User login
FDA approves combo pill for severe, acute pain
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
FDA OKs new high-dose naloxone product for opioid overdose
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
FDA approves cell-based flu shot for ages 6 months and older
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
Adalimumab biosimilar Cyltezo gets interchangeability designation
The Food and Drug Administration approved a supplement to the biologics license application of the adalimumab biosimilar drug Cyltezo (adalimumab-adbm) that makes it the first interchangeable biosimilar with Humira (adalimumab), the original branded version of the drug, its manufacturer Boehringer Ingelheim announced Oct. 15.
The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases, including seven of Humira’s nine indications for adults and pediatric patients: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The interchangeability designation means that Cyltezo was tested in an additional clinical trial in which patients were successfully switched back and forth multiple times from Humira to Cyltezo and allows pharmacists to autosubstitute Humira with Cyltezo. In these cases, individual state laws control how and whether physicians will be notified of this switch.
Cyltezo is just the second biosimilar to be designated as interchangeable with its originator biologic product. The first approval, announced July 28, was for the interchangeability of Semglee (insulin glargine-yfgn) with the originator Lantus.
The agency based its decision on positive data from the VOLTAIRE-X study of 238 patients with moderate to severe chronic plaque psoriasis in which Cyltezo had no meaningful clinical differences from Humira in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups.
Cyltezo will not be commercially available in the United States until July 1, 2023, according to Boehringer Ingelheim.
The Food and Drug Administration approved a supplement to the biologics license application of the adalimumab biosimilar drug Cyltezo (adalimumab-adbm) that makes it the first interchangeable biosimilar with Humira (adalimumab), the original branded version of the drug, its manufacturer Boehringer Ingelheim announced Oct. 15.
The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases, including seven of Humira’s nine indications for adults and pediatric patients: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The interchangeability designation means that Cyltezo was tested in an additional clinical trial in which patients were successfully switched back and forth multiple times from Humira to Cyltezo and allows pharmacists to autosubstitute Humira with Cyltezo. In these cases, individual state laws control how and whether physicians will be notified of this switch.
Cyltezo is just the second biosimilar to be designated as interchangeable with its originator biologic product. The first approval, announced July 28, was for the interchangeability of Semglee (insulin glargine-yfgn) with the originator Lantus.
The agency based its decision on positive data from the VOLTAIRE-X study of 238 patients with moderate to severe chronic plaque psoriasis in which Cyltezo had no meaningful clinical differences from Humira in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups.
Cyltezo will not be commercially available in the United States until July 1, 2023, according to Boehringer Ingelheim.
The Food and Drug Administration approved a supplement to the biologics license application of the adalimumab biosimilar drug Cyltezo (adalimumab-adbm) that makes it the first interchangeable biosimilar with Humira (adalimumab), the original branded version of the drug, its manufacturer Boehringer Ingelheim announced Oct. 15.
The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases, including seven of Humira’s nine indications for adults and pediatric patients: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The interchangeability designation means that Cyltezo was tested in an additional clinical trial in which patients were successfully switched back and forth multiple times from Humira to Cyltezo and allows pharmacists to autosubstitute Humira with Cyltezo. In these cases, individual state laws control how and whether physicians will be notified of this switch.
Cyltezo is just the second biosimilar to be designated as interchangeable with its originator biologic product. The first approval, announced July 28, was for the interchangeability of Semglee (insulin glargine-yfgn) with the originator Lantus.
The agency based its decision on positive data from the VOLTAIRE-X study of 238 patients with moderate to severe chronic plaque psoriasis in which Cyltezo had no meaningful clinical differences from Humira in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups.
Cyltezo will not be commercially available in the United States until July 1, 2023, according to Boehringer Ingelheim.
Lupin recalls irbesartan and hydrochlorothiazide/irbesartan tablets
Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”
Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”
The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.
Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.
Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.
The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”
Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”
The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.
Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.
Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.
The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 mg and 300 mg/12.5 mg because of the potential presence of the N-nitrosoirbesartan impurity.
“As part of Lupin’s ongoing assessment, analysis revealed that certain tested active pharmaceutical ingredient (API) batches (but not finished product batches) were above the specification limit for the impurity, N-nitrosoirbesartan,” the company said in a news release posted on the U.S. Food and Drug Administration’s website. It notes that the impurity is a “probable human carcinogen.”
Lupin discontinued the marketing of irbesartan and irbesartan/HCTZ tablets on Jan. 7, 2021. It says it “has received no reports of illness that appear to relate to this issue” and is issuing the recall out of “an abundance of caution.”
The company, however, goes on to note that from Oct. 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches) to September 30 of this year, Lupin received four reports of illness from irbesartan and 0 reports from irbesartan/HCTZ.
