The U.S. Food and Drug Administration (FDA) on Friday set dates for key meetings that could have a major impact on the U.S. vaccination effort and the drive to get booster shots in arms – including the potential authorization of vaccines for children as young as 5 years old.
The FDA announced that it has set meetings for its influential Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss newly available data for the currently available COVID-19 vaccines. Currently, in the United States, the vaccines from Moderna and Johnson & Johnson have received Emergency Use Authorization (EUA) from the FDA, while the Pfizer-BioNTech vaccine has received the FDA’s full approval.
“Vaccines are one of the most important interventions for bringing an end to the ongoing pandemic,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “It’s critical that as many eligible individuals as possible get vaccinated as soon as possible.”
On Thursday, Oct. 14, and Friday, Oct. 15, the VRBPAC will meet to discuss authorizations for booster doses of the Moderna and Johnson & Johnson COVID-19 vaccines. The Thursday meeting will be devoted to Moderna’s two-dose mRNA vaccine, and Friday’s will discuss a second dose of J&J’s single-shot jab. Both vaccines are currently authorized for Americans 18 and older. In August, the FDA authorized a third dose of the Moderna vaccine for certain immunocompromised people.
The news comes as the White House reports that the booster effort is off to a “very strong start.”
“We estimate that by day’s end, almost 2 million Americans will have rolled up their sleeves and gotten a booster shot,” White House coronavirus response coordinator Jeff Zients said at a briefing Friday.
Also on the Oct. 15, the panel will hear a presentation from the National Institute of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) about “mixing and matching” booster doses, and will discuss that data.
“Once vaccinated, we want to ensure that individuals continue to be protected against the adverse effects of COVID-19,” Marks continued. “The available data make clear that protection against symptomatic COVID-19 in certain populations begins to decrease over time, so it’s important to evaluate the information on the use of booster doses in various populations.”
On Tuesday, Oct. 26, in anticipation of a request from Pfizer to amend its EUA, the VRBPAC scheduled a meeting to discuss authorizing the Pfizer-BioNTech mRNA vaccine in children 5-11, a milestone which many parents nationwide are eagerly awaiting.
“We know from our vast experience with other pediatric vaccines that children are not small adults, and we will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population, which may need a different dosage or formulation from that used in an older pediatric population or adults,” Acting FDA Commissioner Janet Woodcock said in a statement.
California Gov. Gavin Newsom announced Friday that the state will mandate COVID-19 vaccinations for all school children once the FDA gives full approval for those age groups.
All of the meetings will be streamed live on the FDA’s YouTube page, other social media platforms and its website.
As of Thursday, Sept. 30, more than 214 people in the U.S. have received at least one dose of a COVID-19 vaccine, or 64.6% of the U.S. population, with more than 184 million fully vaccinated, accounting for 55.6% of the total population, according to data from the Centers for Disease Control and Prevention (CDC). More than 4 million people have received a booster dose of a COVID-19 vaccine, per the CDC.
