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The Food and Drug Administration released documents detailing Moderna's coronavirus vaccine candidate's "favorable safety profile" on Tuesday ahead of the Vaccines and Related Biological Products Advisory Committee meeting scheduled for Thursday.
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The documents revealed no safety objections from the FDA, which puts a second vaccine closer to approval. Pfizer and BioNTech vaccine doses began to be administered Monday after approval last week.
"Safety data from a November 11, 2020 interim analysis of approximately 30,350 participants … with a median of 7 weeks of follow-up after the second dose supported a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA," according to an FDA document. "These safety data are the primary basis of FDA’s safety review."
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Moderna, a Massachusetts-based biotech company, requested emergency use authorization for its vaccine candidate on Nov. 30.