Irbesartan is an angiotensin II receptor blocker indicated for treatment of hypertension in patients with type 2 diabetes, elevated serum creatinine, and proteinuria.
Irbesartan/HCTZ tablets include irbesartan and hydrochlorothiazide, a thiazide diuretic, indicated for hypertension in patients not adequately controlled with monotherapy or as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals.
Lupin is notifying wholesalers, distributors, and retail outlets to immediately discontinue sales of the affected product lots and return them to the company. Specific lot numbers can be found here.
The company is advising patients to continue taking their medication and to contact their pharmacist, physician, or health care professional for advice regarding an alternative treatment.
Patients and physicians are also advised to report any adverse events or side effects related to the affected products to MedWatch, the U.S. Food and Drug Administration’s Safety Information and Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
FDA panel backs second dose for Johnson & Johnson vaccine recipients
It was the second vote in as many days to back a change to a COVID vaccine timeline.
In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.
It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.
Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.
In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.
This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
Limited data
The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.
These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.
But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.
Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.
“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”
“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.
She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.
But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.
“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.
Who needs a second dose?
On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.
COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.
The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.
The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.
Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.
The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.
“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
Trying to avoid confusion
Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.
“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.
Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.
Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.
“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.
Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.
“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.
“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.
It was the second vote in as many days to back a change to a COVID vaccine timeline.
In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.
It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.
Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.
In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.
This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
Limited data
The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.
These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.
But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.
Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.
“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”
“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.
She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.
But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.
“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.
Who needs a second dose?
On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.
COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.
The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.
The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.
Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.
The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.
“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
Trying to avoid confusion
Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.
“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.
Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.
Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.
“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.
Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.
“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.
“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.
It was the second vote in as many days to back a change to a COVID vaccine timeline.
In its vote, the committee said that boosters could be offered to people as young as age 18. However, it is not clear that everyone who got a Johnson & Johnson vaccine needs to get a second dose. The same panel voted Oct. 14 to recommend booster shots for the Moderna vaccine, but for a narrower group of people.
It will be up to a Centers for Disease Control and Prevention (CDC) panel to make more specific recommendations for who might need another shot. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet next Oct. 21 to discuss issues related to COVID-19 vaccines.
Studies of the effectiveness of the Johnson & Johnson vaccine in the real world show that its protection — while good — has not been as strong as that of the mRNA vaccines made by Pfizer and Moderna, which are given as part of a two-dose series.
In the end, the members of the FDA’s Vaccines and Related Biological Products Advisory Committee said they felt that the company hadn’t made a case for calling their second shot a booster, but had shown enough data to suggest that everyone over the age of 18 should consider getting two shots of the Johnson & Johnson vaccine as a matter of course.
This is an especially important issue for adults over the age of 50. A recent study in the New England Journal of Medicine found that older adults who got the Johnson & Johnson vaccine were less protected against infection and hospitalization than those who got mRNA vaccines.
Limited data
The company presented data from six studies to the FDA panel in support of a second dose that were limited. The only study looking at second doses after 6 months included just 17 people.
These studies did show that a second dose substantially increased levels of neutralizing antibodies, which are the body’s first line of protection against COVID-19 infection.
But the company turned this data over to the FDA so recently that agency scientists repeatedly stressed during the meeting that they did not have ample time to follow their normal process of independently verifying the data and following up with their own analysis of the study results.
Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said it would have taken months to complete that rigorous level of review.
Instead, in the interest of urgency, the FDA said it had tried to bring some clarity to the tangle of study results presented that included three dosing schedules and different measures of effectiveness.
“Here’s how this strikes me,” said committee member Paul Offit, MD, a professor of pediatrics and infectious disease at Children’s Hospital of Philadelphia. “I think this vaccine was always a two-dose vaccine. I think it’s better as a two-dose vaccine. I think it would be hard to recommend this as a single-dose vaccine at this point.”
“As far as I’m concerned, it was always going to be necessary for J&J recipients to get a second shot,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
Archana Chatterjee, MD, PhD, dean of the Chicago Medical School at Rosalind Franklin University of Medicine and Science, said she had changed her vote during the course of the meeting.
She said that, based on the very limited safety and effectiveness data presented to the committee, she was prepared to vote against the idea of offering second doses of Johnson & Johnson shots.
But after considering the 15 million people who have been vaccinated with a single dose and studies that have suggested that close to 5 million older adults may still be at risk for hospitalization because they’ve just had one shot, “This is still a public health imperative,” she said.
“I’m in agreement with most of my colleagues that this second dose, booster, whatever you want to call it, is necessary in these individuals to boost up their immunity back into the 90-plus percentile range,” Dr. Chatterjee said.
Who needs a second dose?
On Oct. 14, the committee heard an update on data from Israel, which saw a wave of severe breakthrough infections during the Delta wave.
