FDA delays meeting on COVID-19 vaccine for children under 5 to review more data

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The U.S. Food and Drug Administration has delayed a meeting a few COVID-19 vaccine for children youthful than 5 that was initially scheduled to happen subsequent week, elevating questions on after they’ll have the ability to get vaccinated in opposition to the lethal virus. The FDA stated it needs to see more data from Pfizer earlier than continuing.

Kids youthful than 5 are the one age group within the U.S. that can’t but get the vaccine.  

The FDA stated it’s suspending a meeting by an skilled panel — scheduled for February 15 — to give the company time to contemplate extra data, “allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines.”

Given the current rise in baby hospitalizations amid the Omicron surge, the panel had been anticipated to resolve if children under 5 ought to begin getting Pfizer’s vaccine in two doses, earlier than data on a 3rd potential dose was evaluated. But now, the FDA stated it believes “additional information regarding the ongoing evaluation of a third dose should be considered.”

“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 stated in an announcement. 

Pfizer and BioNTech said they anticipate to have data on three vaccine doses in early April.

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