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Law360 (December 21, 2020, 8:56 PM EST) -- The vaccine developed by Pfizer and BioNTech became the first COVID-19 vaccine to receive regulatory approval in the European Union, which announced plans Monday to begin vaccinations before the end of the year.
The COVID-19 vaccine developed by Pfizer and BioNTech has received regulatory approval from the European Union. In photo, the Pfizer plant in Puurs, Belgium. (AP Photo/Virginia Mayo)
"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," European Commission President Ursula von der Leyen said in a statement Monday.
The vaccine will be marketed in the EU under the brand name Comirnaty, which, according to a BioNTech, represents "a combination of the terms COVID-19, mRNA, community and immunity." It has been approved for use by people age 16 and older.
Pfizer and BioNTech had requested approval for their vaccine on Dec. 1, but the EMA said it has been conducting a "rolling review" of the vaccine since at least Oct. 6. Rolling reviews involve evaluating nonclinical data about the vaccine as it becomes available.
The EMA's review of the Comirnaty vaccine wasn't without hiccups — regulatory documents related to Pfizer and BioNTech's vaccine candidate were "unlawfully accessed" during a cyberattack earlier this month.
"Our thorough evaluation means that we can confidently assure EU citizens of the safety and efficacy of this vaccine and that it meets necessary quality standards," EMA Executive Director Emer Cooke said in a statement Monday.
While the vaccine by Pfizer and BioNTech will be the first to be distributed in the EU, other European countries have already jumped ahead of the EMA's approval. The United Kingdom, a former member of the EU, gave Pfizer and BioNTech approval for the vaccine on Dec. 2. On Sunday, Swiss health regulator Swissmedic announced that it had also approved the vaccine.
The European Commission said it plans to distribute a total of 200 million doses of the vaccine by September but plans to leave determining which groups to prioritize up to each member state. The commission said it plans on "working to activate" purchasing an additional 100 million doses as well.
The commission also said it expects to make a decision on Moderna's COVID-19 vaccine by Jan. 6 at the latest. The U.S. Food and Drug Administration signed off on Moderna's request for emergency use authorization of its COVID-19 vaccine Friday.
Other vaccine candidates, like those being developed by Johnson & Johnson and AstraZeneca, have yet to formally apply for marketing authorization from the EMA, but the agency has said it has already begun conducting rolling reviews of those prospective vaccines.
--Additional reporting by Ben Kochman, Adam Lidgett and Dorothy Atkins. Editing by Gemma Horowitz.
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