Maryland-based Novavax NVAX is engaged in developing innovative vaccines to prevent serious infectious diseases.
Currently, NVAX has only one marketed product in its portfolio, its novel protein-based COVID-19 vaccine, NVX-CoV2373. The company is currently marketing two versions of NVX-CoV2373 — one marketed in partnership with the Serum Institute of India (Serum) under the trade name Covovax and another version produced by Novavax that is marketed under the trade name Nuvaxovid.
The company’s COVID vaccine gained authorization for use as a primary two-dose regimen of COVID vaccine in adults across 43 countries, including Australia, European countries, Japan and India. The company has already entered into advance purchase agreements with many of these nations for supplying doses of its COVID vaccine.
After a long-awaited period, NVAX secured emergency use authorization (EUA) from the FDA for its COVID vaccine as a primary two-dose regimen in adults in July 2022. The company has also signed an agreement with the U.S. government to supply 3.2 million doses of its protein-based COVID-19 vaccine.
Management has also been engaged in securing authorizations for younger populations and booster doses of its COVID vaccine in the above markets. Currently, a booster dose of NVX-CoV2373 is authorized for use in Japan, Australia and New Zealand. The vaccine has also been authorized for use in adolescents (aged 12 to 17 years) in the European Union (EU), India, Japan, Australia and Thailand.
Novavax is also evaluating NVX-CoV2373 across multiple studies. In August 2022, the company initiated the phase IIb/III Hummingbird study, which is evaluating the vaccine for use in younger children aged between 6 months and 11 years. Novavax also recently completed administering a booster dose of NVX-CoV2373 in a late-stage study in adolescents.
NVAX is also advancing the clinical development of its Omicron-based COVID vaccine. While topline data is expected in third-quarter 2022, management expects to initiate a regulatory filing for this Omicron-specific vaccine candidate by 2022-end.
Apart from its COVID-19 vaccine, Novavax is also evaluating pipeline candidates for influenza and respiratory syncytial virus (RSV).
Novavax developed its nanoparticle seasonal influenza vaccine candidate NanoFlu for senior patients aged 65 years and above. In March 2020, the company announced positive top-line data from a pivotal phase III study on the same, which demonstrated the efficacy and safety of NanoFlu. A regulatory application for NanoFlu is expected to be filed shortly.
Novavax is evaluating a COVID-19-influenza combination (CIC) vaccine candidate in a phase I/II study. The CIC vaccine is a combination of NVX-CoV2373 and NanoFlu in a single formulation. This April, Novavax announced initial data from this study, which demonstrated the CIC vaccine to be feasible and immunogenic. The immune responses were comparable to the standalone NanoFlu and the standalone NVX-CoV2373 formulations. NVAX expects to begin a phase III study evaluating the efficiency of this vaccine in the next year.
Novavax is developing its RSV vaccine candidate ResVax, which is in the phase III stage, for protecting infants by immunizing their mothers against the disease. ResVax is also being investigated in phase II and phase I study for addressing older adults and pediatric patient population, respectively, for the given indication. Novavax is currently looking for an opportunity to bring ResVax to the market globally via several potential commercial partners.
Though the FDA has granted EUA to the Novavax vaccine for use as a primary two-dose regimen in adults, a vast majority of which has already been vaccinated with an approved mRNA-based vaccine developed by Moderna MRNA and Pfizer PFE/BioNTech BNTX.
While Novavax is yet for label expansion in the United States for use in adolescents or as a booster dose, Moderna and Pfizer/BioNTech are currently way ahead of the curve. The vaccines developed by them dominate the U.S. market and are the only jabs that have received full approval for use in the country. While Moderna’s vaccine is approved for use in adults aged 18 years and older, the Pfizer/BioNTech vaccine is approved for use in individuals aged 12 years and older.
The Moderna and Pfizer/BioNTech vaccines are also authorized for use in individuals aged six months and above in the United States.A third and fourth booster dose of Moderna and Pfizer/BioNTech vaccines have also been authorized for use in certain age groups by the FDA.
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