There is another good news in the pursuit of a COVID-19 vaccine, the fifth vaccine developer has released the promising results of a small, early trial. On Tuesday, Novavax Inc., of Gaithersburg, Maryland, released the results via a press release to media and showed the vaccine appeared safe and elicited a similar immune response to active infection with COVID-19.
Dr. William Schaffner, a professor, and infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee said in a statement that this is “Good news,” “I think it clearly boosts confidence that we will have one or more vaccines.”
Reuters have reported that the researchers also have published early trial results, and have begun providing their candidate vaccine to members of the military. Also with the first two publishing in major journals Moderna, AstraZeneca and Pfizer have all released promising Phase 1 results. On the media call, The company President, Dr. Gregory Glenn said that in the new trial the participants were divided into four groups of 25. According to the shared slides, the groups were divided like, One group received a placebo. One group received one dose of the vaccine, called NVX‑CoV2373. A third group received two 5-microgram doses of the vaccine plus an adjuvant meant to boost the vaccine’s strength. The last group received two higher doses, of 25 micrograms, plus the booster.
The other good news about this vaccine is that none of the trial participants had a severe reaction to the vaccine; most just had sore arms for a day or two. And to the second dose, the reaction of the vaccine was more significant than the first, which is typical. The data shows that the vaccine seems to have generated an immune reaction similar to those in people who have recovered from COVID-19. So the true effectiveness of this trial cannot be determined until the vaccine candidate is tested in many more volunteers.
To complete the development of NVX‑CoV2373 and to scale up manufacturing, Novavax has received $1.6 billion from the federal government. And the government will own 100 million doses of developmental vaccines. According to the report given by company CEO and president Stanley Erck, they have started production in six other countries, including in Europe, India, and other parts of Asia, producing 1-2 billion doses next year.
“It was acceptable to release results via a press release, because several of the other companies have done it, and “it has become the new normal.” It would be “terrible for the company” if it came out later the information they released was shown to be inaccurate,” Schaffner said. And he also mentioned that “The side effects seen in the study were very encouraging, and a “small price to pay for protection against COVID-19.”
Schaffner concluded with a statement that “he is confident that the U.S. Food and Drug Administration will support the company’s move to shortly begin a Phase 2 trial in the U.S. and Australia, including older patients, and a large, Phase 3 trial by the end of September”.