FDA Delayed Decision on Pfizer’s Vaccine for Children Due to Low Number of COVID-19 Cases in Trial: Gottlieb

Then-Food and Drug Administration Commissioner Scott Gottlieb speaks in New York City on Oct. 10, 2017. Eduardo Munoz/Reuters

The Food and Drug Administration (FDA) pushed back a decision on whether to clear Pfizer’s COVID-19 vaccine for children under 5 because both arms of Pfizer’s clinical trial have a low number of COVID-19 cases, a Pfizer board member and former FDA commissioner says.

“Since there’s a low number of cases overall in the clinical trial—most kids are not getting symptomatic COVID—one case in one direction or another can tip the perception of the vaccine’s overall effectiveness,” Dr. Scott Gottlieb, the former FDA commissioner who now sits on Pfizer’s board, said on CNBC’s “Squawk Box.”

FDA officials analyzed data from when the trial gave children 6 months of age to 4 years old a two-dose primary regimen and determined the data was not enough for emergency use authorization.

The trial includes approximately 8,300 children 12 or younger.

“The data that we saw made us realize that we needed to see data from a third dose, as in the ongoing trial, in order to make it the term determination that we could proceed with doing an authorization,” Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, told reporters on a call.

Officials cited a preliminary assessment done by FDA experts on the trial data, but have not made that assessment or the data public. Asked for the assessment, an FDA spokeswoman declined to provide it, citing federal law. The Epoch Times has filed a Freedom of Information Act request for the document.

Before the Feb. 11 announcement of a delay, a meeting of the agency’s vaccine advisory panel was scheduled for Feb. 15. If the data were strong enough, authorization could have come within hours of the meeting.

Instead, regulators are waiting for data from the expanded trial, which is testing a three-dose primary series. That data is not expected until April, according to Pfizer and its partner, BioNTech.

A person is injected with Pfizer's COVID-19 vaccine in Dallas, Texas, in a file image. LM Otero/AP Photo

It will be easier to make a decision when the trial isn’t ongoing, Gottlieb said.

“The FDA wanted to take the time for this data set to effectively settle down. That point’s probably going to be after they’ve administered the third dose and have the data from that third dose, that they’re going to have a complete dataset that isn’t continuing to evolve, that the Omicron wave will have passed, that children will have received that dose, and gotten maximal efficacy. At that point you’ll be able to get more of a fixed perception of the vaccine’s overall effectiveness,” he said.

Pfizer’s COVID-19 vaccine is available to all Americans 5 or older, and is the only one available to youth 17 and younger.

Because of waning effectiveness against the Omicron variant of the CCP (Chinese Communist Party) virus, which causes COVID-19, U.S. officials recommend all Americans 12 and older get a booster shot, or a third dose, of Pfizer’s vaccine. Some children 5 to 11 with weakened immune systems can also get an additional dose.

Children who contract COVID-19 are much more likely than other populations to show no symptoms, and are at little risk of contracting severe COVID-19. A small number have been hospitalized, with a subset dying. The rate of hospitalizations attributed to COVID-19 among children has risen since Omicron emerged in late 2021. Just 11 children died after being admitted to hospitals with the disease between July 1 and Dec. 18, 2021, and none died between Dec. 19 and Dec. 31, 2021, researchers found in an analysis of hospitals in 14 states published Tuesday.