The EU drug authority, the European Medicines Agency (EMA), recommended on 9 September that myocarditis and pericarditis must be classified as possible side effects of the two existing “messenger and glycoconjugate” (mRNA) classes of the Wuhan pneumonia (novel coronavirus disease, Covid-19) vaccine. The EMA also recommends that people with a history of capillary leak syndrome (CLS, or blood clots) not receive a single dose of Johnson & Johnson’s Wuhan Lung vaccine.
The EMA noted that the PRAC concluded that in very rare cases, myocarditis and pericarditis may occur after Comirnaty (Pfizer-BNT) and Spikevax (Modena) vaccines, and therefore recommended that these two conditions be added to the side effects list in the generic versions of these two vaccines The Committee recommends that the two vaccines be labeled with warning signs for the attention of health care professionals and those receiving these vaccines.
The Commission said it made these conclusions after an in-depth review of 145 and 19 cases of myocarditis, and 138 and 19 cases of pericarditis, respectively, following Comirnaty and Spikevax vaccination in the European Economic Area as of May 31 of this year. The doses of these two vaccines administered in the EEA during this period were 177 million and 20 million doses, respectively.
According to the EMA report, the two aforementioned cases occurred mainly within 14 days after vaccination, more often after the second dose and in younger male adults. This is consistent with the claims made by the U.S. health authorities last month.
The committee also recommended that capillary leakage syndrome be included as a side effect of the Johnson & Johnson vaccine and that people with a history of the disease not receive the Johnson vaccine; the EMA last month requested that blood clots be included in the AstraZeneca vaccine. “(AstraZeneca) vaccine side effects. Both vaccines are adenovirus vector-based vaccines.