Pfizer-BioNTech and the Food and Drug Administration (FDA) have backed away from a plan for the drug company to apply for Emergency Use Authorization (EUA) of its COVID vaccine for infants and children as young as six months through four years of age.
Citing insufficient data on the effectiveness of a third dose of the vaccine, 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 a statement Friday Pfizer informed the agency “new data recently emerged”:
Based on the agency’s preliminary assessment, and to allow more time to evaluate additional data, we believe additional information regarding the ongoing evaluation of a third dose should be considered as part of our decision-making for potential authorization.
Therefore, the FDA is postponing the Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for Feb. 15. This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.
Woodcock and Marks defended themselves in their statement that, from the start of the pandemic, “we 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,” they added.
Marks said in a teleconference parents are experiencing “urgency” in getting their youngest children vaccinated, the New York Post reported, and he suggested the delay in approval for the shots for young children will actually inspire confidence in the end.
“I hope that reassures people that the process has a standard that … we follow,” he added. “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.”
Marks, FDA’s top vaccine regulator, asserted the surprising announcement of the delay “was not based on the dropping numbers of cases” reported throughout the country.
“It’s still a staggering number of cases each day that we’re having,” he continued. “Since the early days of the pandemic, we’ve always followed the science in this ever-changing situation.”
The Hill reported Friday that, when Marks was asked during a press briefing if the data indicated two doses of the vaccine did not provide enough protection, he “did not directly answer.”
“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 said.
The New York Times, nevertheless, referred to the announcement of the change in plans between the FDA and Pfizer as “a striking reversal.”
According to the Times report:
Pfizer-BioNTech asked for the delay after the companies discovered that the Omicron wave had led to a far higher rate of infection than they had previously recorded among young volunteers in their clinical trial. The new data underscored that the Omicron variant was better than the earlier Delta variant at evading the vaccine’s protection, and it showed that two doses, which had already fallen short by another measure, were not effective enough.
FDA requested Pfizer’s application for authorization for two shots for young children “weeks ago,” the Times noted, “despite disappointing results from the trial that were announced in December.”
In mid-January, CNBC reported White House chief medical advisor Dr. Anthony Fauci expressed his hope the FDA would approve Pfizer’s vaccine for babies and toddlers in February.
Fauci also said, according to the report, younger children would likely need three doses, since two shots did not produce a durable immune response in the drug company’s clinical trials with two-to-four-year-olds.
Children’s Health Defense, however, asserted a COVID vaccine for children is not necessary at all:
FDA’s announcement of the reversal also came on the same day the Centers for Disease Control and Prevention (CDC) released data showing the COVID booster shots are not durable, losing much of their effectiveness after a few months. The published data raises the concern that Americans will be told they need a fourth shot to be protected and to comply with vaccine mandates.
On February 1, Pfizer CEO Albert Bourla announced that, in response to a request from FDA, the company would be submitting its data on its vaccine trials for babies and children under five.
“Ultimately, we believe that three doses of the vaccine will be needed for children 6 months through 4 years of age to achieve high levels of protection against current and potential future variants,” Bourla said. “If two doses are authorized, parents will have the opportunity to begin a COVID-19 vaccination series for their children while awaiting potential authorization of a third dose.”
Daniel Horowitz, senior editor at The Blaze, and host of the Conservative Review podcast, wrote upon Pfizer’s announcement, “It’s utterly senseless.”
“Pfizer is now asking to authorize a dangerous, outdated shot for babies and toddlers, for whom the virus does not pose a statistical risk and for a virus against which the shots have failed to show any benefit,” Horowitz explained:
They are quite literally pushing a shot with the hopes of ameliorating symptoms (not stopping transmission) of a virus that is a cold for young children and much less dangerous than RSV. But here’s the kicker: The trial they conducted showed that two doses failed to even produce positive results, and they are still working on a trial for a three-dose regimen. Plus, we have a new variant. So, what exactly are they seeking authorization for?
Ugur Sahin, M.D., CEO of BioNTech continued to maintain in a statement in the Pfizer press release, “Our vaccine has already demonstrated a favorable safety, tolerability and efficacy profile in multiple clinical trials and real-world studies for all age groups starting from 5 years old.”
Pfizer-BioNTech and FDA had hoped the vaccine for infants and young children could be approved by the end of February. The companies now expect to have data on three-dose vaccination available in April.
This content is solely for educational and discussion purposes. Any treatment undertaken in terms of COVID (or any illness) should be discussed with a licensed medical professional.