March 16, 2021 18:08
These days, the covid-19 vaccine produced by AstraZeneca is the focus of media attention that the company would have gladly done without. Already criticized for its delivery delays, the vaccine is now suspected of causing serious side effects. On 11 March, several countries suspended the administration. France, Germany, Italy and Spain joined on March 15.
Which countries have suspended the vaccine?
By the afternoon of March 15, at least twelve countries had suspended the use of the AstraZeneca vaccine. These are mainly European countries: France, Denmark, Germany, Italy, Spain, Norway, Iceland, Bulgaria, the Netherlands and Ireland, in addition to Thailand and the Democratic Republic of the Congo. Other EU countries – Austria, Luxembourg, Estonia, Lithuania and Latvia – have blocked some specific batches of the vaccine, allowing the other doses to be used.
As for France, President Emmanuel Macron specified that the suspension of the vaccine was decided pending the opinion of the European Medicines Agency (EMA), expected for the afternoon of March 16.
Why were these decisions made?
Concerns are based on some serious cases of thrombus formation in vaccinated people. In Denmark, a 60-year-old patient died of thrombosis (a vascular obstruction caused by a thrombus) shortly after receiving the AstraZeneca vaccine. The country’s health authorities have decided to apply a strict precautionary principle by suspending administration of the drug for two weeks. “It is currently not possible to establish whether or not there is a link. We will act promptly, a thorough investigation is needed, ”explained Danish health minister Magnus Heunicke.
Norway aligned with this position when three vaccinated people under the age of fifty were hospitalized with blood clots (one of them died on March 14). In addition, there was one death due to a brain haemorrhage.
Also fueling fears is the fact that authorities have detected cases of skin bleeding in young people who had been given the vaccine. The problem was taken absolutely seriously. “It is serious and could be a sign of a decrease in the number of platelets,” said the Norwegian Institute of Public Health.
According to the European Medicines Agency, thirty cases of thrombosis have been detected up to 10 March in about five million Europeans (residing in the European economic zone) vaccinated with the product of the Anglo-Swedish laboratory.
Has the link between these side effects and the vaccine been confirmed?
No. The possible side effects of vaccines are accurately communicated to the health authorities. This list, as exhaustive as possible, is a guarantee in monitoring the vaccination campaign. But it is not enough: a detailed analysis must be carried out later to understand whether the vaccine is responsible for the reported diseases or whether it is normal to observe them in these proportions compared to the general population.
At the moment, the EMA believes that the number of thromboses observed among vaccinated people is no higher than that found in the general population. The UK, where more than ten million doses of the AstraZeneca vaccine have been injected, follows the same line. “Considering the large number of doses administered and the frequency with which thrombosis can occur naturally, the evidence we have does not suggest that the vaccine is the cause”, assured the BBC Phil Bryan, head of vaccines for the British agency. of pharmaco-vigilance, Medicines and healthcare products regulatory agency.
As for the AstraZeneca laboratory, on March 14 it released a statement announcing that “a thorough examination of all available safety data on the more than 17 million vaccines administered in the European Union and the United Kingdom showed no evidence of a risk of thrombosis. deep vein or thrombocytopenia “.
Do these side effects call into question the usefulness of the vaccine?
The EMA believes that “the benefits of vaccines continue to outweigh the risks”. This position is also supported by the World Health Organization (WHO). On March 12 Margaret Harris, WHO spokesperson, said that “any security alert must be subject to investigation”, but at the same time “there is no reason not to use” AstraZeneca’s vaccine.
The evaluation of a drug passes from the evaluation of the risks it presents compared to the benefits. In the case of the AstraZeneca vaccine, its effectiveness against symptomatic forms of covid-19, whose rate is around 60 percent, continues to tip the scales in favor of use. This evaluation can change with the increase of knowledge on the subject, therefore it is useful to follow both the efficacy and the inconveniences produced by a drug over time.
What is the position of France?
In France, the vaccine is currently administered to people aged 50 to 74 who are at risk of comorbidities, as well as patients over 75 years of age. The administration takes place not only in doctors’ offices but also in pharmacies from 15 March, to speed up the vaccination campaign. At first, the health authorities maintained a position similar to that of the EMA. On 11 March, Health Minister Olivier Véran supported the recommendations of the National Medicines Safety Agency (ANSM), according to which there was “no reason to suspend vaccination with AstraZeneca”.
Responding to questions live on the Twitch video platform on March 14, Prime Minister Jean Castex had invited to continue the use of the vaccine in France: “At this stage you have to have faith in this vaccine and get vaccinated. I say this solemnly. Otherwise we will have delays in vaccinations. The French will be less protected and the health crisis will last longer ”.
On March 15 Emmanuel Macron announced the provisional suspension of the vaccine pending the opinion of the European Medicines Agency (EMA). “The decision that has been taken in accordance with our European policy is to suspend vaccination with AstraZeneca as a precaution, waiting to be resumed quickly if the EMA allows it”.
What are the other side effects of the AstraZeneca vaccine?
The main side effects that appeared during the trials were pain and increased sensitivity in the injection area. Other reactions are headache, fatigue, body aches or fever. More than one in ten people experience these symptoms, often with great intensity. In some cases, the symptoms can force the person to become ill.
This trend was observed during large-scale vaccination. According to the latest ANSM report, 3,013 reports of over 454 thousand vaccinations with the AstraZeneca product were made in France up to 4 March. “The great majority of cases concern pseudo-influenza syndromes, often of strong intensity (high fever, colors, headaches)”, specifies the Ansm.
Other rarer side effects have been reported, but there is currently no link between these effects and the vaccine. Serious side effects known as “of particular interest”, such as deaths, cardiac arrhythmia problems or loss of taste and smell would be extremely rare: only fifteen possible cases have been reported in France, and a link with the vaccine has not yet been found. .
(Translation by Andrea Sparacino)
This article appeared in the French newspaper Le Monde.
To know
The opinion of the British medicines authority and that of the EMA
- The UK drug surveillance agency (MHRA) collects reports of side effects on drugs and vaccines in the UK. The authority told the Guardian that, as of February 28, it had received more notifications of blood clots from people vaccinated with Pfizer-Biontech than from people who had received the Oxford-AstraZeneca drug: 38 vs. 30. In none of the two cases, however, had exceeded the mean population level.
- The safety committee of theEuropean Medicines Agency “It currently remains of the opinion that the benefits of the AstraZeneca vaccine in preventing covid-19, with its associated risk of hospitalization and death, outweigh the risks of side effects.” Future decisions will be announced on March 16, instead of March 18, as previously announced.
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