Novavax, a U.S. biotechnology company that received funding from a Bill Gates-backed organization, has started phase 1 of its clinical trials for a CCP (Chinese Communist Party) virus vaccine.
The Maryland-based company said on Monday it is beginning human trials of the vaccine in Australia, and expects preliminary immunogenicity and safety results in July.
The safety of the vaccine will be tested on 131 adult volunteers in Melbourne and Brisbane aged between 18 and 59, the company announced. Novavax’s research chief Dr. Gregory Glenn said the first phase of the trial will look for early signs of the vaccine’s effectiveness.
“We are in parallel making doses, making vaccine in anticipation that we’ll be able to show it’s working and be able to start deploying it by the end of this year,” Glenn said during a virtual press briefing from the company’s Maryland headquarters.
The first volunteer participating in the the phase 1 clinical trial received a dose of the vaccine Tuesday morning local time.
The president and CEO of the late-stage biotechnology company, Stanley C. Erck, said in a statement that the first phase of the vaccine’s clinical trial is “a significant achievement.”
“Administering our vaccine in the first participants of this clinical trial is … bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic,” he said.
“We look forward to sharing the clinical results in July and, if promising, quickly initiating the phase 2 portion of the trial.”
The first phase of the clinical trial will be randomized, observer-blinded, and placebo-controlled, Novavax said.
Novavax’s vaccine (NVX-CoV2373), which is a type of recombinant vaccine, will be developed by using genetic engineering to replicate harmless copies of the “spike” protein that covers the outer surface of the CCP virus and invades human cells. Novavax developed copies of the protein in giant laboratory vats of insect cells, which were extracted and purified by researchers who packaged the spike protein into virus-sized nanoparticles.
The replicas of the spike protein are then injected into vaccine recipients to stimulate an immune response, including through the greater production of antibodies, which may provide longer-lasting protection against viral infection.
“The way we make a vaccine is we never touch the virus,” Novavax told The Associated Press last month, adding that it “… looks just like a virus to the immune system.”
Novavax received its largest ever investment of $388 million from the Coalition for Epidemic Preparedness and Innovations (CEPI), which was co-founded and set up in November 2017 with funding from the Bill and Melinda Gates Foundation.
Billionaire Bill Gates told “Fox News Sunday” last month that life in the United States will only return to “normal” when a vaccine for the CCP virus has “gotten out to basically the entire world.”
“We will eventually get a vaccine. Even before then, if we do the right things, we’ll be able to open up significant parts of the economy,” he said.
“Entering clinical trials is an important step on the path to delivering a safe, effective, and globally accessible vaccine against COVID-19,” Dr. Richard Hatchett, CEO of Oslo-based CEPI, said in a statement.
“Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax’ vaccine candidate.”
“Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay,” Hatchett added.
Novavax said that if phase 1 is a success, it will begin phase 2 of its trial in multiple countries, including in the United States, which will assess immunity, safety, and COVID-19 disease reduction in age groups outside of 18 to 59.
Reuters contributed to this report.
