EMA backs Pfizer and Moderna variant-adapted vaccines

The European Medicines Agency (EMA) has endorsed this Thursday authorize on the European Union the use of vaccines adapted to new variants of SARS-CoV-2 developed by the pharmaceutical companies Pfizer and Moderna as a reinforcement for a broader protection against covid-19 in people over 12 years of age.

After an extraordinary meeting at its headquarters in Amsterdam, the EMA explained in a statement that these bivalent vaccines “can extend protection against different variants and therefore are expected to help maintain optimal protection” against covid-19 as the virus evolves.

New injections could be given at least 3 months after the last dose received of a vaccine against covid-19, and the agency warns that the original vaccines from Pfizer and Moderna “remain effective (as primary vaccination) in preventing serious illness, hospitalizations and deaths” associated with covid-19.

“These vaccines are adapted versions of the original shots Comirnaty (Pfizer/BioNTech) and Spikevax (Moderna) aimed at attacking the Omicron BA.1 subvariant, in addition to the original strain of SARS-CoV-2. Vaccines are adapted (i.e. updated) to better match circulating variants,” the European agency said.

The studies analyzed by the EMA experts before giving their support to these vaccines showed that both preparations “can trigger strong immune responses” against BA.1 and the original variant of the virus in people previously vaccinated with the primary regimen, and were “particularly effective” in protecting against the Omicron subvariant than the original preparations that have been used so far in vaccination campaigns.

As for security, side effects that have been observed in clinical trials with adapted vaccines are comparable to those observed with the originaltherefore “mild and short-lived,” he said.

The EMA, which recalls the importance of adapted vaccines to combat the pandemic, since “It is not possible to predict how the virus will evolve in the future and what variants will circulate this winter”, will now send its conclusions to the European Commission, which has the last word on the approval of these vaccines.

“Other adapted vaccines that incorporate different variants, such as Ómicron’s BA.4 and BA.5 subvariants, are currently under review by the EMA or they will be introduced soon and, if authorized, will further expand the range of available vaccines,” he adds.

The European Commissioner for Health, Stella Kyriakides, said in a statement that the Community Executive will proceed “with an accelerated authorization of these vaccines to ensure that they can be quickly implemented throughout the EU“.

“Subject to the scientific evaluation of the EMA, we also expect an opinion on the adapted vaccines Omicron BA.4 and BA.5 in the coming weeks as part of our broad vaccine portfolio approach that has characterized our work from the beginning”, added the curator.

Most European countries already have the possibility of a new wave of infections in the fall and the need to reinforce the population’s immunity with a new dose, especially the most vulnerable and the elderly.

“We need to be prepared to face another winter with covid-19,” warned Kyriakides, who called on EU countries to plan and launch their vaccination campaigns for the fall.


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