Coronavirus, Moderna requests authorization for its vaccine in Europe and the USA

The pharmaceutical company announces that today it will file the application for the authorization of its vaccine in the United States and Europe. The effectiveness is 94.1% and rises to 100% against severe forms of Covid-19. The FDA meeting for the examination is expected on December 17, 2020

(photo: pearson0612 via Pixabay) News of vaccines against Covid-19 follow one another and we can follow all the steps towards approval in real time. Today it is the turn of the modern pharmaceutical company which, after announcing, about two weeks ago, that its vaccine is 94.5% effective, has just warned in a press release that it will file the request of the 'authorization of its vaccine in the United States and Europe, to the respective regulatory authorities Fda (Food and Drug Administration) and Ema (European Medicines Agency). Updated data indicate that the vaccine is 94.1% effective against Covid-19 and up to 100% in preventing severe forms.

Requests have started

The Cove Phase 3 clinical trial has exceeded the 2-month post-administration monitoring required to apply for US FDA emergency clearance for clearance for emergency use. Moderna therefore asks the FDA for this authorization for timely access to the vaccine. In addition, it asks the EMA for conditional marketing authorization and to go ahead with the continuous reviews (rolling reviews), already initiated with international regulatory agencies. Conditional authorization is another type of approval that serves to ensure faster treatment, given the benefits outweigh the risks. Requests will be filed today 30 November 2020. Furthermore Moderna announces that the US FDA has already scheduled a meeting for the examination of the material provided and concerning the vaccine, therefore the data on safety and efficacy, on Thursday 17 December 2020.

I benefits to date

The vaccine, called mRNA-1273, is developed in collaboration with Niaid, directed by Antony Fauci, part of the US National Institutes of Health - Nih.

The phase 3 study has involved 30 thousand participants and reached the main objective, which is the effectiveness of the vaccine confirmed with a certain amount of data. So far, 196 cases of Covid-19 have been registered, of which 185 in the group that, according to the experimental procedure, did not receive the vaccine but a placebo (in the previous announcement in mid-November there were still 95 confirmed cases). Reaching this threshold and the data lead to estimate vaccine efficacy in 94.1% of cases, ie vaccination prevents about 94 cases of Covid-19 disease out of 100. The efficacy could rise up to 100% in the forms serious illness.

"The vaccine continues to be well tolerated", adds Moderna, "and to date no serious safety problems have been recorded".