All COVID-19 vaccines authorised for public rollout in South Africa and globally have undergone rigorous clinical trials and due process has been strictly adhered to.
Clinical trials refer to research that is done to answer a specific question about a medical product. These trials typically start with early research and then progresses to small-scale, late-stage and large-scale research. In a phase 1 clinical trial, the safety of a medical product like a medicine or vaccine is studied, normally in a small number of healthy volunteers. In phase 2, researchers look at the medicine's efficacy and the optimal doses needed. If all goes well, the trial proceeds to phase 3 (involving 3 000 or more participants). In phase 3, the focus is on showing and confirming the evidence found in the previous phases and to prove that a medicine or vaccine is safe, beneficial and effective for its intended purpose in a larger population of people.
All authorised COVID-19 vaccines have undergone rigorous, multi-phase testing including large, phase 3 clinical trials that have involved tens of thousands of people. These trials were specifically designed to ensure that the vaccines are safe and effective, and identify any common side effects or other safety concerns.
- Once a clinical trial has shown that a vaccine is safe and effective, a series of independent reviews of the efficacy and safety evidence is required. These include regulatory review and authorisation in the country where the vaccine is manufactured.
- All this needs to happen before the World Health Organization (WHO) considers a vaccine for what is called 'pre-qualification'.
- Vaccines that pass each level of scrutiny are then reviewed by an external panel of experts convened by the WHO. This panel, which is independent from the vaccine producer, analyses the clinical trial results of each vaccine along with other information and recommends whether the vaccine should be used, and if so, how the vaccine should be used.
SAHPRA's FAQ published 23 July 2021 explains: "Based on completed clinical trials for the vaccines, SAHPRA has registered the vaccine for use in South Africa, subject to certain conditions. These conditions include that the vaccine be supplied and administered in accordance with the National COVID-19 vaccination plan and guidelines. Furthermore, the companies must submit to SAHPRA longer term clinical data from ongoing studies to monitor the safety of the vaccine (pharmacovigilance) with agreed timelines, as outlined in their approved risk management plan."
Some of the vaccines being rolled out to the public have been authorised under what is known as emergency use authorisation (EUA) by the US Food and Drug Administration (US FDA). In an emergency, like a pandemic, it may not be possible to present the FDA with all evidence usually required for approving a new medicine, medical device, or a medical test. In this case, the FDA issues EUA for the medicine (in this case COVID-19 vaccines), device or test based on the available evidence strongly suggesting that patients will benefit from the treatment or test. Outside of a declared emergency, EUA is never granted.
Furthermore, though a vaccine has EUA granted to it by the US FDA (or US FDA approval granted, as in the case of the Pfizer-BioNtech vaccine), before it is considered for the South African public, it is fully evaluated by SAHPRA, which conducts an in-depth and extensive scientific and clinical analysis of the safety and efficacy of all medical products used in South Africa. This process is explained in more detail in question 1.
This also means that means that close monitoring of vaccine recipients continues at all times to track and document the full range of vaccine-related side effects and also to stay on top of vaccine effectiveness in preventing severe COVID-19 illness and death.
Furthermore, research focusing on vaccine efficacy against COVID-19 viral variants of concern is ongoing and used to guide South Africa's vaccine roll-out plan.
Read more on the reasons why COVID-19 vaccines being rolled out could be developed in a short space of time compared to traditional vaccine development.
- On 23 August 2021 the US Food and Drug Administration (US FDA) approved the Pfizer-BioNtech COVID-19 vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older. This is the US FDA's first approved COVID-19 vaccine. The vaccine continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
- On 10 September SAHPRA approved the use of the Pfizer-BioNtech vaccine, in terms of Section 21 of the Medicines and Related Substance Act 101 of 1965 (The Medicines Act) to include individuals twelve years and older. This was as a consequence of the review of updated safety and efficacy information submitted as conditions of Section 21 (a mechanism that enables emergency use access and also enables SAHPRA to authorise the use of medicine subject to certain conditions) initially authorised on 16 March 2021. Read the detail.