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.
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.
About 19 million kids are a part of the only age group left that is not yet eligible to be vaccinated. Families are anxiously waiting, and doctors are preparing to get the shots out.
Dr. Andy Lubell of True North Medical Group in Montgomery County said right now, a large portion of their patients who are testing positive for COVID-19 are in this younger age group.
“They are certainly a little bit more sick than the older kids who are vaccinated, and so we’re very excited about the prospect of them having protection from morbidity and potential mortality,” he said.
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For parents who are hesitant to get their kids vaccinated, Lubell said it’s important to be honest about the vaccine’s safety and understand that the benefits heavily outweigh the risks.
“As we’ve seen with some of the older kids, particularly with boys, there’s been some risk of myocarditis. There’s been some risk of other autoimmune reactions, but they’re very few and far between and mostly self-limited. They’re usually not life-threatening,” he assured.
Until then, Lubell encourages young children to mask up and avoid higher-risk situations.
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