FDA Plan to Fast-track Pfizer’s COVID Vaccine Gets Delayed

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Pfizer director Dr. Scott Gottlieb said to CNBC this week that vaccines for children under the age of 5 have been delayed due to low Covid cases in trial.

One case in one direction or another can tip the perception of the vaccine’s overall effectiveness,” said the current Pfizer board member and former FDA chief.

Gottlieb added, “I suspect there’s only going to be 15% to 20% of parents who go out and get their young kids vaccinated.”

“Most kids are not getting symptomatic Covid,” said Gottlieb.

“The FDA wanted to take the time for this data set to effectively settle down,” Gottlieb said on CNBC’s “Squawk Box.” “That point’s probably going to be after they’ve administered the third dose and have the data from that third dose.”

He further said, “At that point you’ll be able to get more of a fixed perception of the vaccine’s overall effectiveness” in that younger group, the only cohort not cleared in the U.S. for the shots.

The Food and Drug Administration had originally planned to consider authorizing two doses of what would ultimately be a three-dose vaccine for kids under 5 as soon as this month.

Last Friday the agency said that it’s now going to wait on data about the effectiveness and safety of a third dose, which Pfizer and its vaccine partner, BioNTech, have said won’t come until April.

Gottlieb said, “For the parents who were going to vaccinate their kids, this was very important.”

About 1,100 pediatric deaths have occurred from Covid since the beginning of the pandemic, with about 400 in kids under 5, the former FDA chief pointed out. By comparison, Gottlieb said, only five children have died from the flu in the last two years.

Gottlieb expects the Centers for Disease Control and Prevention to institute a “permissive recommendation,” rather than a mandate for children under 5 to get vaccinated. “They’re not going to say, ‘Children under the age of 5 should get vaccinated.’ They’ll say something like, ‘They could get vaccinated to reduce their risk,’” he said.

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