COVID-19 cases are falling rapidly there after the country widely deployed booster doses of the Pfizer vaccine.
The FDA’s Dr. Marks said Oct. 15 that the agency was leaning toward creating greater flexibility in the emergency use authorizations (EUAs) for the Johnson & Johnson and Moderna vaccines so that boosters could be more widely deployed in the United States too.
The FDA panel on Oct. 14 voted to authorize a 50-milligram dose of Moderna’s vaccine — half the dose used in the primary series of shots — to boost immunity at least 6 months after the second dose.
Those who might need a Moderna booster are the same groups who’ve gotten a green light for third Pfizer doses, including people over 65, adults at higher risk for severe COVID-19, and those who are at higher risk because of where they live or work.
The FDA asked the committee on Oct. 15 to discuss whether boosters should be offered to younger adults, even those without underlying health conditions.
“We’re concerned that what was seen in Israel could be seen here,” Dr. Marks said. “We don’t want to have a wave of severe COVID-19 before we deploy boosters.”
Trying to avoid confusion
Some members of the committee cautioned Dr. Marks to be careful when expanding the EUAs, because it could confuse people.
“When we say immunity is waning, what are the implications of that?” said Michael Kurilla, MD, PhD, director of the division of clinical innovation at the National Institutes of Health.
Overall, data show that all the vaccines currently being used in the United States — including Johnson & Johnson — remain highly effective for preventing severe outcomes from COVID-19, like hospitalization and death.
Booster doses could prevent more people from even getting mild or moderate symptoms from “breakthrough” COVID-19 cases, which began to rise during the recent Delta surge. The additional doses are also expected to prevent severe outcomes like hospitalization in older adults and those with underlying health conditions.
“I think we need to be clear when we say waning immunity and we need to do something about that, I think we need to be clear what we’re really targeting [with boosters] in terms of clinical impact we expect to have,” Dr. Kurilla said.
Others pointed out that preventing even mild-to-moderate infections was a worthy goal, especially considering the implications of long-haul COVID-19.
“COVID does have tremendous downstream effects, even in those who are not hospitalized. Whenever we can prevent significant morbidity in a population, there are advantages to that,” said Steven Pergam, MD, MPH, medical director of infection prevention at the Seattle Cancer Care Alliance.
“I’d really be in the camp that would be moving towards a younger age range for allowing boosters,” he said.
This article was updated on 10/18/21. A version of this article first appeared on Medscape.com.
FDA advisors vote to recommend Moderna boosters
A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.
The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:
- Over age 65
- Ages 18 to 64 who are at higher risk for severe COVID
- Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are
The agency is not bound by the committee’s vote but usually follows its recommendations.
Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.
“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.
Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”
“I’ve got some real issues with this vote,” he said.
“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.
Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.
Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.
After the advisory committee votes, the director of the CDC has to approve its recommendation.
Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.
Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.
In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.
To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.
Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.
The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.
This article was updated Oct. 15 and first appeared on WebMD.com.
A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.
The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:
- Over age 65
- Ages 18 to 64 who are at higher risk for severe COVID
- Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are
The agency is not bound by the committee’s vote but usually follows its recommendations.
Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.
“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.
Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”
“I’ve got some real issues with this vote,” he said.
“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.
Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.
Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.
After the advisory committee votes, the director of the CDC has to approve its recommendation.
Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.
Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.
In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.
To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.
Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.
The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.
This article was updated Oct. 15 and first appeared on WebMD.com.
A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.
The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:
- Over age 65
- Ages 18 to 64 who are at higher risk for severe COVID
- Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are
The agency is not bound by the committee’s vote but usually follows its recommendations.
Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.
“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.
Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”
“I’ve got some real issues with this vote,” he said.
“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.
Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.
Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.
After the advisory committee votes, the director of the CDC has to approve its recommendation.
Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.
Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.
In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.
To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.
Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.
The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.
This article was updated Oct. 15 and first appeared on WebMD.com.
‘Impressive’ results for novel antidepressant, so why the FDA delay?
A novel antidepressant (AXS-05, Axsome Therapeutics) appears to have a rapid and durable effect in patients with major depressive disorder (MDD), results of an open label, phase 3 trial, show. Yet, its new drug application (NDA) remains in limbo with the U.S. Food and Drug Administration for reasons that are unclear.
In the study, which included 876 patients with MDD, results showed the drug, a combination of dextromethorphan and bupropion, had a clinical response rate of 80% and a remission rate of almost 70%. In addition, functional improvements were “substantial” and AXS-05 was determined to be “generally safe and well-tolerated.”
The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
The study
The COMET trial was a phase 3, multicenter, U.S. trial, in which patients with MDD were treated with AXS-05 twice daily for up to 12 months. Patients had to have a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 25. They could have completed a prior AXS-05 study or be newly enrolled.
