/ 23 August 2021

No link found between deaths and Covid-19 vaccine, health regulator says

Johnson & Johnson Vaccine Administered At Colorado Fire Department
Side-effects are common when you receive any type of vaccine, a senior vaccine researcher says. (Photo by Michael Ciaglo/Getty Images)

The South African Health Products Regulatory Authority (Sahpra) received 1 473 reports of Covid-19 vaccine side-effects over a period of almost three months, but investigations showed no link between the drugs and people dying.

The side-effect cases account for only 0.02% of the almost 7.1-million doses of vaccines administered in South Africa between the start of the nationwide vaccination roll-out on 17 May until 31 July. 

The majority of reports amounted to “mild and non-serious adverse events following immunisation”, Sahpra said in a recent statement. The side-effects include a mild headache, pain and redness at the injection site and a mild fever that generally disappears within a few days after receiving the injection in the arm.

Side-effects are common when you receive any type of vaccine, Dr Benjamin Kagina, a senior researcher in vaccinology at Vaccines for Africa at the University of Cape Town, told the Mail & Guardian.

“It is normal. Mild side-effects that people experience are more to do with the immune system kicking in, coming to detect the vaccine that has been put in your body,” Kagina said.

“The feeling of fever and sometimes fatigue and headaches is a time that your body’s reacting to the vaccine, which is what you’d expect as your body mounts an immune response. So these are pretty much expected mild and common side-effects.”

Only 53 of the reported side-effects cases received by the health regulatory body were described as serious. This number translates to only 0.0007% of the more than seven million people vaccinated by the end of July. 

“Reported serious [adverse events following immunisation] have been found to be extremely rare for the Covid-19 vaccines,” according to Sahpra.

“Serious side-effects require hospitalisation or prolonging an existing hospitalisation; may be life-threatening; result in a congenital birth defect; or result in death.”

According to the health regulatory body, causality assessments on 32 death cases were completed “of which 28 were coincidental to vaccination” — meaning the deaths were not linked to the vaccination. The remaining four were “unclassifiable” due to inadequate information about the patients, while 21 cases are still being investigated. 

Kagina said there were mechanisms to continue monitoring vaccines before and after injection.

““People should have confidence in the process and the systems that are put in place. There is a lot at stake because millions and millions of vaccines are given every day. And we know these vaccines are usually beneficial,” he said.

He emphasised that efforts were made to ensure vaccines underwent quality control checks before being distributed, adding: “Even after they have been injected into people’s arms there is continuous assessment of how people react to them”.

Public and health professionals can report side-effects following vaccination to Sahpra using the Med Safety App or by calling the Covid-19 hotline on 0800 029 999.

Sahpra’s microsite, in collaboration with the national department of health, keeps track of side-effects relating to the Covid-19 vaccines and all results and updates are available to the public here.

South Africa had administered more than 10.5-million Covid-19 vaccines by Sunday, with over 4.8-million people now fully vaccinated.