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Pfizer, Moderna ask for emergency approval of COVID-19 vaccines in Europe

Pfizer, Moderna ask for emergency approval of COVID-19 vaccines in Europe
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Pfizer and Moderna have asked for emergency approvals of their COVID-19 vaccine candidates in Europe, the region’s health regulatory agency announced on Tuesday. 

Both companies filed for conditional marketing authorizations, the European Medicines Agency (EMA) said. 

The agency said a decision could be issued “within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.” 

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The EMA’s Committee for Human Medicinal Products began a “rolling review” of Pfizer and BioNTech’s vaccine candidates on Oct. 6, and is expected to conclude its review by Dec. 29. The committee started a separate rolling review of Moderna’s vaccine on Nov. 16, and will finish this review by Jan. 12. 

Pfizer CEO Albert Bourla said in a statement on Tuesday that the filing “marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need.” 

Pfizer and its German partner, BioNTech, requested emergency use authorization for its COVID-19 vaccine candidate from the Food and Drug Administration (FDA) in November after unveiling final data that showed its vaccine to be 95 percent effective “against COVID-19 beginning 28 days after the first dose.” 

Moderna, which said its vaccine was 94.1 percent effective in preventing COVID-19 and 100 percent effective against severe COVID-19, announced that it filed for emergency FDA authorization on Monday. 

The FDA’s Vaccines and Related Biological Products Advisory Committee is expected to hold separate meetings later this month to evaluate the vaccine candidates. A Centers for Disease Control and Prevention panel is expected to vote Tuesday on vaccine distribution plans in the U.S.