Anti-Covid vaccine: With Pfizer or Moderna, risk of myocarditis remains 'very rare' overall for Drug Safety Agency
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Anti-Covid vaccine: With Pfizer or Moderna, risk of myocarditis remains ‘very rare’ overall for Drug Safety Agency

As part of the Enhanced Vaccine Surveillance System for Covid-19, the EPI-PHARE group has conducted a new pharmacoepidemiology study on the risk of developing myocarditis after injection of an mRNA vaccine from Pfizer Laboratories (Comirnaty) and from Moderna (Spikevax).

According to new data reported by ANSM on July 22, 2022, the risk of developing myocarditis increases but remains low after the first dose of mRNA vaccine and this risk decreases with lengthening of the time between doses. This is what emerged from the new study conducted in particular by the National Agency for the Safety of Medicines (ANSM).

The risk of developing myocarditis is increased for the first booster dose (the third dose), although it is significantly lower than after the second dose, and will decrease with the lengthening of the interval between doses.

In most cases, the patient’s condition improves on its own or with the help of treatment. The risk of developing post-injection myocarditis generally remains ‘very rare’: less than 1 per 10,000 vaccinated. Young people are most at risk. anyways, “These pharmaco-epidemiological data do not question the benefit/risk ratio of the vaccines against Covid-19 Comirnaty and Moderna, whose efficacy against severe forms of Covid-19 is approximately 90%.”still refers to ANSM.

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An earlier study by EPI-PHARE, the results of which were published in Nature Communications, showed that there is a risk of developing myocarditis in the week following vaccination against Covid-19 with mRNA vaccines, especially after the second dose of Spikevax vaccine for men and women aged 12 to 50 general. This previous study also confirmed the positive clinical development of myocarditis.

EPI-PHARE is a group of scientific interest in the epidemiology of health products created by the National Agency for the Safety of Medicines (ANSM) and the French health insurance.

In a recent study published on July 22, there is indeed a risk of developing myocarditis after the first booster dose (the third dose). This risk is less than after the second dose and decreases with increasing time between successive doses.

Based on data from the National Health Data System (SNDS), EPI-PHARE conducted a new study aimed at measuring the effect of the first booster dose (the third dose) and the delay between other doses on the risk of developing myocarditis. The study included 4,890 cases of myocarditis in people 12 years of age or older, who were admitted to French hospitals between December 27, 2020 and January 31, 2022, as well as 48,900 control cases.

The risk of developing myocarditis increases during the first week after administration of the third dose of Kommernati and Specifax, but with a lower risk for the third dose than for the second.

In more detail, the estimated cases of excess myocarditis associated with the third dose globally are 0.25 cases per 100,000 doses of Comirnaty vaccine and 0.29 cases per 100,000 doses of Spikevax vaccine, which corresponds to one case of myocarditis attributable to vaccination for the 398,000-dose administration. A third from Comirnaty and 340,000 a third dose of Spikevax.

The largest excess cases were observed in men under 30 years of age, with a maximum of 1.2 cases per 100,000 third dose of Comirnaty, which corresponds to 1 case of myocarditis per 87,000 third dose.

Thus, this study shows, on the one hand, that the risk of developing myocarditis increases for the first booster dose (the third dose), although it is less pronounced than after the second dose, and on the other hand decreases with the lengthening of the time between doses. However, myocarditis associated with mRNA vaccines remain rare events with respect to the number of exposed subjects.

Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane surrounding the heart) are usually caused by a viral infection such as Covid-19 and tend to occur in young adults. In most cases, the patient’s condition improves on its own or with the help of treatment.

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