The review process has now started.
PRETORIA – SA has received its first Covid-19 vaccine candidate application from Johnson & Johnson and has started the review process, the chief executive of the South African Health Products Regulatory Authority, Dr Boitumelo Semete, told a virtual media briefing on Monday.
The authority has engaged with other companies conducting clinical trials and expects to see more submissions soon as they hope to make their products available in South Africa.
She said that as regulators it was important for the organisation to be “enablers” of access but also to ensure that quality products reached the local market by following processes agreed to and aligned at a global level.
She said corners would not be cut and each application would be considered scientifically to ensure the quality, safety and efficacy of any Covid-19 vaccine in South Africa.
Professor Helen Rees, chairperson of the entity’s board and co-director of the Wits centre for vaccinology, said no licences had been approved in South Africa yet.
She said she expected a lot more results from clinical trials in the next few months but warned that low-middle countries like South Africa would not have the luxury of a slew of vaccines to choose from.
Rather there would be vaccines coming through in small quantities so it would be a matter of deciding who gets the vaccine.
The early target would not be children – who are usually the target group – but adults, such as healthcare workers who are on the front line, those over 65 and with comorbidities.
Asked why ordinary citizens should take a vaccine for Covid-19, Semete referred to the huge impact vaccines have had in eradicating major diseases such as polio.
With the coronavirus, we were going through a second wave with talks of other countries going to experience a third wave, so it was not a disease which was going to go away simply by treating it.
Rees said the scientific and public health world, “with tiny exception”, endorsed a vaccine which, with clean water, “was probably the most important public health intervention that we have”.
Without a vaccine, she said the number of infections and deaths would just go up and up, and it was not practical to wait for 60-70% of the population to become infected to say we had herd immunity. “We absolutely need a vaccine; if you look at the numbers of people dying, the first thing is stop people getting ill and dying, and the second is to stop transmission,” she said.
Both spoke of the role the regulator in ensuring that any vaccine which is licenced or given a conditional approval had gone through rigorous scientific review “so we have full confidence in terms of safety, quality and efficacy”.