Even though the company’s analysis found it could reduce the likelihood of mild-to-severe disease, the US Food and Drug Administration has expressed concern about a potential hazard of heart inflammation from Novavax Inc’s COVID-19 vaccine.
Within 20 days of receiving the protein-based injection, four incidences of myocarditis were found in Novavax’s roughly 30,000 patient trial, which took place between December 2020 and September 2021. In briefing notes disclosed on Friday, FDA staff noted that these occurrences highlight the worry of a strong correlation with this vaccine, akin 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%. Myocarditis and another type of heart inflammation known as pericarditis were flagged as a “relevant recognised risk” in Novavax’s documents, according to the regulator. This has yet to be agreed upon by the company.
In response to the FDA’s safety concerns, Novavax stated that natural background myocarditis occurrences can be anticipated in any suitably large database. They think there is inadequate evidence to demonstrate a causal association based on their reading of all the clinical facts supporting NVX-CoV2373, the company stated.
After receiving placebo, one patient in the study developed myocarditis.
NVX-CoV2373, according to Novavax, will contribute to promoting vaccination in those who have been reluctant to get immunised, and the company has begun an educational campaign on vaccine options. Despite the extensive availability of authorised or approved vaccines, the SARS-CoV-2 pandemic remains uncontrollable in the United States and there is a demand for vaccines created using well-understood technology platforms, it stated.
Well before Omicron and Delta variants became the prevalent strains, the FDA evaluated data from Novavax’s experiment. The FDA staff stated that given the effectiveness prediction in the clinical trial of this vaccine, it is far more probable than not that the vaccine will provide some substantive layer of safety against COVID-19 owing to Omicron, particularly against more serious diseases.
In Novavax’s study, which included individuals from across the United States and Mexico, the vaccine had a 90.4% efficacy rate. The FDA’s remarks were included in a briefing note prepared ahead of a meeting of the agency’s outside advisers recently.
Those experts will use the remarks of their staff to help them decide whether or not to endorse the vaccination. Although the FDA is not required to adopt the advice of its independent experts, it frequently does so.