Wednesday, September 2, a coronavirus vaccine candidate made by Novavax, shows an early clinical trial safe and elicits an immune response.
The results had previously been announced by the company in early August.
Using a randomized, placebo-controlled trial — the gold-standard method study — scientists gave the vaccine or a placebo, an inert substance like saline, to 131 healthy adults in May.
Eighty-three people got the vaccine with adjuvant, an agent to boost the body’s immune response. Another 25 got the vaccine without the booster and 23 got the placebo. Participants also received a second injection 21 days after the first.
Volunteers came from two locations in Australia and they were all under the age of 60. People who had COVID-19 or who had recovered from COVID-19 were excluded from the trial.
The volunteers came from two locations in Australia and they were all under the age of 60. People who had COVID-19 or who had recovered from COVID-19 were excluded from the trial.
In a Phase 1 trial, doctors mostly watch to see if the vaccine is safe, but they also check to see if it produced a response.
Participants were told to record any potential symptoms or soreness, for 35 days. Volunteers were also given a swab test for COVID-19 if they had any symptoms and were tested 35 days after their first injection.
On day 35, there were no serious or unusual adverse events. One person reported a mild fever that lasted for a day after the second shot. Otherwise, most didn’t have any reaction at all, or if they did have a reaction, it was mild. Two people in two of the vaccine groups had headaches, fatigue, and malaise for a median of two days or less. Two people from two of the vaccine groups had fatigue, malaise, and tenderness. After the second vaccination, most people didn’t have any problems, or they were mild. One person had tenderness after the second shot and eight had joint pain and fatigue.
The vaccine seemed to generate an immune response. All the volunteers who got the vaccine developed neutralizing antibodies after the second dose.
It also seemed to generate T-cells, the type of immune cells that also help protect the body from infection, in the 16 volunteers who were randomly selected and tested for T-cell response.
The benefit of adding an adjuvant to the vaccine was clear, based on the antibody response is generated, the study found. It also showed the value of the second dose on day 21.
According to Dr. Gregory Glenn, President of Research and Development at Novavax, “Based on the positive Phase 1 results, we have begun multiple Phase 2 clinical trials, from which we expect to collect preliminary efficacy.”
“Novavax is committed to generating the safety, immunogenicity, and efficacy data that will support confident usage of the vaccine, both in the US and globally, and the data published today further bolsters our conviction that this is possible,” he added.
Dr. Paul Offit, Director of the Vaccine Education Center and Professor of Pediatrics at the Children’s Hospital of Philadelphia, “It will need to be tested in tens of thousands of people to see not just their response, but if you can prove that it is protective. So we wait for months to see if that happens.”
Offit also noted, compared to some of the other candidates among the 33 COVID-19 vaccines in various stages of development right now, this one may have an advantage, because it uses an approach that has been successfully tried with other vaccines, like those that protect against shingles.