Medicines

TGA considers myocarditis warning for COVID vaccine


The TGA says it is “actively considering” adding a warning about myocarditis and pericarditis to the Comirnaty (Pfizer) COVID-19 vaccine data sheet following a similar move by the US Food and Drug Administration (FDA).

The US regulator updated the fact sheets for the  Pfizer-BioNTech and Moderna COVID-19 vaccines on 25 June based on reports of rare adverse events, particularly following the second dose and with onset of symptoms within a few days after vaccination.

According to the TGA, there have been 26 cases of suspected myocarditis or pericarditis reported in Australia after 2.9 million Pfizer vaccine doses have been given up to 27 June 2021,.

In the US and Israel, cases of myocarditis and pericarditis have mostly been reported in young men and have been mild. However in Australia eight of the 26 reports were in men and 18 were in women. One of the men was 18 years old and another was 23 years old, while the others were aged 41–72 years. The women were aged 23–47 years old. At the time of reporting, the majority of individuals had recovered or were recovering.

“As we have limited experience of Comirnaty [Pfizer vaccine] in this age group and after the second dose, the TGA is considering international evidence in our ongoing investigation of this issue,” the regulator said.

“The TGA is actively considering the need for updates to the approved Product Information, and has sought advice from the Advisory Committee on Vaccines on this issue.”

It noted that myocarditis and pericarditis were much more common with COVID-19 infection and the risks to the heart could be more severe in this context. The benefits of protection against COVID-19 far outweighed these rare and generally mild side effects, it concluded.

“We encourage people to seek medical attention if they experience symptoms that could suggest myocarditis or pericarditis such as of chest pain, shortness of breath and palpitations. Typically these have occurred within seven days of vaccination, particularly after the second dose of Comirnaty.”

However, some cardiologists in the US have criticised the CDC analysis of the myocarditis reports, saying it may underestimate risk with vaccine use in children and young adults, and especially in children with co-morbid conditions. They said more work was needed to define risk in young people as this was the age group now being targeted for vaccination.

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