were aged 30 years or older, according to the researchers.
Utah is seeing a higher-than-average rate of EVALI cases, with 26/million cases, compared with 4/million nationally.
Vitamin E acetate has been considered to have a suspect role in EVALI and was identified in the majority of THC cartridge samples tested in this study; however, those samples represented only six patients, according to the researchers. They added that testing of different THC cartridge samples by the Food and Drug Administration and other laboratories has shown vitamin E acetate concentrations of 31%-88% and lower-than-expected THC concentrations (14%-76% versus the typically advertised 75%-95%).
“The potential role of vitamin E acetate in lung injury remains unknown; however, the identification of vitamin E acetate among products collected from patients in Utah and elsewhere indicates that the outbreak might be associated with cutting agents or adulterants. Ascertaining the potential contribution of diluents to the current outbreak will require data from multiple states and analysis at the national level,” the researchers concluded.
The authors reported that they had no conflicts.
SOURCE: Lewis N et al. MMWR Morb Mortal Wkly Rep. Early Release. Oct. 22, 2019. 68:1-5.
Federal health officials once again are warning individuals to refrain from using all e-cigarette and vaping products, especially those containing tetrahydrocannabinol (THC).
The restated warning, issued by the Centers for Disease Control and Prevention, is based on a study of 83 patients with e-cigarette, or vaping, product use–associated lung injury (EVALI) in Utah, where researchers found several common characteristics, most strikingly the use of THC-containing products.
Fifty-three patients were interviewed by researchers. Of them, 49 (92%) reported use of THC-containing e-cigarette or vaping products during the 3 months preceding illness; 35 (66%) reported using nicotine-containing products; and 32 (60%) reported using both THC- and nicotine-containing products.
In addition, 17 (32%) patients reported exclusive use of THC-containing products, whereas only 3 (6%) reported exclusive use of nicotine-containing products. Non-medical THC use is illegal in Utah.
The median age of patients was 26 years, 3 years older than the national median; more than one-third were aged 30 years or older, according to the researchers.
Utah is seeing a higher-than-average rate of EVALI cases, with 26/million cases, compared with 4/million nationally.
Vitamin E acetate has been considered to have a suspect role in EVALI and was identified in the majority of THC cartridge samples tested in this study; however, those samples represented only six patients, according to the researchers. They added that testing of different THC cartridge samples by the Food and Drug Administration and other laboratories has shown vitamin E acetate concentrations of 31%-88% and lower-than-expected THC concentrations (14%-76% versus the typically advertised 75%-95%).
“The potential role of vitamin E acetate in lung injury remains unknown; however, the identification of vitamin E acetate among products collected from patients in Utah and elsewhere indicates that the outbreak might be associated with cutting agents or adulterants. Ascertaining the potential contribution of diluents to the current outbreak will require data from multiple states and analysis at the national level,” the researchers concluded.
The authors reported that they had no conflicts.
SOURCE: Lewis N et al. MMWR Morb Mortal Wkly Rep. Early Release. Oct. 22, 2019. 68:1-5.
FROM MMWR
FDA approves Trikafta for treatment of cystic fibrosis
in patients aged 12 years or older, the first triple-combination therapy approved for that indication.
Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.
In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.
The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.
“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.
Find the full press release on the FDA website.
in patients aged 12 years or older, the first triple-combination therapy approved for that indication.
Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.
In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.
The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.
“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.
Find the full press release on the FDA website.
in patients aged 12 years or older, the first triple-combination therapy approved for that indication.
Approval for Trikafta was based on results from two clinical trials in patients with cystic fibrosis with an F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In the first trial, a 24-week, randomized, double-blind, placebo-controlled study of 403 patients, the mean percent predicted forced expiratory volume in 1 second increased by 14% from baseline, compared with placebo. In the second trial, a 4-week, randomized, double-blind, active-controlled study of 107 patients, mean percent predicted forced expiratory volume in 1 second was increased 10% from baseline, compared with tezacaftor/ivacaftor, according to the FDA press release.
In the first trial, patients who received Trikafta also saw improvement in sweat chloride, reduction in the number of pulmonary exacerbations, and reduction of body mass index, compared with placebo.
