The ball is now in the court of the Member States.
Despite its suspension in the United States, where more than seven million people have already been vaccinated with this anti-Covid serum, the European Medicines Agency (EMA) estimated on Tuesday that the benefit of the Janssen laboratory vaccine was greater than risks.
At the same time, the risk assessment committee of the AEM admitted the existence of "a possible link" between atypical thromboses and the product of the subsidiary of the American group Johnson & Johnson.
Eight cases have been identified in the United States, including one fatal.
These blood clots, coupled with a drop in platelet levels, should be classified as "very rare side effects related to the vaccine," said Sabine Straus.
The chair of the AEM's risk assessment committee added that it was "not possible at present to identify very clear risk factors".
As such, two studies must be carried out, one commissioned from the Janssen company by the AEM, and a second carried out by the European Agency itself.
Insisting on the prevention of these conditions considered rare and treatable if identified in time, Sabine Straus invited people with side effects after being vaccinated, such as chest pain, or difficulty in breathing, "to consult" quickly.
Some 200,000 doses delivered in France
What will be the consequences of this advice for the vaccination campaign in France?
The process should be similar to what happened for AstraZeneca in mid-March.
In the coming days, the High Authority for Health (HAS) should issue an opinion on the use of the Johnson & Johnson vaccine.
Recommendations for use could be given, as for the AstraZeneca, which the HAS recommends to reserve for those over 55 years old.
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Two hundred thousand doses of the serum have already been delivered to France and are currently in logistics circuits.
If the green light from the HAS was given by the end of the week, the Janssen company's vaccine could be available in pharmacies from this weekend, said the services of the Ministry of Health on Tuesday.
Because the government reaffirms it: no question of doing without AstraZeneca or Johnson & Johnson in the battle for vaccination against Covid-19.
Especially since the American vaccine has the advantage of requiring only one dose.
The risk of a slight reluctance
The objective of immunizing 30 million people by June 15 is therefore maintained, "with cautious assumptions concerning the rates of use" of the two vaccines incriminated in cases of thrombosis, one explained to the ministry. of Health.
That is to say by anticipating a slight reluctance on the part of the public, without however expecting a mass refusal.
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A position that arouses the skepticism of pharmacologist Jean-Louis Montastruc, member of the Academy of Medicine. “Since there are alternatives to these two vaccines, I would rather recommend turning to others,” he assesses. Not that he doubts the benefit-risk balance, that he claims to be in favor of vaccines. “But even if the risk of thrombosis is minimal, it has become unbearable for the population, it is the feedback that we have from the ground. We must also take note of the social fact in pharmacovigilance, otherwise we risk causing a fiasco, with people who refuse to go to be vaccinated, ”he says.
