FDA adds warning about rare heart inflammation to Pfizer, Moderna Covid shots

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The US drug regulator, the Food and Drug Administration (FDA), has added a warning to the literature that accompanies Pfizer Inc/BioNTech and Moderna Covid-19 vaccine shots to indicate the rare risk of heart inflammation after its use, reports Reuters.

For each vaccine, the fact sheets for healthcare providers have been revised to include a warning that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly after the second dose and with the onset of symptoms within a few days after vaccination, the FDA has said.

As of June 11, more than 1,200 cases of myocarditis or pericarditis have been reported to the US Vaccine Adverse Event Reporting System (VAERS), out of about 300 million mRNA vaccine doses administered.

The cases appear to be notably higher in males and in the week after the second vaccine dose. The Centres for Disease Control and Prevention has identified 309 hospitalisations from heart inflammation in persons under the age of 30, of which 295 have been discharged.

Vials with Pfizer-BioNTech and Moderna Covid-19 vaccine labels are seen in this illustration picture. — Reuters
Vials with Pfizer-BioNTech and Moderna Covid-19 vaccine labels are seen in this illustration picture. — Reuters

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