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# FDA Panel Backs Novavax Covid-19 Vaccine
- URL: https://www.fdaweb.com/fda-panel-backs-novavax-covid-19-vaccine/
- Published: 2022-06-07T12:00:00.000Z
- Updated: 2026-09-14T17:47:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5151998

FDA’s Vaccines and Related Biological Products Advisory Committee 6/7 voted unanimously (21 to 0) to recommend that the agency grant Novavax an emergency use authorization for its Covid-19 vaccine and its use in individuals 18 years of age and older. 

FDA’s [briefing document](https://www.fda.gov/media/158912/download?ref=fdaweb.com) said vaccine efficacy against confirmed mild, moderate or severe Covid-19 was 90.4%. “All Covid-19 cases in the \[Novavax\] arm were mild; in the placebo arm, 11% of cases were moderate and 5% were severe. Several panel members expressed the desire to have seen more recent clinical data showing the vaccine’s effectiveness against more recent variants. FDA earlier noted that when data were collected in 2021 the predominant circulating Covid-19 strain was the B.1.1.7 (Alpha) variant. 

On the safety side, FDA said: “Multiple events of myocarditis/pericarditis were reported in temporal relationship to NVX-CoV2373 administration, similar to myocarditis following mRNA Covid-19 vaccines and raising concern for a causal relationship to NVX-CoV2373\. Events of lymphadenopathy were infrequent but reported by a higher proportion of participants in the NVX arm, with the highest rate observed after Dose 2 (0.2%). Review of the data also identified small imbalances in certain thromboembolic events, including cardiac and neurovascular events, hypersensitivity events, cholecystitis, uveitis, cardiac failure, and cardiomyopathy. However, a causal association between vaccination and these events cannot be concluded based on available data.”