Pfizer to file COVID-19 vaccine emergency use authorization with FDA - Business Insider

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Pfizer said the vaccine, which it is developing with BioNTech, was 95% effective at preventing COVID-19 in a late-stage trial.
Pfizer and BioNTech are about to request that the US Food and Drug Administration review their coronavirus vaccine for emergency authorization.

The vaccine was 95% effective at preventing COVID-19 in a late-stage trial.

The FDA has said it might take weeks to review the shot and decide whether it will authorize it.

The complicated logistics of delivering vaccines and ensuring each person gets properly immunized could mean most Americans won't get access to the immunization until mid-2021.

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Pfizer and BioNTech will on Friday ask regulators to sign off on the emergency use of their coronavirus vaccine, a step that could allow the shot to be given more widely.

Pfizer said Friday that it was preparing to file for an emergency use authorization with the US Food and Drug Administration, days after announcing that the vaccine was 95% effective at preventing COVID-19 in a late-stage trial.

The drugmaker added that it planned to submit applications to other agencies worldwide in the coming days.

Pfizer said that of the 170 cases of COVID-19 seen in the clinical trial, 162 of those illnesses occurred in people who got a placebo. The company also said the vaccine did not cause serious side effects, and may prevent severe disease.

The results have not been published in a medical journal or peer-reviewed by other scientists. It's not clear how long protection from the shots lasts or whether vaccinated people could still spread the disease.

Moderna, a biotech company, is also planning to seek emergency authorization from the FDA for its vaccine. Moderna said its…
Allana Akhtar
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