The fate of part of the vaccination strategy in France is undoubtedly played out this Tuesday at the end of the afternoon.
The European Medicines Agency (EMA) must unveil its recommendations for this product at 5 p.m., the first injections of which on people aged at least 55 in France are supposed to begin at the end of the week.
The stake is crucial because Janssen, subsidiary of the American group Johnson and Johnson, weighs a very important weight in the deliveries of doses expected by the end of June.
Still it will be necessary that it does not end up “unloved” like AstraZeneca, which struggles to convince a part of the eligible population.
We take stock.
Why is the EMA speaking out?
Experts from the EMA's pharmacovigilance risk assessment committee (PRAC) have been examining in recent days the cases of thrombosis identified following a Janssen vaccination, outside the European Union where it is not yet administered.
In announcing this investigation, on April 9, the Agency had reported "four serious cases of unusual blood clots", including three in the United States (where this vaccine is already authorized and used since the end of February).
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Since then, a total of six cases (including one death) have been recorded across the Atlantic.
These are only women, aged 18 to 48.
This also led the CDC to recommend, on April 14, a "pause" in the Janssen vaccination.
This could end by Friday and this product could be limited to certain categories of people, said Sunday Anthony Fauci, the "Mr. vaccination" of US President Joe Biden.
On the Johnson & Johnson vaccine pause, Dr. Anthony Fauci tells @MarthaRaddatz: "We'll know by Friday where we're going with this."
https://t.co/dU120vpKgd pic.twitter.com/TQ0dR423Yg
- This Week (@ThisWeekABC) April 18, 2021
What could the decision of the EMA be?
Difficult to answer this question.
Doctors expect the recommendations to be the same as for the AstraZeneca vaccine, which works on the same principle (adenovirus) as that of Janssen.
On April 7, the EMA then concluded that this type of unusual thrombosis "should be listed as very rare side effects" of the "AZ" vaccine, while ensuring that the benefits of continuing the injections outweighed the risks.
She had not established a proven link between age or sex and the occurrence of such a disorder.
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AstraZeneca vaccine: "Thrombosis should be listed as rare side effects"
Several European countries, however, immediately decided to reserve AstraZeneca for older adults, considering that the benefit / risk ratio was less favorable in young people but that it remained very important beyond a certain age.
In France, for example, you must be at least 55 years old to be able to receive this vaccine.
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In its latest pharmacovigilance report, published last Friday, the National Medicines Safety Agency reported 23 cases of atypical thrombosis after AstraZeneca vaccination in France, including 8 deaths.
9 of these cases were recorded from April 2 to 8.
This figure should be compared with that of injections carried out, ie more than 2,725,000 as of April 8.
What could this change in France?
France has always relied heavily on Janssen to speed up vaccination.
This product has the great advantage, compared to the three already administered (AstraZeneca, Pfizer / BioNTech and Moderna) of being single-dose.
That is, a single injection is sufficient.
As 7.5 million doses are supposed to be delivered in France in May and June combined (17.8% of the total over these two months), these are potentially as many people who can be vaccinated.
For the moment, as a precaution, Janssen is also "targeted" on people aged at least 55 years and the first injections are supposed to start at the end of the week (200,000 doses arrived in mid-April).
The High Authority for Health had validated this product for all adults and it has not yet modified its recommendations, pending the opinion of the EMA.
If it is confirmed and perpetuated that Janssen remains reserved for the 55 years and over, it will be necessary to redirect the other vaccines towards the youngest.
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It remains to be seen whether Janssen will arouse the same distrust as AstraZeneca, shunned by many people who are nevertheless entitled to it. As the two vaccines work on the same principle and that the side effects mentioned are similar, several doctors believe that "the damage is done" and that this newcomer will also have difficulty finding his audience. "I dare to hope that one does not order too much", testified Monday morning François Bricaire, member of the Academy of medicine, who vaccinates every morning in Paris.