The most common adverse events associated with Trikafta during the trials were headaches, upper respiratory tract infections, abdominal pains, diarrhea, rashes, and rhinorrhea, among others. The label includes a warning related to elevated liver function tests, use at the same time with products that induce or inhibit a liver enzyme called cytochrome P450 3A4, and cataract risk.
“At the FDA, we’re consistently looking for ways to help speed the development of new therapies for complex diseases, while maintaining our high standards of review. Today’s landmark approval is a testament to these efforts, making a novel treatment available to most cystic fibrosis patients, including adolescents, who previously had no options and giving others in the cystic fibrosis community access to an additional effective therapy,” said acting FDA Commissioner Ned Sharpless, MD.
Find the full press release on the FDA website.
Vaping-linked lung injuries near 1,500
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
according to the latest update provided by the Centers for Disease Control and Prevention. Thirty-three deaths have been confirmed.
E-cigarette–linked lung injuries, now called EVALI, occurred in all U.S. states (except Alaska), the District of Columbia, and the U.S. Virgin Islands. Seventy percent of patients are male, and 79% are under age 35 years.
Information on the substances used over the previous 3 months before symptom onset was available for 849 patients and included the following:
- 78% reported using THC-containing products, with or without nicotine-containing products;
- 31% reported exclusive use of THC-containing products;
- 58% reported using nicotine-containing products, with or without THC-containing products; and
- 10% reported exclusive use of nicotine-containing products.
CDC is now doing additional testing on available samples for chemical in the bronchoalveolar lavage fluid, blood, or urine, as well as lung biopsy or autopsy specimens. CDC is also validating methods for aerosol emission testing of case-associated product samples from vaping products and e-liquids.
In a related development, JUUL, maker of e-cigarette products, has announced that it will suspend the sale of nontobacco, nonmenthol flavors (mango, creme, fruit, and cucumber) in the United States, pending review by the Food and Drug Administration. The JUUL announcement comes in advance of an expected FDA ban on flavored e-cigarettes.
The CDC continues its investigation into EVALI but stated, “Since the specific cause or causes of lung injury are not yet known, the only way to assure that you are not at risk while the investigation continues is to consider refraining from use of all e-cigarette, or vaping, products.”
For more information and resources visit For the Public, For Healthcare Providers, and For State and Local Health Departments pages, as well as the CDC’s Publications and Resources page.
FDA approves rivaroxaban for VTE prevention in hospitalized, acutely ill patients
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
The Food and Drug Administration has approved rivaroxaban (Xarelto) for the prevention of venous thromboembolism (VTE) in hospitalized, acutely ill patients at risk for thromboembolic complications who do not have a high bleeding risk, according to a release from Janssen.
FDA approval for the new indication is based on results from the phase 3 MAGELLAN and MARINER trials, which included more than 20,000 hospitalized, acutely ill patients. In MAGELLAN, rivaroxaban demonstrated noninferiority to enoxaparin, a low-molecular-weight heparin, in short-term usage, and it was superior over the long term, compared with short-term enoxaparin followed by placebo.
While VTE and VTE-related deaths were not reduced in MARINER, compared with placebo, patients who received rivaroxaban did see a significantly reduction in symptomatic VTE with a favorable safety profile.
According to the indication, rivaroxaban can be administered to patients during hospitalization and can be continued after discharge for 31-39 days. The safety profile in MAGELLAN and MARINER was consistent with that already seen, with the most common adverse event being bleeding.
The new indication is the eighth for rivaroxaban, the most of any direct oral anticoagulant; six of these are specifically for the treatment, prevention, and reduction in the risk of VTE recurrence.
“With this new approval, Xarelto as an oral-only option now has the potential to change how acutely ill medical patients are managed for the prevention of blood clots, both in the hospital and for an extended period after discharge,” said Alex C. Spyropoulos, MD, of Northwell Health at Lenox Hill Hospital, New York, and a member of the steering committee of the MAGELLAN trial.
Find the full press release on the Janssen website.
FDA approves Reyvow for acute migraine treatment
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
The Food and Drug Administration has approved lasmiditan (Reyvow) for acute treatment of migraines with and without auras in adults.
The agency’s Oct. 11 announcement said the approval is based on results from a pair of randomized, double-blind, placebo-controlled trials that included 3,177 adult patients with a history of migraine with and without aura. The percentage of patients whose pain and most bothersome migraine symptom (nausea, light sensitivity, or sound sensitivity) resolved after 2 hours was higher in patients receiving lasmiditan than in patients receiving placebo.
