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Novavax, Inc. NVAX announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has a prolonged conditional marketing authorisation (CMA) for its protein-based COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), as a homologue and heterologous booster dose in adults (over 18 years of age).
Nuvaxovid awarded an ADULT MAC through the European Commission (EC) in December last year. The EC also awarded a CMA to Nuvaxovid to save you from COVID-19 in teenagers over the age of 12 to 17 in July 2022.
The CHMP’s latest advice was based on data from a phase II study conducted in Australia, another phase II study conducted in South Africa, and the UK-sponsored COV-BOOST study. The data showed that a third dose of the vaccine generated higher immune reactions compared to the insights observed in late-stage studies comparing Nuvaxovid. The vaccine also induced a physically powerful antibody reaction when used as a heterologous booster dose.
According to the company, it is possible that the most recent authorization will only allow Nuvaxovid to be used as a booster, regardless of vaccination history.
Nuvaxovid, as a booster for adults, has already been to Japan, Australia and New Zealand.
Keep in mind that the industry called Nuvaxovid has not yet been approved by the FDA in the United States.
Novavax shares have plunged 77. 7% this year against the industry’s 24. 6% drop.
Image source: Zacks Investment Research
Last month, NVAX filed a regulatory application with the FDA, which aims to expand the Emergency Use Authorization (AEU) granted to its Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373).
The EUA will expand the label for the use of the vaccine as a homologous and heterologous booster dose in adults.
If legal as a booster dose, Novavax would possibly target a larger/broader segment of the adult population in the U. S. market. The U. S. department of homeland security has already been vaccinated but has not yet obtained a booster dose of the vaccine.
Novavax is also advancing the clinical progression of its Omicron-based COVID vaccine. The company plans to initiate regulatory filing for this specific Omicron vaccine candidate until the end of 2022.
Investors point out that the COVID-19 vaccine market in the U. S. The U. S. Food and Drug Administration is led by Pfizer PFE/BioNTech BNTX and Moderna MRNA, which market mRNA-based vaccines. Vaccines developed by those companies dominate the U. S. market. approval in the country.
Earlier this week, the FDA granted euA to MNR’s adapted bivalent PFE/BNTX and Omicron BA. 4/BA. 5 vaccines for use as booster doses for singles. These boosters can be given at least two months after vaccination number one or booster vaccination. This makes the COVID-19 vaccine festival intense for NVAX in the coming days.
Novavax lately has a rank of Zacks No. 3 (Hold). You can see the full list of Zacks’ Rank 1 (Strong Buy) stocks from today here.
Want the latest recommendations from Zacks Investment Research?Today you can download 7 movements for the next 30 days. Click to get this loose report from Pfizer Inc. (PFE): Moderna, Inc. Free Inventory Analysis Report (MNR): Novavax, Inc. Free Inventory Analysis Report (NVAX): Free ADR Inventory Analysis Report Sponsored by BioNTech SE (BNTX): Free Inventory Analysis Report To read this article in Zacks. com, click here. Zacks Investment Research