Though Novavax, Inc. NVAX is one of a handful of vaccine makers that has secured authorizations for its protein-based COVID-19 vaccine in the United States, the company still struggles to establish a foothold in the target market.
Novavax developed its own novel coronavirus vaccine NVX-CoV2373, a protein-based vaccine that utilizes the company’s proprietary nanoparticle technology. 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. In the United States, the vaccine is marketed as Novavax COVID-19 Vaccine, Adjuvanted.
Novavax’s COVID-19 vaccine is also its first marketed product which has also been authorized for emergency use in more than 40 countries, including the United States. The struggle for market share is due to the delayed product launch of the vaccine. The FDA filing for the protein-based vaccine, which was supposed to have been done by May 2021, was completed after multiple delays in January 2022.
This delayed filing resulted in a substantial loss of market share to mRNA-based COVID-19 vaccines developed by Pfizer PFE/BioNTech BNTX and Moderna MRNA, who have not had a strong product launch but also established a strong hold on the market. By the time, Novavax was granted authorization for its vaccine, most of the population had already completed primary vaccination using Pfizer/BioNTech and Moderna’s approved mRNA-based vaccines. The mRNA-based vaccines were also the first ones authorized by the FDA in 2020.
This was also one of the likely reasons for management to slash Novavax’s total 2022 revenue guidance down to $2 billion from the previously provided range of $4-$5 billion. Like mRNA-based vaccines, Novavax vaccines have demonstrated high levels of efficacy against even mild disease.
The vaccines developed by Moderna and Pfizer/BioNTech are the only ones that have received full approval for use in adults in the United States. While Moderna’s vaccine is approved for adults aged 18 years and older, the Pfizer/BioNTech vaccine is approved for use in individuals aged 12 years and older. Both these vaccines are also authorized for use in individuals aged six months and above in the United States. Novavax’s vaccine is currently authorized as a primary regimen in adults and adolescents aged 12 years and older.
Moderna and Pfizer/BioNTech have also secured EUA from the FDA for using their respective Omicron BA.4/BA.5-adapted bivalent vaccines as a single booster dose. The bivalent vaccines of these companies are authorized for use inindividuals aged six months and older.
Novavax is also lagging in the development of Omicron-specific vaccines. This makes the company vulnerable in terms of gaining a substantial market share in the targeted space.
(NOTE: This article is being re-issued to correct a mistake. The original version, published yesterday, January 26, 2023, shall no longer be relied upon.)
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