European health authorities will soon review bivalent vaccines from Pfizer/BioNTech and Moderna, suitable for variants of the Omicron family. Professor Élisabeth Bouvet, president of the vaccination technical commission at the Haute Autorité de Santé, explains that the HAS will issue its opinion on these new vaccines at the beginning of September.
What can we expect from the vaccines, adapted to the Omicron variants, and which are expected in the fall?
Better efficiency on the different variants of the Omicron family! These bivalent vaccines combine the current vaccine and a vaccine specifically directed at Omicron. As we know, the effectiveness of current vaccines on Omicron is not excellent… It is not zero either. They are not particularly effective on infections linked to the virus, but remain legitimate to fight against severe forms of the disease.
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What we would like is that these vaccines make it possible to fight against contamination, because today, protecting the population against serious forms of the virus is something that we know how to do. The longer it goes, the older the people who go to intensive care because of a Covid-19 infection or have comorbidities.
What do we know about the effectiveness of these bivalent vaccines against Omicron?
For the time being, we have no data showing us the effective protection that these new vaccines provide to infected people. We cannot know today what we will gain in terms of clinical efficacy thanks to these vaccines… We are at a stage where we can be delighted to benefit from vaccines adapted to Omicron, but we do not we are not sure of their gain in efficiency.
Is it common practice to approve a vaccine without having access to its human clinical data?
On the one hand, it shouldn’t be done because the human clinical data of a vaccine are important. In a context like this, however, it is difficult to establish the effectiveness of a vaccine on humans. This is in fact what we do with the influenza vaccine: each year, the formula of these vaccines changes, and we do not wait to have access to any clinical data whatsoever to authorize the placing on the market.
Are these “new generation” vaccines coming too late?
You still have to be aware that we are coming to the end of a wave linked to the Omicron variant. These vaccines may be late compared to what we have seen circulating, but with this virus, it is possible that new variants will appear. It is possible that there will be surprises regarding the subvariants related to Omicron.
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Having vaccines that contain a greater quantity of antigens will undoubtedly allow us to broaden the immune responses to new potentially dangerous variants.
Taking into account the arrival of these new vaccines, is the Haute Autorité de Santé likely to give new recommendations in the fall?
On August 30, we will issue an opinion to the Technical Commission for Vaccinations (CTV) on these two new bivalent vaccines developed by Pfizer / BioNTech and Moderna. The files are under investigation. This commission will then give us its opinion. The High Authority for Health will then meet around a college. It is this same college which will rule and which will make new recommendations: this is scheduled for September 5th.
Is the envisaged scenario of a vaccine campaign grouped between influenza and Covid-19 still relevant this year?
Very likely, apart from the second vaccination booster against Covid-19, which we always recommend for over 60s and people with comorbidities, the scenario recommended by the High Authority for Health is to provide a booster or a injection of vaccine associated with that of the flu when the vaccination campaign against the flu will begin on October 15th. If we do not face a new epidemic wave linked to another variant of SARS-CoV-2 by then, this is what will certainly be recommended.
Today, what epidemic scenario would encourage the health authorities to open new booster injections to all French people?
If a new variant, which would cause serious forms of infection in the youngest people for example, were to appear, this question would be considered. Furthermore, if a vaccine proves to be particularly effective against SARS-CoV-2 infections, it would again be necessary to consider recommending new injections to all French people. For the moment, vaccines only protect against severe forms of the disease.