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Will the US FDA approve a protein-based COVID-19 vaccine? — Precision vaccination
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When the US FDA’s Vaccine Commission approved the protein-based COVID-19 vaccine produced in Maryland on June 7, 2022, many expected the approval to continue soon.
However, according to a statement issued by Novavax Inc. on July 1, 2022, the vaccines listed on this World Health Organization are under FDA review.
Novavax “is waiting for the US Emergency Use Authorization (EUA) for the prototype COVID-19 vaccine and is committed to bringing it to market.
“Clinical data generated so far indicate that this prototype vaccine provides a wide range of immune responses, including those against circulating variants such as Omicron BA.4 / 5.”
Novavax is already on track with its variant program, accelerating its focus on Omicron BA.4 / 5, as recommended by the FDA in its guidance on June 30, 2022.
“We expect to have additional preclinical data on Omicron BA.4 / 5 in late summer or fall and will be able to offer Omicron-containing vaccines in the fourth quarter of 2022.”
At an FDA meeting in late June, the Novavax team highlighted data showing the protein-based structural characteristics of Novavax. COVID-19 vaccine It displayed epitopes in both the original strain and the new SARS-CoV-2 virus variant and contributed to the production of widely cross-reactive antibodies.
Additional data from Phase 2 and Phase 3 trials, as well as in vitro data on neutralizing antibody and receptor inhibition from study participants, showed cross-reactivity with all viral variants tested, especially after booster immunization. is showing.
“Novavax continues to believe in the importance of vaccines that provide a wide range of immune responses against a variety of mutants, given the fact that COVID-19 continues to evolve,” the company said.
Novavax initially submitted an EUA request to the FDA in January 2022.
Another company that wants to bring this non-mRNA vaccine to the United States is the Serum Institute (SSI) in India. On June 30, 2022, local media reported that SSI was seeking approval to export millions of versions of the Novavax vaccine Covovax to the United States in July 2022 under the Nuvaxovid ™ brand name.
As of July 2, 2022, Nuvaxovid has been approved for adult use in more than 40 countries. Recently, the Taiwan Food and Drug Administration has granted Nuvaxovid an EUA.
Nuvaxovid (NVX-CoV2373) is a protein-based vaccine designed from the gene sequence of the first strain of SARS-CoV-2 beta coronavirus.
This Novavax vaccine integrates a patented saponin-based Matrix-M adjuvant. It has a powerful and well-tolerated effect by stimulating the invasion of antigen-presenting cells into the injection site, enhancing antigen presentation in local lymph nodes, and promoting an immune response. Helps immunized people make antibodies against the virus.
In July 2020, Novavax was awarded $ 1.6 billion by the US Federal Government to complete late-stage clinical development and provide 100 million doses of the NVX-CoV2373 vaccine.
Note: This vaccine news article is not sponsored content.
Precision Vaccinations Publish fact-checked, research-based vaccine news curated for mobile readers.
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