“Very rare cases of myocarditis and pericarditis have been observed following vaccination with Covid 19 mRna vaccines.” The episodes occurred “more often in younger men and after the second dose of the vaccine, usually within days” of administration. “Current evidence suggests a probable causal association between myocarditis and mRna vaccines“. This is the conclusion of the experts of the Global Advisory Committee on Vaccine Safety (Gacvs) of the World Health Organization (WHO), which after analyzing” all the available information “updates its guidelines. Notwithstanding that, the panel, “the benefits of mRna vaccines outweigh the risks”, guaranteeing a “reduction in hospitalizations and deaths associated with Covid”.
“The available data – indicates the WHO Gacvs – suggest that the immediate course of post-vaccination myocarditis and pericarditis is generally mild and responds to conservative treatment (rest, treatment with non-steroidal anti-inflammatory drugs). Follow-up is ongoing. to determine long-term outcomes “, as well as” more rigorous studies are underway using alternative data sources and more robust protocols, including comparing vaccinated and non-vaccinated populations.
“The vaccinated – recommends the committee – should be advised to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis, such as new onset and persistent chest pain, shortness of breath or palpitations after vaccination”. As for physicians, “they need to be aware of the risk of myocarditis and pericarditis with mRna vaccines, and know who is most likely to get them. Health care providers also” need to pay attention “to warning signs,” especially in adolescents or young males. ” in which “coronary events are less likely to be the source of these symptoms. Where possible, suspected cases should be evaluated and followed up by a cardiologist. “It is however” important to rule out other potential causes of myocarditis and pericarditis, including infection with Covid-19 and other viruses. For this evaluation, it may be necessary to consult an infectious disease specialist and / or rheumatologist. “
The WHO therefore expresses itself in line with the US and EU drug agencies. Both the Fda and the EMA, the Geneva agency recalls, have released updates on product information of the Covid-19 vaccines to mRna Comirnaty * from Pfizer / BioNTech and Spikevax * from Moderna. These and other regulatory bodies have issued notices and various communication materials, aimed at the public and healthcare professionals, with indications on the actions to be taken after vaccination.
In the US, experts from GACVS WHO point out, “a strong signal of myocarditis / pericarditis has recently been reported with Covid mRna vaccines. However, the US Advisory Committee on Immunization Practices (Acip) has concluded that the benefits of these vaccines continue to outweigh the risks of myocarditis and pericarditis, even among young people. According to data from the US Vaccine Adverse Events Reporting System (Vaers), as of 11 June 2021, about 40.6 cases of myocarditis were reported per million second doses among males and 4.2 cases per million among females in the age group 12-29 years. For those over 30, reporting rates were 2.4 (males) and 1.0 (females), respectively. ) per million second doses “.
In Europe, “the EMA Pharmacovigilance Risk Assessment Committee (Prac), at its meeting on July 5-8, examined the latest European data, confirming that there is a plausible causal relationship between myocarditis and mRna vaccines” .