Thursday, October 21

Europe advances the evaluation of Moderna’s vaccine to January 6


Experts evaluate Moderna's vaccine

Experts evaluate Moderna’s vaccine
EFE

The European Medicines Agency (EMA) announced this Thursday that it has convened a Extraordinary meeting on January 6 for their experts to finalize their vaccine evaluation of covid-19 developed by the modern pharmaceutical company, which was originally scheduled for the 12th.

The agency received this Thursday, “ahead of schedule”, the latest data packet pending that its specialists needed in order to evaluate Moderna’s application to obtain a conditional marketing license for its drug in the European Union.

This would allow the EMA advance the announcement of its conclusions on the safety and efficacy of that vaccine, because the information packet received today contains information “specific to the manufacture of the vaccine for the EU market”.

In an update, the agency stresses that “it has made great progress in evaluating the application for commercial authorization of the mRNA-1273 vaccine” from Moderna, and has maintained a “continuous dialogue with the company“which has ensured that the questions that arose to its experts during the evaluation” were followed up and addressed quickly. ”

The Committee for Human Medicines (CHMP) may announce its final opinion on the drug on 6 January, as long as “the evidence convincingly shows that the benefits of the vaccine outweigh any potential risks“that involves the injection.

The virtual meeting scheduled for almost three weeks for 12 January 2021 will remain on the CHMP agenda, in case it is necessary to meet again when no definitive conclusions are reached on the 6th.

EMA Director Emer Cooke argued in a note that the agency has “constantly revised its schedule to further simplify all aspects of the procedure that must be implemented for a solid scientific assessment leading to a marketing authorization“in all EU countries.

“He number of infections is increasing across Europe and we are aware of the enormous responsibility we have to bring a vaccine to market as quickly as possible while maintaining the strength of our scientific review, “he added.

The EMA has scheduled an extraordinary meeting next Monday in which it plans to finalize its evaluation of the covid-19 vaccine developed by the pharmaceutical companies Pfizer and BioNTech, which is expected to allow European countries to start their vaccination campaigns before the end of year.

The CHMP makes an “independent regulatory assessment of the evidence generated on vaccines before making a recommendation on their use in European citizens”, and, when it announces a positive opinion, the European Commission speed up your decision-making process to give a license to market the drug in the EU in a couple of days.


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