Novavax's COVID-19 vaccine goes into mid-stage human trials: Details here
As the number of COVID-19 cases continues to explode around the world, drug companies from different companies are racing to get a safe preventive vaccine ready. In the latest effort to make this happen, US biotech company Novavax Inc. has started a mid-stage human trial with its experimental shot, dubbed NVX-CoV2373, in South Africa. Here is all you need to know about it.
Backed by the US government's Operation Warp Speed and CEPI, the Novavax vaccine candidate is being tested on nearly 3,000 volunteers as part of a Phase-2b clinical trial at Wits University. The participants will be split into two key groups: one with approximately 2,665 healthy adults and the other with about 240 medically stable, HIV-positive adults.
By including HIV-positive adults in the trial, Novavax aims to determine the efficacy, immunogenicity, and safety of its shot across a diverse representative population. "Because South Africa is experiencing a winter surge of COVID-19 disease, this...trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data," said Novavax research chief Gregory Glenn.
The people participating in both study cohorts will either get a shot of NVX‑CoV2373 with its Novavax's proprietary Matrix‑M adjuvant or a placebo. Neither the administrator nor the subjects would know if they received a placebo or the vaccine. As the African volunteers get vaccinated, Novavax will expand its Phase-2 trial in the US and Australia with about 1,500 subjects, including older adults.
In the early Phase-1 trial with a smaller subset of participants, Novavax's shot had displayed promising results. According to the data, which has been submitted to the FDA for review, the shot was able to induce a high level of neutralizing antibodies - far more than that witnessed in recovered patients - in all 131 of the study participants, without any major side effects.
NVX-CoV2373 is expected to move into a larger Phase-3 trial by the end of September, and become available for emergency use by the end of 2020. Novavax has already signed a deal with India's Serum Institute to let the latter manufacture and commercialize the vaccine in India as well as all other countries, except those designated as upper-middle, high-income nations by the World Bank.
