We may be a step closer towards a two-dose vaccine for our youngest children, aged 6 month to 5 years-old, but head’s up that there will probably be a recommended third dose before long. Here’s why.
The New York Times reported a study by Pfizer-BioNTech (which included about 1,200 children younger than two and about 1,500 between two and four) proved safe, but children aged two to four didn’t show as strong a response to the vaccine as the ones aged six months to two years.
Now, the vaccine manufacturer is eying a third dose for children, but the FDA—in an unusual move—is sending signals that they’d like to review the data for the two-dose regimen in children ages five and under. Why the rush? Dr. Janet Woodcock, the acting F.D.A. commissioner, and Dr. Peter Marks, an agency regulator who oversees its vaccines office, said on Tuesday that it was important to act quickly given the surge in Omicron cases, which has now peaked in many parts of the country, and the likelihood that other variants will follow.
Scientists and researchers seem to agree that there’s no downside to authorizing the use of a two-dose regimen, but according to Albert Bourla, Pfizer’s chairman and chief executive, “ultimately, we believe that three doses of the vaccine will be needed for children six months through four years of age to achieve high levels of protection against current and potential future variants.” If two doses are authorized in the meantime, “parents will have the opportunity to begin a Covid-19 vaccination series for their children while awaiting potential authorization of a third dose.”
The approval of a two-dose vaccine for children younger than five must be first authorized by the F.D.A., then voted on by a panel of the C.D.C. Finally, Dr. Rochelle Walensky, the agency’s director, must decide whether the C.D.C should recommend the shots as government policy.
Bottom line: don’t get in line yet. But considering the C.D.C. released a study that of hundreds of pediatric hospitalizations in six cities last summer where nearly all of the children who became seriously ill had not been fully vaccinated, you should definitely keep an eye on this as it progresses along the approval process.
—Shelley Massey
Photo by CDC via Pexels
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