The long-awaited green light has arrived in the EU for the first VACCINES anti-Covid updated. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency EMA has in fact recommended today to authorize two VACCINES adapted to provide broader protection against Covid. These are the Pfize-BioNTech Comirnaty vaccine, bivalent and aimed at covering the original strain of the virus and Omicron 1, and the Moderna Spikevax vaccine, bivalent and also aimed at the original strain and Omicron BA.1.
The VACCINES, explains the EMA in the note announcing the verdict, are intended for use in people aged 12 years and over who have received at least the primary vaccination course against Covid. They will therefore be used as boosters. These VACCINES are adapted versions of the original VACCINES Comirnaty* (Pfizer/BioNTech) and Spikevax* (Moderna).
Adapted VACCINES can broaden protection against different variants and, explains the EMA, “should therefore help maintain optimal protection against Covid-19 as the virus evolves”. Studies have shown that both the bivalent Comirnaty and the bivalent Spikevax updated to BA.1 “can trigger strong immune responses against Omicron BA.1 and the original virus in previously vaccinated people”, highlights the EU body. In particular, these shield products “were more effective in triggering immune responses against the BA.1 subvariant than the original VACCINES”.
And the side effects observed "were comparable" to those observed with the old VACCINES. Effects "typically mild and short-lived". The two opinions of the CHMP will now be transmitted to the European Commission, which will adopt a final decision. As for the new Comirnaty, the agency's experts explain that it can be used from 12 years of age and up, at least 3 months after the last dose of a Covid vaccine.
The opinion is based on two studies. The first, conducted on over 55s already vaccinated with 3 doses of Pfizer, found that the immune response to the Omicron BA.1 subvariant was greater with the bivalent than with the original vaccine (based on the level of antibodies obtained against Omicron BA.1). The immune response to the Wuhan strain was comparable for both VACCINES.
The study involved more than 1.800 people (about 300 received the adapted booster). Other data come from a study involving over 600 people aged 18-55 with 3 doses of Pfizer under their belt: here the immune response to Omicron BA.1 is measured in those who received the fourth dose with a vaccine containing only Omicron 1 compared to the original and was greater.
Finally, based on previous data, it was concluded that the immune response to a booster with the bivalent in adolescents would be at least equal to that of adults. As for the new Spikevax*, this too can be used from 12 years of age, at least 3 months after the primary vaccination or a booster dose with a Covid vaccine. The opinion is based on data from a study involving more than 800 adults aged 18 and over, and found a stronger immune response against the original virus and the Omicron 1 subvariant compared to a booster with the original vaccine.
Analyzing the available data, it was also concluded that Moderna's bivalent could be used as a first booster after a primary series and that the immune response in adolescents aged 12-17 would be at least equal to that of adults, given that previous results with Spikevax showed a comparable effect. The adapted VACCINES work in the same way as the originals, the EMA specifies. The companies that produce them have submitted applications to modify the current marketing authorizations of the VACCINES already authorized to include the use of the new versions in order to obtain the approval.
Article published on 1 September 2022 - 20:23