Lasmiditan is a serotonin 5-hydroxytryptamine1F–receptor agonist, giving it a unique mechanism of action as compared with other migraine treatments.
The most common adverse events associated with lasmiditan include dizziness, fatigue, paresthesia, and sedation. There is a risk of driving impairment while taking the medication, and patients are advised not to operate or drive machinery for 8 hours after taking lasmiditan.
“Reyvow is a new option for the acute treatment of migraine, a painful condition that affects one in seven Americans. We know that the migraine community is keenly interested in additional treatment options, and we remain committed to continuing to work with stakeholders to promote the development of new therapies for the acute and preventive treatment of migraine,” said Nick Kozauer, MD, acting deputy director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research.
Eli Lilly, the drug’s manufacturer, said in a news release that “the recommended controlled substance classification for Reyvow is currently under review by the Drug Enforcement Administration and is expected within 90 days of today’s FDA approval, after which Reyvow will be available to patients in retail pharmacies” in oral doses of 50 mg, 100 mg, and 200 mg.
CDC updates guidance on vaping-associated lung injury
The Centers for Disease Control and Prevention has released an updated interim clinical guidance for health providers for evaluating and treating patients with lung injury associated with e-cigarette use or vaping.
In a telebriefing, Anne Schuchat, MD, CDC principal deputy director, and her colleagues answered questions about the current investigation into the source of this lung injury outbreak and the updated clinical guidance. Dr. Schuchat said, “I can’t stress enough the seriousness of these injuries.” She added, “We are not seeing a drop in cases” but a continuation of the trend of hospitalization and deaths that started in August 2019.
Investigation update
The investigation to date has yielded some information about current cases of lung injury related to vaping:
• The acronym EVALI has been developed to refer to e-cigarette, or vaping products use associated lung injury;
• 1,299 EVALI cases have been reported as of Oct. 8;
• No single compound or ingredient has emerged as the cause of these injuries, and more than one substance may be involved;
• Among the 573 patients for whom data are available on vaping products used in the previous 90 days, 76% reported using THC-containing products; 58% reported using nicotine-containing products; 32% reported exclusive use of THC-containing products, and 13% reported exclusive use of nicotine-containing products;
• Of the 700+ samples sent to the CDC for analysis, most had little or no liquid remaining in the device, limiting content analysis. In 28 THC-containing samples, THC concentrations were found to be 13% - 77% (mean 41%).
• A “handful” of cases of readmission have been reported and the CDC is currently investigating whether these cases included patients who took up vaping again or had some other possible contributing factor.
• The CDC is currently developing an ICD-10 code relevant to EVALI.
Clinical guidance update
The CDC provided detailed guidance on evaluating and caring for patients with EVALI. The recommendations focus on patient history, lab testing, criteria for hospitalization, and follow-up of these patients.
Detailed history of patients presenting with suspected EVALI is especially important for this patient population, given the many unknowns surrounding this condition. The updated guidance states, “All health care providers evaluating patients for EVALI should ask about the use of e-cigarette, or vaping, products and ideally should ask about types of substances used (e.g.,THC, cannabis [oil, dabs], nicotine, modified products or the addition of substances not intended by the manufacturer); product source, specific product brand and name; duration and frequency of use, time of last use; product delivery system, and method of use (aerosolization, dabbing, or dripping).” The approach recommended for soliciting accurate information is “empathetic, nonjudgmental” and, the guidelines say, patients should be questioned in private regarding sensitive information to assure confidentiality.
A respiratory virus panel is recommended for all suspected EVALI patients, although at this time, these tests cannot be used to distinguish EVALI from infectious etiologies. All patients should be considered for urine toxicology testing, including testing for THC.
Imaging guidance for suspected EVALI patients includes chest x-ray, with additional CT scan when the x-ray result does not correlate with clinical findings or to evaluate severe or worsening disease.
Recommended criteria for hospitalization of patients with suspected EVALI are those patients with decreased O2 saturation (less than 95%) on room air, are in respiratory distress, or have comorbidities that compromise pulmonary reserve. As of Oct. 8, 96% of patients with suspected EVALI reported to CDC have been hospitalized.