Of 876 patients included in the study, 611 were newly enrolled. The mean age was 42.4 years, and 62.4% were women. Just over half (58.1%) were White, with 35.6% Black, and 2.0% Asian. The mean body mass index was 31.4 kg/m2.
The mean MADRS total score at baseline was 32.7 and the Sheehan Disability Scale (SDS) score was 20.0.
Presenting efficacy data in 609 newly enrolled patients, the team showed that MADRS total scores fell sharply on starting AXS-05, by 9.1 points at week 1, 14.0 points at week 2, and 21.2 points at week 6.
By 6 months, the reduction over baseline was 23.9 points, which was maintained out to 12 months, at a mean reduction of 23.0 points.
The proportion of patients achieving a clinical response, defined as a greater than or equal to 50% improvement in MADRS scores, was 18.8% at week 1, 39.7% at week 2, and 73.2% at week 6. There was a clinical response in 84.6% of patients at 6 months and in 82.8% at 12 months.
Clinical remission, defined as a MADRS score less than or equal to 10, was achieved in 8.3% of patients at week 1, rising to 21.5% at week 2, and 52.5% at week 6. At 6 months, 68.7% of patients were in clinical remission, reaching 69.0% at 12 months.
These benefits were accompanied by substantial improvements in depressive symptoms on the Clinical Global Impression of Improvement scale, with a marked or moderate improvement seen in 86.7% of patients at 6 months and 93.1% at 12 months.
Moreover, a clinical response in functioning on the SDS was achieved by 80.6% of patients at 6 months and 75.9% at 12 months.
The safety analysis of AXS-05 in the entire cohort suggested it was well-tolerated, with dizziness seen in 12.7% of patients, along with nausea in 11.9%, headache in 8.8%, dry mouth in 7.1%, and decreased appetite in 6.1%.
The rate of discontinuation due to adverse events was 8.4%, and there were no signs of psychotomimetic effects, cognitive impairment, weight gain, or increased sexual dysfunction.
and increased rates of suicidal ideation resolution, and was also effective for treatment-resistant depression.
Results from an analysis of the ASCEND phase 2 and GEMINI phase 3 trials also suggested that AXS-05 was superior to both bupropion and placebo in achieving rapid and sustained improvements in depression symptoms.
FDA delay
Yet despite these seemingly positive findings, the FDA appears to have issues with the agent’s new drug application.
As reported in August, the agency reviewed the NDA for AXS-05 for the treatment of MDD, but at that time the drug’s manufacturer revealed that the agency had identified “deficiencies that preclude labeling discussions at this time.”
With the latest results presented at ECNP 2021, this news organization asked Axsome about the status of the NDA and whether there had been any further discussions and/or movement with the FDA.
Instead of a direct reply from the drug company, this news organization was directed to a statement released by Axsome in August announcing that the FDA had informed the company that its NDA review “would not be completed by the Prescription Drug User Fee Act target action date of August 22, 2021.”
“The FDA did not request additional information from the company, and the review of the application is ongoing,” the statement said. Axsome did not respond to further questions.
‘Impressive’ remission rate
Commenting on the research, Marin Jukic, PhD, department of physiology and pharmacology, Karolinska Institutet, Stockholm, who was not involved in the research, said AXS-05 “looks promising in relation to the efficacy and tolerability results” with a remission rate that is “truly impressive.”
However, Dr. Jukic cautioned that it was an open-label trial and therefore had no placebo or active comparator arms.
He noted that it would be “interesting to compare the efficacy with placebo and escitalopram, for example, to evaluate the potential for the benefits and efficacy better.”
The research was funded by Axsome Therapeutics, and, except for one, the researchers for the four studies are employees of Axsome Therapeutics.
A version of this article first appeared on Medscape.com.
A novel antidepressant (AXS-05, Axsome Therapeutics) appears to have a rapid and durable effect in patients with major depressive disorder (MDD), results of an open label, phase 3 trial, show. Yet, its new drug application (NDA) remains in limbo with the U.S. Food and Drug Administration for reasons that are unclear.
In the study, which included 876 patients with MDD, results showed the drug, a combination of dextromethorphan and bupropion, had a clinical response rate of 80% and a remission rate of almost 70%. In addition, functional improvements were “substantial” and AXS-05 was determined to be “generally safe and well-tolerated.”
The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
The study
The COMET trial was a phase 3, multicenter, U.S. trial, in which patients with MDD were treated with AXS-05 twice daily for up to 12 months. Patients had to have a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 25. They could have completed a prior AXS-05 study or be newly enrolled.
Of 876 patients included in the study, 611 were newly enrolled. The mean age was 42.4 years, and 62.4% were women. Just over half (58.1%) were White, with 35.6% Black, and 2.0% Asian. The mean body mass index was 31.4 kg/m2.
