Covid-19: first two vaccines adapted to Omicron authorized in Europe, HAS opinion awaited

A new booster vaccination campaign against Covid-19 for fragile people this fall, but with which vaccine? Probably not the one used so far. New products, supposed to be more effective against the Omicron variant which has dominated the viral landscape since the end of 2021, are very close to being authorized. So a great hope: that they block the infection and the transmission of the virus more than the current ones.

This Thursday, the European Medicines Agency (EMA) gave the green light to the use of “bivalent” Pfizer/BioNTech and Moderna vaccines adapted to Omicron BA.1, i.e. whose composition is based both on the original strain of the virus and on this variant. Messenger RNA technology has a great advantage: it allows you to “adapt” in a few weeks.

These two new vaccines “can broaden protection against different variants and should therefore help maintain optimal protection against Covid-19 as the virus evolves”, said the EMA. The one developed by Moderna has already been authorized in mid-August in the United Kingdom, and distribution should begin there in the coming days.

HAS recommendations expected on September 5

In France, the Technical Commission for Vaccinations (CTV) of the High Authority for Health (HAS) was officially seized on Tuesday for an opinion concerning these same vaccines from Moderna and Pfizer/BioNTech adapted to BA.1. The HAS will then meet in collegial formation on Monday September 5 in order to issue its recommendations, told La Dépêche Pr Élisabeth Bouvet, president of the CTV. These are usually followed by the government.

In a second step, “in the fall” but on a date still undetermined, the European and French health authorities will have to decide on the vaccines suitable for BA.4 and BA.5. The latter has been largely in the majority across the Atlantic but also in Europe since June, and it is hard to see what variant could replace it in the short term.

The United States preferred to “step over” step BA.1, so that the products used target the dominant strain of the virus and are potentially even more effective. On Wednesday, the US Food and Drug Administration (FDA) therefore gave the green light to the use of vaccines from Pfizer/BioNTech and Moderna adapted to Omicron BA.4 and BA.5.

No clinical data in humans yet

This speed of authorization has a counterpart: clinical trials in humans have not yet been carried out for these candidate vaccines adapted to BA.4/5, so there is a lack of precise data confirming their efficiency gain. They “should provide increased protection against the Omicron variant,” said the FDA, which was based in particular on clinical data from previous vaccines. The EMA could choose to wait for more information to decide.

In France, these new products should not be available before October, according to the president of the new Committee for monitoring and anticipating health risks, Brigitte Autran. “You don’t have to wait [leur] arrived to be vaccinated, it would be counterproductive and dangerous for the most fragile, ”she urged in Le Parisien on August 16. For the moment, his call is far from being heard: nearly 17,000 people receive a second booster dose of vaccine every day, the lowest since the end of March.

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Covid-19: first two vaccines adapted to Omicron authorized in Europe, HAS opinion awaited

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