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