The mean MADRS total score at baseline was 32.7 and the Sheehan Disability Scale (SDS) score was 20.0.
Presenting efficacy data in 609 newly enrolled patients, the team showed that MADRS total scores fell sharply on starting AXS-05, by 9.1 points at week 1, 14.0 points at week 2, and 21.2 points at week 6.
By 6 months, the reduction over baseline was 23.9 points, which was maintained out to 12 months, at a mean reduction of 23.0 points.
The proportion of patients achieving a clinical response, defined as a greater than or equal to 50% improvement in MADRS scores, was 18.8% at week 1, 39.7% at week 2, and 73.2% at week 6. There was a clinical response in 84.6% of patients at 6 months and in 82.8% at 12 months.
Clinical remission, defined as a MADRS score less than or equal to 10, was achieved in 8.3% of patients at week 1, rising to 21.5% at week 2, and 52.5% at week 6. At 6 months, 68.7% of patients were in clinical remission, reaching 69.0% at 12 months.
These benefits were accompanied by substantial improvements in depressive symptoms on the Clinical Global Impression of Improvement scale, with a marked or moderate improvement seen in 86.7% of patients at 6 months and 93.1% at 12 months.
Moreover, a clinical response in functioning on the SDS was achieved by 80.6% of patients at 6 months and 75.9% at 12 months.
The safety analysis of AXS-05 in the entire cohort suggested it was well-tolerated, with dizziness seen in 12.7% of patients, along with nausea in 11.9%, headache in 8.8%, dry mouth in 7.1%, and decreased appetite in 6.1%.
The rate of discontinuation due to adverse events was 8.4%, and there were no signs of psychotomimetic effects, cognitive impairment, weight gain, or increased sexual dysfunction.
and increased rates of suicidal ideation resolution, and was also effective for treatment-resistant depression.
Results from an analysis of the ASCEND phase 2 and GEMINI phase 3 trials also suggested that AXS-05 was superior to both bupropion and placebo in achieving rapid and sustained improvements in depression symptoms.
FDA delay
Yet despite these seemingly positive findings, the FDA appears to have issues with the agent’s new drug application.
As reported in August, the agency reviewed the NDA for AXS-05 for the treatment of MDD, but at that time the drug’s manufacturer revealed that the agency had identified “deficiencies that preclude labeling discussions at this time.”
With the latest results presented at ECNP 2021, this news organization asked Axsome about the status of the NDA and whether there had been any further discussions and/or movement with the FDA.
Instead of a direct reply from the drug company, this news organization was directed to a statement released by Axsome in August announcing that the FDA had informed the company that its NDA review “would not be completed by the Prescription Drug User Fee Act target action date of August 22, 2021.”
“The FDA did not request additional information from the company, and the review of the application is ongoing,” the statement said. Axsome did not respond to further questions.
‘Impressive’ remission rate
Commenting on the research, Marin Jukic, PhD, department of physiology and pharmacology, Karolinska Institutet, Stockholm, who was not involved in the research, said AXS-05 “looks promising in relation to the efficacy and tolerability results” with a remission rate that is “truly impressive.”
However, Dr. Jukic cautioned that it was an open-label trial and therefore had no placebo or active comparator arms.
He noted that it would be “interesting to compare the efficacy with placebo and escitalopram, for example, to evaluate the potential for the benefits and efficacy better.”
The research was funded by Axsome Therapeutics, and, except for one, the researchers for the four studies are employees of Axsome Therapeutics.
A version of this article first appeared on Medscape.com.
A novel antidepressant (AXS-05, Axsome Therapeutics) appears to have a rapid and durable effect in patients with major depressive disorder (MDD), results of an open label, phase 3 trial, show. Yet, its new drug application (NDA) remains in limbo with the U.S. Food and Drug Administration for reasons that are unclear.
In the study, which included 876 patients with MDD, results showed the drug, a combination of dextromethorphan and bupropion, had a clinical response rate of 80% and a remission rate of almost 70%. In addition, functional improvements were “substantial” and AXS-05 was determined to be “generally safe and well-tolerated.”
The findings were presented at the virtual congress of the European College of Neuropsychopharmacology.
The study
The COMET trial was a phase 3, multicenter, U.S. trial, in which patients with MDD were treated with AXS-05 twice daily for up to 12 months. Patients had to have a Montgomery-Åsberg Depression Rating Scale (MADRS) score of at least 25. They could have completed a prior AXS-05 study or be newly enrolled.
Of 876 patients included in the study, 611 were newly enrolled. The mean age was 42.4 years, and 62.4% were women. Just over half (58.1%) were White, with 35.6% Black, and 2.0% Asian. The mean body mass index was 31.4 kg/m2.
The mean MADRS total score at baseline was 32.7 and the Sheehan Disability Scale (SDS) score was 20.0.
