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US FDA adds warning about rare heart inflammation to Pfizer-BioNTech, Moderna COVID-19 vaccines

US FDA adds warning about rare heart inflammation to Pfizer-BioNTech, Moderna COVID-19 vaccines

FILE PHOTO: Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/Illustration/File Photo

The US drug regulator on Friday (Jun 25) added a warning to the literature that accompanies Pfizer-BioNTech and Moderna COVID-19 vaccine shots to indicate the rare risk of heart inflammation after its use.

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 onset of symptoms within a few days after vaccination, the FDA said.

As of Jun 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.

READ: 'Very small risk' of heart inflammation after second dose of mRNA COVID-19 vaccine: Singapore expert committee

The cases appear to be notably higher in males and in the week after the second vaccine dose. The United States Centers for Disease Control and Prevention (CDC) identified 309 hospitalisations from heart inflammation in people under the age of 30, of which 295 have been discharged.

Health regulators in several countries have been investigating cases of myocarditis and pericarditis, more frequently found in young men, after a shot of Pfizer or Moderna, vaccines that are based on the mRNA technology.

READ: Israel sees probable link between Pfizer COVID-19 vaccine and small number of myocarditis cases

The latest update from FDA follows an extensive review of information and the discussion by CDC's Advisory Committee on Immunization Practices meeting on Wednesday.

Pfizer and Moderna did not immediately respond to requests for comment after business hours.

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Source: Reuters/ta

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