A vial of Novavax COVID-19 vaccine with a blurred needle in the background.

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

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

The heart conditions — 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 outer lining of the heart.

US vaccine developer Novavax said no concerns about heart inflammations were raised during the clinical trials of Nuvaxovid, and more data would be gathered.

“We will work with the relevant regulators to assure our product information is consistent with our common 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 overall severe adverse outcomes from vaccines were very rare.

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

“My take on this is really there’s nothing to be worried about,” he said.

“In reality, it’s a very small number of people. This is not considered to be a major issue.”

How long has Novavax been in Australia?

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

TGA figures show about 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 COVID-19 vaccination use in children aged 12 to 17.

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

“Three cases were likely to represent myocarditis and 21 were likely to represent pericarditis,” the latest TGA Vaccine Safety Report said.

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

Professor Esterman said regulatory bodies like the TGA had a few ways to deal with reported adverse events.

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

“If it’s more serious, in addition they can insist on a warning label on the packet. 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 the Pfizer and BioNTech alliance, with the vast majority of those affected recovering fully.

What is the Novavax jab?

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

Unlike mRNA and viral vector vaccines, which contain genetic material telling your body how to make the spike protein, the Novavax vaccine contains the actual spike protein.

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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