The European Medicines Agency (EMA) said on Aug. 3 that the Maryland-based drug firm's Nuvaxovid vaccine should list myocarditis (heart muscle inflammation) and pericarditis (heart lining inflammation) as potential side effects. It has asked Novavax to provide additional data on the side effects.
According to the agency, both healthcare professionals and people wanting to get the vaccine should be warned about the risks of Nuvaxovid. Cardiac inflammation has also been noted as risks linked to the mRNA COVID-19 vaccines from Pfizer and Moderna.
Novavax told the Epoch Times in an email that during the vaccine's clinical trials, the rate of myocarditis observed between those injected with the actual shot and a placebo were close.
"As more data becomes available, we will better understand the nature and magnitude of any potential risk of myocarditis and pericarditis," it wrote. "We will work with the relevant regulators to assure our product information is consistent with our common interpretation of the incoming data.
A month prior, the EMA added anaphylaxis – severe allergic reaction – as a side effect of the Novavax shot.
"The product information [for] Nuvaxovid will be updated with severe allergic reaction and unusual or decreased feeling in the skin as new side effects," it said on July 14. The decision followed the assessment of the EMA's Pharmacovigilance Risk Assessment Committee. "A few cases" of anaphylaxis linked to the vaccine were reported, but the EMA refused to disclose the actual figure. (Related: European Medicines Agency adds SEVERE allergic reaction to Novavax COVID shot's side effects.)
According to The COVID Blog, the Novavax sub-unit protein vaccine delivers the SARS-CoV-2 spike protein using an insect virus. It also utilizes saponin from the soap bark tree (Quillaja saponaria) native to South America to trigger an immune response in the body.
The U.S. Food and Drug Administration (FDA) granted the Novavax shot an emergency use authorization (EUA) on July 13. Dr. Robert Califf, the head of the American regulator, said in a statement that the EUA granted to Novavax "expands the available vaccine options for the prevention of COVID-19."
Under the EUA, the two-dose Novavax vaccine is permitted for use on adults aged 18 and older – with an interval of several weeks between the two doses.
The FDA later remarked that the vaccine's clinical trials did raise concerns about cardiac inflammation, and that it alerted both recipients and healthcare providers about these. Furthermore, the regulator also ordered Novavax to conduct post-authorization observational studies to evaluate a potential connection between its vaccine and "adverse events of special interest" – including myocarditis and pericarditis.
The Novavax shot's product label for the U.S. market warned against injecting it to people with a history of allergic reactions to any of its components. But even before it was granted EUA in July, staffers at the FDA pointed out that the vaccine increased the risk of myocarditis.
In documents released June 3, staff members at the regulator cited four events of myocarditis – inflammation of the heart muscle – that occurred during clinical trials of the vaccine. Novavax conducted trials of its sub-unit protein vaccine on almost 30,000 patients between December 2020 and September 2021.
"These events raise the concern for a causal association with this vaccine, similar to the association documents with mRNA COVID-19 vaccines. Data from passive surveillance during post-authorization use in other countries also indicate a higher than expected rate of myocarditis and pericarditis [heart lining inflammation] … associated with the vaccine," they wrote.
"Further evaluation is needed to inform the risk of myocarditis and pericarditis, and their outcomes, as additional data emerge over time."
Watch this video about the FDA's emergency approval of the Novavax vaccine.
This video is from the TKWK T.V channel on Brighteon.com.