A Maryland-based vaccine manufacturing company, Novanax, has successfully reached a $1.6 billion deal with the federal government for development and manufacturing of a vaccine that happens to show auspicious results in early clinical trials. The results of the trial were published early this month in The New England Journal of Medicine. Now Novanax has said that they would start final testing stage of their potential coronavirus vaccine in the United Kingdom with plans to initiate another large trial in the United States in October.
Another day, another launch of a Phase 3 trial for a coronavirus vaccine! @katie_thomas & I have a story this afternoon about Novavax moving their protein-based vaccine into trials in the UK, with another in the works for the US next month. https://t.co/FIXnUHJ9cU
— Carl Zimmer (@carlzimmer) September 24, 2020
The trial is one of the 11 vaccines worldwide that made it to its final stages. It will be the fifth late-stage trial from a company that is supported by Operation Warp Speed, an effort by the federal official to expediate the efforts to bring the coronavirus vaccine to market. While, the company is relatively lagging behind from the front turners in vaccine developments, experts and researchers are excited about this candidate vaccine because of its promising results in early trials, where monkeys were vaccinated and developed strongest antibody titers compared to any vaccine developed so far, resulted in development of strong protection against the Covid-19 virus.
The new Phase-III clinical trial study plans to recruit around 10,000 individuals in the UK and they will be grouped into treatment and control group. Nearly one half of the volunteers are expected to receive two doses of the experimental vaccine, 21 days apart, and the others from the control group will receive a placebo. Novanax stated, that they plan to recruit participants aged above 65, it would considerably prioritize the most effected group by Covid-19 including racial/ethnic minorities.
Natalie Dean, a biostatistician at the University of Florida, says that final trial will determine whether Novavax can live up to that promise. Yet the Phase-III British trial is relatively smaller than those of other leading vaccines, but the vaccine potency – ability to produce maximum immune response (like antibodies) against the virus, might clearly answers whether it will live up to that promise. Novavax has allied with a large number of manufacturers including Serum Institute of India, a renowned large vaccine manufacturer, to produce massive vaccine manufacturing, hoped to produce as many as two billion doses a year. Company states that storage temperature for vaccine is between 36 and 46 degrees Fahrenheit, which is a favorable temperature allowing easy vaccine distribution as per “standard vaccine channels.”
The company’s U.S. trial in collaboration with the National Institutes of Health is expected to include 30,000 people and to begin in the middle of October. The trial’s goal is that the vaccine shows over 60% efficacy than placebo and plans to publish the trail design soon.
Dr. Gregory M. Glenn, Novavax’s president for research and development, said in an interview on Thursday, “The company was running a smaller safety trial in South Africa, in addition to the larger Phase 3 trials in the United Kingdom and the United States.”