The two-shot vaccine from BioNTech and Pfizer gained official approval for people 16 and older in the European Union on Monday, two days after Switzerland approved its use through a normal procedure.
The European Medicines Agency recommended Pfizer-BioNTech’s coronavirus vaccine Comirnaty® (BNT162b2) throughout the 27-nation E.U. based on its findings — similar to those from Swiss medical regulator Swissmedic on Saturday — that the level of protection afforded seven days after the second injection of the vaccine is more than 90% effective against COVID-19.
"This will provide a controlled and robust framework to underpin E.U.-wide vaccination campaigns and protect E.U. citizens," the agency said in a statement.
EMA, based in Amsterdam, granted conditional marketing authorization after an expedited approval process, and the E.U.'s executive commission signed off hours later, clearing the way for vaccinations to begin just before Christmas. EMA approves drugs and vaccines for E.U. member nations, Iceland, Liechtenstein and Norway. A conditional marketing authorization allows people to gain early access to medicines that are likely to fulfill an unmet medical need, including in emergency situations such as the coronavirus pandemic.
"As we have promised, this vaccine will be available for all E.U. countries, at the same time, on the same conditions. The first batches of this vaccine will be shipped from Pfizer's manufacturing site here in Belgium within the next days," European Commission President Ursula von der Leyen said in a statement. "This is a very good way to end this difficult year, and to finally start turning the page on COVID-19. This is our first vaccine. More will be approved soon, if they prove to be safe and effective."
The vaccine is delivered in two doses into the arm, at least 21 days apart. EMA said the most common side effects — pain and swelling at the injection site, tiredness, headache, muscle and joint pain, chills and fever — are usually mild or moderate and get better within a few days.
It said a "very large" clinical trial, with 44,000 people, showed the shots work 95% of the time: eight of 18,198 people who received them got the virus. Among those who got a dummy injection, 162 of 18,325 people developed COVID-19 symptoms. The trial had participants at risk of severe COVID-19, including those with asthma, chronic lung disease, diabetes, high blood pressure or a body mass considered obese.
“Today’s positive news is an important step forward in our fight against this pandemic, which has caused suffering and hardship for so many,” said EMA's executive director, Emer Cooke, an Irish pharmacist with three decades of experience handling international regulatory affairs.
The head of EMA's expert committee on innovative new medicines said no politics entered into the decision-making despite nations' pressure for quick action. "The focus was entirely on the science," Dr. Harald Enzmann of Germany said. "That was a scientific assessment, full stop."
'One step closer'
BioNTech and Pfizer welcomed the decision in a joint statement. “Today is a particularly personal and emotional day for us at BioNTech," said Dr. Ugur Sahin, CEO and co-founder of the Germany-based company.
"Being in the heart of the E.U., we are thrilled to be one step closer to potentially delivering the first vaccine in Europe to help combat this devastating pandemic," he said. "We are standing by ready to start the delivery of initial vaccine doses across the E.U. as soon as we get the green light."
Pfizer’s chairman and CEO, Dr. Albert Bourla, said the companies were "ready to start delivering this vaccine to government-designated sites all across the E.U. where cases of disease continue to rise and several countries are managing lockdowns.”
EMA officials say they are examining more than 46 vaccines in development. The regulatory agency will issue its opinion on Moderna's vaccine on January 6, von der Leyen said.
Both the Pfizer-BioNTech and Moderna experimental two-dose vaccines appear to be highly effective using the brand-new messenger RNA, or mRNA technology. Neither were made with the coronavirus itself, so no one could catch COVID-19 from them.
Instead, they were made from a synthetic version of genetic code that can program someone’s cells to produce copies of a fragment of the virus. When that happens, the fragment causes the immune system to go on the attack in case the real virus intrudes.
The Pfizer-BioNTech vaccine has received some level of approval in about 15 nations, including emergency authorization use in Bahrain, Britain, Canada and the United States, where it has begun to be administered to health care workers and high-risk populations. It is considered an unlicensed product, suitable for temporary use, because the benefits are seen as outweighing the risks due to the pandemic.
In Switzerland, there is no legal basis for emergency authorization, so its regulators approved it in a normal but fast-tracked licensing process. Drug makers are obliged to keep providing foll0w-up data so regulators can find any more side effects and how long the vaccines last.
BioNTech and Pfizer offered 400 million doses to E.U. officials, who pre-ordered only half that amount with an option for 100 million more. That means more doses of the vaccine or others will be needed to immunize all of the E.U.'s 450 million inhabitants.
The World Health Organization’s director-general, Tedros Adhanom Ghebreyesus, has repeatedly said the breakneck speed with which the coronavirus vaccines have been developed is greatly encouraging, but it will still take a full range of tools such as tests, diagnostics and treatments to stop a virus that has infected 76.9 million people and killed 1.69 million people worldwide.
