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 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 June 11, more than 1,200 cases of myocarditis or pericarditis
have been reported to the U.S. 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 CDC identified 309 hospitalizations
from heart inflammation in persons under the age of 30, of which 295
have been discharged.
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 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.
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.
(Reporting by Maria Ponnezhath and Manojna
Maddipatla in Bengaluru; Editing by Chris Reese
and Daniel Wallis)
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