On Tuesday, 30 November, European Medicines Agency (EMA) [Executive] Director Emer Cooke assured the European Parliament committee responsible for public health (ENVI) that vaccines adapted to the new SARS-CoV-2 variant—the Omicron variant—could be authorised, if need be, within three to four months.
“We know that viruses mutate, and we are prepared”, Ms Cooke repeated to MEPs, pointing out that recommendations on the subject had already been sent to Member States and pharmaceutical companies.
Nevertheless, she explained that it was not yet clear, at this stage, whether the available vaccines should be adapted to the new variant and that analysis on that subject was still ongoing. The adapted vaccines will thus only be potentially authorised once this analysis has been completed.
“A lot of this work will have to go on at company level at this stage”, she emphasised: companies will notably have to “look at adapting their formulations to include the new sequencing” and then “show that the production system works”.
For the time being, the EMA director nonetheless assured that, according to the available data, the four vaccines that have already been authorised in the EU remain effective. Incidentally, a fifth vaccine may soon be added to this portfolio of vaccines: Ms Cooke has, in fact, confirmed that a recommendation to authorise the Covid-19 vaccine developed by the laboratory Novavax is expected to be issued by the EMA in the coming weeks (see EUROPE 12834/20).
In addition, she indicated that the agency would probably publish its recommendations on administering a booster dose using a vaccine different from the one used for the first round of vaccination (see EUROPE 12839/9) by this Friday. (Original version in French by Agathe Cherki)