A certain acceleration in the race for the virus.
The Pfizer / BioNTech alliance announced on Tuesday that it had filed the request for conditional authorization of its vaccine against Covid-19 with the European Medicines Agency (EMA).
The "formal request" to the EMA was filed Monday, said in a statement the German laboratory BioNTech which is associated with the American giant Pfizer.
Pfizer and BioNTech filed their application in the United States on November 20, two days after the publication of the final results of their clinical trial.
These show that their vaccine candidate is 95% effective in preventing the novel coronavirus, without causing major problems.
The submission of the authorization request to the EMA completes the so-called “rolling review” process, launched on October 6.
If the agency concludes that the benefits of the vaccine candidate outweigh its risks of protection against the virus that paralyzes the planet, it will recommend the granting of a conditional marketing "which could potentially allow the use of BNT162b2 in Europe before the end of 2020, ”the press release said.
Accelerated procedure
The British government said last week that the American and German laboratories had communicated the data of their clinical trials to the British Medicines and Healthcare products Regulatory Agency (MHRA) for the green light.
The duo is thus slightly ahead of Moderna, which on Monday evening, filed its application for approval with the US Drug Agency, with the intention of completing the same process with the EMA, to distribute its vaccine. in the European Union.
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Based in Amsterdam, the European Medicines Agency's mission is to authorize and control medicines in the European Union.
The final green light, given by the European Commission, allows laboratories to market their medicine in all EU countries.
While the Covid-19 officially appeared a year ago in China, the EMA has implemented an accelerated procedure known as “continuous review” or “rolling review”.
The vaccines from Pfizer / BioNTech, Moderna and Oxford / AstraZeneca are the three vaccine projects that have been undergoing this ongoing review for several weeks.
