Covid: a new generation of vaccines expected at the start of the school year

Again booster vaccines against Covid are expected at the start of the school year to better adapt to the variants in circulation. In any case, if they receive a favorable opinion from the European Medicines Agency (EMA). She begins her review of fall-winter novelties on Thursday.

This first meeting of the new school year will also be the most important. The EMA will present its opinion there on the new generation of Covid vaccines messenger RNA (mRNA) of Pfizer-BioNTech and Moderna. These are so-called “bivalent” mRNA vaccines, because they are based on two Covid strains at the same time, the original and an Omicron strain. The hope is that they will thus be more adapted to the evolution of the variants.

Quick focus

The great strength of mRNA vaccines is that they are faster to develop than a conventional vaccine. To the point that Europe is struggling to follow. The EMA will examine on Thursday the bivalent vaccines comprising the Omicron BA.1 strain, whose application for authorization dates from the end of July. But on August 26, Pfizer-BioNTech submitted to Europe the “version 2” of its booster shot (intended for over 12s) including the BA.4/5 strains, currently in circulation.

A bit tight to examine it on Thursday, but Pfizer can already supply it. “If they are authorized, the bivalent vaccines adapted to BA.1 and BA.4/5 will be available in Europe from the beginning of September”, assured Pfizer on August 26. He hopes for a conditional authorization including this variation since it “follows the recommendation of the European Medicines Agency […] to work on introducing bivalent vaccines adapted to Omicron,” he recalls.

Conversion

Moderna goes just as fast . Its bivalent Spikevax BA.1 vaccine has already been authorized in mid-August in Great Britain for those over 18 and on August 29 in Switzerland. He too has a BA.4/5 version, of which the United States already ordered 66 million doses at the end of July for 1.74 billion dollars with an option for an additional 234 million doses. In the aftermath, in early August, Europe reached an agreement to convert the remaining Moderna deliveries in 2022 to bivalent Spikevax if authorized and ordered an additional 15 million doses…

This says a lot about the dominance of the two mRNA giants, which already have the largest European delivery framework agreements. Out of 4.2 billion doses of agreements signed by Europe since the start of the pandemic (including 1.7 billion already delivered), Pfizer-BioNTech has 2.4 billion and Moderna, 460 million. By comparison, Sanofi has a framework agreement for 300 million doses, with 75 million confirmed if its Covid vaccine obtains marketing authorization.

The most anticipated

The latter (developed with the British GSK) is in France the most anticipated of the start of the school year in the category of “classic”, non-mRNA and non-bivalent novelties. Sanofi finalized its application for marketing authorization in Europe at the end of July. But its protective tests against Omicron BA.4/5 will not be known until October and an opinion from the EMA will await a next meeting, possibly at the end of September.

If the French giant arrives late, it has advantages: unlike mRNA, to be stored at -70 degrees, its vaccine can be stored between 2 and 8° C. The logistics of pharmacies are much simplified. But this is also the case with the booster vaccine from the Spanish company Hipra, of which Europe ordered 250 million doses at the beginning of August, provided that it is authorized.

This testifies to an appetite which did not benefit the Franco-Austrian biotech Valneva . Its inactivated vaccine was authorized at the end of June as a primary vaccination course for those over 18, but not in recall and only received a European order for 1.25 million doses, which France did not even join. Europe has hardly any primary vaccination needs, already having a vaccination coverage of 86% (compared to 70% worldwide).