Clinical trials have begun in South Africa of an experimental Covid-19 vaccine developed in the United States by Novavax.
Given that South Africa was experiencing a winter surge of Covid infections, ‘this important Phase 2b clinical trial has the potential to provide an early indication of efficacy’, said Novavax research chief Gregory Glenn.
South Africa is the fifth worst-affected country in the world, with more than 589 800 recorded cases and just under 12 000 deaths.
Reuters reported that the trial of Novavax’s NVX-CoV2373, backed by a multi-million dollar grant from the Bill & Melinda Gates Foundation, was being conducted in two separate groups.
The first would evaluate efficacy, safety and immunogenicity in 2 665 healthy adults. The second would evaluate safety and immunogenicity in about 240 medically stable, HIV-positive adults.
Novavax expected its vaccine, once approved, would be supplied to South Africa through a deal signed earlier this year with the Serum Institute of India to develop and commercialize NVX-CoV2373.
The vaccine candidate is one of nearly 30 being tested in human clinical trials worldwide.
Reuters said early-stage data from a small clinical trial of the vaccine had shown that it produced high levels of virus-fighting antibodies, and the company aimed to begin larger studies to obtain regulatory approvals as early as December.
It was reported yesterday that Dr Shabir Madhi, professor of vaccinology at Wits University, would lead the clinical trial.
‘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,’ said Madhi
‘I am pleased to work with Novavax as the principal investigator in this clinical trial, following Novavax’s Covid-19 vaccine’s positive Phase 1 data, which provides strong rationale for moving development forward in a larger subset of adults,’ he said.
Novavax said it intended to begin Phase 2 of the small clinical trial in the United States and Australia in the near future, and aimed to begin Phase III as soon as late September.
Positive cases grew in South Africa yesterday by 2 541 to a cumulative total of 589 886 (with 477 671 recoveries). Deaths rose by 143 to 11 982.
The highest tally of cases is in Gauteng (200 237), followed by KwaZulu-Natal (106 037), the Western Cape (102 609) and the Eastern Cape (84 092).