Surgeon General reassures parents FDA won't cut corners on under-5 vaccine review

The FDA could make its decision in late February on whether to authorize a COVID vaccine for the last group still not eligible for shots: toddlers and preschoolers, between the ages of 6 months and 5.

The US Surgeon General Dr. Vivek Murthy is trying to reassure parents the CDC and FDA reviews of the study data will be thorough.

"There are a number of steps ahead to determine if the vaccine is both safe and effective for our kids under 5," Dr. Murthy says. "And, please know that the FDA will not cut any corners in their review process."

In December, Pfizer and its vaccine partner BioNTech announced the companies' two-dose vaccine performed well in the youngest group of children under 2, but failed to produce an effective immune response in children 2 to 4.

That raises a question about whether a third dose may be needed, although Pfizer is applying for emergency authorization of only its two-dose vaccine.

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The company is moving forward with its study of a three-dose vaccine.

Dr. Murthy says parents may be wondering what's changed since the initial disappointing study findings in December.

His answer: the omicron surge.

In January alone, over 3.5 million children tested positive for COVID-19, according to the American Academy of Pediatrics.

"With many children in particular, as well as adults, being infected and ending up in the hospital during the Omicron surge, it turns out that has actually facilitated the collection of important clinical data, additional clinical data that we did not have in December," Murthy says.  "Whether that changes the risk-benefit profile is what the FDA will be assessing."

Parents of younger children are divided on the vaccine.

A Kaiser Family Foundation survey released Tuesday found about 30% of parents of toddlers and preschoolers plan to get them vaccinated as soon as the under-5 vaccine is approved.

White House Coronavirus Response Coordinator Jeff Zients says the Biden Administration has secured enough under 5 vaccine to meet demand, and it will be ready to ship as soon as the FDA and CDC make a decision.

"We cannot begin actually packing and shipping until the FDA authorization, and then there’s the CDC/ACIP process, which generally takes place a matter of days after the FDA,"

Once the CDC makes its recommendation, he says it could take a few days to a week to roll out the vaccine.

"But we’ll move as fast as possible, pending the decision of CDC and FDA," Zients says. "I think the preparation we’re doing now will enable us to do so."

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