FDA authorizes Pfizer-BioNTech Covid-19 vaccine
The first Covid-19 vaccine has arrived in America.
The FDA issued an emergency use authorization for the Pfizer-BioNTech vaccine late Friday, marking a historic turning point in the fight against a deadly pandemic, but that one will still leave a long road ahead as the Big Pharma and federal officials try to scale up and roll out limited doses while the virus continues to ravage the US.
The EUA comes 24 hours after a committee of outside experts voted 17-4 to recommend the agency authorize the vaccine. In a 44,000-person Phase III trial, the vaccine was 95% effective at preventing symptomatic Covid-19 and did not trigger serious adverse events, although it did induce mild symptoms such as headache and fatigue. The data was publicly reviewed by the FDA and published in The New England Journal of Medicine.
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