Novavax on Monday announced it would proceed with phase two clinical trials to determine if its coronavirus vaccine candidate showed positive results for patients.
The Maryland-based firm is one of several companies around the world working to develop a vaccine to protect against COVID-19, the disease caused by the novel coronavirus. Its move to begin the second phase of study comes just weeks after reporting that its vaccine showed promising signs in early trials.
Phase two trials will be conducted in South Africa, one of the countries experiencing the most pronounced outbreaks amid the pandemic. As of Monday, the country had reported more than 587,000 confirmed cases of COVID-19 and about 11,800 deaths caused by it, according to a Johns Hopkins University database.
Gregory Glenn, Novavax’s president of research and development, cited the impact of the virus in South Africa in a statement addressing the phase two trials.
“Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data,” he said.
Shabir Madhi, who will lead the trials, added that “the major motivation for the COVID-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own.”
Phase one trials for the vaccine candidate produced “robust antibody responses,” Novavax said in early August. The company said tests showed that people who received the vaccine had higher levels of antibodies than in people who had already recovered from the coronavirus.
Every participant in the first trial who received the vaccine candidate produced antibodies, Novavax said.
The phase two trial will evaluate its efficacy, safety and immunogenicity in more than 2,600 healthy adults. The testing will also evaluate safety for hundreds of medically stable, HIV-positive adults, the company added.
Novavax received a $15 million grant from the Bill & Melinda Gates Foundation as part of its efforts to develop a vaccine.
More than 100 possible vaccines are being developed around the world. Companies including Moderna, AstraZeneca and Pfizer have developed candidates that are currently in phase three trials.
Russia announced last week that a coronavirus vaccine was ready for use in the country, however, phase three trials for the drug have reportedly not been completed. Anthony Fauci, the top infectious disease expert in the U.S., said he “seriously” doubts Russia’s vaccine is proven to be safe and effective.