Infectious Disease

The fifth COVID-19 vaccine enters part three growth in america

December 28, 2020

2 min read

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Novovax has begun enrolling adult volunteers in 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 study, funded by the NIH and the Biomedical Advanced Research and Development Authority, will include up to 30,000 volunteers in 115 locations in the United States and Mexico.

Covid vaccination

Novovax will enroll up to 30,000 adults in a Phase 3 study of its COVID-19 vaccine.
Photo credit: Adobe Stock

“Addressing the unprecedented health crisis of COVID-19 has required extraordinary efforts from 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 start of this trial – the fifth COVID-19 vaccine candidate to be tested in a Phase 3 trial in the US – shows our determination to end the pandemic by developing several safe and effective vaccines.”

The study participants are divided into two cohorts – one with people aged 18 to 64 years and a second group with people aged 65 and over. The organizers hope to enroll at least 25% of the participants in the older age group.

Anthony S. Fauci

Alex Azar II

According to the CDC, by December 26, more than 1.9 million people in the United States had received a dose of either of the two COVID-19 vaccines already approved by the FDA for emergency use.

The government’s drive to expedite COVID-19 vaccine development, Operation Warp Speed, is already delivering millions of doses [FDA]- Authorized vaccines for Americans every week, ”said HHS Secretary Alex Azar II tweeted in response to the Novavax announcement. “When the results of additional clinical studies agree [the FDA’s] Standards, more vaccines with different approaches would be available to fight COVID-19. “

The vaccines currently being administered in the US – one from Pfizer and BioNTech, the other from 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 temperatures above freezing – up to 46 ° F, according to the NIH – and, like the Pfizer and Moderna vaccines, is given in two doses.

AstraZeneca and Janssen have also reached phase 3 development for their COVID-19 vaccine candidates. The Janssen vaccine is the only one of the five vaccines that are given in one dose instead of two.

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Peter Hotez, MD, PhD, FASTMH, FAAP)

Peter Hotez, MD, PhD, FASTMH, FAAP

It is becoming clear that in order 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 studies of Novovax vaccines indicated that it was one of the best in terms of virus neutralizing antibodies (VNA). Given that VNAs are emerging as a potential correlate of protection, I am pleased that this vaccine is undergoing Phase 3 testing and approval for emergency use. I also hope that this vaccine will be part of ours as an important vaccine for low and middle income countries.

Reference:

Keech C et al. N Engl J Med. 2020; doi: 10.1056 / NEJMoa2026920.

Peter Hotez, MD, PhD, FASTMH, FAAP

Professor of Pediatrics

Dean of the National School of Tropical Medicine

Baylor College of Medicine

Co-Director, Center for Vaccine Development

Texas Children’s Hospital

Disclosure: Hotez reports inventing a COVID-19 vaccine technology from Baylor College of Medicine that was recently licensed exclusively to one company.

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