Novavax says COVID-19 vaccine highly protective in trial, including against variants
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Novavax said its COVID-19 vaccine was 100% protective against moderate and severe disease and 90.4% protective overall during a phase 3 trial that included almost 30,000 adults in Mexico and the United States.
The vaccine, NVX-CoV2373, was 93% effective against SARS-CoV-2 variants of concern and 91% effective among high-risk populations, the company said. All hospitalizations and deaths occurred in the placebo group, and preliminary safety data was also encouraging, Novavax said.
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“These data show consistent, high levels of efficacy and reaffirm the ability of the vaccine to prevent COVID-19 amid ongoing genetic evolution of the virus,” Novavax president of research and development Gregory M. Glenn, MD, said in a press release. “Our vaccine will be a critical part of the solution to COVID-19, and we are grateful to the study participants and trial staff who made this study possible, as well as our supporters, including the U.S. government.”
Results from another phase 3 trial in the United Kingdom also showed that the vaccine was 100% protective against severe disease. The AMA recently updated its code set to include codes for the Novavax vaccine.
The company said it intends to file for regulatory authorization in the third quarter this year and “remains on track to reach manufacturing capacity of 100 million doses per month by the end of the third quarter and 150 million doses per month by the end of the fourth quarter of 2021.”
“Novavax is one step closer to addressing the critical and persistent global public health need for additional COVID-19 vaccines,” Novavax president and CEO Stanley C. Erck said in the press release. “These clinical results reinforce that NVX-CoV2373 is extremely effective and offers complete protection against both moderate and severe COVID-19 infection.”
Perspective
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These are the second positive phase 3 results from Novavax. It was expected to do well just as it did in its first phase 3 result. This is an important vaccine because it uses a different vaccine platform — one that I think has a lot of promise and is something similar to what is used in the Sanofi influenza vaccine. This will likely be submitted for emergency use authorization to the FDA and is likely to be approved. This will be another vaccine in the world market that will get us closer to vaccinating all the high-risk populations in the world. I think the fact that Novavax had success will likely spur more use of this technology, the recombinant baculovirus system, for other vaccines. One of the aspects of the COVID-19 pandemic that I think will be looked back on historically is that this was a time when many different vaccine platform technologies were able to rise to the occasion and maybe start a new golden age of vaccinology.
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