Novavax (NASDAQ:NVAX)
Novavax (NASDAQ:NVAX) recently shared the news that the FDA has approved the use of their protein-based COVID-19 vaccine, Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), in adolescents aged 12–17.
In the past month, NVAX has received its first EUA from the FDA for the primary two-dose regimen of its COVID vaccination in people aged 18 and up.
Data from the ongoing pediatric expansion of the phase III PREVENT trial, which tested NVX-CoV2373 in 2,247 adolescents, provided the basis for this label expansion. The critical effectiveness endpoint of the study, neutralizing antibodies to NVX-CoV2373, was met, with adolescent participants exhibiting antibody responses comparable to those observed in young adults (18–26 years old) in the phase III PREVENT project. Adolescents had an antibody response that was 1.5-fold larger than young adults.
This analysis relies on data collected at the time when the Delta variety was the most common in the United States. In clinical trials, NVX-CoV2373 showed a 78.29% effectiveness against the Delta variant.
Novavax’s (NASDAQ:NVAX) stock price has fallen by 74.7% this year, which is far worse than the industry’s decrease of 20.6%.
After receiving the EUA award, the next step for Novavax will be to ask the CDC for a policy recommendation (CDC). If the CDC follows through on this suggestion, the business will be able to begin distributing doses of its COVID vaccine in the United States.
In addition to the 40+ countries where it is now approved for use, Novavax’s COVID-19 vaccine has received approval in Australia, Canada, Europe, and India. Novavax (NASDAQ:NVAX) is now selling two different formulations of NVX-CoV2373: one developed in collaboration with the Serum Institute of India and sold as Covovax, and another developed in-house and sold as Nuvaxovid.
Moderna and Pfizer/BioNTech are currently light years ahead of the curve, whereas Novavax (NASDAQ:NVAX) has yet to fully capitalize on the potential of the U.S. market. In the United States, according to the CDC, 75.7% of the population (aged 12 and up) have finished the primary regimen of a COVID vaccination by the 17th of August 2022. These vaccines are not only the most widely used in the United States; they are also the only ones with full FDA approval. The Pfizer/BioNTech vaccine is licensed for use in those 12 years and older, while Moderna’s is only safe for adults.
Emergency administration of the Moderna and Pfizer/BioNTech vaccines is also approved for use in people aged six months and up in the United States. In some cases, the FDA has approved a third and even a fourth booster dosage of a vaccine made by Moderna or Pfizer/BioNTech.
The company submitted an application to the FDA last week to broaden the EUA for Novavax COVID-19 Vaccine, Adjuvanted.
Featured Image : Megapixl © Joaquincorbalan
Author Shariq Khan 
