FDA delays meeting on Pfizer's COVID-19 vaccine for children under 5 to review more data
The U.S. Food and Drug Administration has delayed a meeting about a COVID-19 vaccine for children younger than 5 that was originally scheduled to take place next week, raising questions about when they'll be able to get vaccinated against the deadly virus. The FDA said it wants to see more data from Pfizer before proceeding.
Kids younger than 5 are the only age group in the U.S. that cannot yet get the vaccine. Given the recent rise in child hospitalizations amid the Omicron surge, an expert panel was expected to meet on February 15 and decide if kids under 5 should start getting Pfizer's vaccine in two doses — before data on a third possible dose was evaluated.
But now, the FDA said it believes "additional information regarding the ongoing evaluation of a third dose should be considered."
The delays gives 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."
"We 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," the FDA said in a statement.
Pfizer and BioNTech said they expect to have data on three vaccine doses in early April.
Early data from Pfizer showed that two low doses of its COVID vaccine, while safe, didn't offer enough immunity against the virus for kids of preschool age, the 2- to 4-year-olds.
Contributing: The Associated Press