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After nearly a year of waiting and wondering, we finally have a tentative timeline for when COVID-19 vaccines for children aged 5 to 11 might be authorized. The White House announced a plan today that hinges on FDA and CDC decisions, which should be finalized by Nov. 3 if all goes well. There is as yet no timeline for vaccines for children younger than 5.
The upcoming decisions will cover Pfizer shots, specifically; Pfizer has asked the FDA to expand its emergency use authorization (EUA) to include children aged 5 to 11. Making this happen involves a few government agencies, and they meet in order, like so:
The FDA’s advisory panel on vaccines, VRBPAC, will meet on Oct. 26 to discuss Pfizer’s application and vote on whether the vaccine should be authorized for kids 5 to 11. This meeting is public, and you can tune in here.Shortly afterward, the FDA will issue its official decision. If the advisory panel votes yes, it’s likely that the FDA will grant the authorization. Next, the CDC’s advisory panel on vaccines, ACIP, meets to discuss and vote on who should be recommended to get the vaccine. This meeting is also public, and the webcast link will be shared here.Shortly afterward, the CDC makes their official recommendation. Keep an eye on the news.According to the White House, “we will be ready to begin getting shots in arms in the days following a final CDC recommendation.”When will we know if the vaccine is safe for children?
The agencies will be looking over safety and efficacy data submitted by Pfizer, and potentially other data that may be available. If there are any concerns about whether the vaccine is safe enough or effective enough, we’ll hear about them during this process.
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One of the key moments to pay attention to will happen just prior to the Oct. 26 meeting: Staffers at the FDA usually prepare a report with their interpretation of the submitted data and post it publicly on the VRBPAC meetings page. (Expect it to be uploaded here, toward the bottom, labeled something like “Briefing document - FDA.”) Major news outlets will report on this, since the FDA’s take on the data is the first big clue about whether it’s up to snuff.
As both a parent and a health reporter, I’ll be watching for that document and the reaction to it. If there are red flags, that might mean the vaccine won’t be authorized or recommended according to the proposed timeline. After all, the November preparations are only for if the vaccine is judged to be safe and effective.
By Halloween the FDA will have likely made their decision; it’s the FDA that decides whether the vaccine should be on the market, while the CDC makes recommendations about who should get it. If the FDA thinks the vaccine looks good, the CDC phase should be pretty smooth and straightforward. On the other hand, if the FDA’s panel had concerns about the vaccine’s safety or efficacy in certain groups of people, the CDC may decide not to recommend it for those groups. And if the FDA were to give a flat-out “no,” the CDC panel probably won’t even bother to meet.
When can I make an appointment for my kid’s vaccine?
According to the White House’s plan, the federal government has already purchased enough of the Pfizer vaccine to supply all 28 million 5-to-11-year-olds in the U.S.
In addition to the places where adults can already get vaccines, there will be new vaccine clinics set up specifically to reach kids. The plan notes these will include:
Pediatricians’ officesChildren’s hospitalsPharmaciesSchool and community clinicsCommunity health centers and rural health centersKeep an eye out in your community for these clinics to be announced, and consider asking your child’s school or pediatrician if they have plans to start giving the vaccine. Unlike other vaccines, which are purchased by healthcare providers, all COVID-19 vaccines are currently paid for by the federal government and distributed to authorized vaccination sites. According to the White House’s plan, these sites will be able to start giving vaccines “within days” of the final recommendation from the CDC—and it looks like that could mean the first week of November.
