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Experts question unusual authorization plan for Covid vaccine for kids under 5


The Food and Drug Administration’s willingness to consider authorizing a Covid-19 vaccine developed by Pfizer and BioNTech for children under the age of 5 — without evidence yet that it would be protective — is raising concerns among some vaccine experts who fear the plan could backfire and undermine vaccine uptake in this group. Pfizer and BioNTech confirmed Tuesday that they had been asked by the FDA to submit an application for the use of a two-dose vaccine in children 6 months to 4 years old. Data on a third shot would be submitted to regulators once they became available in the spring — ostensibly clearing the way for the agency to authorize a three-shot regimen for the youngest children who can get vaccinated. If the two-dose series is authorized by the FDA and the Centers for Disease Control and Prevention, potentially sometime this month, parents who want to vaccinate children under 5 could begin to do so before Pfizer has proven that the va

STAT News - February 2, 2022

View the full story here: https://www.statnews.com/2022/02/02/worry-vaccinating-under-5-could-backfire/