Vaccines against Covid-19: risks of thrombosis, myocarditis… Pharmacovigilance reveals the truth about adverse effects

Three years of hindsight and investigation of an extraordinary amount of data: in a study unprecedented in its scale, the French Network of Pharmacovigilance Centers revealed its truths on the possible adverse effects of the vaccine used to fight Covid-19. Since the start of the first vaccination campaign against the virus, in late 2020, 30 regional pharmacovigilance centers spread across France have recorded and analyzed post-vaccination reports made by patients and healthcare professionals. For these constructs, it is therefore a question of coordinating clinical and epidemiological investigations to find out whether the signals emitted are linked to vaccination.

Why Implement Pharmacovigilance?

According to statistics shared by the National Agency for Safety of Medicines and Health Products (ANSM) in June 2023, approx. 157 million doses Operated in France for the last three years. in parallel, 200,000 reports ANSM were sent, however, without knowing whether the observed adverse effects were attributable to vaccination. 25% of these reports (i.e. 50,000 of them) were classified as “severe”: this therefore concerns 0.03% of the injections performed in France.

Vice President of the French Network of Pharmacovigilance Centers (RFCRPV) Dr. “It was completely unprecedented to observe a drug administered to such a large number of people in such a short time interval,” commented Aurelie Grandvulemin, with our colleagues. Future Science. This pharmacovigilance makes it possible to highlight potential adverse effects in any case that would not have been observed during clinical trials prior to the release of these vaccines.

Thrombosis cases are observed?

The French Network of Pharmacovigilance Centers has therefore chosen this thread. Back in Spring 2021: Cases of thrombosis (formation of small blood clots in veins) following certain injections have been reported. “We sent a signal very quickly on this topic, because we received a certain number of declarations for patients with or without previous risk factors vaccinated by Pfizer, Moderna or AstraZeneca, explains Dr. Aurélie Grandvuillemin. So maybe something was happening. . thing.”

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Pharmacovigilance centers then initiate two epidemiological investigations. This showed no statistically increased risk for vaccines using messenger RNA technology (Pfizer/Biontech and Moderna). A statistical signal, however, was confirmed for the AstraZeneca adenovirus vaccine, particularly in those under 55 years of age. The risk of thrombosis is estimated to be 1 per 100,000 people vaccinated. Health authorities subsequently identified 30 cases of rare thrombosis in France, when 4 million doses of the AstraZeneca vaccine were injected. Nine people died.

Risks of Myocarditis and Pericarditis?

Also in 2021, reports were shared with pharmacovigilance centers about cases of inflammation of the heart muscle and the membrane around the heart in people who were vaccinated. “Rare but potentially serious” signs of “myocarditis” and “pericarditis” have been found in some patients who received messenger RNA vaccines.

In July 2021, a situation update conducted by the National Agency for Safety of Medicines and Health Products finally indicated that the indication linked to these adverse effects is “confirmed”, but remains “rare” and “do not call” is not in question. Question the benefit/risk ratio of vaccines”.

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A year later, Health Insurance confirms that “vaccination with Komirneti (Pfizer-Biontech) and Spikevax (Moderna) increases the risk of myocarditis and pericarditis within 7 days after vaccination”, especially in young people under 30 years of age. However, health authorities insist that the number of cases of myocarditis and pericarditis “appears to be rare considering the high doses administered”.

Menstrual problems after vaccination in women?

It is this potential adverse effect that sparked interest in the scientific community as late as 2021. Almost three years later, a new study conducted by the ANSM showed that the risk of heavy menstrual bleeding There has been an increase of 20% Between one and three months after the injection of the first dose of a vaccine against Covid-19 using so-called messenger RNA technology.

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According to the data shared, 8 women were affected per vaccinated patient. “At the European level, heavy menstrual bleeding was considered an adverse effect of the mRNA vaccines Comrnati and Spikevax by the EMA in October 2022 after an evaluation of pharmacovigilance data, particularly those shared by the ANSM. These distortions were added later. Summaries of product characteristics (SmPC) and package inserts for these two vaccines,” the study explains.