Novavax (NASDAQ: NVAX) announced Monday that its COVID-19 vaccine candidate was shown to be both safe and 90.4% effective at preventing symptomatic infection in a late-stage clinical trial of nearly 30,000 participants across the United States and Mexico.
Additionally, the vaccine, NVX-CoV2373, demonstrated 100% protection against moderate and severe disease and offered high efficiency against some variant strains, including the Alpha variant first discovered in the United Kingdom.
Novavax observed 77 confirmed COVID infection among the trial's 29,960 participants--with 63 cases coming from the placebo group, while 14 cases were confirmed in the vaccine group--resulting in an overall efficacy of 90.4%. All hospitalizations in the trial occurred in the placebo group.
Dr. Gregory Glenn, president of research and development at Novavax, stated that this Phase 3 trial confirms that NVX-CoV2373 shows "consistent, high levels of efficacy and reaffirms the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus."
Novavax plans to file for an emergency use authorization with the U.S. Food and Drug Administration (FDA) in the third quarter.
NVX-CoV2373 is a two-dose, protein-based vaccine candidate that introduces an engineered coronavirus spike protein to an individual's immune system to trigger the production of neutralizing antibodies.
If authorized for emergency use, Novavax will be the fourth vaccine available in the U.S., following the authorizations of the Pfizer (NYSE: PFE)-BioNTech (NASDAQ: BNTX), Moderna (NASDAQ: MRNA) and Johnson & Johnson (NYSE: JNJ) shots.
Novavax's vaccine data comes as U.S. officials say that the country has more than enough vaccines to vaccinate the entire American population of over 330 million people, according to CNBC. President Joe Biden has already committed to donate at least 20 million vaccine doses of the Pfizer-BioNTech, Moderna and J&J shots, as well as 60 million doses of the AstraZeneca (NASDAQ: AZN)- Oxford vaccine, which is not authorized for use in the U.S.
But that may not be enough. On Monday, the World Health Organization (WHO) warned that the global COVID-19 outbreak is spreading at a much faster pace than the worldwide distribution of vaccines, raising concern that the virus may continue to mutate further and evade vaccine protection.
WHO Director-General Dr. Tedros Adhanom Ghebreyesus stated during a press conference on Monday that there are enough available vaccine doses globally "to drive down transmission and save many lives if they're used in the right places for the right people."
Tedros added that while G7 countries have pledged distribution of 870 million vaccine doses globally, the world still needs more. This is where Novavax could help. The biotech stated on Monday that it remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter, and 150 million doses by the end of the fourth quarter.
"If you are going to stop this pandemic, you can't just stop it in the U.S.," CEO Stanley Erck told Bloomberg News in an interview on Monday, calling the NVX-CoV2373 well suited for use in lower-income countries. "We can ship it at just standard refrigerated temperatures, and it can go anywhere in the world."