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European regulators to assess first COVID-19 vaccine by Dec. 29

WASHINGTON: The European Medicines Agency (EMA) will meet by Dec. 29 “at the latest” to decide if the coronavirus vaccine developed by Pfizer and BioNTech is safe and effective enough to be approved, the agency announced on Tuesday.

The state of play: Pfizer and BioNTech have already submitted their vaccine for emergency authorization with the U.S. Food and Drug Administration, as well as in the U.K., Australia, Canada and Japan, per AP.

The EMA also said on Tuesday that it could decide to approve the coronavirus vaccine developed by Moderna Inc. as early as Jan. 12 if the data the company submitted proved the vaccine’s safety and effectiveness.

EMA said it had already begun a “rolling review” on the Moderna vaccine based on laboratory data previously submitted, but will now start reviewing data on how well the vaccine triggers an immune response against the virus.

The big picture: The EMA’s announcement comes almost two weeks after Pfizer said that its coronavirus vaccine is 95% effective and has no serious side effects. Moderna said it filed for an emergency use authorization with the FDA and the EMA this week, and that its vaccine is 94.1% effective.

What to watch: Initial vaccine distribution could begin around the world before the end of the year.

Courtesy: (Axios)

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