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Pfizer/BioNTech vaccine approved by FDA for emergency use in the US

The US is due to start administering the vaccine to the public today

FDA building

The FDA announced that the Pfizer/BioNTech coronavirus vaccine, which offers up to 95% protection against COVID-19, is safe and effective.

After the emergency use authorisation, officials said the US will start administering the vaccine to the public today.

Three million doses are being distributed across locations in all 50 states in the US, with a facility in Michigan being the first to despatch a shipment on Sunday.

The Pfizer/BioNTech vaccine has already been approved for emergency use in four other countries: the UK, Canada, Bahrain and Saudi Arabia. The US will follow these countries in giving the vaccine to the elderly and health workers first.

Since November, coronavirus deaths have been rising sharply in the US, with the highest total number of deaths in a single day anywhere in the world being recorded on Saturday. That total, 3,309 Covid-related deaths, was reported on the Johns Hopkins University website.

"The FDA's authorisation for emergency use of the first Covid-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world," said Stephen Hahn, head of the FDA.

Hahn emphasised that the review process had been "open and transparent" and that authorisation was given only after the FDA had ascertained that the vaccine met the agency’s "rigorous, scientific standards for safety, effectiveness, and manufacturing quality".

On 10 December, a US FDA advisory committee panel recommended Pfizer/BioNTech’s COVID-19 vaccine for emergency use, after voting that the vaccine's benefits outweighed its risks.

Pfizer will need to file a separate application to receive full approval for the vaccine, as full approval is not included as part of the emergency use approval.

Article by
Iona Everson

14th December 2020

From: Research, Regulatory



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