Presenting efficacy data in 609 newly enrolled patients, the team showed that MADRS total scores fell sharply on starting AXS-05, by 9.1 points at week 1, 14.0 points at week 2, and 21.2 points at week 6.
By 6 months, the reduction over baseline was 23.9 points, which was maintained out to 12 months, at a mean reduction of 23.0 points.
The proportion of patients achieving a clinical response, defined as a greater than or equal to 50% improvement in MADRS scores, was 18.8% at week 1, 39.7% at week 2, and 73.2% at week 6. There was a clinical response in 84.6% of patients at 6 months and in 82.8% at 12 months.
Clinical remission, defined as a MADRS score less than or equal to 10, was achieved in 8.3% of patients at week 1, rising to 21.5% at week 2, and 52.5% at week 6. At 6 months, 68.7% of patients were in clinical remission, reaching 69.0% at 12 months.
These benefits were accompanied by substantial improvements in depressive symptoms on the Clinical Global Impression of Improvement scale, with a marked or moderate improvement seen in 86.7% of patients at 6 months and 93.1% at 12 months.
Moreover, a clinical response in functioning on the SDS was achieved by 80.6% of patients at 6 months and 75.9% at 12 months.
The safety analysis of AXS-05 in the entire cohort suggested it was well-tolerated, with dizziness seen in 12.7% of patients, along with nausea in 11.9%, headache in 8.8%, dry mouth in 7.1%, and decreased appetite in 6.1%.
The rate of discontinuation due to adverse events was 8.4%, and there were no signs of psychotomimetic effects, cognitive impairment, weight gain, or increased sexual dysfunction.
and increased rates of suicidal ideation resolution, and was also effective for treatment-resistant depression.
Results from an analysis of the ASCEND phase 2 and GEMINI phase 3 trials also suggested that AXS-05 was superior to both bupropion and placebo in achieving rapid and sustained improvements in depression symptoms.
FDA delay
Yet despite these seemingly positive findings, the FDA appears to have issues with the agent’s new drug application.
As reported in August, the agency reviewed the NDA for AXS-05 for the treatment of MDD, but at that time the drug’s manufacturer revealed that the agency had identified “deficiencies that preclude labeling discussions at this time.”
With the latest results presented at ECNP 2021, this news organization asked Axsome about the status of the NDA and whether there had been any further discussions and/or movement with the FDA.
Instead of a direct reply from the drug company, this news organization was directed to a statement released by Axsome in August announcing that the FDA had informed the company that its NDA review “would not be completed by the Prescription Drug User Fee Act target action date of August 22, 2021.”
“The FDA did not request additional information from the company, and the review of the application is ongoing,” the statement said. Axsome did not respond to further questions.
‘Impressive’ remission rate
Commenting on the research, Marin Jukic, PhD, department of physiology and pharmacology, Karolinska Institutet, Stockholm, who was not involved in the research, said AXS-05 “looks promising in relation to the efficacy and tolerability results” with a remission rate that is “truly impressive.”
However, Dr. Jukic cautioned that it was an open-label trial and therefore had no placebo or active comparator arms.
He noted that it would be “interesting to compare the efficacy with placebo and escitalopram, for example, to evaluate the potential for the benefits and efficacy better.”
The research was funded by Axsome Therapeutics, and, except for one, the researchers for the four studies are employees of Axsome Therapeutics.
A version of this article first appeared on Medscape.com.
FROM ECNP 2021
CDC: Children just as vulnerable to COVID as adults
The study, which focused on 1,000 schools in Arizona’s Maricopa and Pima counties, found that there were 113 COVID-19 outbreaks in schools without mask requirements in the first month of in-person learning. There were 16 outbreaks in schools with mask requirements.
“Masks in schools work to protect our children, to keep them and their school communities safe, and to keep them in school for in-person learning,” CDC Director Rochelle Walensky, MD, said at an Oct. 13 White House briefing.
But, she said, more than 95% of schools across the country had remained open through the end of September, despite 1,800 school closures affecting nearly 1 million students.
Protection for children in school is just one piece of the puzzle, Dr. Walensky said – there must also be COVID-safe practices at home to limit transmission. A CDC study published in October found that children had similar infection rates, compared with adults, confirming there is risk to people of all ages.
“For those children not yet eligible for vaccination, the best protection we can provide them is to make sure everyone around them in the household is vaccinated and to make sure they’re wearing a mask in school and during indoor extracurricular activities,” Dr. Walensky said.
Meanwhile, Pfizer’s vaccine for children ages 5-11 may be approved by early November. The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet Oct. 26 to discuss available data, and the CDC’s Advisory Committee on Immunization Practices will meet Nov. 2. A decision is expected soon after.
A version of this article first appeared on WebMD.com.
