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Just received your Critical Emergency Use Authorization (USA) in the USA, Pfizer (NYSE: PFE) and BioNTechis (NASDAQ: BNTX) The coronavirus vaccine has received similar approval in Europe.
Both companies announced on Monday that their BNT162b2, which will also be known in Europe under the brand name Comirnaty, has received a conditional marketing authorization (CMA) from the European Commission (EC) for patients 16 years of age or older.
This is roughly the equivalent of the US EUA in that it is the culmination of a fast-track approval process for a vaccine or drug that combats serious health threats, such as coronavirus. The CMA is valid for one year.
Image source: Getty Images.
This approval means that the Pfizer and BioNTech vaccine can now be used in all 27 countries of the European Union (EU).
“We are grateful that this authorization is bringing hope to people across the continent as we look forward to turning this crisis around and heading into the new year,” said Pfizer CEO Albert Bourla in announcing the news. of the company.
The companies will immediately start distributing doses of the vaccine throughout the EU in accordance with the EC’s contract and distribution terms. Pfizer and BioNTech have agreed to supply 200 million doses this year and next, with an option of up to an additional 100 million. Comirnaty / BNT162b2 is a two-dose vaccine, with a booster three weeks after the initial injection.
Those doses will be produced at BioNTech’s manufacturing facilities in its home country of Germany and at a Pfizer site in Belgium.
While BioNTech shares rose 2.2% after the news was released on Monday, in contrast to the 0.4% drop in the S&P 500 Index – Pfizer fell 0.8%.
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