Exact four weeks. It is all that remains for the European Medicines Agency (EMA) to issue an opinion on the Pfizer / BioNTech vaccine: on December 29. Thus, its distribution, which depends on the approval of the Amsterdam-based regulator, will start in the last days of the year and in the first days of 2021.
Two weeks after that procedure, the EMA will meet on January 12 for the foreseeable approval of Moderna’s vaccine.
Pfizer and BioNTech finalized their submission to the EMA on Monday, which has been reviewing the companies’ large-scale clinical trial data continuously since October.
The EMA has on the table the application for a conditional marketing authorization for a vaccine against COVID-19 developed by BioNTech and Pfizer. “The evaluation will be carried out under an accelerated schedule. An opinion on the marketing authorization could be issued in a few weeks, depending on whether the data presented is robust and complete enough to demonstrate the quality, safety and efficacy of the vaccine.” , reports the European Medicines Agency.
“Such a short time frame is only possible because the EMA has already reviewed some data on the vaccine on an ongoing basis,” states the EMA: “During this phase, the EMA has evaluated the data on the quality of the vaccine (such as information on its components and how it is produced), as well as the results of laboratory studies.The EMA has also analyzed the results on the efficacy of the vaccine and initial safety data that emerged from a large-scale clinical trial at as they were available. ”
The EMA will now evaluate the data submitted as part of the formal application for conditional marketing authorization, and will continue to work on the evaluation over Christmas. “If the data presented is strong enough to reach a conclusion on the quality, safety and efficacy of the vaccine, the EMA Scientific Committee for Human Medicines (CHMP) will conclude its evaluation during an extraordinary meeting scheduled for December 29. later than”.
“These timelines are based on the type of data evaluated so far in the context of ongoing review and may be subject to change as the evaluation progresses,” states the EMA.
If the EMA concludes that the benefits of the vaccine outweigh its risks in protecting against COVID-19, it will recommend granting a conditional marketing authorization. The European Commission will then speed up its decision-making process in order to grant a conditional marketing authorization valid in all EU Member States and within days.
Regarding Moderna’s vaccine,