The MRNA vaccines from BioNTech / Pfizer and Moderna may be associated with rare cases of heart inflammation, according to analysis of 321 cases after vaccination released on Friday by the European Medicines Agency.
Myocarditis and pericarditis are inflammatory conditions of the heart with symptoms that include shortness of breath, palpitations and chest pain.
The PRAC Safety Committee analyzed 145 cases of myocarditis and 138 cases of pericarditis following the BioNTech / Pfizer vaccine. For Modernas jab, the PRAC analyzed 19 cases of each condition.
At the end of May, around 177 million doses of the BioNTech / Pfizer vaccine and 20 million doses of Moderna had been given in the European Economic Area.
The PRAC recommended updating product information to include this side effect and increase awareness among healthcare professionals and vaccine recipients.
The Committee also recommended that the marketing authorization for the Johnson & Johnson vaccine be restricted to persons with a history of capillary leakage syndrome. It advised to add a side effect warning for the serious condition where fluid leaks from small blood vessels causing swelling, low blood pressure, blood thickening and low blood albumin levels.
Three such cases have been reported to EMA, one in a person with a previous syndrome history following the Johnson & Johnson jab. All cases occurred within two days of vaccination; two of the three died. As of June 21
Finally, the PRAC advised that the product information for the Oxford / AstraZeneca vaccine includes a warning to raise awareness of cases of Guillain-Barre syndrome (GBS) that may have been reported after vaccination.
The syndrome causes neuritis and can result in pain, numbness, muscle weakness and difficulty walking.
Currently, available data confirm or exclude “neither a possible association with the vaccine,” the PRAC said. But given GBS seriousness, there were case warnings.
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