Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they received conditional authorization from European regulators.
The European Commission confirmed that it granted a conditional marketing authorization for the vaccine developed by the two companies, making it the first available COVID-19 vaccine in the European Union.
The news follows an earlier announcement that the companies had received a positive opinion from European regulators on their COVID-19 vaccine.
“Today we add an important chapter to a European success story,” European Commission President Ursula von der Leyen said in the release. “We approved the first safe and effective vaccine against COVID-19. More vaccines will come soon. Doses of the vaccine approved today will be available for all EU countries, at the same time, on the same conditions. The upcoming European vaccination days will also be a great moment of unity.
“This is a good way to end this difficult year, and to start turning the page on this pandemic. We are all in this together.”
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued the positive opinion, recommending CMA of Pfizer and BioNTech’s COVID-19 vaccine in individuals 16 years of age and older, according to a news release.
CHMP advisors based their positive opinion on data from the companies’ Phase 3 clinical study, which included a 95% efficacy rate. The European Commission will review the CHMP recommendation, with a final decision on CMA expected in the near future. CMA would make the vaccine available to all 27 EU member states.
The vaccine was made available in the United Kingdom earlier this month and received FDA emergency use authorization in the U.S. just over a week later.
Pfizer and BioNTech said the vaccine has been authorized or approved for emergency use in more than 15 countries in total, with regulatory reviews underway in several more, as well as further submissions forthcoming.
“Today is a particularly personal and emotional day for us at BioNTech,” BioNTech CEO & co-founder Ugur Sahin said in the release. “Being in the heart of the EU, we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic. We are standing by ready to start the delivery of initial vaccine doses across the EU as soon as we get the green light.”
“We are pleased with the Committee’s strong vote of confidence in our data,” added Pfizer chairman & CEO Albert Bourla. “If the European Commission issues an authorization, we are ready to start delivering this vaccine to government-designated sites all across the EU where cases of disease continue to rise and several countries are managing lockdowns.”
This story was updated to convey that, following an earlier announcement that the vaccine was positively reviewed, the European Commission granted authorization.
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