- The European Commission conditionally cleared Pfizer and BioNTech's coronavirus vaccine for use across all 27 EU member countries, broadening the global rollout of the first shot proven to protect against COVID-19 in a late-stage study.
- The vaccine, which will be distributed under the brand name Comirnaty in the EU and Switzerland, is now authorized in over 40 countries, including the U.S., partners Pfizer and BioNTech said in a statement Monday.
- Supplies will remain limited in the coming months, however. The two drugmakers expect to manufacture 50 million doses, enough to vaccinate 25 million people, by the end of the year, more than two-thirds of which will go to the U.S., the EU and the U.K.
With the EC's decision, much of Europe is added to the list of countries where a coronavirus vaccine is now available, at least for the first few groups of people prioritized for access.
Like regulators in the U.K. and U.S., the European Medicines Agency rapidly reviewed and cleared Pfizer and BioNTech's vaccine, which the companies formally submitted for authorization on Dec. 1.
The work of health authorities was made easier by the strongly positive study results supporting the vaccine, which was shown to be 95% effective in preventing COVID-19 in a trial of some 44,000 people.
On a conference call Tuesday, BioNTech executives said delivery of doses from manufacturing sites the company runs in Germany, as well as a Pfizer plant in Belgium, would begin within days. Some 12.5 million doses are allocated to the EU through the end of the year, and would be distributed under a plan specified by the EC.
In the U.S., where the Food and Drug Administration granted emergency authorization on Dec. 11, distribution has already begun. As of Monday morning, roughly 4.6 million doses have been shipped across the U.S. and about 614,000 people have received their first of two shots, according to data from the Centers for Disease Control and Prevention.
Rollout in the EU comes as a number of European countries have closed down travel to the U.K. over concern of a new coronavirus variant now spreading in and around London. Scientists are still working to determine how the mutations observed in the new variant, which U.K. officials have said is more infectious, affect the virus' transmission and whether they cause more severe disease.
In theory, the vaccine developed by Pfizer and BioNTech, as well as a similar one from Moderna, could be quickly adapted to incorporate changes in the coronavirus' genome.
"We could be able to provide a new vaccine technically within six weeks," said Ugur Sahin, BioNTech's CEO, in the Tuesday press conference. "Of course, this is not only a technical question. We have to deal with the question of how regulators — FDA, EMA and other authorities — would see that."
Both Pfizer and BioNTech's as well as Moderna's vaccines rely on genetic sequences encoding for a coronavirus protein to train the body's immune system. Adjusting that sequence is relatively easy, but the companies would not have clinical trial data proving the new sequence is equally protective.
Sahin added, however, that the likelihood Pfizer and BioNTech's current vaccine would work is "relatively high," noting most sites on the target SARS-CoV-2 protein have not changed.