Vaccine for children 5-11 years, Magrini (Aifa): “No myocarditis warnings”

“The safety studies” of the anti-Covid vaccine in the 5-11 year range, both “in the 3,500 children vaccinated in the experimental phase and in the 3.5 million already immunized in the US, mainly with a 1 dose, after 16 days of observation “they say” there has been no safety alert, nor cases of myocarditis, which usually appear 5 days after vaccination. ” This was stated by the AIFA director general, Nicola Magrini, in a videoconference hearing in the Senate Hygiene and Health Commission, on the post-vaccination myocardial risks in the pediatric range. Magrini then announced that an AIFA report on myocarditis and one dedicated to the vaccinated dialysis population will be released next week. “On very rare adverse events such as those of myocarditis” after the anti-Covid vaccination “there is a pharmacovigilance that has different levels – recalled Magrini – the first is made up of reports that arrive at AIFA from health professionals, then there is is a second, more scientific and analytical, of our offices and also Europe between the confronted and the expected with respect to an event, from myocarditis to thrombosis. From a first comparison, an alarm signal can arise for the third level which is the validation or the estimation of the event. This is the probative level that decides the incidence of an adverse effect which will then be included in the technical data sheet of the product. So there is an exchange on a global level, at the time of authorization in the USA , where 3.5 million children have already been immunized, no worrying signs of pharmacovigilance were born “. “The phenomenon of myocarditis and pericarditis is under the attention of EMA and the various task forces of which AIFA is also a member – he continued – and Ema has recently disclosed the evidence on the risks of myocarditis in the population over 12 years, a figure published on December 3, with a very rare risk for mRna vaccines, 1 case per 20 thousand subjects and slightly different between the two vaccines “. CARDIOLOGISTS – The data on the dangers of myocarditis for those who are vaccinated against Covid “are reassuring”. And the risk-benefit ratio “always remains favorable to immunization from the pandemic virus” say the specialists of the Italian Society of Cardiology (Sic), gathered today for the press conference to present the 82nd national congress which opens today in Rome, in presence and remotely, to close on 12 December. “There has been a great deal of media attention in recent days for the risk of myocarditis and pericarditis after the Covid vaccine with mRna. The data, however, are reassuring. A study on ‘Circulation’ has just come out which shows that, in the United States , the subjects who were affected by myocarditis after vaccination – and this two days after the vaccine inoculation – the disease was mild, early discharge from the hospital and no deaths were recorded “, explained the president Sic Ciro Indolfi. “The cost-benefit of the anti Covid vaccination – added Indolfi – is certainly in favor of vaccination”. While highlighting a slightly higher risk in young people under the age of 30 (about 15 cases out of 100 thousand), President Sic reassures that “cases of myocarditis were mild, more frequent in males and in subjects aged about 15 with a fast resolution in 95% of cases “. And on the basis of the series just published, it is confirmed that “in the rare myocarditis in young people under the age of 21 there was no death”. Gianfranco Sinagra, Sic vice president, provided some data: we know that in the years before the pandemic and the extensive vaccination “the estimated number of myocarditis was 20-25 per 100 thousand inhabitants every year. The number of myocarditis linked to Covid not related with the vaccine, in general, it is 11 per 100 thousand people a year and the number of myocarditis reasonably attributable to the vaccine is less than 5 per 100 thousand patients a year. So we are dealing with numbers that are 4 or 5 times lower compared to myocarditis that are generally observed “. Even if in young males this percentage increases, in any case” the benefit-risk balance – said Sinagra – remains largely in favor of vaccination practice which is to be recommended together with social distancing measures and mask because they are the only tools that can relaunch life, the economy, education and restore a prospect for the future that the pandemic is curtailing “.