Pfizer director Dr. Scott Gottlieb says Shots for kids under five delayed due to low Covid cases in trial

February 16, 2022: -On Monday, the Food and Drug Administration’s plan to fast-track Pfizer’s Covid vaccine for children under five years old was delayed because of a “low number of cases overall in the clinical trial,” Dr. Scott Gottlieb told CNBC.

“Most kids do not get symptomatic Covid,” said the current Pfizer board member and former head of the FDA. “One case in one direction or another can tip the perception of the vaccine’s effectiveness.”

“The FDA wants to take the time for this data set to settle down effectively,” Gottlieb said. “That point’s probably going to be after they’ve administered the third dose and have the data from that third dose.” He added, “At that, you’ll be able to get more of a fixed perception of the vaccine’s overall effectiveness” in that younger group, the cohort not cleared in the U.S. for the doses.

The FDA had initially planned to consider authorizing two doses of what would ultimately be a three-dose vaccine for kids under five as soon as this month. Although, the agency said on Friday 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 till April.

“I suspect there’s going to be 15% to 20% of parents who go out and get their young kids vaccinated,” should shot for children under 5 get emergency authorization, Gottlieb said. He adds, “For the parents who were going to vaccinate their kids, which was important.” He further said.

While children are overall at a lesser risk of Covid, very young kids, especially those with preexisting health conditions, are still not in the clear, Gottlieb said. The former FDA chief pointed out that about 1,100 pediatric deaths have occurred from Covid since the beginning of the pandemic, with nearly 400 in kids under 5. 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 mandate children under 5 to get vaccinated. “They’re not going to say, ‘Children under the age of 5 should get vaccinated.’ They will say something like, ‘They could get vaccinated to reduce their risk,'” he said.