This Monday pharmaceuticals Pfizer and BioNTech have requested of the approval for their coronavirus vaccine by the European Medicines Agency (EMA), the regulator of the European Union (EU), after taking the same step both in the United States and in the United Kingdom in previous days.
Moderna has also completed the same procedure. According to official information released this Tuesday by the EMA, between December 29 and January 12, at the latest, they will have decided whether to give the green light to the prototypes. Pfizer-BioNTech's could be the first, with a deadline of 29 December, and Moderna's of 12 January.
We have submitted a formal Application for Conditional Marketing Authorization tono @EME_News for #mRNA vaccine candidate #BNT162b2 against #COVID 19. It will be assessed according to tono #EME's normal stringent standards for quality, safety and efficacy. https://t.co/sn1n4ojz6s pic.twitter.com/2sadnjjlp9- BioNTech SE (@BioNTech_Group) December 1, 2020
According to information published on Tuesday by the Financial Times , the EMA could authorise use in the Union on 29 December, making it practically impossible for the vaccination process to begin in the Member States before 2021.
Pfizer and BioNTech already submitted the application for authorisation to the UK on 23 November and could receive approval this week. London, in fact, hopes to be able to start the distribution of the vaccine between the 7th and 9th of this month and, hypothetically, to start the vaccination on the 7th, despite the fact that only in hospitals and for health personnel.
Pfizer and BioNTech's prototype has, according to data provided by the company, an efficiency of 95%. In general, the effectiveness was consistent among age, gender, race and ethnic demographic groups, with an effectiveness observed for adults over 65 years of age of more than 94%.
Study findings were based on 170 confirmed cases of covid-19. The trial would also have shown that the prototype, which has been named BNT162b2, has an overall favourable tolerability, with no serious safety problems reported so far.
The trial would also have shown that the prototype, which has been named BNT162b2, has an overall favourable tolerance, without serious safety problems so far. Despite the urgency to have vaccines on the market and to start the vaccination process widely everywhere, if the EMA does not finally give the green light until 29 December, it will have taken significantly longer than the UK regulator.
As part of the Brexit transition period, the EMA still monitors the actions of national agencies, including the British Medicines and Healthcare products regulatory agency. But under a special regulation approved by London, if a suitable covid-19 vaccine candidate is available, such as Pfizer-BioNTech's or Moderna's, which on Monday requested emergency authorisation from the United States, the legislation implemented allows for temporary authorisation of the supply.
This is why the UK could have the Pfizer vaccine earlier than the European Union, even though the time difference would be little more than symbolic. Pfizer also expects the US regulator, the Food and Drug Administration, to rule on emergency authorisation on December 10.