20 Aug The South African Health Products Regulatory Authority reaffirms the safety of routine childhood vaccination
20 August 2026 – SAHPRA hereby reaffirms the safety of routine childhood vaccination used in South Africa based on ongoing evidence and monitoring.
Vaccination remains one of the most effective and safest ways to protect the public against serious and potentially life-threatening vaccine-preventable diseases, which is supported by decades of scientific evidence globally. SAHPRA’s primary responsibility is to protect public health by ensuring that vaccines used in South Africa meet the appropriate standards of safety, efficacy and quality. All vaccines are subject to rigorous regulatory oversight throughout their lifecycle. This includes evaluation of their safety, efficacy and quality before registration and continuous safety monitoring through robust surveillance systems at a country level, and international evidence to ensure their standards are maintained throughout the years they are used by the public.
Childhood vaccination is recommended by the National Department of Health (NDoH), the National Institute for Communicable Diseases, the World Health Organization, and public health authorities globally as the most effective way to protect children from serious vaccine-preventable diseases. The routine childhood immunisation schedule is based on the best available scientific evidence from multiple sources. The timing of each vaccination is informed by evidence about the age when children are most vulnerable to particular vaccine-preventable diseases. Following the recommended schedule helps ensure timely and most effective protection against vaccine-preventable diseases and when vaccination can provide effective protection.
Based on the evidence currently available, there is no change to SAHPRA’s assessment of the safety and effectiveness of routine childhood vaccines used in South Africa. The vast majority of adverse events following immunisation (AEFI) are minor, such as mild fever and pain, redness and swelling at the injection site, which signal a healthy immune response. Because most serious AEFI are often coincidental and not always caused by the vaccine, all suspected serious AEFI must be reported. All reported AEFI are investigated through ongoing monitoring and assessed to determine if the vaccine caused the AEFI.
“SAHPRA and the NDoH encourage parents and caregivers to follow the Expanded Programme on Immunisation (EPI-SA) guidance on vaccination and speak to a healthcare professional if they have any questions. Patient safety is our top priority. We encourage anyone to report any suspected AEFI to us via the treating healthcare professional.”
ADVICE TO HEALTHCARE PROFESSIONALS
Healthcare professionals should reassure parents and caregivers that childhood vaccines used in the EPI-SA schedule undergo rigorous evaluation for safety, quality and effecicacy before approval, with vaccine safety thereafter continuously being monitored as they are being used.
Healthcare professionals are encouraged to provide parents and caregivers with clear, evidence-based information about the benefits and potential adverse reactions associated with vaccination, and to address questions or concerns about vaccine safety. Parents and caregivers should be advised to follow the recommended childhood immunisation schedule to ensure timely protection against vaccine-preventable diseases.
South Africans are encouraged to obtain vaccine information from trusted, evidence-based sources, including the NDoH, the National Institute for Communicable Diseases (NICD), the South African Vaccination and Immunisation Centre (SAVIC), Vaccines for Africa Initiative (VACFA) and Wits-ALIVE.
ADVICE TO PATIENTS
Parents and caregivers should be reassured that childhood vaccines are carefully evaluated by SAHPRA before approval and that ongoing monitoring of their safety by SAHPRA helps ensure that any safety concerns are identified and acted upon. South Africa has established systems and independent scientific expertise to evaluate vaccine safety and inform immunisation policy. Parents and caregivers are encouraged to follow the recommended EPI-SA schedule and to obtain information about vaccines from trusted, evidence-based sources.
REPORT SUSPECTED ADVERSE EVENTS FOLLOWING IMMUNISATION (AEFIs)
Healthcare professionals and members of the public are urged to report any suspected AEFI to SAHPRA. Reporting of AEFIs should be made via the treating healthcare professional to ensure all necessary information is available, which will enable timeous case investigation.
SAHPRA remains committed to ensuring the safety of medicines available in South Africa and will update the public if new scientific evidence changes current recommendations.