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

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February 13, 2022
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FDA delays meeting on Pfizer’s COVID-19 vaccine for children under 5 to review more data
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The U.S. Meals and Drug Administration has delayed a gathering a few COVID-19 vaccine for kids youthful than 5 that was initially scheduled to happen subsequent week, elevating questions on once they’ll be capable of get vaccinated in opposition to the lethal virus. The FDA mentioned it desires to see extra information from Pfizer earlier than continuing.

Youngsters youthful than 5 are the only age group within the U.S. that can’t but get the vaccine. Given the current rise in little one hospitalizations amid the Omicron surge, an skilled panel was anticipated to satisfy on February 15 and resolve if children beneath 5 ought to begin getting Pfizer’s vaccine in two doses — earlier than information on a 3rd doable dose was evaluated. 

However now, the FDA mentioned it believes “further data relating to the continuing analysis of a 3rd dose needs to be thought of.” 

The delays offers the company time to think about the extra information, “permitting for a clear public dialogue as a part of our ordinary scientific and regulatory processes for COVID-19 vaccines.”

“We’ll present an replace on timing for the advisory committee assembly as soon as we obtain further information on a 3rd dose on this age group from the corporate’s ongoing medical trial and have a chance to finish an up to date analysis,” the FDA mentioned in a press release. 

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

Early information from Pfizer confirmed that two low doses of its COVID vaccine, whereas secure, did not supply sufficient immunity in opposition to the virus for youths of preschool age, the 2- to 4-year-olds.

Contributing: The Related Press 


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