The South African Health Products Regulatory Authority (SAHPRA) says it is conducting a study on 28 people who have died after receiving either the Pfizer or Johnson and Johnson vaccines in South Africa.
According SAHPRA, 28 people died after being vaccinated in South Africa as of the seventh of July.
The authority says, however, there is no evidence at this stage that the individuals had died as a direct result of taking these vaccines.
Briefing parliament’s portfolio committee on health, SAHPRA said there have been over 3 700 complications reported besides the fatalities.
SAHPRA CEO, Dr Tumi Semete, says a comprehensive study is being undertaken to determine if there is any link.
“There’s causality studies that are currently ongoing. And what the causality studies to say we need to determine if the event that we saw is indeed related to the vaccine or related to something else. So these are very complex studies that will be conducted. So autopsies will be done. The history of the individual as to what other medication they were taking. It’s quite an extensive process that is being undertaken but we while the process is being done we do note these fatalities.”
SAHPRA board chairperson, Professor Helen Rees says it also has to be borne in mind that the data came from some of the first recipients of the vaccines. These, she says, are mostly the elderly who have comorbidities.
SAHPRA was also questioned about the use of Ivermectin for the treatment of COVID-19.
The regulator says there is no conclusive evidence that it reduces hospital admissions, disease complications or mortality.
Dr Semete says for this reason, this drug should not be used routinely in the management of any stage of COVID-19. She told the committee that it can only be prescribed in the context of a sufficiently powered Randomised Clinical Trials or for controlled compassionate use by doctors who take responsibility for the outcome. She added that in South Africa, no one has so far applied for the registration of Ivermectin for the treatment of COVID-19.
“So the current findings is that you know even with the evidence from all these pool studies it is still inconclusive whether ivermectin does provide a clinical benefit or not. So it’s still very much in its clinical equipoise. And the most recent studies this one from Colombia wherein there was no significant difference between individuals that were put on ivermectin and those on Placebo in terms of the severity of the disease and hospitalisation,” says Dr Semete.
Over 5.3 million vaccinations have been administered so far in South Africa, with almost 1.8 million people having been fully vaccinated.
The president of the South African Medical Research Council (SAMRC), Dr Glenda Gray, says the country will see a drop in COVID-19 deaths if it is able to vaccinate most people.
“At a global level, 3.6 billion doses of vaccine have been given. We know at a global level that they have been found to be effective and safe. We would like a little more precision about what happened to this person. Any death happening within 28 days of vaccination, should get a post mortem. At a global level, these vaccines have been used so it’s unlikely that in South Africa, we going to see more deaths or more side effects than anywhere else in the world. All of them have been found to reduce your risk of being hospitalised or dying,” says Dr Gray.
More than 1.5 million South Africans between the ages of 35 and 49 have already registered for their COVID-19 vaccination. The Department of Health says that more than a million people registered on Thursday last week alone.
Health Department’s update on South Africa’s vaccination programme