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The Food and Drug Administration (FDA) has scheduled key advisory group meetings in the coming weeks to discuss the booster doses of Moderna and Johnson & Johnson’s COVID-19 vaccines, mixing and matching of vaccine doses. and vaccines for children aged 5 to 11.
The first meetings, on recalls for Moderna and Johnson & Johnson, will take place on October 14 and 15. The panel will also discuss the data available on the use of a booster of a different vaccine than that used for a person’s primary series.
It is likely that more Americans, especially those 65 and older who have received Moderna and those who have received the Johnson & Johnson vaccine, will need boosters. Meetings are part of the process of determining which vaccine recipient will be eligible.
Once FDA panels have convened to recommend whether or not to authorize additional doses, the agency will determine whether to accept the recommendation. Then, the Centers for Disease Control and Prevention will convene their own advisory groups to further refine the recommendation.
Both vaccines are currently authorized for emergency use to prevent COVID-19 in people 18 years of age and older.
The Biden administration last week cleared booster shots for some Pfizer-BioNTech vaccine recipients, though the process has been messy and controversial.
Pfizer initially asked the FDA to approve the boosters for all adults, though the agency’s advisory committee ended up restricting the recommendation. Regulators said they were not sure there was enough data to conclusively show that the original vaccine’s immunity was waning and that a booster was beneficial.
In addition to the two recalls, the FDA is also convening an advisory group on October 26 to discuss whether to authorize Pfizer’s vaccine for children aged 5 to 11.
The company said earlier this week that it had submitted initial clinical trial data, even though it was not yet a formal emergency clearance request.
The FDA said it was announcing the hearing “in anticipation of demand.”
The FDA is under pressure to act quickly on childhood vaccines. Over 100 lawmakers wrote at the agency in August to ask for a timeline, and many experts see childhood immunizations as a key step in ending the pandemic.
Senior FDA officials provided an update earlier in September, although they said they could not come up with an exact date for an authorization.
“We know from our extensive experience with other pediatric vaccines that children are not little adults, and we will be conducting a comprehensive evaluation of the submitted clinical trial data to support the safety and the effectiveness of the vaccine used in a younger pediatric population, which may need a different strength or formulation than that used in an older pediatric population or in adults, ”said Acting FDA Commissioner Janet Woodcock , in a press release.
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