The new Pfizer-BioNTech and Moderna vaccines adapted to the omicron variant of the coronavirus and its subvariants –Comirnaty Original/Omicron BA.1 and Spikevax Bivalent Original/Omicron BA.1– have a positive opinion from the human medicines committee today ( CHMP) of the European Medicines Agency (EMA), which has recommended that they be authorized in the European Union (EU). Yesterday, the American Food and Drug Administration (FDA) already gave its approval so that these vaccines can be administered as booster doses in the United States.
This is a new advance to combat COVID-19, as stated by the Commissioner for Health and Food Safety, Stella Kyriakides: “Today’s positive opinions from the European Medicines Agency on the first two mRNA vaccines adapted to variants, from BioNTech-Pfizer and Moderna, are important in protecting Europeans against the likely risk of waves of autumn and winter infections. We need to be prepared to face another winter with COVID-19.”
After holding an extraordinary meeting, EMA sources have stated that adapted vaccines “can extend protection against different variants.” The agency hopes that the administration of these drugs will help “maintain optimal protection” against COVID as SARS-CoV-2 evolves and new variants circulate.
Adapted Pfizer and Moderna Vaccines Induce Strong Immune Responses Against Omicron BA.1 and Parent Coronavirus Strain in Previously Vaccinated People
The EMA has also reported that new doses of these vaccines could be administered at least three months after the last dose received of any vaccine against COVID-19, and in his official Twitter account It has specified that it recommends its approval so that they can be received by “persons 12 years of age or older who have completed their initial course of vaccination against COVID.”
Vaccines that protect against current and future variants of SARS-CoV-2
The Comirnaty and Spikevax vaccines have been updated to better match circulating variants of the coronavirus and provide greater protection against COVID-19. Efficacy and safety studies have shown that Comirnaty Original/Omicron BA.1 and Spikevax Bivalent Original/Omicron BA.1 can induce potent immune responses against omicron BA.1 and the original strain of coronavirus in previously vaccinated people.
Specifically, they were found to be more effective in generating immune responses against the BA.1 subvariant than the original vaccines. As for the side effects observed after the administration of the adapted vaccines, they were similar to those caused by the original ones and, in general, they were mild and of short duration.
Stella Kyriakides has explained that the next step will be “an accelerated authorization of these vaccines to ensure that they can be quickly deployed throughout the EU”, and that “adapted versions of these vaccines will be used as booster doses targeting the original virus and the subvariant omicron BA.1. They are developed to offer greater and broader protection against current and future variants. Subject to scientific evaluation by the EMA, we also expect an opinion on the BA.4 and BA.5 omicron adapted vaccines in the coming weeks.”
Stella Kyriakides concludes that: “All people eligible to receive a vaccine or booster dose should receive it as soon as possible. The pandemic is not over, but the rapid development and adaptation of vaccines to respond to this virus is one of the greatest successes in modern medical history: now let’s make sure we protect as many as possible, for ourselves and our loved ones.” .
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