Rare mRna-myocarditis vaccines, “probable link” for WHO

“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 a few 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 available information” updates its guidelines. Notwithstanding that, the panel points out, “the benefits of mRna vaccines outweigh the risks”, guaranteeing a “reduction in hospitalizations and deaths associated with Covid”. Read also “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 more rigorous studies are underway using alternative data sources and more robust protocols, including the comparison between vaccinated and non-vaccinated populations “.” To the vaccinated – recommends the committee – advised to seek immediate medical attention if they develop symptoms suggestive of myocarditis or pericarditis, such as new 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, in fact, the Geneva agency recalls , disseminated product information updates for the Covid-19 vaccines to Pfizer / BioNTech’s mRna Comirnaty * and Moderna’s Spikevax *. indications on the actions to be taken after vaccination. In the USA, the experts of GACVS WHO underline, “a strong signal of myocarditis / pericarditis has recently been reported with Covid mRna vaccines. However, the United States Advisory Committee on Immunization Practices (ACIP) 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 Vaccine Adverse Events Reporting System (Vaers) of the USA, as of 11 June 2021, about 40.6 cases of myocarditis per million second doses were reported among males and 4.2 cases per million among females in the age groups. aged between 12 and 29 years. For those over 30, the reporting rates were 2.4 (males) and 1.0 (females) per million second doses, respectively. “In Europe,” the Pharmacovigilance Risk Assessment Committee (Prac) of the Ema, in its meeting of 5-8 July, examined the latest European data, confirming that there is a plausible causal relationship between myocarditis and mRna vaccines “.