Sydney, May 26 : US-based biotechnology company Novavax is testing a new coronavirus vaccine on human subjects for the first time, launching a phase one clinical trial with a massive grant from an agency founded by Bill Gates, kicking off a storm of concerns online.
Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020, Novavax said on Monday.
“Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global Covid-19 pandemic,” said Stanley Erck, President and Chief Executive Officer of Novavax.
“We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial.”
The Phase 1/2 clinical trial is being conducted in two parts. The Phase 1 portion of the trial is enrolling approximately 130 healthy participants 18 to 59 years of age at two sites in Australia.
The Phase 2 portion is expected to be conducted in multiple countries, including the US, and would assess immunity, safety and Covid19 disease reduction in a broader age range.
The trial is being supported by the recently announced funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI), an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics.
NVX-CoV2373 includes Novavax’ proprietary Matrix-M adjuvant to enhance immune responses and stimulate high levels of neutralising antibodies.
Novavax said it identified NVX-CoV2373 as its lead SARS-CoV-2 candidate following pre-clinical testing that demonstrated high immunogenicity and high levels of neutralising antibodies.
The availability of a safe and effective vaccine for COVID-19 is well-recognised as a key tool to control the pandemic. At the same time, the efforts needed to rapidly develop, evaluate and produce this at scale are enormous.
According to the WHO, it is important to evaluate as many vaccines as possible as we cannot predict how many will turn out to be viable.
To increase the chances of success, it is critical to test all candidate vaccines until they fail, the WHO said, adding that it is working to ensure that all of them have the chance of being tested at the initial stage of development.
Over 120 vaccines have been proposed across the world including in India.
There are currently several vaccines in clinical evaluation, and about 70 in pre-clinical evaluation.
India’s Union Health Minister Harsh Vardhan on Sunday said that at least four of the 14 candidate vaccines for novel coronavirus in the country may enter the clinical trial stage very soon.