New stage for the vaccination campaign against Covid-19 intended for people at risk this fall.
As expected, the High Authority for Health approved new vaccines adapted to Omicron on Tuesday.
These are messenger RNA products developed by Pfizer/BioNTech and Moderna, called “bivalent” because they target both the original strain of SARS-CoV-2 and the Omicron BA.1 or BA variant. 5.
These vaccines can be used interchangeably, once they are available on French soil.
We do the full story.
What are these new vaccines?
There are three of them: the Pfizer/BioNTech vaccine and the Moderna vaccine adapted to BA.1, as well as the Pfizer/BioNTech vaccine adapted to BA.4 and BA.5.
The European Medicines Agency has already authorized them since the beginning of September.
The Moderna vaccine adapted to BA.4/5 could in turn be approved at the end of September.
Will they be more effective?
The only clinical data we have, for the moment, are levels of neutralizing antibodies following an injection.
A booster dose of the Moderna vaccine adapted to BA.1 increases the antibody titers against the Omicron BA.1 variant almost 2 times compared to a booster dose of the current vaccine, for example.
Faced with Omicron BA.5, which became the majority in France at the end of June, the American firm did not present a comparison.
The United States very quickly asked manufacturers to develop bivalent vaccines adapted to Omicron BA.4 and BA.5, in order to target the predominant strain and hope to gain in efficiency.
Pfizer/BioNTech and Moderna complied.
But the American and then European authorities had to make do with the clinical data of the previous vaccines, those adapted to BA.1, and the so-called “pre-clinical” data of those adapted to BA.4/5.
A strategy similar to that already applied for flu vaccines, updated each year according to the viral strain in circulation.
Read alsoCovid-19: can we do without clinical trials to approve certain vaccines suitable for Omicron?
Experts think that these bivalent vaccines will make it possible to gain in effectiveness - in particular against infection, weak point of those used for almost two years -, but it is impossible to say to what extent.
“The clinical efficacy expected for these new bivalent vaccines is at least equivalent or even superior to that of the original monovalent vaccines, without this probable superiority currently being able to be demonstrated in real life”, recognizes the HAS.
Who will they be for?
The High Authority maintains its recommendation to administer an additional booster dose this autumn to people aged at least 60, to adults suffering from comorbidities whatever their age, to pregnant women, to children and adolescents at high risk, as well than to all the people living around them.
It now adds health professionals.
Nothing new, since these are categories already eligible for a second reminder since mid-summer.
The Moderna vaccine has been banned for almost a year in people under 30 due to the risk of myocarditis and pericarditis, and so will its new versions adapted to Omicron.
Apart from this particular case, the three new vaccines can be “used interchangeably” for boosters, instead of the current ones.
From when will they be administered?
Questioned by Le Parisien in early September, the Directorate General of Health told us that the new vaccines adapted to BA.1 “should arrive in October” and that those adapted to BA.4.5 “could be available from November”.
The HAS also insists on “the interest of coupling this new reminder campaign with that of vaccination against seasonal flu which will start on October 18th”.
Nevertheless, eligible people who have not yet received their 2nd booster dose are invited not to wait for these adapted versions.
Indeed, while France has been affected by an epidemic resumption since the beginning of September, the vaccines currently used are still effective against severe forms of the disease.