Novavax Coronavirus Vaccine Is Safe, Phase 1 Clinical Trial Results Show

Published results of the early stage clinical trial for the Novavax coronavirus vaccine candidate show that the vaccine is safe and stimulates immune response. The results were published on Wednesday in The New England Journal of Medicine.

Novavax used the gold standard method of study in conducting the trial in May, which involved administering either the vaccine or a placebo to 131 healthy adults from two locations in Australia under the age of 60. Eighty-three of the volunteers received the vaccine with adjuvant, an agent known to elicit the body’s immune response. Twenty-five got the vaccine without adjuvant, while 23 got the placebo. All the volunteers got a second injection 21 days after the initial shot.

The goal of the phase 1 trial was to test if the coronavirus vaccine was safe but the researchers also used the trial to see if it would produce a response. After 35 days, the researchers found that none of the volunteers experienced any serious or unusual events during the trial period.

The volunteers recorded their experiences for 35 days, including potential symptoms and soreness, and were subjected to a COVID-19 swab test following their first injection to confirm that their symptoms were not related to COVID-19.

According to the report, only one volunteer experienced a mild fever after the second injection. The rest of the volunteers did not have any adverse reaction to either the vaccine or the placebo, except for two others who reported a mild headache, fatigue, and malaise for about two days and eight others who reported having mild joint pain and fatigue.

The researchers revealed that at day 35, volunteers who received two doses of the vaccine with adjuvant developed four to six times more antibodies than the others. Such levels were also found to be greater than the antibodies developed by recovered COVID-19 patients. The vaccine also produced T-cells, the type of immune cells responsible for protecting the body from infection.

In a statement, Novavax President for Research and Development Dr. Gregory Glenn said the firm had already begun multiple Phase 2 clinical trials following the positive results of the Phase 1 trials. “Novavax is committed to generating the safety, immunogenicity and efficacy data that will support confident usage of the vaccine, both in the U.S. and globally, and the data published today further bolsters our conviction that this is possible,” he said.