Covid-19: SA drug regulator evaluating medical records of 28 people who died after vaccine shot

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So far, around 5.5 million South Africans have been vaccinated.
So far, around 5.5 million South Africans have been vaccinated.
Gallo Images/Misha Jordaan
  • The South African Health Products Regulatory Authority has received 3 730 reports of adverse events following Covid-19 vaccinations.
  • The health regulator is also examining the records of 28 people who died after receiving their Covid-19 jabs.
  • Out of the 28 fatalities, 24 people received the Pfizer vaccine.

The South African Health Products Regulatory Authority (Sahpra) is evaluating medical records of 28 people who died after receiving their Covid-19 vaccine.

Sahpra has received 3 730 reports of, "... adverse events following immunisation", and 279 reports of what it terms adverse events of special interest.

Out of these cases, 28 fatalities were reported.

Four of those who died got the Johnson & Johnson jab and 24 the Pfizer vaccine.

READ | Pfizer, BioNTech strike deal with SA facility to deliver over 100 million Covid-19 vaccines a year

This emerged on Wednesday, during Sahpra's briefing to the Portfolio Committee on Health on the country's vaccine programme and the approval of several other Covid-19 vaccines.

Sahpra CEO Boitumelo Semete-Makokotlela said there are a range of side effects that the regulator is looking at.

"Again, we do consider how many individuals were vaccinated. We have had some fatalities, and there are studies ongoing," she said, adding:

We need to determine if the event that we saw is indeed related to the vaccine or related to something else. These are very comprehensive studies that would be conducted. Autopsies will be done, and the history of the individuals and the medication that they were taking. It is quite an extensive process that is going to be conducted.

"While this process is ongoing, we do note these fatalities, and we continue to monitor. What we can say is that these fatalities do not at this point outnumber what you would generally see in the public. We are doing assessments," she said.

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So far, around 5.5 million South Africans have been vaccinated.

According to the National Health Department's figures, just over one million people have received the J&J vaccine and 4.5 million the Pfizer jab.

Of the Pfizer jabs administered, 3.6 million people got their first dose, and 873 533 received their second dose.

Sahpra board chairperson Helen Rees said their main task is to establish that vaccines are safe and trusted.

She said:

"This is why we are very happy to go through the repeated processes. It is very important that we know and trust that the medicines we get from a pharmacy or clinic is safe and it works, and has quality manufacturing behind it. If we don’t trust the process, we won’t be able to trust any of the medicines and so it has to be an independent process. It has to be science-driven, and it has to be in the public health interest."

Rees said that it can't be business as usual amid a global pandemic, especially for health regulators.

"Everything to do with Covid-19 is fast tracked, but that does not mean that corners are cut. When we started with the vaccine, we started with people over 60.

"For people in this age group, they are more likely to get heart problems and strokes or other respiratory diseases. When you see those difficulties, one has to ask, is that caused by the vaccine or is it something that was going to happen in the normal course of events," she said adding that all factors have to be analysed before a conclusion can be reached.

Tohlang Sehloho, Sahpra senior manager for clinical evaluation and management, said the deaths probably had to do with the age groups.

READ HERE | Covid-19: How long will we still be required to wear masks? We ask the experts

"The comorbidities are common in that age group. Assessments are ongoing, and that would include post mortems and other investigations," he said.

DA MP Evelyn Wilson expressed concern about the adverse effects people experience after getting a jab.

"It is concerning that Pfizer has bigger reactions than the J&J vaccine. That concerns me a little bit. I know these are early days, and our vaccination programme has only been rolled out for a few months, but there are those who are anti vaccinations, and we need to dispel that," she said.

ANC MP Tshilidzi Bethuel Munyai proposed that the committee schedule a session that focuses on deaths of people who had received Covid-19 vaccinations.

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