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AstraZeneca vaccine: five minutes to understand the debate on its side effects

2021-03-14T14:46:37.950Z


Several countries have suspended the use of this anti-Covid product, due to reported cases of thrombosis. The French authorities, on the


After Iceland, Denmark, Norway and Bulgaria, Ireland's turn.

His Ministry of Health announced this Sunday morning the suspension of vaccination against Covid-19 with AstraZeneca.

This decision was taken as a precaution, after the discovery of cases of post-vaccination thrombosis in various European countries.

In France, the authorities are sticking to the benefit / risk ratio of this vaccine and have maintained its use, recalling that a possible causal link with the disorders mentioned has not been demonstrated for the moment.

The latest pharmacovigilance report, updated on Saturday, notes that no serious signal directly linked to one of the batches involved has been identified to date.

We take stock.

Why have countries suspended the use of AstraZeneca?

Denmark was the first country to make such a move on Thursday, quickly followed by Iceland and Norway.

The Norwegian Health Products Agency has reported "four new serious cases of blood clots in adults" who received an injection of the AstraZeneca vaccine.

Bulgaria followed them the next day, before Ireland's decision announced this Sunday morning.

Other countries, such as Austria, Romania and Italy, have for their part withdrawn only one or more batches (and not necessarily the same). All invoke the precautionary principle, pending in-depth investigations .

What do the French authorities say about it?

For the moment, there are no plans to suspend the use of AstraZeneca in France.

"The risk benefit balance is extremely favorable to the AstraZeneca vaccine," the Director General of Health, Jérôme Salomon, insisted on BFMTV on Sunday.

"People who catch Covid are more at risk of having severe thrombosis than vaccinated people," immunologist Stéphane Paul, member of the Covid-19 vaccine committee, told us on Thursday.

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On Saturday evening, the National Medicines Safety Agency (ANSM) announced that 316,800 doses of the same ABV5300 batch as the one suspended in Austria had been delivered to France since February 9.

“Almost half” of them have already been administered.

But among the undesirable cases which have been reported concerning this batch, "there is no case of death, no case of endangerment of the vital prognosis and there are also no cases of thrombosis and thrombocytopenia, ”the agency said.

On the other hand, “although there is only one case in France to date, but taking into account its seriousness and the existence of Austrian cases of multiple thromboses which led to the suspension of batch ABV5300, we let us consider that there is a signal on cases of coagulopathies ”, we read in the pharmacovigilance report.

However, "in view of the available data, there is nothing to conclude that this effect is related to the vaccine", writes the ANSM in addition.

Mathieu Molimard, head of the pharmacology department at Bordeaux University Hospital, would not be surprised if the number of reports of thrombosis or phlebitis increases in the coming days.

“As soon as a person has one, they're going to report it all the more now, but that doesn't necessarily mean the actual proportion is increasing.

This is called awareness bias, ”he explains.

What do we know more generally about the side effects of this vaccine?

In total, the latest report published by the ANSM reports 6,362 adverse effects, including 3013 “potentially linked to the AstraZeneca vaccine”, as of March 4.

By this date, more than 450,000 injections had been performed with this product.

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These adverse effects are most often influenza-like illnesses (38.4% of the total, 12.6% if only influenza-like illnesses considered serious are taken into account).

This can manifest as fever and / or headache, fatigue, etc.

Gastrointestinal disorders account for 721 adverse reactions from the start (11.3% of the total), of which 261 are “serious” (4.1% of the total).

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But be careful, it would be difficult to want to relate these figures to the total number of injections.

As Mathieu Molimard reminds us, “the aim of pharmacovigilance is to look for possible serious side effects, as if we were looking for a needle in a haystack.

"But if, as soon as a person is a little feverish, they report it, the hay will grow bigger and it will be more difficult to find the needle.

If you have a little fever, so what?

It may simply be that you have been vaccinated, but this is not necessarily intended to be part of pharmacovigilance.

Otherwise, there is the risk of being quickly drowned, ”he adds.

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For example, many people vaccinated with AstraZeneca felt unwell for a few hours but did not report it to their doctor.

“When I was vaccinated, the doctor warned me that I might have a fever.

Suddenly, I thought it was planned and not really considered a side effect, ”testifies for example Sébastien, 48, who spent 24 complicated hours after the injection.

"We know, and this has been observed in the clinical studies which have made it possible to validate these vaccines including AstraZeneca, that a fraction of people, especially young people, can develop this kind of symptoms", indicated on February 12 Alain Fischer, chairman of the Vaccine Strategy Orientation Council, on France Info.

"About 30% of people vaccinated can experience flu-like symptoms, but which are most often not serious and which do not necessarily justify being notified to pharmacovigilance", specifies Mathieu Molimard.

This figure cannot be known precisely without conducting a full pharmacology survey on a sample of vaccinated people, for example.

Where are we with the vaccination with AstraZeneca in France?

For the moment, this controversy over adverse effects has no impact on the vaccination rate.

Friday was even that of a new record, with more than 170,000 first-time injections in 24 hours.

There had been 120,000 the day before and 113,000 the previous Friday, according to data from Public Health France.

In total, more than 1.2 million people have received a first dose of AstraZeneca vaccine (the recommended interval between the two injections is 9 to 12 weeks).

Initially intended for caregivers regardless of their age, it is now also available to 50-74 year olds with co-morbidities.

Source: leparis

All life articles on 2021-03-14

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