Fifth COVID-19 vaccine reaches phase 3 development in US
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Novovax has begun enrolling adult volunteers for a phase 3 trial of its COVID-19 vaccine candidate — the fifth COVID-19 vaccine to reach phase 3 development in the United States.
The randomized, placebo-controlled trial, which is funded by NIH and the Biomedical Advanced Research and Development Authority, will enroll up to 30,000 volunteers from 115 sites in the United States and Mexico.
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“Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts on the part of government, academia, industry and the community,” Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in a press release. “The launch of this study — the fifth investigational COVID-19 vaccine candidate to be tested in a phase 3 trial in the United States — demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines.”
Study participants will be separated into two cohorts — one that includes individuals aged 18 to 64 years, and a second group that includes individuals aged 65 years or older. The organizers hope to enroll at least 25% of participants in the older age group.
According to the CDC, as of Dec. 26, more than 1.9 million people in the U.S. had received a dose of one of the two COVID-19 vaccines already approved for emergency use by the FDA.
The government’s endeavor to speed up COVID-19 vaccine development, Operation Warp Speed, “is already delivering millions of doses of [FDA]-authorized vaccines each week to Americans,” HHS Secretary Alex Azar II tweeted in response to the Novavax announcement. “If the results of additional clinical trials meet [the FDA’s] standards, more vaccines using different approaches would be available to fight COVID-19.”
The vaccines currently being administered in the U.S. — one developed by Pfizer and BioNTech, the other by Moderna Inc. and the NIH — both use messenger RNA technology. Novavax’s candidate, NVX-CoV2373, is a protein-based vaccine that uses the company’s recombinant protein nanoparticle technology and an adjuvant, MatrixM. It can be stored at above-freezing temperatures — up to 46°F, according to the NIH — and is given in two doses, just like the Pfizer and Moderna vaccines.
AstraZeneca and Janssen also have reached phase 3 development in their COVID-19 vaccine candidates. The Janssen vaccine is the only one of the five given in one dose instead of two.
Perspective
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Peter Hotez, MD, PhD, FASTMH, FAAP
It’s becoming clear that to vaccinate the nation against COVID-19, we will need additional vaccines beyond the two mRNA vaccines, and possibly at least five to six vaccines. Published results from the phase 1 trials of vaccine from Novovax showed it was one of the best in terms of virus-neutralizing antibody (VNA) levels. Given VNAs are emerging as a potential correlate of protection, I’m excited to see this vaccine go through phase 3 testing and emergency use authorization. I’m also hoping this vaccine might join ours as important vaccines for low- and middle-income countries.
Reference:
Keech C, et al. N Engl J Med. 2020;doi:10.1056/NEJMoa2026920.
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