COVID-19 Resource Center

COVID-19 Resource Center

Issue: January 2021
Source:

Press Release

Disclosures: Azar and Fauci report no relevant financial disclosures.
December 28, 2020
2 min read
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Fifth COVID-19 vaccine reaches phase 3 development in US

Issue: January 2021
Source:

Press Release

Disclosures: Azar and Fauci report no relevant financial disclosures.
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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.

COVID Vaccine
Novovax will enroll up to 30,000 adults for a phase 3 trial of its COVID-19 vaccine.
Credit: Adobe Stock

“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.

Anthony S. Fauci
Alex Azar II

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.