Israel sees probable link between Pfizer vaccine and myocarditis cases
Israel's health ministry said on Tuesday that it found cases of heart inflammation, mainly in young men who received the Pfizer (PFE.N) COVID-19 vaccine in Israel, Possibly related to their vaccinations.
Pfizer said in a statement that it was aware of the Israeli observation of myocarditis & said no causal link had been established for its vaccine.
It said the adverse events are thoroughly reviewed & that Pfizer meets regularly with the Israel Health Ministry's Department of Vaccine Safety to review the data.
In Israel, 275 cases of myocarditis were reported between December 2020 & May 2021 among more than 5 million vaccinated people, revealing the findings of a study the ministry said was commissioned to investigate the matter.
Most of the patients who experienced heart inflammation did not spend more than four days in the hospital and 95% of the cases were classified as mild, according to the study, which was conducted by the ministry by three teams of experts.
"There is a possible link between men aged 16 to 30 years receiving second-dose [Pfizer's] vaccine & the presence of myocarditis," the study said in a statement. According to the findings, such a link was seen more in men aged 16 to 19 than in other age groups.
A US Centers for Disease Control & Prevention (CDC) advisory group last month recommended further studies into the possibility of a link between myocarditis & mRNA vaccines, with Pfizer & Moderna Inc.
At a May 24 meeting, the CDC advisory group said data from the Vaccine Adverse Event Reporting System (VAERS) -- which relies on individuals to report results -- had higher than expected myocarditis or pericarditis cases seen in 16 to 24 Shown in numbers. -Years old.
However, the group also noted that data from another database—the Vaccine Safety Datalink (VSD), did not show that rates of myocarditis and pericarditis following COVID-19 vaccination differed from expectations. The VSD has data from nine healthcare organizations & can be used to compare vaccinated populations with unvaccinated people.
Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, said parents should still vaccinate their children because the known risks of COVID-19 include multi-system inflammatory syndrome.
"This issue of a transient myocarditis associated with a vaccine is a theoretical & unproven risk at this time," Offit said. "So I think in the world of weighing relative risks, disease is a major risk."
The European Medicines Agency (EMA) said last week that heart swelling after receiving the Pfizer vaccine was not a cause for concern because such events were at the same rate as in the general population. It was added at the time that young men were particularly prone to the condition.
Pending a health ministry report, Israel had barred its 12- to 15-year-old population from being eligible for vaccines. A senior official said that parallel to publishing those findings, a committee of the ministry approved immunization of adolescents.
Israel's pandemic-response coordinator, Nachman Aish, told Radio 103 FM, "The committee gave the green light to vaccinate children aged 12 to 15 & it will be possible by next week." "The efficacy of the vaccine outweighs the risk."
Israel has been a world leader in its vaccination rollout.
With COVID-19 infections a day only a handful & the total active cases nationwide at only 340, the economy has fully opened up, although restrictions on visiting tourism remain in place.
About 55% of Israel's population has already been vaccinated. As of Tuesday, restrictions on social distancing & the need for special green vaccination passes to enter some restaurants & venues had been dispensed with.