Slowdown in vaccination campaigns in Northern Europe.
Denmark, then Iceland and Norway decided on Thursday to suspend the use of the AstraZeneca vaccine against Covid-19 until further notice.
Italy has also announced that it will ban a batch of this product.
These suspensions come "after reports of serious cases of blood clot formation (
Editor's note: also called thrombosis
)", explained the Danish National Health Agency.
The Scandinavian country also indicates to have recorded a death by thrombosis of a person who had received the vaccine.
Please note, the Danish health authority specifies that this "pause" is applied by "precautionary principle".
“At present, we cannot conclude that there is a link between the vaccine and blood clots,” she admitted.
“There is always a risk associated with vaccines (...).
It went well in Denmark, but there are some risks with AstraZeneca's vaccine that need to be looked at in more depth.
It seems to me the right way to proceed, ”reacted Danish Prime Minister Mette Frederiksen.
"A political choice that seems disastrous to me"
A precautionary principle?
"It's rather the opposite", annoys Jean-Daniel Lelièvre, head of the infectious diseases department at the Henri-Mondor hospital in Créteil and vaccine expert at the High Authority for Health (HAS), who recalls that the benefit of AstraZeneca's product has already been demonstrated.
"Do you have a vaccine that prevents people from going to the hospital and dying and we stop it because we think there is a death?"
It is a political choice which can be criticized and which seems disastrous to me.
"
“Perhaps these countries were a little cooled during the vaccination against the H1N1 flu (
Editor's note: which had led to several cases of narcolepsy-cataplexy
).
Maybe they have enough vaccines to continue the vaccination without AstraZeneca, ”asks Stéphane Paul, immunologist at the Saint-Etienne University Hospital and member of the Covid-19 vaccines scientific committee.
No more cases of thrombosis than usual
The European Medicines Agency (EMA) is reassuring.
She reaffirmed this Thursday that the AstraZeneca vaccine could be used despite the investigation she is currently conducting on these "thromboembolic events", "the benefits of the vaccine continuing to outweigh its risks".
France is following the recommendations of the EMA, said the Minister of Health Olivier Véran, this Thursday evening.
“According to the National Medicines Safety Agency (
ANSM
), there is no need to suspend vaccination with AstraZeneca,” he said.
As of March 9, only 22 cases of thrombosis have been reported for more than three million dose injections of AstraZeneca in the European Economic Area, according to the EMA.
That is to say a figure lower than “that observed in the general population”.
“In the files of phase 3 clinical trials, this type of case has never been reported in a significant way.
There are only 22 cases of blood coagulation out of 150,000 people vaccinated, ”says Stéphane Paul.
Shunned by some caregivers for its side effects and its supposed lower effectiveness compared to RNA vaccines (70% against more than 90% for Pfizer / BioNTech and Moderna), AstraZeneca's product therefore continues to arouse mistrust.
Already Monday, Austria announced that it had stopped administering a batch of this vaccine, after the death of a 49-year-old nurse who succumbed to “serious bleeding disorders” a few days after receiving it.
Four other European countries - Estonia, Lithuania, Latvia and Luxembourg - immediately suspended vaccinations with doses from this batch.
But, after a preliminary investigation, the EMA said on Wednesday that there was no link between the vaccine and the death in Austria.
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"People die in real life"
Of the millions of people vaccinated with the AstraZeneca product, it "is normal" to register deaths, "since people also die in real life", insists Jean-Daniel Lelièvre.
"The eternal problem", recalls Mathieu Molimard, head of the medical pharmacology department of the Bordeaux University Hospital, is to establish "whether it is a coincidence or if there is a cause and effect link.
This is where pharmacovigilance comes in ”.
“Today, it does not seem to me that we have any evidence to say that there is a causal link between the vaccine and these blood clots.
At the slightest risk identified, we will not hesitate for a second to say so, ”notes this former ANSM contributor.
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And even if the death that occurred in Denmark was indeed linked to the AstraZeneca product, "it should be compared with all the deaths avoided thanks to the vaccine," recalls Jean-Daniel Lelièvre.
However, for the moment, the risk / benefit balance of this antidote tilts heavily in its favor.
In addition, patients with Covid-19 "are more at risk of developing thrombosis than those vaccinated, even with AstraZeneca", observes Stéphane Paul.
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Will the announcement of this Scandinavian break have an effect on French support for the AstraZeneca product?
“For the moment, we do not feel any impact with the customers of pharmacies, indicates Philippe Besset, president of the Federation of pharmaceutical unions of France (FSPF).
And even if one or two voluntary clients would prefer not to be vaccinated for fear of side effects, the waiting lists are so gigantic for being bitten in pharmacies that it will have no impact on the vaccination rate ” , he says.
According to him, the only thing slowing down the campaign is above all "the lack of available doses".
