The South African Health Products Regulatory Authority (SAHPRA) and the National Immunisation Safety Expert Committee have reassured the public that both the Pfizer and Johnson and Johnson COVID-19 vaccines are safe to use.
Both vaccines were subjected to rigorous requirements, where clinical trials were performed to demonstrate their safety before being cleared for usage in the country.
National Immunisation Safety Expert Committee member, Professor Hannelie Meyer, on Wednesday said data currently suggests that less than 10% of those who get vaccinated will experience adverse events like headaches, fever and chills.
“[These] don’t pose a potential risk to the person and it’s part of the body’s immune response. It’s also important to note that it’s not the same in all people. These events are mild. They happen within the first couple of hours … and they hardly ever need any management,” Meyer said.
She said although certain adverse events are more common, if these symptoms exceed a certain period of time, medical help should be sought.
“You should not assume that all reactions are linked to the vaccine. We are now vaccinating millions of people and there are many other diseases. So you could be incubating another disease at the same time that you are vaccinated.
“[But] if these minor events don’t subside within the first two to three days or if they become more severe, or if there is something out of the ordinary that you are concerned about within the 30 days after vaccination, then you do need to seek medical assistance,” Meyer said.
SAHPRA’s Vigilance Manager Mafora Matlala said even as vaccines are being administered, the authority continues to monitor any reports on the vaccines.
“We continuously review international literature, safety databases and any regulatory decisions made elsewhere. For instance, the FDA [USA Food and Drug Administration agency] in April identified some thrombosis issues and that was communicated in South Africa, and we put the roll-out on hold because of safety concerns. Then we further reviewed the safety of the product and found that the benefit-risk profile was still favourable,” Matlala said.
Matlala said there is more to gain from receiving the jab than there is to lose from not doing so.
“When we look at the adverse events that we have received so far in the system, they are quite few, with just over 2 000, compared to the doses that have been administered so far, which is about 9.5 million as of [Tuesday]… The benefits of these vaccines actually do outweigh the risks that may be out there,” she said.
She has encouraged South Africans to download the SAHPRA Med Safety smartphone application to keep up to date with medical safety news.
The authority is expected to launch a microsite on Friday, where more information on adverse events can be accessed.