The Sweden has suspended the use of the Moderna vaccine against Covid-19 for people under 30 years of age as a precaution. The public health agency said the suspension is linked to “signs of increased risk of side effectsi, such as inflammation of the heart muscle or pericardium. The risk of being hit is very low “. Also there Denmark meanwhile he reported that people under the age of 18 will no longer receive the RNA vaccine developed in the US as a precaution. According to the agency, the data collected by the Scandinavian countries show the suspicion of increased risk of cardiac inflammation, although the number of cases is very small. Preliminary data from the study have been sent to the European Medicines Agency and will be evaluated. A precautionary stop that comes at the same time as the publication of three studies: one on Jama and the other two on The New England of Medicine in which the data are analyzed and the rarity of cases is emphasized.
“The hypothesis that Moderna’s Covid vaccine, which contains higher doses of mRna, created more myocarditis in young people does not seem to me to have numbers to support it. It may be that I am wrong, it may be that these two countries have data that recommend it. But it seems like excessive caution to me and it seems to me that the uneven approach in Europe does not help good communication on vaccines ”explained Guido Rasi, scientific advisor to the Covid emergency commissioner, Francesco Paolo Figliuolo, and former executive director of the European drug agency Ema. Rasi therefore expresses perplexity for the decisions of the two countries: “if there are numbers released in the last 48 hours that I am not aware of, I will change my mind, but with the numbers we have there are no substantial differences between vaccines, there is no it is a real problem of dangerous reactions right now, with the numbers we know and with the massive use that has been made, with billions of doses all over the world ”. For Rasi, “good institutional education, of governments and health institutions of other countries communicate to European colleagues of the decision that is being taken so that everyone prepares. This would be good institutional education that these governments seem to me not to be reserving these countries for us ”.
A note arrived from Amsterdam, the headquarters of the EMA, explaining that “preliminary analyzes” of new data, relating to reports of unwanted cardiac effects following vaccination against Covid with mRna products, and “from Nordic countries” including Sweden and Denmark, “indicate the possibility that the risk of myocarditis in younger men may be higher after a second dose of Spikevax, ”Moderna’s vaccine,“ compared to a second dose of Comirnaty ”from Pfizer / BioNTech,“ although further evaluation is needed. The Prac will evaluate the new data to determine if it is necessary to update the current recommendations in the product information ”. “In July 2021 – recall from the European Medicines Agency – the Prac concluded that myocarditis and pericarditis, inflammatory heart conditions, they can occur in very rare cases after vaccination with Comirnaty or Spikevax, more often after the second dose and in younger men ”. For this reason, “the committee recommended listing both conditions as side effects in the product information for these vaccines, along with a warning to raise awareness among health professionals and people receiving these vaccines. Health workers have also received a communication ”on the subject.
Now, continues the EU regulatory body, “the conclusions of the Prac are supported by new analyzes of data from Nordic countries (Denmark, Finland, Norway and Sweden), which show myocarditis occurs more frequently after the second dose of Comirnaty and Spikevax ”. But “preliminary analyzes” suggest “also the possibility that the risk of myocarditis in younger men may be higher after a second dose of Spikevax than after a second dose of Comirnaty, although further evaluation of the data is necessary”.
Just two days ago, a study was published in the prestigious Jama Internal Medicine magazine in which it is claimed that acute myocarditis in those receiving m-Rna vaccines against Covid is rare and it has an incidence of 5.8 cases per 1 million individuals after the second dose. The study is based on a population of nearly 2.4 million people. The researchers included individuals enrolled in the health care system Kaiser Permanente Southern California (KPSC) aged 18 years or older who received at least Pfizer or Moderna mRNA vaccine between December 14, 2020 and July 20, 2021.
The cohort had an average age of 49 and included people of different gender and ethnicity. Potential cases of postvaccine myocarditis were identified based on physician reports and the criteria were hospitalization within 10 days of vaccination with a discharge diagnosis of myocarditis. Over a 10-day observation period, among the 2,392,924 who received at least one dose there were 15 confirmed cases of myocarditis: 2 after the first dose and 13 after the second, for an observed incidence of 0.8 cases for one million first doses and 5.8 cases for one million second doses. All were men, with an average age of 25 (20-32). Of the patients with myocarditis after vaccination, none had previous heart disease. Eight patients received Pfizer and 7 Moderna. All were hospitalized, 14 (93%) reported chest pain one to 5 days after vaccination. No patient required intensive care admission or readmission after discharge. In the unvaccinated group, consisting of 1,577,741 individuals, the median age was 39 years (28-53) and there were 75 cases of myocarditis during the study period, of which 39 (52%) involved the men; the mean age in this case was higher and equal to 52 years (32-59). Given the observational nature of this study, the researchers conclude, “no relationship has been established between vaccination and myocarditis“.
Only yesterday two other publications in The New England of Journal for Medicine, as reported on Twitter by US scientist Eric Topol, further demonstrated the rarity of myocarditis cases. Inflammations that in 95% of cases are mild in the analysis of the data arrived from Israel where a death was recorded.
I study it his Jama
The study on Nejm / 1
The study on Nejm / 2