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FDA has raised concerns about possibility of cardiac inflammation of the Novavax COVID vaccination

Key Takeaways:


Even though the company's evidence showed that it could reduce the likelihood of mild-to-severe disease, the US Food and Drug Administration has highlighted concerns about a probable risk of heart inflammation by Novavax Inc.'s COVID-19 vaccine.


Within 20 days of receiving the protein-based shot, four incidences of myocarditis were found in Novavax's roughly 30,000 patient trials, which took place between December 2020 and September 2021.


In briefing notes disclosed on Friday, FDA staff noted, "These instances raise the worry for a causal association with this vaccine, comparable to the association observed with mRNA COVID-19 immunizations."


Following the FDA's study of data from the company's trial, the company's stock dropped roughly 14%.


According to the regulator, myocarditis and another type of heart inflammation known as pericarditis were flagged as an "important recognised risk" in Novavax's documents. This is yet to be decided upon by the company.


Novavax stated that natural background myocarditis occurrences could be expected in any suitably big database in response to the FDA's safety concerns.


"We think there is insufficient evidence to demonstrate a causal association based on our reading of all the clinical data supporting NVX-CoV2373," the company said.


After getting a placebo, one patient in the study developed myocarditis.




NVX-CoV2373, according to Novavax, will play a role in promoting vaccination among those who have been reticent to get immunized, and the company has begun an educational campaign on vaccine options.


"Despite the widespread availability of authorized or approved vaccines, the SARS-CoV-2 pandemic remains uncontrollable in the United States... there is a demand for vaccines created utilizing well-understood technology platforms," it stated.


Before the Omicron and Delta variants became the prevalent strains, the FDA evaluated data from Novavax's experiment.


The FDA staff stated, "Based on the efficacy estimates in the clinical trial of this vaccine, it is far better likely than not that the vaccine will give some substantial level of protection against COVID-19 owing to Omicron, in particular towards more severe disease."


In Novavax's study, which included individuals from across the United States and Mexico, the vaccine had a 90.4 percent efficacy rate.


The FDA's remarks were included in a briefing note prepared ahead of a meeting of the agency's outside advisers on May 7.


Those advisers will utilize the remarks of its staff to help them decide whether or not to recommend authorizing the vaccination on Tuesday. Although the FDA is not required to adopt the advice of its independent experts, it frequently does so.