Novavax - A COVID Vaccine for the World

In June 2021, the world got some more good news about the fight against COVID-19. A vaccine developed by Novavax, Inc., showed in phase 3 clinical trials that it offers a greater than 90 percent efficacy at preventing symptomatic infection with SARS-CoV-2, the virus that causes COVID-19. Officially called NVX-CoV2373, this vaccine also offers 100 percent protection from moderate and severe COVID infections, which typically require medical treatment and hospitalization. 

For individuals in high-risk categories—those aged 65 or older, and younger people with serious underlying health conditions—the protein-based Novavax vaccine demonstrated 91 percent efficacy in keeping them from developing symptoms of COVID-19. 

These results are approximately equal to those obtained with the currently authorized Pfizer-BioNTech and Moderna vaccines.

The phase 3 research showed that the Novavax vaccine is safe and, overall, well-tolerated by recipients. Similar to the transitory side effects experienced by many people who have received the other COVID vaccines, the Novavax trial participants reported a day or two of headaches, muscle aches, and fatigue. And like the Pfizer and Moderna vaccines, the Novavax product requires a regimen of two shots in order to achieve proper effectiveness. 

Novavax, Inc., is a smaller pharmaceutical manufacturer based in Gaithersburg, Maryland. The company’s vaccine development was supported by the National Institute of Allergy and Infectious Diseases (NIAID) and a research department of the United States Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.

Help beyond borders

Experts note that the Novavax product may be more useful beyond the U.S., since the country’s vaccine supply is currently saturated with the previously approved brands. Novavax’s leadership has stated that they are considering waiting for emergency authorization from the Food and Drug Administration until the fall of 2021. Meanwhile, looking toward a likely role in stemming COVID-19 in the rest of the world, Novavax has applied for official licensing in India, South Korea, the European Union, and the United Kingdom. 

The company plans to manufacture approximately 100 million doses monthly by the close of the third quarter of 2021, followed by about 150 million per month by the end of the year. 

Novavax’s results highlight the question of vaccine access for less-resourced countries like India and other nations still in the thick of battle against COVID-19. The fact that the new vaccine can be stored at room temperature enhances its suitability for the developing world. 

A global perspective on public health

As time progresses, the U.S.’s supply of authorized vaccines—the mRNA-based Pfizer and Moderna and the one-shot, adenovirus-based Johnson & Johnson—is growing. The U.S. simply may not need to provide additional emergency use authorizations (EUAs) for new vaccines, since it already has a steady supply of safe and reliable options.  

Through the international vaccine-sharing program Gavi, Novavax has already committed to distributing more than 1 billion doses in countries where the need remains great. 

The question of booster shots for immunity does carve out another potential role for Novavax in the U.S., however: the new vaccine’s protein-based structure likely gives it the potential to be effective at amplifying the protection of different vaccines administered previously.