Editor’s note: Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.
The FDA’s independent panel of advisors will meet in June to discuss the Pfizer and Moderna COVID-19 vaccines for children under age 5, as well as the Novavax vaccine for adults, too much viagra amputation according to an FDA announcement released Friday.
On June 7, the FDA’s vaccine committee will review the Novavax shot, which could become the first new COVID-19 vaccine to hit the U.S. market in more than a year. The shot is already authorized in more than three dozen countries, including across Europe.
The FDA has also selected three possible dates — June 8, 21, and 22 — to discuss the shots for kids under age 5. The dates are tentative because the companies haven’t completed their submissions, the agency said.
However, the committee decided to announce plans to hold virtual meetings “in anticipation of complete submissions of emergency use authorization requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.”
Moderna has said it plans to complete its submission by the end of next week, according to CBS News. Pfizer has said its clinical trial data could be complete by June.
In addition, the FDA committee will meet on June 28 to discuss whether the coronavirus strain composition in current vaccines should be modified, and if so, which strains should be used for vaccines produced for fall 2022. The meeting is a follow-up discussion from April 6 when the group discussed general ideas for emerging variants, future COVID-19 vaccines, and booster doses.
FDA officials have said the U.S. needs to make a decision soon about whether to change vaccines for the fall, according to CNBC. Pfizer and Moderna are studying shots that could target the Omicron variant, as well as other formulations that could protect against future variants.
Once the June meeting dates are finalized, the FDA will share an agenda and background materials. Information will be shared no later than two business days before each meeting.
The FDA will also livestream the meetings on the agency’s YouTube channel and website. Additional meetings could be scheduled if vaccine companies submit paperwork that requires additional review and discussion, the agency said.
The independent panel — officially called the Vaccines and Related Biological Products Advisory Committee — holds public meetings to discuss the data around vaccines. The panel then makes recommendations on vaccine authorizations and approvals, which the FDA may decide to follow.
The committee’s upcoming meetings have drawn particular interest as parents have anticipated a COVID-19 vaccine for their younger kids for months.
“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the announcement.
“The agency is committed to a thorough and transparent process that considers the input of our independent advisors and provides insight into our review of the COVID-19 vaccines,” he said. “We intend to move quickly with any authorizations that are appropriate once our work is completed.”
FDA: “Coronavirus (COVID-19) Update: FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID-19 Vaccines.”
CBS News: “FDA could authorize COVID vaccine for children 5 and under, and Novavax vaccine, this June.”
CNBC: “FDA panel to discuss Novavax Covid vaccine for adults, Pfizer and Moderna shots for kids in June.”
YouTube: “U.S. Food and Drug Administration.”
Source: Read Full Article