FDA Delays Controversial COVID-19 Vaccine Decision for Young Children

The FDA’s decision on granting an emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years old will be delayed.

The FDA is postponing its Vaccines and Related Biological Products Advisory Committee meeting originally scheduled for February 15. Pfizer notified the agency about new data from its ongoing clinical trial, the FDA said in a statement.

“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,” the FDA said.

FDA’s move to consider the EUA in children under 5 years old has come under fire, in part, because Pfizer and BioNTech’s interim trial results suggested that two doses of the vaccine did not produce a strong immune response in children 2 through 4 years old, per The New York Times.

The FDA’s rush, the advisory committee meeting and the potential EUA alarmed some experts.

“We’ve never done that before, that’s what gives me some pause,” Dr. Gregory Poland, founder and director of the Mayo Vaccine Research Group in Minnesota, and editor in chief of the journal Vaccine, told The New York Times. “I don’t like that there isn’t more data.”

Plus, “with the ebbing of the Omicron surge, many scientists feel the agency could afford to wait for results on the third shots, which are expected in just a few weeks,” The New York Times said.

Other experts are concerned about the agency issuing a EUA for COVID-19 vaccines for the younger age group.

A study published in Nature demonstrated that children under 18 with no comorbidities have virtually no risk of death. In addition, a large study conducted in Germany showed zero deaths for children under 5-years-old and a case fatality rate of three out of a million in children without comorbidities.

“There is absolutely no COVID emergency for children under 5-years-old,” said Mary Holland, president and general counsel of the non-profit organization Children’s Health Defense, in a news release.

“Considering that healthy children have virtually zero risk of complications or death from COVID, and that the adverse events being reported following COVID vaccination are at historic rates and climbing, it’s outrageous that the FDA is even discussing an EUA vaccine for this age group,” Holland wrote.

Multiple studies have shown that children who are hospitalized with COVID tend to have conditions that predispose them to severe illness, including diabetes, chronic lung disease or heart problems, The New York Times said.

“Instead of authorizing the vaccine for all 18 million children aged 6 months to 4, the agency might consider recommending it only for children at high risk until more evidence becomes available, some experts said,” according to the publication.

Meanwhile, the FDA did not give an exact date for rescheduling the advisory committee meeting. The FDA “will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation.”

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,” the FDA said. "The goal was to understand if two doses would provide sufficient protection to move forward with authorizing the use of the vaccine in this age group.”

“Our approach has always been to conduct a regulatory review that’s responsive to the urgent public health needs created by the pandemic, while adhering to our rigorous standards for safety and effectiveness. Being able to begin evaluating initial data has been useful in our review of these vaccines, but at this time, we believe additional information regarding the ongoing evaluation of a third dose should be considered,” the FDA added.