TGA releases latest covid vaccine safety report

There have been no new vaccine-related deaths identified since 2022, the regulator has reported.

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Reporting rates of adverse events following covid boosters are “very stable” according to the TGA’s latest covid vaccine safety report.

The report, released this week, showed a “small number” of myocarditis and pericarditis cases have been reported for booster doses.

“This is a recognised risk with the Comirnaty (Pfizer) and Spikevax (Moderna) vaccines and we are closely monitoring these events,” the report stated.

“So far, reports of myocarditis after a booster dose are very rare, occurring in less than 1 in every 100,000 doses administered.”

Almost 66 million doses of covid vaccine have been administered across Australia since the rollout started to April 16, with about 138,000 adverse reactions reported. This amounts to a reporting rate of 2.1 per 1000 doses.

Four main covid vaccines are provisionally approved for use in Australia, including Comirnaty, Spikevax, Vaxzevria (AstraZeneca) and Nuvaxovid (Novavax).

The TGA reported Vaxzevria was not currently available as existing batches have expired. 

Bivalent vaccines for both mRNA vaccines are also now registered in Australia to cover the Omicron BA.1 and BA.4-5 variants.

“The TGA closely monitors reports of suspected side effects (also known as adverse events) to the COVID-19 vaccines,” the TGA said.

“This is the most intensive safety monitoring ever conducted of any vaccines in Australia. We encourage people to report suspected side effects, even if there’s only a very small chance a vaccine was the cause.”

The TGA reported that it was continuing to closely review all deaths that are reported in the days and weeks after covid vaccination.

From the beginning of the vaccine to 16 April, the TGA has identified 14 reports where the cause of death was linked to vaccination, from a total of 985 reports received and reviewed.

“There have been no new vaccine-related deaths identified since 2022,” it said.

“The 14 deaths likely to be related to vaccination occurred in people aged 21-81 years old. There have been no deaths in children or adolescents determined to be linked to COVID-19 vaccination.”

The most frequently reported side effects associated with the vaccines include headache, muscle and joint pain, fever, chills and nausea. Skin reactions at the site of the injection are also common and can include pain, swelling, redness and an itchy rash. These are recognised side effects of vaccination and are usually transient and mild.

The report breaks down the adverse events reports for each vaccine.

• Comirnaty – to 16 April 2023, more than 44 million doses of this mRNA vaccine have been administered in Australia, as well as about 951,000 doses of the bivalent booster vaccines. About 81,000 adverse reports have been received by the TGA. Reporting rates of “likely myocarditis cases” from all doses for all ages are 2.4 per 100,000 doses.
• Spikevax – to 16 April, more than five million doses have been administered in Australia, as well as about 632,000 doses of the bivalent booster vaccines. About 7500 adverse reports have been received by the TGA. Reporting rates of “likely myocarditis cases” from all doses for all ages are 3.2 per 100,000 doses.
• Nuvaxovid – to 16 April, 251,000 doses have been administered in Australia. About 1000 adverse reports have been received by the TGA. Myocarditis is reported in around 3-4 in every 100,000 doses of Nuvaxovid. Overall, pericarditis is reported in 13 in every 100,000 doses but is more common in men aged 18-49 years (estimated at 27 per 100,000 doses).
• Vaxzevria – while this vaccine is provisionally approved for use in Australian adults, it is not currently available as existing batches have expired and very few doses have been used since 2021. Just under 14 million doses have been administered in Australia. About 48,700 adverse reports have been received by the TGA.