The study, which focused on 1,000 schools in Arizona’s Maricopa and Pima counties, found that there were 113 COVID-19 outbreaks in schools without mask requirements in the first month of in-person learning. There were 16 outbreaks in schools with mask requirements.
“Masks in schools work to protect our children, to keep them and their school communities safe, and to keep them in school for in-person learning,” CDC Director Rochelle Walensky, MD, said at an Oct. 13 White House briefing.
But, she said, more than 95% of schools across the country had remained open through the end of September, despite 1,800 school closures affecting nearly 1 million students.
Protection for children in school is just one piece of the puzzle, Dr. Walensky said – there must also be COVID-safe practices at home to limit transmission. A CDC study published in October found that children had similar infection rates, compared with adults, confirming there is risk to people of all ages.
“For those children not yet eligible for vaccination, the best protection we can provide them is to make sure everyone around them in the household is vaccinated and to make sure they’re wearing a mask in school and during indoor extracurricular activities,” Dr. Walensky said.
Meanwhile, Pfizer’s vaccine for children ages 5-11 may be approved by early November. The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet Oct. 26 to discuss available data, and the CDC’s Advisory Committee on Immunization Practices will meet Nov. 2. A decision is expected soon after.
A version of this article first appeared on WebMD.com.
The study, which focused on 1,000 schools in Arizona’s Maricopa and Pima counties, found that there were 113 COVID-19 outbreaks in schools without mask requirements in the first month of in-person learning. There were 16 outbreaks in schools with mask requirements.
“Masks in schools work to protect our children, to keep them and their school communities safe, and to keep them in school for in-person learning,” CDC Director Rochelle Walensky, MD, said at an Oct. 13 White House briefing.
But, she said, more than 95% of schools across the country had remained open through the end of September, despite 1,800 school closures affecting nearly 1 million students.
Protection for children in school is just one piece of the puzzle, Dr. Walensky said – there must also be COVID-safe practices at home to limit transmission. A CDC study published in October found that children had similar infection rates, compared with adults, confirming there is risk to people of all ages.
“For those children not yet eligible for vaccination, the best protection we can provide them is to make sure everyone around them in the household is vaccinated and to make sure they’re wearing a mask in school and during indoor extracurricular activities,” Dr. Walensky said.
Meanwhile, Pfizer’s vaccine for children ages 5-11 may be approved by early November. The Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee will meet Oct. 26 to discuss available data, and the CDC’s Advisory Committee on Immunization Practices will meet Nov. 2. A decision is expected soon after.
A version of this article first appeared on WebMD.com.
New FDA guidance aims to cut sodium in processed foods
The Food and Drug Administration has issued voluntary, short-term sodium reduction targets for food manufacturers, chain restaurants, and food service operators for processed, packaged, and prepared foods, with an eye toward reducing diet-related conditions such as heart disease and obesity.
The new targets seek to decrease average sodium intake from approximately 3,400 mg/day to 3,000 mg/day, about a 12% reduction, over the next 2.5 years, acting FDA Commissioner Janet Woodcock, MD, and Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, said in joint statement.
Although this reduction keeps the average intake above the recommended limit of 2,300 mg/day for individuals 14 years and older as per the Dietary Guidelines for Americans, “we know that even these modest reductions made slowly over the next few years will substantially decrease diet-related diseases,” they added.
The FDA first proposed recommendations for reducing sodium content in draft guidance released in 2016.
Since, then a number of companies in the food industry have already made changes to sodium content in their products, “which is encouraging, but additional support across all types of foods to help consumers meet recommended sodium limits is needed,” Dr. Woodcock and Dr. Mayne said.
They emphasized that the new guidance represents short-term goals that the food industry should work to meet as soon as possible to help optimize public health.
“We will continue our discussions with the food industry as we monitor the sodium content of the food supply to evaluate progress. In the future, we plan to issue revised, subsequent targets to further lower the sodium content incrementally and continue to help reduce sodium intake,” Dr. Woodcock and Dr. Mayne said.
AHA: A good first step that does not go far enough
In a statement, the American Heart Association said the new targets will play “a critical role in helping people across the country achieve healthier levels of sodium and improved well-being overall. These targets will be an important driver to reduce sodium consumption, which can have significant health benefits and lead to lower medical costs.”
“Lowering sodium levels in the food supply would reduce risk of hypertension, heart disease, stroke, heart attack, and death in addition to saving billions of dollars in health care costs over the next decade,” the AHA said.
But the AHA also said lowering sodium intake to 3,000 mg/day is not enough.
“Lowering sodium further to 2,300 mg could prevent an estimated 450,000 cases of cardiovascular disease, gain 2 million quality-adjusted life-years, and save approximately $40 billion in health care costs over a 20-year period,” the AHA said.
