COVID-19 vaccines are ready for the formal approval: The European Union plans to approve Pfizer’s vaccine on December 29 and Moderna’s on January 12. The committee in charge of granting permission to distribute the vaccine has been convened for these dates, and in the meantime the regulator will analyze the available data on the antidotes
Europen Union plans COVID-19 vaccines approval soon
The American pharmaceutical company Pfizer and the German company BioNTech have submitted a formal application to the European Medicines Agency (EMA) to receive authorization to market and distribute their candidate for the coronavirus mRNA BNT162b2 vaccine that they have developed jointly, in the hope that the first doses can begin to be distributed before the end of this year.
The application comes one day after their rival, the US Modern pharmaceutical company, also submitted its request to the European regulator yesterday. The race for the vaccine has accelerated in recent weeks and within minutes of Pfizer’s announcement, the EMA confirmed receipt of both applications and expected to issue its authorization in a few weeks to respond as soon as possible to the health emergency of the coronavirus pandemic, marking in red on the calendar the dates of the crucial battle that the population will have to face next year.
Specifically, the EMA has announced that it could authorize Pfizer’s antidote on December 29 and Moderna’s on January 12, 2021, the respective dates on which it has exceptionally convened the committee in charge of evaluating and ruling on the use of new medicines for human use in the European Union.
Evaluation will be carried out with an “accelerated schedule”
The evaluation procedure will be carried out under an “accelerated schedule” due to the circumstances in which all the countries are facing the expansion of covid-19, the regulatory agency has explained in a statement. Therefore, depending on whether the data submitted are “sufficiently robust and complete” to demonstrate the quality, safety and efficacy of the vaccines, an opinion on authorization could be issued in a few weeks.
These short deadlines set by the European Union “are only possible because the EMA has already reviewed some of the data on the COVID-19 vaccines during an ongoing review” to which they have been subjected. During this phase, the Agency of the Medicine has been evaluating the data on the quality of the vaccine (the information on the elements that compose them and the process of production) and the results of the studies that have contributed, in addition to the results on the effectiveness of the antidotes in the clinical trials that have been carried out on a large scale.
The European Union permit that the COVID-19 vaccines are expected to receive will be a conditional marketing authorization (CMA), i.e., an approval to meet “unmet medical needs” based on less complete data than normally required in these cases. However, the EMA has stressed that the conclusions from the analysis that the COVID-19 vaccines will now undergo must demonstrate that the benefits of the vaccine outweigh any risks.
When the COVID-19 vaccines will be approved?
Therefore, once the permit is granted, companies will have to provide more data from new or ongoing trials in the pre-defined timeframes to confirm that these benefits still outweigh the risks. Once the EMA issues its verdict (expected on December 29 and January 12), it will be the European Commission that will issue a marketing authorization valid for all European Union (EU) countries.
