The South African Health Products Regulatory Authority (SAHPRA) has urged South Africans to report adverse effects experienced due to COVID-19 vaccines. This call comes at a time when reporting of such events has hit a low in the country.
Florah Matlala, head of the Pharmacovigilance unit at SAHPRA, highlighted the importance of reporting these events.
“Reporting of adverse events is very important because it contributes to the greater safety of medicines globally. Some questions have been raised regarding South Africa’s level of reporting. We are aware of that and we are doing everything in our power to promote the reporting of these events,” stated Matlala.
Matlala spoke during a SAHPRA webinar where vaccine safety and adverse events was discussed.
The World Health Organisation (WHO) states that an adverse event is any untoward medical occurrence which follows immunisation, and which does not necessarily have a cause relationship with the usage of the vaccine. If not rapidly and effectively dealt with, it can undermine confidence in a vaccine and ultimately have dramatic consequences for immunisation coverage and disease incidence.
Vaccine safety crucial
According to SAHPRA CEO, Dr. Boitumelo- Semete-Makokotela, the authority ensures that vaccines undergo requisite evaluations and assessments before being made available to the public.
Matlala urged people to continue reporting adverse events, especially since COVID-19 vaccines are still new on the market.
“By reporting these adverse events, we can ensure that everybody is safe,” said Matlala.
In a statement released by SAHPRA Tuesday, it ‘noted with concern’ that a safety report involving the COVID-19 Pfizer vaccine, has been distributed on various communication platforms in SA. This report, directed to the United States Food and Drug Administration (FDA) by Pfizer, indicates ‘adverse effects of special interest’ (AESIs). However, it is important to note that not all of these events were linked to the vaccine.
The SAHPRA has since confirmed that the benefit-risk profile of the Pfizer vaccine remains favourable and safe to use.
“Because of the concern of the safety of the COVID-19 vaccines, we have been sharing these reports with the specific manufacturers. In this way, they can be aware of the safety profile of their products,” she stated.
Med Safety App
Matlala also indicated that SAHPRA is in the process of acquiring a system where all adverse events, that have been received from the Med Safety App, are shared with the relevant companies.
“Companies can now see what is relevant to their product via this system. While we don’t have this system in place just yet, we are still sharing the adverse events from COVID-19 vaccines with specific manufacturers,” she said.
Remember to download the SAHPRA Med Safety App, and call the SAHPRA helpline if any questions or challenges 012 501 0311 pic.twitter.com/blyeZ0ZkQV— Prof. Mosa Moshabela (@MoshabelaMosa) August 13, 2021
Matlala further indicated that healthcare workers across the country have been trained on how to use the Med Safety App. In this way, SAHPRA is able to reach all populations living in rural areas.
“All healthcare professionals were trained during the COVID-19 vaccine rollout. The National Department of Health covered several modules which are available on our website,” she added.
Matlala said that the issue of poor signal in rural areas might pose a challenge. For this reason, the traditional way of reporting such events, will remain in place.
“There is still a need for us to consider the rural areas. Therefore, people can still go to their healthcare providers at clinics where they can report these events. However, I need to indicate that we are not reaching these facilities enough,” she concluded. – Health-e News