More good news in the pursuit of a COVID-19 vaccine: A fifth vaccine developer has released promising results from a small, early trial.
Novavax Inc., of Gaithersburg, Maryland, released the results via a press release and call with media late Tuesday, showing the vaccine appeared safe and elicited a similar immune response to an active infection with COVID-19.
"Good news," said Dr. William Schaffner, a professor and infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee. "I think it clearly boosts confidence that we will have one or more vaccines."
Moderna, AstraZeneca and Pfizer have all released promising Phase 1 results, with the first two publishing in major journals. Chinese researchers also have published early trial results, and have begun providing their candidate vaccine to members of the military, Reuters reported.
In the new trial, participants were divided into four groups of 25, company president Dr. Gregory Glenn said on the media call, sharing slides of the results. 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.
None of the trial participants had a severe reaction to the vaccine; most just had sore arms for a day or two. Reactions to the second dose of the vaccine were more significant than the first, which is typical.
The vaccine seems to have generated an immune reaction similar to those in people who have recovered from COVID-19, the data shows. True effectiveness cannot be determined until the vaccine candidate is tested in many more volunteers.
Novavax has received $1.6 billion from the federal government to complete development of NVX‑CoV2373 and to scale up manufacturing. The government will own 100 million doses of the developmental vaccine.
The company also has started production in six other countries, including in Europe, India and other parts of Asia, producing 1-2 billion doses next year, according to company CEO and president Stanley Erck.
The company plans to publish the trial results in a peer reviewed journal, which is the standard for scientific publications.
Schaffner said he thinks it was acceptable to release results via 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.
The side effects seen in the study were very encouraging, Schaffner said, and a "small price to pay for protection against COVID-19."
Based on these results, 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.
"Onward!" Schaffner said.
Contact Karen Weintraub at [email protected]
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