Will the U.S. FDA Authorize a Protein-Based COVID-19 Vaccine?

When the U.S. FDA’s vaccine committee endorsed the Maryland-produced protein-based COVID-19 vaccine on June 7, 2022, many people expected authorization would immediately follow.

However, according to Novavax Inc.’s statement issued on July 1, 2022, this World Health Organization Listed vaccine remains under FDA review.

Novavax stated ‘it is awaiting U.S. emergency use authorization (EUA) for our prototype COVID-19 vaccine, and we are committed to bringing it to market.

‘Clinical data generated to date demonstrate that this prototype vaccine offers broad immune responses including against circulating variants, such as the Omicron BA.4/5.’

Novavax is already well underway in our variant program and will accelerate our focus on Omicron BA.4/5, as recommended by FDA in their guidance on June 30, 2022.’  

‘We expect to have additional preclinical data on Omicron BA.4/5 in the late summer or fall, and expect to be in a position to provide an Omicron-containing vaccine in Q4 of 2022.’

During the late June FDA meeting, Novavax’s team highlighted data showing the structural features of Novavax's protein-based COVID-19 vaccine displayed epitopes across both the original strain and emerging SARS-CoV-2 virus variants, contributing to the generation of broadly cross-reacting antibodies. 

Additional data from Phase 2 and Phase 3 trials and in vitro data on neutralizing antibodies and receptor inhibition from trial participants show cross-reactivity with all virus variants tested, particularly following booster doses.

‘Novavax continues to believe in the importance of vaccines that offer broad immune responses against a variety of variants, given the fact that COVID-19 will continue to evolve,’ said the Company.

Novavax originally submitted a request to the FDA for EUA in January 2022. 

Another company hoping to bring this non-mRNA vaccine to the USA is the Serum Institute in India (SSI). On June 30, 2022, local media reported SSI is seeking approval to export millions of its version of the Novavax vaccine, Covovax, under the brand name Nuvaxovid™, to the USA in July 2022.

As of July 2, 2022, Nuvaxovid has received authorization for use in adults from more than forty countries. Recently, the Taiwan Food and Drug Administration granted EUA for Nuvaxovid.

Nuvaxovid (NVX-CoV2373)  is a protein-based vaccine engineered from the genetic sequence of the first strain of the SARS-CoV-2 beta coronavirus.

This Novavax vaccine integrates the patented saponin-based Matrix-M adjuvant, which has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response and helping an immunized person make antibodies against the virus.

In July 2020, Novavax was awarded $1.6 billion by the U.S. federal government to complete late-stage clinical development and deliver 100 million doses of the NVX‑CoV2373 vaccine.

Note: This vaccine news article is not sponsored content.

PrecisionVaccinations publishes fact-checked, research-based vaccine news curated for mobile readership.