As for medical treatment of these patients, corticosteroids have been found helpful. The statement noted, “Among 140 cases reported nationally to CDC that received corticosteroids, 82% of patients improved
The natural progression of this injury is not known, however, and it is possible that patients might recover without corticosteroids. Given the unknown etiology of the disease and “because the diagnosis remains one of exclusion, aggressive empiric therapy with corticosteroids, antimicrobial, and antiviral therapy might be warranted for patients with severe illness. A range of corticosteroid doses, durations, and taper plans might be considered on a case-by-case basis.”
The report concludes with a strong recommendation that patients hospitalized with EVALI are followed closely with a visit 1-2 weeks after discharge and again with additional testing 1-2 months later. Health care providers are also advised to consult medical specialists, in particular pulmonologists, who can offer further evaluation, recommend empiric treatment, and review indications for bronchoscopy.
Mitch Zeller, JD, director, Center for Tobacco Products with the Food and Drug Administration emphasized the extraordinary complexity of the EVALI problem but noted that the FDA and CDC “will leave no stone unturned until we get to the bottom of it.”
The Centers for Disease Control and Prevention has released an updated interim clinical guidance for health providers for evaluating and treating patients with lung injury associated with e-cigarette use or vaping.
In a telebriefing, Anne Schuchat, MD, CDC principal deputy director, and her colleagues answered questions about the current investigation into the source of this lung injury outbreak and the updated clinical guidance. Dr. Schuchat said, “I can’t stress enough the seriousness of these injuries.” She added, “We are not seeing a drop in cases” but a continuation of the trend of hospitalization and deaths that started in August 2019.
Investigation update
The investigation to date has yielded some information about current cases of lung injury related to vaping:
• The acronym EVALI has been developed to refer to e-cigarette, or vaping products use associated lung injury;
• 1,299 EVALI cases have been reported as of Oct. 8;
• No single compound or ingredient has emerged as the cause of these injuries, and more than one substance may be involved;
• Among the 573 patients for whom data are available on vaping products used in the previous 90 days, 76% reported using THC-containing products; 58% reported using nicotine-containing products; 32% reported exclusive use of THC-containing products, and 13% reported exclusive use of nicotine-containing products;
• Of the 700+ samples sent to the CDC for analysis, most had little or no liquid remaining in the device, limiting content analysis. In 28 THC-containing samples, THC concentrations were found to be 13% - 77% (mean 41%).
• A “handful” of cases of readmission have been reported and the CDC is currently investigating whether these cases included patients who took up vaping again or had some other possible contributing factor.
• The CDC is currently developing an ICD-10 code relevant to EVALI.
Clinical guidance update
The CDC provided detailed guidance on evaluating and caring for patients with EVALI. The recommendations focus on patient history, lab testing, criteria for hospitalization, and follow-up of these patients.
Detailed history of patients presenting with suspected EVALI is especially important for this patient population, given the many unknowns surrounding this condition. The updated guidance states, “All health care providers evaluating patients for EVALI should ask about the use of e-cigarette, or vaping, products and ideally should ask about types of substances used (e.g.,THC, cannabis [oil, dabs], nicotine, modified products or the addition of substances not intended by the manufacturer); product source, specific product brand and name; duration and frequency of use, time of last use; product delivery system, and method of use (aerosolization, dabbing, or dripping).” The approach recommended for soliciting accurate information is “empathetic, nonjudgmental” and, the guidelines say, patients should be questioned in private regarding sensitive information to assure confidentiality.
A respiratory virus panel is recommended for all suspected EVALI patients, although at this time, these tests cannot be used to distinguish EVALI from infectious etiologies. All patients should be considered for urine toxicology testing, including testing for THC.
Imaging guidance for suspected EVALI patients includes chest x-ray, with additional CT scan when the x-ray result does not correlate with clinical findings or to evaluate severe or worsening disease.
Recommended criteria for hospitalization of patients with suspected EVALI are those patients with decreased O2 saturation (less than 95%) on room air, are in respiratory distress, or have comorbidities that compromise pulmonary reserve. As of Oct. 8, 96% of patients with suspected EVALI reported to CDC have been hospitalized.
