Pfizer to request emergency FDA approval for its COVID-19 vaccine

Pfizer to request emergency FDA approval for its COVID-19 vaccine


Pfizer and BioNTech said they will ask the feds for emergency approval of their experimental coronavirus vaccine on Friday, a key step that could make the shot available next month.

The Manhattan-based drugmaker and the German biotech firm will be the first to seek a so-called emergency use authorization in the US for their COVID-19 inoculation, which was 95 percent effective and posed no serious safety concerns in a major clinical trial.

The vaccine could be distributed to “high-risk populations” in the US by mid- to late December if the Food and Drug Administration approves the request, the companies said in a news release.

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“Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer CEO Albert Bourla said in a statement.

The application boosts US

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