Covid-19 vaccines are safe – SAHPRA

The processes of monitoring and evaluation, including remedies available to people who have experienced adverse reactions, was unpacked at a webinar entitled “Self Reporting Suspected Adverse Drug Reactions (ADRs) of Medicines and Vaccines,” jointly hosted by the South African Health Products Regulatory Authority (SAHPRA), the South Africa Health Technologies Advocacy Coalition (SAHTAC), PATH, the Department of Health (DoH), Government Communication and Information Systems (GCIS) on Monday 13 September 2021.

Speakers included: Prof. Hannelie Meyer, National Immunisation Safety Expert Committee (NISEC) chairperson; Ms Mafora Matlala, SAHPRA Pharmacovigilance manager; and Ms Marione Schonfeldt, from the Department of Health.

During the webinar, speakers were able to engage participants on the processes of identifying adverse drug reactions and how these can be reported for further evaluation.  These processes apply to the Covid-19 vaccine and medical products in general.

In relation to Covid-19 vaccines, and other medicines more generally, SAHPRA’s Ms Mafora Matlala explained that it was important to clearly demonstrate causality, also known as cause and effect, between the drug and the reaction.  She said that “an adverse drug reaction or a harsh reaction to a drug, is characterised by the occurrence of a suspected causal (cause and effect) relationship between the drug and the reaction. Causality is crucial to being able to clearly determine the safety of the vaccine.”

NISEC’s Professor Hannelie Meyer, in explaining the processes of investigation of reports of adverse reactions, which help to identify causality, cited statistics from 17 May to 31 August 2021 during which 12 166 043 doses of Covid-19 were administered.  She said, “for this period, SAHPRA and NISEC received 86 reports of death (0.0007%) among people who received the vaccine.  Of these 46 cases are under investigation and 40 have been investigated and causality assessed.  Of this, 34 cases were found to be coincidental, 13 of which had Covid-19 and 1 was a breakthrough infection.  Six cases were unclassifiable due to inadequate information. We can therefore say with confidence that our investigations to date, indicate that the Covid-19 vaccines are safe.”

An obvious, but important point to be made is that, prior to Covid-19, the usual number of deaths in the country was about 1250 deaths per day. This has increased to approximately 1,600 deaths per day.  The vaccination programme is implemented in this context, and it is therefore inevitable that there will be some deaths recorded.  SAHPRA and NISEC’s role is to investigate the deaths reported to ascertain whether they can be linked in any way to prior vaccination.

Dr Zameer Brey, Technical Advisor to the Vaccine Rollout Programme and Health Expert working in partnership with the Solidarity Fund, drawing on this emphasized that “Of the 14.6 million doses of vaccines administered in South Africa to date, not a single death can be attributed to the vaccine.  This is despite rigorous monitoring and evaluation.  So while the vaccines are proving to be very safe, there is also increasing evidence from around the world, that those who are vaccinated can be protected from hospitalisation and death.  This means that while vaccines are safe, they are also a very powerful tool we have to fight this pandemic.”

The Department of Health in partnership with SAPHRA have made the reporting of adverse events a high priority component of the national vaccination rollout program. They have considered normative guidance provided by the  World Health Organisation and other best practices to inform the local system of reporting and investigation of severe events. In this regard, multiple channels have been made accessible to the public and health workers including:

• SAHPRA’s Med Safety App
• The SAHPRA website
• The Covid-19 call centre 0800 029 999
• Any local health facility

Dr Zameer Brey concluded that “In light of the overwhelming evidence of the benefits, safety and effectiveness of the vaccines, it should not escape us that being vaccinated is good for both the individual and those around them as well.  We urge people to get vaccinated.  The more people are vaccinated, the safer we will be as a country.  This is the most effective way to ensuring the economy stays open, jobs protected and for life to return to normal.”

The Solidarity Fund’s Dr Saul Johnson, a well-known epidemiologist and public health specialist, concludes saying, “We have seen over decades that vaccines are very effective in treating diseases like Covid-19.  With over five billion doses have been administered globally, we are increasingly seeing the rates of hospitalisation and death in those who are vaccinated decreasing.  The models are telling us that we could still see a fourth wave of the pandemic, but there is no doubt that vaccinations can prevent serious illness and death.  We urge all people who are eligible to please vaccinate.  Lives and livelihoods depend on your action.”

NDoH Contact Centre number 

The NDoH contact centres are able to assist with vaccination, registration and booking support, Covid-19 health-related queries as well as post-vaccination medical care enquiries.

The contact centre is available on 0800-029-999.

The sites are open from 07:00 to 20:00, Monday to Friday and 08:00 to 18:00 on weekends and public holidays.

For people wanting information outside of these hours, you can visit the SA Coronavirus website or use the WhatsApp Support Line: 0600-123456.

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