The EMA has submitted its latest findings on AstraZeneca, the vaccine which has faced several controversies in recent days. However, the instructions and medical guidelines for the vaccine could be changed.

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The AstraZeneca coronavirus vaccine is “safe and effective” and “is not associated” with a higher risk of blood clots, the European Medicines Agency (EMA) said on Thursday.

The committee came to a clear scientific conclusion: this is a safe and effective vaccine,” EMA Executive Director Emer Cooke said in a video conference.

This announcement was eagerly awaited by several countries, such as Nigeria, whose citizens had been worried and sceptical of the health safety of the vaccine. Concern had risen after the onset of several cases of bleeding problems or blood clots, sometimes leading to death.

But it was especially important to European countries where majority of the casualties have occurred, as the batch imported by Nigeria has been passed as safe.

The European Medicines Agency had authorized it for all over 18s, but some European nations had initially reserved it for those under 65 due to lack of evidence on its effectiveness in older people. Then its use was widened without age limit in view of data obtained in Scotland and England.

Now, several European health authorities like those of France and Germany has recommended inoculations for only people over 55 years of age.

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Pending further data, the HAS recommends using mRNA vaccines at people eligible for vaccination aged less than 55 years”, indicates the health authority of France in an opinion delivered this Friday.

This opinion follows that of the European Medicines Agency, issued urgently this Thursday following reports of serious adverse events. They had led some fifteen European countries to suspend its use while shedding light on these new suspicions, which had not appeared during clinical trials and were therefore not known when the Authorization had endorsed the distribution to European market on January 29.

On March 18, the EMA delivered its verdict: there was no significant increase in the overall risk, a number of adverse effects were normally expected in the vaccinated population, and the benefit provided by the vaccine is still much greater than the possible risk.

However, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency considered that “the possibility of a link between the vaccine, and cases of disseminated intravascular coagulation (DIC) and cerebral venous thrombosis (CVT) cannot be ruled out to date, ” with respectively 7 cases of DIC and 17 of TVC that has resulted in a total of 9 deaths, reported to the EMA by countries in Europe and the UK, out of around 20 million people vaccinated.

But French health authorities noted that “almost all of these cases occurred in people under 55 years of age, the majority of which were women” and the number of cases reported is “5 times higher for the CIVD and 8 times more for cerebral tthrombophlebiti” than one would expect in those under 50. Additional studies are underway and enhanced surveillance has been put in place in country.


In the meantime, the HAS considers that the AstraZeneca vaccination “can resume without delay,” but “given the progress of the vaccination campaign, which will concern elderly populations over the next two months, and the existence of alternatives for the youngest, HAS recommends at this stage to use the AstraZeneca vaccine only for people aged 55 and over, who constitute the vast majority of current priority people,” said HAS.

Those under 55 who have already received a dose will have to wait for a new opinion to come very soon “which will be issued,” according to the pharmacovigilance data which will provide more hindsight, promises the French health authority.

The Minister of Health said in a tweet that the government would follow this advice.

Thank you to all our doctors, pharmacists who will all be mobilized today to continue the vaccination campaign,” his tweet translated.

Germany’s health minister, Jens Spahn, also drew attention to the risk of cerebral vein thrombosis for women under 55, urging that doctors be informed of the potential risks so as to duly warn patients of that age grade.

After the green light from the European Medicines Agency, Germany resumed vaccination with AstraZeneca.

AstraZeneca plc is a British-Swedish multinational pharmaceutical and biotechnology company with its headquarters in Cambridge, England. AstraZeneca has a portfolio of products for major diseases including oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory and inflammation areas.

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