The AHA is urging the FDA to “follow [this] action with additional targets to further lower the amount of sodium in the food supply and help people in America attain an appropriate sodium intake.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has issued voluntary, short-term sodium reduction targets for food manufacturers, chain restaurants, and food service operators for processed, packaged, and prepared foods, with an eye toward reducing diet-related conditions such as heart disease and obesity.
The new targets seek to decrease average sodium intake from approximately 3,400 mg/day to 3,000 mg/day, about a 12% reduction, over the next 2.5 years, acting FDA Commissioner Janet Woodcock, MD, and Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, said in joint statement.
Although this reduction keeps the average intake above the recommended limit of 2,300 mg/day for individuals 14 years and older as per the Dietary Guidelines for Americans, “we know that even these modest reductions made slowly over the next few years will substantially decrease diet-related diseases,” they added.
The FDA first proposed recommendations for reducing sodium content in draft guidance released in 2016.
Since, then a number of companies in the food industry have already made changes to sodium content in their products, “which is encouraging, but additional support across all types of foods to help consumers meet recommended sodium limits is needed,” Dr. Woodcock and Dr. Mayne said.
They emphasized that the new guidance represents short-term goals that the food industry should work to meet as soon as possible to help optimize public health.
“We will continue our discussions with the food industry as we monitor the sodium content of the food supply to evaluate progress. In the future, we plan to issue revised, subsequent targets to further lower the sodium content incrementally and continue to help reduce sodium intake,” Dr. Woodcock and Dr. Mayne said.
AHA: A good first step that does not go far enough
In a statement, the American Heart Association said the new targets will play “a critical role in helping people across the country achieve healthier levels of sodium and improved well-being overall. These targets will be an important driver to reduce sodium consumption, which can have significant health benefits and lead to lower medical costs.”
“Lowering sodium levels in the food supply would reduce risk of hypertension, heart disease, stroke, heart attack, and death in addition to saving billions of dollars in health care costs over the next decade,” the AHA said.
But the AHA also said lowering sodium intake to 3,000 mg/day is not enough.
“Lowering sodium further to 2,300 mg could prevent an estimated 450,000 cases of cardiovascular disease, gain 2 million quality-adjusted life-years, and save approximately $40 billion in health care costs over a 20-year period,” the AHA said.
The AHA is urging the FDA to “follow [this] action with additional targets to further lower the amount of sodium in the food supply and help people in America attain an appropriate sodium intake.”
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has issued voluntary, short-term sodium reduction targets for food manufacturers, chain restaurants, and food service operators for processed, packaged, and prepared foods, with an eye toward reducing diet-related conditions such as heart disease and obesity.
The new targets seek to decrease average sodium intake from approximately 3,400 mg/day to 3,000 mg/day, about a 12% reduction, over the next 2.5 years, acting FDA Commissioner Janet Woodcock, MD, and Susan Mayne, PhD, director of the FDA’s Center for Food Safety and Applied Nutrition, said in joint statement.
Although this reduction keeps the average intake above the recommended limit of 2,300 mg/day for individuals 14 years and older as per the Dietary Guidelines for Americans, “we know that even these modest reductions made slowly over the next few years will substantially decrease diet-related diseases,” they added.
The FDA first proposed recommendations for reducing sodium content in draft guidance released in 2016.
Since, then a number of companies in the food industry have already made changes to sodium content in their products, “which is encouraging, but additional support across all types of foods to help consumers meet recommended sodium limits is needed,” Dr. Woodcock and Dr. Mayne said.
They emphasized that the new guidance represents short-term goals that the food industry should work to meet as soon as possible to help optimize public health.
“We will continue our discussions with the food industry as we monitor the sodium content of the food supply to evaluate progress. In the future, we plan to issue revised, subsequent targets to further lower the sodium content incrementally and continue to help reduce sodium intake,” Dr. Woodcock and Dr. Mayne said.
AHA: A good first step that does not go far enough
In a statement, the American Heart Association said the new targets will play “a critical role in helping people across the country achieve healthier levels of sodium and improved well-being overall. These targets will be an important driver to reduce sodium consumption, which can have significant health benefits and lead to lower medical costs.”
“Lowering sodium levels in the food supply would reduce risk of hypertension, heart disease, stroke, heart attack, and death in addition to saving billions of dollars in health care costs over the next decade,” the AHA said.
But the AHA also said lowering sodium intake to 3,000 mg/day is not enough.
“Lowering sodium further to 2,300 mg could prevent an estimated 450,000 cases of cardiovascular disease, gain 2 million quality-adjusted life-years, and save approximately $40 billion in health care costs over a 20-year period,” the AHA said.
The AHA is urging the FDA to “follow [this] action with additional targets to further lower the amount of sodium in the food supply and help people in America attain an appropriate sodium intake.”
A version of this article first appeared on Medscape.com.