As for medical treatment of these patients, corticosteroids have been found helpful. The statement noted, “Among 140 cases reported nationally to CDC that received corticosteroids, 82% of patients improved
The natural progression of this injury is not known, however, and it is possible that patients might recover without corticosteroids. Given the unknown etiology of the disease and “because the diagnosis remains one of exclusion, aggressive empiric therapy with corticosteroids, antimicrobial, and antiviral therapy might be warranted for patients with severe illness. A range of corticosteroid doses, durations, and taper plans might be considered on a case-by-case basis.”
The report concludes with a strong recommendation that patients hospitalized with EVALI are followed closely with a visit 1-2 weeks after discharge and again with additional testing 1-2 months later. Health care providers are also advised to consult medical specialists, in particular pulmonologists, who can offer further evaluation, recommend empiric treatment, and review indications for bronchoscopy.
Mitch Zeller, JD, director, Center for Tobacco Products with the Food and Drug Administration emphasized the extraordinary complexity of the EVALI problem but noted that the FDA and CDC “will leave no stone unturned until we get to the bottom of it.”
The Centers for Disease Control and Prevention has released an updated interim clinical guidance for health providers for evaluating and treating patients with lung injury associated with e-cigarette use or vaping.
In a telebriefing, Anne Schuchat, MD, CDC principal deputy director, and her colleagues answered questions about the current investigation into the source of this lung injury outbreak and the updated clinical guidance. Dr. Schuchat said, “I can’t stress enough the seriousness of these injuries.” She added, “We are not seeing a drop in cases” but a continuation of the trend of hospitalization and deaths that started in August 2019.
Investigation update
The investigation to date has yielded some information about current cases of lung injury related to vaping:
• The acronym EVALI has been developed to refer to e-cigarette, or vaping products use associated lung injury;
• 1,299 EVALI cases have been reported as of Oct. 8;
• No single compound or ingredient has emerged as the cause of these injuries, and more than one substance may be involved;
• Among the 573 patients for whom data are available on vaping products used in the previous 90 days, 76% reported using THC-containing products; 58% reported using nicotine-containing products; 32% reported exclusive use of THC-containing products, and 13% reported exclusive use of nicotine-containing products;
• Of the 700+ samples sent to the CDC for analysis, most had little or no liquid remaining in the device, limiting content analysis. In 28 THC-containing samples, THC concentrations were found to be 13% - 77% (mean 41%).
• A “handful” of cases of readmission have been reported and the CDC is currently investigating whether these cases included patients who took up vaping again or had some other possible contributing factor.
• The CDC is currently developing an ICD-10 code relevant to EVALI.
Clinical guidance update
The CDC provided detailed guidance on evaluating and caring for patients with EVALI. The recommendations focus on patient history, lab testing, criteria for hospitalization, and follow-up of these patients.
Detailed history of patients presenting with suspected EVALI is especially important for this patient population, given the many unknowns surrounding this condition. The updated guidance states, “All health care providers evaluating patients for EVALI should ask about the use of e-cigarette, or vaping, products and ideally should ask about types of substances used (e.g.,THC, cannabis [oil, dabs], nicotine, modified products or the addition of substances not intended by the manufacturer); product source, specific product brand and name; duration and frequency of use, time of last use; product delivery system, and method of use (aerosolization, dabbing, or dripping).” The approach recommended for soliciting accurate information is “empathetic, nonjudgmental” and, the guidelines say, patients should be questioned in private regarding sensitive information to assure confidentiality.
A respiratory virus panel is recommended for all suspected EVALI patients, although at this time, these tests cannot be used to distinguish EVALI from infectious etiologies. All patients should be considered for urine toxicology testing, including testing for THC.
Imaging guidance for suspected EVALI patients includes chest x-ray, with additional CT scan when the x-ray result does not correlate with clinical findings or to evaluate severe or worsening disease.
Recommended criteria for hospitalization of patients with suspected EVALI are those patients with decreased O2 saturation (less than 95%) on room air, are in respiratory distress, or have comorbidities that compromise pulmonary reserve. As of Oct. 8, 96% of patients with suspected EVALI reported to CDC have been hospitalized.
