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The South African Health Products Regulatory Authority (SAHPRA) and the National Immunization Safety Expert Committee reassured the public that Pfizer and Johnson and Johnson COVID-19 vaccines are safe to use.
Both vaccines have been subjected to stringent requirements, where clinical trials have been carried out to demonstrate their safety before being allowed for use in the country.
Professor Hannelie Meyer, a member of the National Expert Committee on Immunization Safety, said on Wednesday that data currently suggests that less than 10% of people who get vaccinated will experience adverse events such as headaches, fever and chills.
“[These] do not pose a potential risk to the person and it is part of the body’s immune response. It is also important to note that it is not the same with everyone. These events are benign. They happen in the first couple of hours… and they hardly ever need management, ”Meyer said.
She said that although some adverse events are more common, if these symptoms exceed a certain period of time, medical help should be sought.
“It should not be assumed that all reactions are related to the vaccine. We are now vaccinating millions of people and there are many other diseases. You could therefore incubate another disease at the same time as you are vaccinated.
“[But] if these minor events do not go away within the first two to three days or if they get worse, or if there is something abnormal which concerns you within 30 days of vaccination, then you must see a doctor help, ”Meyer said.
SAHPRAVigilance Officer Mafora Matlala said that even during vaccine administration, the authority continues to monitor all vaccine reports.
“We are constantly reviewing the international literature, safety databases and all regulatory decisions made elsewhere. For example, the FDA [USA Food and Drug Administration agency] in April identified some thrombosis issues and this was communicated in South Africa, and we suspended the deployment due to safety concerns. Then we looked further into the safety of the product and found that the benefit-risk profile was still favorable, ”said Matlala.
Matlala said there is more to be gained by receiving the jab than there is to be lost by not receiving it.
“When you look at the adverse events that we have received so far in the system, they are quite a few, just over 2,000, compared to the doses that have been administered so far, which are about 9.5 million in [Tuesday]… The benefits of these vaccines actually outweigh any risks that may exist, ”she said.
She 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 viewed.
Distributed by APO Group on behalf of the South African government.
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