Vaccines against Covid-19: clinical data missing… were the new sera adapted to Omicron approved too soon?

Vaccines against Covid-19: clinical data missing... were the new sera adapted to Omicron approved too soon?

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The bivalent vaccines, effective against variants of the Omicron family, will soon be offered in France as part of a new vaccination campaign against Covid-19. However, there are no clinical data on its efficacy in humans.

Almost a year after Omicron’s discovery in South Africa, vaccines adapted to the BA.1 and BA.5 variants will soon be available in France. The bivalent vaccines, developed by Pfizer/BioNTech and Moderna, will be the subject of a special campaign in France starting October 3. “Frail people, over 60 years old, health professionals and people who are in contact with fragile people” will be able to participate in this new campaign, announced François Braun, Minister of Health.

Also read:
Covid-19: reminder, efficacy… in France, what will change with the arrival of new bivalent vaccines adapted to Omicron?

Within the scientific community, however, these vaccines are far from reaching a consensus: prior to any marketing authorization, the Pfizer/BioNTech laboratories did not share clinical data to demonstrate their efficacy in humans. “Agencies could have demanded clinical trials, but they preferred to go fast, making a risky bet for the capital of public trust if it turned out that these vaccines were less effective than monovalent ones,” epidemiologist Antoine Flahault disputes on social networks, echoing from the words of Agence France Presse.

9/2 – There is a lot of confusion in the public and in the media about the withdrawal of vaccines from the #COVID-19. The EMA and the FDA have skipped the usual steps to approve a vaccine. The anti-vaccines are having a blast, they couldn’t dream of a better blessed bread.

— Antoine FLAHAULT (@FLAHAULT) September 23, 2022

Efficiency. This is the nerve of the war for these newcomers to the vaccine landscape. The vaccines used today to fight Covid-19 provide effective protection against severe forms of the disease… but not to stop the infection mechanisms. Will the new vaccines allow to fight against contamination? Will they be more effective in preventing any severe form of the disease? Impossible to know: “The speed with which the development of bivalent vaccines has been carried out does not allow us to know today if they are more effective or not”, Antoine Flahaut also states to the midi office.

“The anti-vaccines are having a field day”

Can a vaccine, therefore, benefit from a marketing authorization without having these data? The practice is common in the pharmaceutical industry, particularly for influenza and rare disease vaccines: “In the first case, manufacturers simply don’t have time to conduct clinical trials for their vaccine candidate, and in the second, there aren’t enough patients to carry.” carried out these trials, says Antoine Flahault, But Covid-19 is not the flu… Therefore, we could have required manufacturers to carry out traditional clinical trials.

Also read:
Vaccines against Covid-19: the Minister of Health, François Braun, wants to “convince” without dramatizing

The risk ? Deconstruct the legitimacy of these new vaccines and sow discord in a public that is already struggling to understand and accept the recommendations of the health authorities. “There is great confusion in the public and the media about the withdrawals of the Covid-19 vaccine, the epidemiologist continues on social networks.”

However, nothing that could jeopardize their safety: “There are data that have been collected from clinical trials carried out on volunteers, explains the professor. Therefore, we have no concerns about the tolerance of these vaccines.”

What are these new effective vaccines against Omicron?

Earlier this month, the Haute Autorité de Santé approved three bivalent vaccines. Two of these vaccines, developed by Pfizer/BioNTech and Moderna, are effective against the BA.1 strain, which arrived in France at the end of 2021. A third vaccine, also designed by Pfizer/BioNTech, has been approved by HAS: this is adapted to BA.4 and BA.5 variants, currently affecting France. These three vaccines had already been approved by the European Medicines Agency.

“Evaluation of the efficacy of Omicron’s BA.5 subvariant-directed bivalent vaccine only focused on mouse trials, explains Antoine Flahault. As for Omicron’s BA.1 subvariant-directed bivalent vaccines, it was associated with human clinical data, but refer to so-called ‘surrogate’ criteria”.

A nurse prepares a vaccine against Covid-19, in Toulouse on December 9, 2021.


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