Only 2000 adverse events reported from almost 10 million vaccine doses administered

The South African Health Products Regulatory Authority (Sahpra) says only 0.02% of “adverse events following immunisation” have been reported, according to their findings.

Saphra and the National Press Club on Wednesday hosted a webinar to educate the public on the Covid-19 vaccine safety.

The regulator has been monitoring adverse events (side-effects) reported by those who were administered with the double-dose Pfizer-BioNTech vaccines and the single-dose Johnson & Johnson (J&J) shot across the country.

Adverse events are any detrimental health event that happens after a person receives a vaccine, according to National Institute for Communicable Diseases (NICD).

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Non-serious adverse events

During the briefing, Sahpra’s Pharmacovigilance manager Mafora Matlala indicated that the adverse events that have been reported to date were non-serious.

Non-serious adverse events include chills, fevers, headaches and nausea.

Matlala said at least 2,000 adverse events had been reported since South Africa began with its vaccine rollout in February.

“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 said the regulator continues to monitor any reports as vaccines are being administered.

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No link to deaths

Saphra has also been investigating the cause of deaths of 53 people who had been vaccinated against Covid-19. The cases had been reported between 17 May and 31 July.

However, the regulator has reiterated that it found no link between Covid-19 vaccines and deaths, based on their investigations.

According to News24, six of 53 people died as a result of Covid-19, while the cause of deaths of five people were inconclusive due to lack of enough information for the investigators to work from.

With the remaining cases, patients died as a result of an existing illness they had before taking the vaccine. These deaths are considered to be coincidental.

Where to report them?

Adverse events usually occur within 28 days following vaccination, however, there is no time limit to reporting an event according to NICD.

Sahpra’s guidelines on health products vigilance state that anyone can report an adverse event.

People who report adverse events will be asked to provide the following:

• Patient identifier (such as initials, date of birth or age, but not their full name)
• Details of the product involved (preferably a trade name of the product)
• Details of the suspected adverse event (give description of the event)
• Contact details for the reporter (name, address, phone number, qualification)

Members of the public can report an adverse effect after vaccination through Saphra’s MedSafety App. The app was developed to engage both patients and healthcare providers on medicines safety issues.

Click here to find instructions on how to use the app.

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