As for medical treatment of these patients, corticosteroids have been found helpful. The statement noted, “Among 140 cases reported nationally to CDC that received corticosteroids, 82% of patients improved
The natural progression of this injury is not known, however, and it is possible that patients might recover without corticosteroids. Given the unknown etiology of the disease and “because the diagnosis remains one of exclusion, aggressive empiric therapy with corticosteroids, antimicrobial, and antiviral therapy might be warranted for patients with severe illness. A range of corticosteroid doses, durations, and taper plans might be considered on a case-by-case basis.”
The report concludes with a strong recommendation that patients hospitalized with EVALI are followed closely with a visit 1-2 weeks after discharge and again with additional testing 1-2 months later. Health care providers are also advised to consult medical specialists, in particular pulmonologists, who can offer further evaluation, recommend empiric treatment, and review indications for bronchoscopy.
Mitch Zeller, JD, director, Center for Tobacco Products with the Food and Drug Administration emphasized the extraordinary complexity of the EVALI problem but noted that the FDA and CDC “will leave no stone unturned until we get to the bottom of it.”
REPORTING FROM A CDC TELEBRIEFING
Vaping-associated lung injury cases nears 1,300
according to a statement released by the Centers for Disease Control and Prevention.
These cases have been reported to the CDC from 49 states, the District of Columbia, and the U.S. Virgin Islands. The increase in lung injury cases from Oct. 1 (reported to be 1,080) represents both new patients and recent reporting of patients previously identified to the CDC.
Twenty-six deaths have been confirmed in 21 states and more deaths are currently being reviewed.
The causes of the injuries are still under investigation. The CDC stated, “The latest findings from the investigation into lung injuries associated with e-cigarette use, or vaping, suggest products containing THC play a role in the outbreak. All patients have a reported history of e-cigarette product use, or vaping, and no consistent evidence of an infectious cause has been discovered. Therefore, the suspected cause is a chemical exposure.” The specific chemical causing the lung injuries associated with vaping remains unknown at this time.
The CDC has created information hubs and resources for the public, for health care providers, and for state and local health department officials. The CDC has also provided additional resources to address the outbreak of vaping-associated lung injuries.
according to a statement released by the Centers for Disease Control and Prevention.
These cases have been reported to the CDC from 49 states, the District of Columbia, and the U.S. Virgin Islands. The increase in lung injury cases from Oct. 1 (reported to be 1,080) represents both new patients and recent reporting of patients previously identified to the CDC.
Twenty-six deaths have been confirmed in 21 states and more deaths are currently being reviewed.
The causes of the injuries are still under investigation. The CDC stated, “The latest findings from the investigation into lung injuries associated with e-cigarette use, or vaping, suggest products containing THC play a role in the outbreak. All patients have a reported history of e-cigarette product use, or vaping, and no consistent evidence of an infectious cause has been discovered. Therefore, the suspected cause is a chemical exposure.” The specific chemical causing the lung injuries associated with vaping remains unknown at this time.
The CDC has created information hubs and resources for the public, for health care providers, and for state and local health department officials. The CDC has also provided additional resources to address the outbreak of vaping-associated lung injuries.
according to a statement released by the Centers for Disease Control and Prevention.
These cases have been reported to the CDC from 49 states, the District of Columbia, and the U.S. Virgin Islands. The increase in lung injury cases from Oct. 1 (reported to be 1,080) represents both new patients and recent reporting of patients previously identified to the CDC.
Twenty-six deaths have been confirmed in 21 states and more deaths are currently being reviewed.
The causes of the injuries are still under investigation. The CDC stated, “The latest findings from the investigation into lung injuries associated with e-cigarette use, or vaping, suggest products containing THC play a role in the outbreak. All patients have a reported history of e-cigarette product use, or vaping, and no consistent evidence of an infectious cause has been discovered. Therefore, the suspected cause is a chemical exposure.” The specific chemical causing the lung injuries associated with vaping remains unknown at this time.
The CDC has created information hubs and resources for the public, for health care providers, and for state and local health department officials. The CDC has also provided additional resources to address the outbreak of vaping-associated lung injuries.
REPORTING FROM CDC
Influenza: U.S. activity was low this summer
Influenza activity in the United States was typically low over the summer months, with influenza A(H3N2) viruses predominating, according to the Centers for Disease Control and Prevention.
From May 19 to Sept. 28, 2019, weekly flu activity – measured by the percentage of outpatient visits to health care professionals for influenza-like illness (ILI) – was below the national baseline of 2.2%, ranging from 0.7% to 1.4%. Since mid-August, however, when the rate was last 0.7%, it has been climbing slowly but steadily and was up to 1.3% for the week ending Sept. 28, CDC data show.
