Health And Welfare

SAHPRA plays a pivotal role in reviewing Covid-19 vaccine quality

According to the World Health Organisation (WHO) there were over 200 vaccine candidates
for COVID-19 being developed as of December 2020, of these, at least 52 candidate vaccines
were in human trial.

Typically, vaccine candidates are evaluated before any are found to be both safe and effective. For example, of all the vaccines that are studied in the lab and laboratory animals,
roughly 7 out of every 100 are considered good enough to move into clinical trials in

Having lots of different vaccines in development increases the chances that there will be one
or more successful vaccines that will be shown to be safe and efficacious for the intended
prioritized populations.

In an effort to enable and support the country’s response in fighting the COVID-19
pandemic, the South African Health Products Regulatory Authority (SAHPRA) has been
proactive in reviewing the safety and efficacy of each vaccine on a case-by-case basis and
only grants approval for public use once it has met acceptable standards of quality.

SAHPRA is an entity of the National Department of Health, to ensure that the health and
well-being of human and animal health is at its core.

Vaccines can prevent disease and also have adverse effects in some individuals. SAHPRA
has a mandate to monitor such adverse effects and ensure that they are recorded and managed
properly so that, should a vaccine become problematic, regulatory action can be taken to
either warn the public about newly discovered adverse effects or remove the vaccine from the
market in order to protect the public. SAHPRA achieves this through its Pharmacovigilance

SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and
registering) all health products. This includes clinical trials, complementary medicines,
medical devices and in-vitro diagnostics (IVDs).

SAHPRA has and will continue to prioritise all COVID-19 applications and will apply an
expedited approach to all COVID-19 related health products, including vaccines.

We have currently four vaccine applications under review. One vaccine is at an advanced stage of review. Another has submitted amendments that would prolong the review process.
The others are in early stage of review.

SAHPRA will unpack the rolling review process as well as the Section 21 process when it
comes to approving vaccines.

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