U.S. FDA Readies Protein-Based COVID-19 Vaccine Review

The U.S. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) announced yesterday confirmed it will review the Novavax COVID-19 vaccine (NVX-CoV2373) for active immunization against SARS-CoV-2 in adults during a digital meeting scheduled for June 7, 2022.

On February 1, 2022, FDA received a request from Maryland-based Novavax Inc. for emergency use authorization of the Novavax COVID-19 Vaccine.

The VRBPAC reviews and evaluates data regarding the safety and efficacy of vaccines and related biological products intended to prevent, treat, or diagnose human diseases.

On June 3, 2022, the VRBPAC digital published access to these presentations.

"Based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease," stated an FDA Briefing Document.

Additionally, Novavax issued a statement late on June 3rd.

'Throughout the pandemic, as publicly available vaccines have been administered, there have been numerous investigations into findings related to myocarditis.'

'The data from our placebo-controlled studies show that overall, in our clinical development program, the rate of myocarditis was balanced between the vaccine and placebo arms (0.007% and 0.005%).'

'Furthermore, in the post-crossover portions of our studies, the cases we have seen are all within the expected rate.'

'Based on our interpretation of all the clinical data supporting NVX-CoV2373, including over 50,000 participants in clinical trials, we believe there is insufficient evidence to establish a causal relationship.'

'We will continue to monitor all adverse events, including myocarditis and pericarditis.'

As of June 4, 2022, Novavax's vaccine has received authorizations in over 170 countries and is Listed by the World Health Organization.

On May 9, 2022, Novavax disclosed its first quarter of 2022 total revenue includes $605 million of revenue comprised of $586 million of product sales from NVX-CoV2373 based on 31 million doses sold by Novavax and $19 million of royalties and adjuvant sales to license partners.

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