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The EU regulator will meet no later than December 29 to decide on the Pfizer vaccine
Pfizer and BioNTech previously announced that they have officially applied to the EU on Monday for conditional approval of their vaccine.
The European Medicines Agency (EMA) announced on Tuesday that it will convene an extraordinary meeting no later than December 29 to decide the conditional approval of the COVID-19 vaccine, developed by the German company BioNTech in collaboration with the American company Pfizer.
The information was provided by the AFP news agency.
“If the data presented is sufficient to assess the quality, efficacy and safety of the vaccine, EMA … will complete the assessment process at an extraordinary meeting scheduled for December 29 at the latest,” he said in a declaration to EMA, the regulatory body of the European Union.
Pfizer and BioNTech previously announced that they have officially applied to the EU on Monday for conditional approval of their vaccine. They did so after a similar request made in the United States.
EMA has confirmed receipt of an application for conditional registration of new coronavirus vaccines from Pfizer and BioNTech. Pfizer, in partnership with the small German company BioNTech, specializing in new mRNA technology in the production of vaccines, has joined the American company Moderna, which also on Monday asked the EU regulatory authority for conditional approval of the his vaccine.
If the conditions are met, registration decisions can be issued within weeks. The goal is to make the vaccine available in Europe by the end of the year, the DPA news agency wrote.
Like Moderna, BioNTech and Pfizer have also sought approval from the US Food and Drug Administration (FDA).
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