PHILADELPHIA (KYW Newsradio) — Pfizer is asking the Food and Drug Administration to greenlight its COVID-19 vaccine for kids under the age of 5. The low-dose shots could be approved by the end of the month.
Pfizer and partner BioNTech are now in the process of submitting clinical trial data to the FDA. They are looking for the agency to amend the emergency use authorization that’s on the books so kids between 6 months and 4 years old can get their shots.
About 19 million kids are a part of the only age group left that is not yet eligible to be vaccinated.
It would be two doses to start. Studies on a possible third dose need to be completed. Each dose is 3 micrograms — one-tenth of what adults get.
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As for what the timeline looks like, the FDA said its vaccine advisory panel will be meeting on Feb. 15.
“I can tell you, everybody that sits around the table at the FDA vaccine advisory committee is a skeptic, and we’re not going to approve this until we’re comfortable that we would give it to our own children or our own grandchildren,” said committee adviser Dr. Paul Offit, of the Children’s Hospital of Philadelphia.
If the FDA gives the OK, this may be added to the Center for Disease Control and Prevention’s previously scheduled meeting with vaccine advisers on Feb. 23 and 24. Shortly thereafter, CDC Director Dr. Rochelle Walensky would make the final decision.
