The EU says Novavax’s COVID-19 vaccine should carry a warning. But this Australian expert says there is no major problem

Written by Javed Iqbal

The European Medicines Agency (EMA) recommends that Novavax’s COVID-19 vaccine carries a warning about the rare possibility that it will cause two types of heart inflammation.

Heart disease — myocarditis and pericarditis — should be listed as new side effects for the vaccine, Nuvaxovid, based on a small number of reported cases, the agency said.

Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the outside of the heart.

US vaccine developer Novavax said no concerns about heart inflammation were raised during clinical trials of Nuvaxovid and that more data would be collected.

“We will work with the relevant regulators to ensure that our product information is consistent with our shared interpretation of the incoming data,” the vaccine developer said.

Adelaide epidemiologist and biostatistician Adrian Esterman said all medicines carried a risk of causing unwanted side effects, but generally serious side effects from vaccines were very rare.

He added that Australia’s medicines regulator, the Therapeutic Goods Administration, would be well aware of the EMA’s recommendation.

“My position on this is really that there’s nothing to be concerned about,” he said.

“In reality, it’s a very small number of people. This is not considered a big problem.”

How long has Novavax been in Australia?

Novavax shot jparticipated in Australia’s national vaccine program in February after being approved by the TGA.

TGA figures show around 189,200 doses of the Novavax shot have been administered in Australia to July 24 this year. Last month, it was provisionally approved by ATAGI for use as a COVID-19 vaccination in children aged 12 to 17.

Of all these doses, the TGA said it had received a small number of reports of suspected myocarditis and/or pericarditis in people given Nuvaxovid.

“Three cases probably represented myocarditis and 21 probably represented pericarditis,” said the latest TGA Vaccine Safety Report.

“As a result of our study, the Product Information (PI) for Nuvaxovid (Novavax) has been updated to include pericarditis as a potential side effect.”

Professor Esterman said regulatory bodies such as the TGA had a few ways of dealing with reported side effects.

“The first is to include a warning on the product information sheet in the package,” he said.

“If it’s more serious, they can also insist on a warning label on the package. And finally, they can take the product off the market.”

In June, the US Food and Drug Administration (FDA) flagged a risk of heart inflammation from the Novavax vaccine.

Myocarditis and pericarditis were previously identified as rare side effects, mostly seen in young men, from RNA vaccines made by Moderna and Pfizer and the BioNTech alliance, with the vast majority of those affected making a full recovery.

What is the Novavax jab?

Novavax hoped that people who had chosen not to take Pfizer and Moderna’s vaccines would favor its shot because it relies on technology that has been used for decades to fight diseases including hepatitis B and influenza.

Unlike mRNA and viral vector vaccines, which contain genetic material that tells your body how to make the spike protein, The Novavax vaccine contains the spike protein itself.

In Novavax’s nearly 30,000-patient trial conducted between December 2020 and September 2021, there were four cases of a type of heart inflammation detected within 20 days of taking the protein-based shot.

About 250,000 doses of Nuvaxovid have been administered in Europe since its launch in December, according to the European Center for Disease Prevention and Control.

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Javed Iqbal

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