The European Medicines Agency (EMA) announced today that it has received a Conditional Marketing Authorization (CMA) application for BNT162b2, a COVID ‑ 19 mRNA vaccine developed by BioNTech and Pfizer. The evaluation of BNT162b2 will proceed with an accelerated schedule. A marketing authorization opinion could be issued within weeks, depending on whether the data submitted is strong and complete enough to demonstrate the quality, safety and efficacy of the vaccine.
According to a written statement from the EMA, "such a short period of time is only possible because the EMA has already examined some data on the vaccine during a rolling test".
During this phase, the EMA evaluated data on the quality of the vaccine (such as information about its components and how it was produced), as well as results from laboratory studies.
The EMA also reviewed results on vaccine efficacy and initial safety data from a large-scale clinical trial as available.
The EMA has announced that it will now evaluate the data submitted as part of the formal conditional marketing authorization application.
The Agency and its scientific committees will continue to work on the evaluation during the Christmas period.
"If the data submitted are strong enough to arrive at the quality, safety and efficacy of the vaccine, the EMA Scientific Committee for Human Medicines (CHMP) will complete its evaluation during an extraordinary meeting scheduled for December 29 at the latest ".
These schedules are based on the type of data that has been evaluated so far in the rolling review and may change as the evaluation progresses. The EMA will communicate the outcome of its assessment.
During the review, and throughout the pandemic, the EMA and its Scientific Committees are supported by the task force COVID-19 EMA, a team of experts from across the European Medicines Regulatory Network to facilitate rapid and coordinated regulatory action on medicines and vaccines for COVID-19.
As stated, if the EMA concludes that the benefits of the vaccine outweigh the risks associated with protection against COVID ‑ 19, it will recommend a conditional marketing authorization. The Commission will then follow up its decision-making process with a view to granting conditional marketing authorization in all EU and EEA Member States within days.
Source: KYPE