Novavax asks FDA to authorize its protein-based COVID-19 vaccine
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Novavax on Monday announced that it has submitted an emergency use authorization request to the FDA for its protein-based COVID-19 vaccine for individuals aged 18 years or older.
The request came more than a month after WHO issued two emergency use listings for the vaccine following the publication of phase 3 trial data in The New England Journal of Medicine, which showed an efficacy rate of more than 90% in a trial of roughly 30,000 participants in the United States and Mexico.
“We're extremely proud of the work of our teams and we look forward to FDA's review of our EUA request,” Novavax President and CEO Stanley C. Erck, MBA, said in a press release. “We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic.”
If authorized, the vaccine would become the fourth COVID-19 vaccine available in the United States. More than 538 million doses of the vaccines manufactured by Pfizer-BioNTech, Moderna and Johnson & Johnson have already been administered in the U.S., according to CDC data.
The first emergency listing issued by WHO last month was for the vaccine dubbed Covovax that is being produced in India under a license from Novavax. That vaccine is part of the COVAX initiative, which aims to provide vaccine equity in lower income countries. The second listing was for the vaccine being marketed by Novavax in Europe and other markets as Nuvaxovid.
“This vaccine has many attractive features,” Karen L. Kotloff, MD, a coauthor of the New England Journal of Medicine study and professor of pediatrics at the University of Maryland, told Healio last month. “It is made from a small piece of protein like many currently licensed vaccines in the U.S. and has convenient refrigerator storage requirements, so it will be an important addition to the COVID-19 vaccine portfolio, in the U.S. and in countries where supply is lacking.”
References:
Dunkle LM, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2116185.
WHO. COVID-19 vaccines WHO EUL issued. https://www.who.int/news/item/17-12-2021-who-lists-9th-covid-19-vaccine-for-emergency-use-with-aim-to-increase-access-to-vaccination-in-lower-income-countries. Accessed Jan. 31, 2022.
Perspective
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The larger the menu for COVID-19 vaccines the better, especially when they use novel platform technologies.
Additionally, for those who are vaccine hesitant about messenger RNA vaccines or the Johnson & Johnson adenovirus platform, the availability of a protein-based vaccine will hopefully melt that hesitancy.
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