FDA announces key panel meetings on Moderna, J&J boosters, vaccines for kids
The Food and Drug Administration (FDA) has scheduled key advisory panel meetings in the coming weeks to discuss booster doses of both Moderna and Johnson & Johnson’s COVID-19 vaccines, mixing and matching vaccine doses, and vaccines for children ages 5 to 11.
The first meetings, on the boosters for Moderna and Johnson & Johnson, will take place Oct. 14 and 15. The panel will also discuss the available data on using a booster of a different vaccine than the one used for a person’s primary series.
It’s likely that some more Americans, especially those age 65 and older who received Moderna and those who received Johnson & Johnson’s vaccine, will need boosters. The meetings are part of the process to determine which of the vaccine recipients will be eligible.
After the FDA panels meet to recommend whether to authorize additional doses, the agency will determine whether to accept the recommendation. Then, the Centers for Disease Control and Prevention will convene its own advisory panels to further refine the recommendation.
Both vaccines are currently authorized for emergency use to prevent COVID-19 in individuals 18 years of age and older.
The Biden administration last week authorized booster shots for certain recipients of Pfizer-BioNTech’s vaccine, though the process was messy and controversial.
Pfizer initially requested FDA approve boosters for all adults, though the agency’s advisory committee ended up narrowing the recommendation. Regulators said they were not certain there was enough data to show conclusively that immunity from the original vaccine was waning, and that a booster shot was beneficial.
In addition to the two boosters, FDA is also convening an advisory panel on Oct. 26 to discuss whether to authorize Pfizer’s vaccine for children ages 5 to 11.
The company earlier this week said it submitted initial data from clinical trials, though it was not yet a formal application for emergency authorization.
FDA said it was announcing the hearing “in anticipation of the request.”
The FDA is under pressure to move quickly on vaccines for children. More than 100 lawmakers wrote to the agency in August asking for a timeline, and many experts see vaccinating children as a key step to ending the pandemic.
Top FDA officials provided an update earlier in September, though they said they could not offer an exact date for an authorization.
“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.