Surgeon general says FDA won’t cut corners in approving COVID-19 vaccine for young kids

U.S. Surgeon General Vivek Murthy is assuring parents that regulators won’t take shortcuts in authorizing a COVID-19 vaccine from Pfizer-BioNTech for kids younger than 5 as the Food and Drug Administration employs a two-step process to get a jump-start on the rollout.

“Pfizer’s application will now undergo the same independent, rigorous, and transparent review process that was used to authorize the vaccines that now more than 250 million Americans have received, including millions of children ages 5 and up,” he said at a White House COVID-19 briefing Wednesday. “It will involve the FDA receiving the full data from Pfizer, posting that data publicly, and then convening its advisory committee for a transparent discussion of the data.”

Dr. Murthy moved to assure parents as Pfizer submits data on a two-dose regimen so the FDA can get input from outside advisers and then decide whether to authorize the vaccine for emergency use by the end of February. All stakeholders involved think a three-dose course might be needed to combat omicron, but they want to move ahead with initial shots before trial data on the extra dose rolls in, which could take months.

“There are a number of steps ahead to determine if the vaccine is both safe and effective for our kids under 5. And please know that the FDA will not cut any corners in their review process,” Dr. Murthy said. “They know that they are the gold standard that all of us rely on.”

It’s unclear how eager parents will be to vaccinate the youngest children, an age group that accounts for around 0.1% of COVID-19 deaths.

The Kaiser Family Foundation released polling Tuesday found only three in 10 parents of children younger than 5 said they would get their child vaccinated “right away” once able. A similar share said they want to “wait and see” how it works for other young children first, and a quarter said they would “definitely not” opt for vaccination. Another 12% said they would vaccinate their young kids “only if required.”

Dr. Murthy highlighted the groups of parents who have been eager to give their children some protection from the disease.

“I know how eager parents and caregivers are for the good news on this front. For much of this pandemic, millions of parents have carried with them an added layer of worry knowing that their children under 5 didn’t have protection from COVID the way older vaccinated children do,” he said. “I felt this worry, too, as a father of a 4-year-old daughter who is not yet eligible to get vaccinated. That’s why I’m hopeful that we may be one step closer to having an added layer of protection for our younger children, and one less worry for their parents.”

For more information, visit The Washington Times COVID-19 resource page.