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COVID vaccine authorization for younger children delayed, FDA seeks more data

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eMediNexus    12 February 2022

Pfizer and BioNTech had submitted a request with the US Food and Drug Administration in the first week of February seeking emergency use authorization of their vaccine in children aged 6 months to 5 years. The agency’s Vaccines and Related Biological Products Advisory Committee had to meet on February 15 to review the data from vaccine trials and make a recommendation on whether the vaccine should be authorized. However, considering the fact that new data have emerged, the FDA has postponed the meeting. 

The Washington Post reported that while the data supported the safety of the vaccine, the data on effectiveness was rather disappointing. Dr. Peter Marks, director of the FDAs Center for Biologics Evaluation and Research, said that the FDA has to see data from an ongoing trial of a third dose of the vaccine in these younger children to go ahead with the emergency use authorization… (CNN, February 12, 2022)

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