FDA sets tentative June dates for meeting on young kids’ vaccine

 The Food and Drug Administration (FDA) on Friday released tentative June dates for its advisory committee to meet to discuss authorizing COVID-19 vaccines for young children, offering a rough timeline for when authorization could come.  

The agency said it is setting aside June 8, 21 and 22 for meetings of its advisory committee for vaccines for children under 5 and will provide more details once applications from Pfizer and Moderna are complete.  

That timetable suggests that if all goes according to plan, authorizations for the vaccine for children under 5 could come in June.  

Some parents have been anxiously awaiting vaccines for young children, and the timeline has been repeatedly delayed.  

Peter Marks, a top FDA vaccine official, also told The Washington Post on Friday that the agency would not delay authorization of the Pfizer or Moderna vaccine to wait for the other, responding in part to a Politico story that reported that was under consideration.  

“We are not going to delay things unnecessarily here,” Marks told the Post. “This whole concept of delaying is not something we will be doing.” 

Amid frustration from some quarters at the pace of vaccines for the youngest children, the FDA has been trying to show it “understands the urgency” while also noting that any review needs to be thorough.

“The agency understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data,” the FDA said Friday.  

Moderna on Thursday asked the FDA for authorization for its vaccine for young children, though the application will not be complete until next week.  

It said its vaccine produced a similar antibody response in children as it did in adults, a positive sign. However, the effectiveness numbers could be seen as relatively low: 51 percent for children under 2, and 37 percent for children ages 2 to 5.

Those numbers are for preventing any infection, though, and came during the omicron wave. Effectiveness against severe disease, a key metric, is expected to be higher.  

The company also said there is a “favorable safety profile.” 

https://thehill.com/policy/healthcare/3471470-fda-sets-tentative-june-dates-for-meeting-on-young-kids-vaccine/