Novavax, Inc. NVAX announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended expanded conditional marketing authorization (CMA) for its protein-based COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), as a homologous and heterologous booster dose in adults (aged 18 years and older).
Nuvaxovid was granted CMA for adults by the European Commission (EC) in December last year. The EC also granted CMA to Nuvaxovid to prevent COVID-19 in adolescents aged 12-17 in July 2022.
The latest CHMP recommendation was based on data from a phase II study held in Australia, another phase II study held in South Africa as well as the UK-sponsored COV-BOOST study. Data from the same showed that a third dose of the vaccine generated increased immune responses compared with the data observed in late-stage studies evaluating Nuvaxovid. The vaccine also induced a robust antibody response when used as a heterologous booster dose.
Per the company, the latest authorization could allow Nuvaxovid to be used as a booster regardless of previous vaccine history.
Nuvaxovid, as a booster for adults, has already been approved in Japan, Australia, and New Zealand.
Please note that the trade name, Nuvaxovid has not been approved yet by the FDA in the United States.
Shares of Novavax have plunged 77.7% this year compared with the industry’s decrease of 24.6%.
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Last month, NVAX filed a regulatory application with the FDA, which seeks to expand the emergency use authorization (EUA) granted to its COVID-19 vaccine called Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373).
The EUA seeks label expansion for the use of the vaccine as a homologous and heterologous booster dose in adults.
If authorized as a booster dose, Novavax can target a larger/wider segment of the adult population in the U.S. market who have already been vaccinated but are yet to receive a booster dose of the vaccine.
Novavax is also advancing the clinical development of its Omicron-based COVID vaccine. The company expects to initiate a regulatory filing for this Omicron-specific vaccine candidate by 2022-end.
Investors must note, the COVID-19 vaccine market in the United States is dominated by Pfizer PFE/ BioNTech BNTX and Moderna MRNA, which market mRNA-based vaccines. The vaccines developed by these companies dominate the U.S. market and are the only jabs that have received full approval in the country.
Earlier this week, the FDA granted EUA to PFE/BNTX and MRNA’s Omicron BA.4/BA.5-adapted bivalent vaccines for use as a single booster dose. These boosters can be given at least two months following primary or booster vaccination. This makes the competition for COVID-19 vaccines intense for NVAX in the days ahead.
Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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