The various public health laboratories of the U.S. Influenza Surveillance System tested over 7,600 respiratory samples from May 19 to Sept. 28, and 22.7% were positive for influenza viruses, Scott Epperson, DVM, and associates at the CDC’s influenza division said Oct. 10 in the MMWR.
Of the 1,737 samples found to be positive, 69.8% were influenza A and 30.2% were influenza B. The subtype split among specimens positive for Influenza A was 71.9% A(H3N2) and 28.1% A(H1N1)pdm09, while the samples positive for influenza B went 93.9% B/Victoria and 6.1% B/Yamagata, they reported.
Over the same time period in the Southern Hemisphere, “seasonal influenza viruses circulated widely, with influenza A(H3) predominating in many regions; however, influenza A(H1N1)pdm09 and influenza B viruses were predominant in some countries,” the CDC investigators noted.
They also reported the World Health Organization recommendations for the Southern Hemisphere’s 2020 flu vaccines. Components of the egg-based trivalent vaccine are an A/Brisbane/02/2018(H1N1)pdm09-like virus, an A/South Australia/34/2019(H3N2)-like virus, and a B/Washington/02/2019-like virus(B/Victoria lineage). The recommended quadrivalent vaccine adds a B/Phuket/3073/2013-like virus(B/Yamagata lineage), they wrote.
“It is too early in the season to know which viruses will circulate in the United States later this fall and winter or how severe the season might be; however, regardless of what is circulating, the best protection against influenza is an influenza vaccination,” Dr. Epperson and associates wrote.
SOURCE: Epperson S et al. MMWR. 2019 Oct 11;68(40):880-4.
Influenza activity in the United States was typically low over the summer months, with influenza A(H3N2) viruses predominating, according to the Centers for Disease Control and Prevention.
From May 19 to Sept. 28, 2019, weekly flu activity – measured by the percentage of outpatient visits to health care professionals for influenza-like illness (ILI) – was below the national baseline of 2.2%, ranging from 0.7% to 1.4%. Since mid-August, however, when the rate was last 0.7%, it has been climbing slowly but steadily and was up to 1.3% for the week ending Sept. 28, CDC data show.
The various public health laboratories of the U.S. Influenza Surveillance System tested over 7,600 respiratory samples from May 19 to Sept. 28, and 22.7% were positive for influenza viruses, Scott Epperson, DVM, and associates at the CDC’s influenza division said Oct. 10 in the MMWR.
Of the 1,737 samples found to be positive, 69.8% were influenza A and 30.2% were influenza B. The subtype split among specimens positive for Influenza A was 71.9% A(H3N2) and 28.1% A(H1N1)pdm09, while the samples positive for influenza B went 93.9% B/Victoria and 6.1% B/Yamagata, they reported.
Over the same time period in the Southern Hemisphere, “seasonal influenza viruses circulated widely, with influenza A(H3) predominating in many regions; however, influenza A(H1N1)pdm09 and influenza B viruses were predominant in some countries,” the CDC investigators noted.
They also reported the World Health Organization recommendations for the Southern Hemisphere’s 2020 flu vaccines. Components of the egg-based trivalent vaccine are an A/Brisbane/02/2018(H1N1)pdm09-like virus, an A/South Australia/34/2019(H3N2)-like virus, and a B/Washington/02/2019-like virus(B/Victoria lineage). The recommended quadrivalent vaccine adds a B/Phuket/3073/2013-like virus(B/Yamagata lineage), they wrote.
“It is too early in the season to know which viruses will circulate in the United States later this fall and winter or how severe the season might be; however, regardless of what is circulating, the best protection against influenza is an influenza vaccination,” Dr. Epperson and associates wrote.
SOURCE: Epperson S et al. MMWR. 2019 Oct 11;68(40):880-4.
Influenza activity in the United States was typically low over the summer months, with influenza A(H3N2) viruses predominating, according to the Centers for Disease Control and Prevention.
