FDA Advisory Committee meeting to discuss use of COVID-19 vaccine on children postponed as new data arises

Samuel Weinmann, Politics Editor

The Food and Drug Administration (FDA) recently postponed an advisory committee meeting to discuss the administration of the Pfizer-BioNTech COVID-19 vaccine for children ages 6 months to 4 years.

The FDA was notified by Pfizer that there were additional findings from its clinical use trials, and upon assessing these findings, members of the government agency decided to postpone the meeting to allow more time to gather data.

The FDA announced their decision in a public statement released Friday, saying, “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.”

According to CNN, the Pfizer vaccine initially appeared to protect infants and toddlers up to 2-years-old, but the “3-microgram dose did not produce the same immune response in 2- to 5-year-olds.”

The three microgram doses in question were the ones under regulatory review, explaining why Pfizer’s new data created concern.

This news comes at a time when many parents are anxiously awaiting approval for their children to get vaccinated. Although these changes likely bring about disappointment, the decision was defended by acting FDA Commissioner Dr. Janet Woodcock, as well as Dr. Peter Marks, the FDA director for the Center for Biologics Evaluation and Research.

The two said in a public statement, “This will give the agency time to consider the additional data, allowing for transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”

Although the meeting was postponed, discussion will resume as new data is collected through clinical use trials.

According to NPR, Marks said that the FDA “realize[s] the need for a vaccine for COVID-19…” and that they “will do… [their] part to move ahead as fast as… [they] can.”