Pfizer Seeks Approval for COVID Vaccine for Kids Under 5
Pfizer is expected to request emergency use authorization for its vaccine for kids ages 6 months to 4 years old, according to multiple reports.
They’ll ask for a two-dose regimen while they continue to research how well three doses works, according to The Washington Post.
Dr. Yvonne Maldonado, the principal investigator in the Pfizer vaccine clinical trial at Stanford for young kids, explained why three doses may be needed.
“The vaccine trials that have been done so far in the under 5-year-old children have demonstrated strong safety, but just not the degree of antibody response especially in 2 to 4-year-olds,” she said. “So it’s hopeful that a third dose in under 5-year-olds will provide a strong antibody response.”
If approved, kids will get one-tenth the dose adults receive.
“I think we have to be a little careful here. I’m sure the FDA and CDC will weigh all of the evidence very, very carefully but I don’t think this is necessarily a slam dunk,” said Dr. George Rutherford, head of infectious disease epidemiology at UCSF.
He added that it may be trickier because data on the third dose still needs to come in.
“We really need to think in terms of these mRNA vaccines, we really need to think in terms of a three-dose series rather than two doses and some mythic booster down the line. These are really three-dose series,” he said. “Let’s have a real close look at the data and make the most prudent decision. We have to be extra, the layers of safety for younger children are even higher.”
The New York Times reported that, “If Pfizer waited for data on a three-dose regimen, the data would not be submitted until late March and the vaccine might not be authorized for that age group until weeks later, according to multiple people familiar with the situation.”
But if the two-dose series is approved, the vaccine could be ready by the end of February.