FDA Announces Postponement of Approval of COVID Vaccine for Babies and Young Children

Young girl with a blue shirt on getting a vaccine


The Food and Drug Administration (FDA) and Pfizer said Friday they are delaying their plan for Pfizer’s Emergency Use Authorization (EUA) for its coronavirus vaccine for children under 5 years old due to insufficient data on the efficacy of a third dose.

Pfizer announced February 1 FDA had asked the drug company, and its partner BioNTech, to submit data on a COVID vaccine series for babies as young as 6 months old and young children up until age 5.

FDA Acting Commissioner Janet Woodcock, M.D. and Director of the Center for Biologics Evaluation and Research Peter Marks, M.D., Ph.D., said in the statement Pfizer informed the agency “new data recently emerged,” leading FDA to believe “additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.”

The agency is “postponing” its meeting of the Vaccines and Related Biological Products Advisory Committee meeting, which was originally scheduled for February 15, the FDA officials said.

“Given that the study is advancing at a rapid pace, the companies will wait for the three-dose data as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” the drug company partners said in a statement reported by CNBC.

Pfizer said more data are needed “because rates of infection and illness remain high in children of this age” due to the newer Omicron variant.

On Friday, The New York Times called the announcement a “striking reversal” that came about after the discovery of “new, disappointing data.”

The report noted:

The turnabout came as the Centers for Disease Control and Prevention released data on Friday showing that booster shots of the Pfizer and Moderna vaccines lose some of their effectiveness against emergency room visits and hospitalizations by the four-month point. The agency said the data was some of earliest evidence on the durability of boosters. While it showed three doses offered better protection than two, it raised sobering questions about how long that protection lasts against severe disease.

Woodcock and Marks framed the postponement as an example of how they “have always followed the science”:

Given the recent omicron surge and the notable increase in hospitalizations in the youngest children to their highest levels during the pandemic so far, we felt it was our responsibility as a public health agency to act with urgency and consider all available options, including requesting that the company provide us with initial data on two doses from its ongoing study.

As The Star News Network reported, the move to authorize a coronavirus vaccine for the youngest children created a firestorm, since other countries have already recommended against vaccinating children under 12, noting the benefits do not outweigh the risks, Reuters reported.

“With the knowledge we have today, with a low risk for serious disease for kids, we don’t see any clear benefit with vaccinating them,” Sweden Health Agency official Britta Bjorkholm said during a recent news conference.

A study from the UK, published in January at Science Direct, found that even children with immune system impairments or vulnerabilities were not at higher risk for serious COVID illness.

Researchers studied 1,527 children and young adults considered to be “immunocompromised” and found COVID infections occurred in the participants “with no increased risk of severe disease,” and no deaths.

Children’s Health Defense (CHD) lists other studies demonstrating that most children are not at risk for developing severe illness from COVID and, therefore, do not require vaccination.

“There is no COVID emergency for children under five years old,” the organization states. “Children have a 99.995% recovery rate, and a body of medical literature indicates that almost zero healthy children under five years old have died from COVID.”

The New York Post reported FDA’s Marks, the agency’s chief vaccine regulator, said in a teleconference a delay in the approval for the vaccines for young children will serve to reassure parents.

“And we follow the science in making sure that anything that we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products,” he said.

Marks added the postponement “was not based on the dropping numbers of cases” reported in the United States.

“It’s still a staggering number of cases each day that we’re having,” he said. “Since the early days of the pandemic, we’ve always followed the science in this ever-changing situation.”

The Hill reported Friday Marks “did not directly answer” when asked if the data indicated two doses of the vaccine did not provide sufficient protection.

“The data that we saw made us realize that we needed to see data from a third dose in the ongoing trial in order to make the determination that we could proceed with doing an authorization,” Marks reportedly said.

In October, FDA authorized the Pfizer vaccine for children aged 5-11 years. Dr. Eric Rubin, a member of the FDA independent advisory panel and also editor-in-chief of New England Journal of Medicine, said in voting to approve it, “We’re never gonna learn about how safe the vaccine is until we start giving it.”

“That’s just the way it goes,” he added.

In late January, White House chief medical advisor Dr. Anthony Fauci said during a press conference he expected the coronavirus vaccine for children under four years of age to consist of three doses.

“Dose and regimen for children 6 months to 24 months worked well, but it turned out the other group from 24 months to 4 years did not yet reach the level of non-inferiority, so the studies are continued,” Fauci said, the New York Post reported.

In January Judge Mark Pittman, of U.S. District Court for the Northern District of Texas ordered FDA to release to the public the data it used to evaluate Pfizer’s coronavirus vaccine by “imposing a dramatically accelerated schedule that should result in the release of all information within about eight months,” Reuters reported.

The court rejected FDA’s request to portion out the documents over a period of about 75 years. The federal agency was responding to a Freedom of Information Act (FOIA) request filed by Public Health and Medical Professionals for Transparency, a group of doctors and scientists seeking approximately 450,000 pages of data about Pfizer’s shot.

The court “concludes that this FOIA request is of paramount public importance,” Pittman, a Donald Trump appointee, wrote.

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