Novavax, one of America's top biotechnology companies and part of the government's Operation Warp Speed (OWS) program, has begun Phase 3 of vaccine trials for coronavirus. The company's vaccine candidate, NVX-CoV2373, will have its final vaccine trials in the United Kingdom in partnership with the government's Vaccines Taskforce.
Around 10,000 volunteers will be recruited in the UK while another trial will follow in the United States next month. Novavax is the fifth OWS company to begin late-stage trials.
The results of their initial phase trials were published in The New England Journal of Medicine. Phase one of tests, involving 131 adults received either a placebo dose, a vaccine without an adjuvant, and a vaccine with the Matrix-M1 adjuvant.
An adjuvant is a vaccine booster which increases antibody production and prolongs immunity. As a result, there were no serious adverse events, and only one participant had a mild fever for one day.
The volunteers also produced high levels of antibodies to fight the virus. Virologist John Moore from Weill Cornell Medicine shared that Novavax's vaccine candidate has produced more antibodies than other vaccine candidates with official publications.
Phase Three of Trials
The company is hopeful that the results will be the same as the larger UK trial. During phase three, half of the participants will receive a double dose three weeks apart and be compared to a placebo shot.
Professor Paul Heath, the head of the UK trials, shared that they will recruit volunteers from high-risk groups. They are looking at healthcare staff, social workers, and other frontliners who are most exposed to the virus. The team will also involve ethnic and racial minorities.
Experts shared that the NVX-CoV2373 is promising since it uses older vaccine technology compared to other developer companies. Novavax uses SARS-CoV-2 spike glycoproteins, a similar method to other existing vaccines. Dr. Paul Offit from the Food and Drug Administration shared that it is a well-worn strategy.
Novavax has also partnered with the Serum Institute of India, which will help the company produce about two billion vaccine doses a year once it is approved. If the last phase of trials is successful, it will be the company's first commercialized vaccine.
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Combining COVID-19 & Flu Vaccines
The goal of phase three is for the vaccine candidate to have 60 percent more efficacy than the placebo. The trials will also end if 1% of participants develop symptoms or if 63 people develop moderate or severe symptoms.
Novavax's Dr. Gregory M. Glenn shared that they are also running a smaller trial in South Africa. In the United States, there will be about 30,000 recruits by mid-October.
In the UK trials, 400 participants will also receive a flu shot to determine if it is safe for patients to receive two vaccines simultaneously. Dr. Heath shared that receiving a COVID-19 and flu shot could simultaneously minimize disease over the busy winter months during the flu season. The company is also developing a particular vaccine that can combine the two into a single shot.
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