Pfizer has said it has not observed a higher rate of the
condition, known as myocarditis, than would normally be expected
in the general population.
In Israel, 275 cases of myocarditis were reported between
December 2020 and May 2021 among more than 5 million vaccinated
people, the ministry said in disclosing the findings of a study
it commissioned to examine the matter.
Most patients who experienced heart inflammation spent no more
than four days in the hospital and 95% of the cases were
classified as mild, according to the study, which the ministry
said was conducted by three teams of experts.
The study found "there is a probable link between receiving the
second dose (of Pfizer) vaccine and the appearance of
myocarditis among men aged 16 to 30," it said in a statement.
According to the findings, such a link was observed more among
men aged 16 to 19 than in other age groups.
Pfizer said in a statement that it is aware of the Israeli
observations of myocarditis, noting that no causal link to its
vaccine has been established.
Adverse events are thoroughly reviewed and Pfizer meets
regularly with the Vaccine Safety Department of the Israeli
Ministry of Health to review data, it said.
Israel had held off making its 12- to 15-year-old population
eligible for the vaccines, pending the Health Ministry report.
In parallel to publishing those findings, a ministry committee
approved vaccinating the adolescents, a senior official said.
"The committee gave the green light for vaccinating 12- to
15-year-olds, and this will be possible as of next week,"
Nachman Ash, Israel's pandemic-response coordinator, told Radio
103 FM. "The efficacy of the vaccine outweighs the risk."
A U.S. Centers for Disease Control and Prevention advisory group
last month recommended further study of the possibility of a
link between myocarditis and mRNA vaccines, which include those
from Pfizer and Moderna Inc.
CDC monitoring systems had not found more cases than would be
expected in the population, but the advisory group said in a
statement that members felt healthcare providers should be made
aware of reports of a "potential adverse event."
Israel has been a world leader in its vaccination rollout.
With COVID-19 infections down to just a handful a day and total
active cases at just 340 across the country, the economy has
fully opened, though restrictions remain on incoming tourism.
About 55% of Israel's population has already been vaccinated. As
of Tuesday, restrictions on social distancing and the need for
special green vaccination passes to enter certain restaurants
and venues were scrapped.
(Reporting by Jeffrey Heller; Additional reporting by Nandakumar
D; Editing by Howard Goller and Christian Schmollinger)
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