France is investigating five cases of myocarditis – inflammation of the heart muscle – which were detected in people who had received Pfizer/BioNTech’s coronavirus vaccine.
At the moment, there is no clear link between the cases and the coronavirus vaccine, the French health authorities said on Friday.
“Thus far, five cases have been declared in France,” the national medicines safety agency (ANSM) said in its weekly Covid-19 vaccine update.
“The available information does not provide enough elements, at this stage, to conclude that the vaccine played a role, but it nevertheless constitutes a potential signal that needs to be monitored," the agency added.
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Several cases of myocarditis were detected in Israel after a second dose of the vaccine, which led ANSM Monitoring Committee “to re-examine the data on inflammation of both the heart muscle and the pericardium collected by the regional pharmacovigilance centres (CRPV) in France since the start of the vaccination campaign."
These possible side effects will be further studied and the results will be shared with the European Medicines Agency (EMA), ANSM added, stressing that the favourable relationship between risks and benefits of the vaccine could not yet be questioned.
A total of 16,030 cases of adverse side effects, most of them “expected and not severe,” such as pain in the place where the vaccine was administered and headaches, have been registered out of “over 13,660,000 vaccines administered since 22 April,” ANSM said.
The agency had already noted cases of higher blood pressure immediately after the administration of the vaccine.
Other side effects are “potential signals” or are “being monitored,” including heartbeat issues, shingles and macrophage activation syndrome, a rare disease linked to the inappropriate stimulation of these immune system cells.
The Brussels Times