From May 19 to Sept. 28, 2019, weekly flu activity – measured by the percentage of outpatient visits to health care professionals for influenza-like illness (ILI) – was below the national baseline of 2.2%, ranging from 0.7% to 1.4%. Since mid-August, however, when the rate was last 0.7%, it has been climbing slowly but steadily and was up to 1.3% for the week ending Sept. 28, CDC data show.
The various public health laboratories of the U.S. Influenza Surveillance System tested over 7,600 respiratory samples from May 19 to Sept. 28, and 22.7% were positive for influenza viruses, Scott Epperson, DVM, and associates at the CDC’s influenza division said Oct. 10 in the MMWR.
Of the 1,737 samples found to be positive, 69.8% were influenza A and 30.2% were influenza B. The subtype split among specimens positive for Influenza A was 71.9% A(H3N2) and 28.1% A(H1N1)pdm09, while the samples positive for influenza B went 93.9% B/Victoria and 6.1% B/Yamagata, they reported.
Over the same time period in the Southern Hemisphere, “seasonal influenza viruses circulated widely, with influenza A(H3) predominating in many regions; however, influenza A(H1N1)pdm09 and influenza B viruses were predominant in some countries,” the CDC investigators noted.
They also reported the World Health Organization recommendations for the Southern Hemisphere’s 2020 flu vaccines. Components of the egg-based trivalent vaccine are an A/Brisbane/02/2018(H1N1)pdm09-like virus, an A/South Australia/34/2019(H3N2)-like virus, and a B/Washington/02/2019-like virus(B/Victoria lineage). The recommended quadrivalent vaccine adds a B/Phuket/3073/2013-like virus(B/Yamagata lineage), they wrote.
“It is too early in the season to know which viruses will circulate in the United States later this fall and winter or how severe the season might be; however, regardless of what is circulating, the best protection against influenza is an influenza vaccination,” Dr. Epperson and associates wrote.
SOURCE: Epperson S et al. MMWR. 2019 Oct 11;68(40):880-4.
FROM MMWR
New York declares end to 2018 measles outbreak
New York State has reported the end of all active measles cases related to the initial outbreak in 2018, but the state is now responding to new, unrelated cases in four counties, according to the Centers for Disease Control and Prevention.
The new cases – two in Nassau County and one each in Monroe, Putnam, and Rockland counties – are “related to measles exposures from international travel but not affiliated with the 2018 outbreak,” the New York State Department of Health said in a written statement. Officials in Rockland County had declared its 2018 measles outbreak, which involved 312 cases in 2018 and 2019, over on Sept. 25.
. Of those cases, 1,163 (93%) were associated with 22 outbreaks, with the two largest occurring in New York City and Rockland County. “These two almost year-long outbreaks placed the United States at risk for losing measles elimination status,” the CDC said in a separate report, but “robust responses … ended transmission before the 1-year mark.”
New York State has reported the end of all active measles cases related to the initial outbreak in 2018, but the state is now responding to new, unrelated cases in four counties, according to the Centers for Disease Control and Prevention.
The new cases – two in Nassau County and one each in Monroe, Putnam, and Rockland counties – are “related to measles exposures from international travel but not affiliated with the 2018 outbreak,” the New York State Department of Health said in a written statement. Officials in Rockland County had declared its 2018 measles outbreak, which involved 312 cases in 2018 and 2019, over on Sept. 25.
. Of those cases, 1,163 (93%) were associated with 22 outbreaks, with the two largest occurring in New York City and Rockland County. “These two almost year-long outbreaks placed the United States at risk for losing measles elimination status,” the CDC said in a separate report, but “robust responses … ended transmission before the 1-year mark.”
New York State has reported the end of all active measles cases related to the initial outbreak in 2018, but the state is now responding to new, unrelated cases in four counties, according to the Centers for Disease Control and Prevention.
The new cases – two in Nassau County and one each in Monroe, Putnam, and Rockland counties – are “related to measles exposures from international travel but not affiliated with the 2018 outbreak,” the New York State Department of Health said in a written statement. Officials in Rockland County had declared its 2018 measles outbreak, which involved 312 cases in 2018 and 2019, over on Sept. 25.
. Of those cases, 1,163 (93%) were associated with 22 outbreaks, with the two largest occurring in New York City and Rockland County. “These two almost year-long outbreaks placed the United States at risk for losing measles elimination status,” the CDC said in a separate report, but “robust responses … ended transmission before the 1-year mark.”