Both companies announced Monday that their BNT162b2 -- which will also be known in Europe under the brand name Comirnaty -- has received conditional marketing authorization (CMA) from the European Commission (EC) for patients aged 16 and older.
This is roughly the equivalent of the American EUA in that it's the culmination of a fast-track approval process for a vaccine or drug that combats acute healthcare threats such as the coronavirus. The CMA is valid for one year.
This approval means that Pfizer and BioNTech's vaccine can now be used throughout the 27 countries of the European Union (EU).
"We are grateful that this authorization is bringing hope to people across the continent, as we hopefully turn the corner of this crisis and approach the new year," Pfizer CEO Albert Bourla said in the company's announcement of the news.
The companies will immediately begin delivering doses of the vaccine throughout the EU according to the EC's distribution and contract terms. Pfizer and BioNTech have agreed to supply 200 million doses this and next year, with an option for up to an additional 100 million. Comirnaty/BNT162b2 is a two-dose vaccine, with a booster following three weeks after the initial shot.
Those doses will be produced in BioNTech's manufacturing facilities in its home country of Germany and at a Pfizer site in Belgium.
While BioNTech's stock rose 2.2% following the release of the news on Monday -- in contrast to the 0.4% slide of the S&P 500 index -- Pfizer slipped by 0.8%.