What happened
Shares of Novavax (NVAX -22.60%) were down 19.3% as of 10:51 a.m. Friday morning. The decline came after the Food and Drug Administration (FDA) released briefing documents for an advisory committee meeting scheduled for June 7. This Advisory Committee will review the submission of Novavax for Emergency Use Authorization (US) of its vaccine against COVID-19 NVX-CoV2373.
And what
Many investors focused primarily on the following statement in the FDA briefing document: “Several events of myocarditis / pericarditis have been reported in temporary relationship with the administration of NVX-CoV2373, similar to myocarditis after mRNA vaccines. COVID-19 and that raised concerns about a causal relationship with NVX. -CoV2373. “
The FDA noted that four of the five adverse events reported in the Novavax data occurred in young men. This demographic group was found to have a higher risk of myocarditis (inflammation of the heart muscle) after receiving COVID messenger RNA (mRNA) vaccines developed by Moderna and its partners Pfizer and BioNTech.
The agency even said that “the risk of myocarditis after NVX-Cov2373 could be higher than that reported during post-authorization use of COVID-19 mRNA vaccines.” Because? No cases of the disease were found in the pre-authorization review of Moderna and Pfizer-BioNTech vaccines.
Image source: Getty Images.
But there is a case to be made for investors to overreact to these comments. The FDA stated that “a causal association between vaccination and these events cannot be concluded based on available data.” Importantly, the agency also said it is “more likely than not” that NVX-CoV2373 will provide protection against COVID-19 caused by the omicron variant of the coronavirus.
Now that
The strong sale of Novavax today could only be temporary. The stockpile is likely to skyrocket next week if the FDA advisory committee gives a positive recommendation for NVX-CoV2373. But we’ll have to wait and see how much myocarditis concerns affect panel thinking.