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How safe are COVID-19 shots? SAHPRA shares the stats

While most South Africans followed the call to mask up, sanitise and social distance when COVID-19 hit the country in 2020, and rejoiced when the vaccine roll-out commenced in February 2021, questions about vaccine efficacy and safety are still being raised.

The South African Health Products Regulatory Authority (SAHPRA) – which was propelled into the deep end when it came to dealing with a plethora of issues regarding COVID-19, from challenging the use of Ivermectin for human use to approving vaccines – has shed some light on how it approves vaccines, monitors their safety and assesses side effects.

SAHPRA is mandated to regulate all health products – including clinical trials, complementary medicines, medical devices and in vitro diagnostics. It also oversees radiation control in South Africa.

“Our Vigilance Unit collects and analyses data from clinical trials and monitors vaccine and medicine safety. The unit ensures that the risks associated with vaccines and medicines used against COVID-19 are identified, managed properly and communicated accordingly,” says SAHPRA’s Pharmacovigilance Unit Manager Mafora Matlala.

Clinical trials and safety surveillance

While clinical trials are research studies performed on people to evaluate a medical, surgical or behavioural intervention; post-marketing surveillance, also known as safety surveillance, monitors the safety of a health product after it has been approved for

use in the general population.

“Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment; while post-marketing surveillance is used to confirm or disprove the safety of a medicine – after it is used in the general population, by a large number of people who have a wide variety of medical conditions – by using approaches such as spontaneous adverse drug reaction (ADR) reporting procedures and pregnancy registries,” adds Matlala.

Countries across the globe have had to monitor the impact of COVID-19 vaccines due to their unprecedented nature and the record timelines involved in their development.

While approving new medicine usually takes about 20 months, SAHPRA reduced the time taken to authorise COVID-19 vaccines to less than 90 working days.

“While some people may find this questionable, we adhered to strict guidelines, without compromising the vaccines’ quality, safety and efficacy, to ensure their prompt availability,” says Matlala.

COVID-19 vaccines were introduced in South Africa in February 2021 through the Sisonke study, which aimed to further monitor the effectiveness and safety of the Janssen (Johnson & Johnson) vaccine amongst healthcare professionals. By the time the study ended, three months later, 495 829 people had received the vaccine, of which 479 768 were healthcare professionals.

South Africa began its national vaccine roll-out in May 2021 with the Comirnaty (Pfizer-BioNTech) and Johnson & Johnson vaccines. To date, SAHPRA has registered the Pfizer-BioNTech, Johnson & Johnson, MC Pharma, CoronaVac and LHC vaccines.

Molnupiravir generic products, Molcovir by Bliss Pharmaceuticals and Molnupiravir 200 DRL by Dr Reddy’s Laboratories were granted authorisations in terms of Section 21 (for emergency use) of the Medicines and Related Substances Act, 1965 (Act 101 of 1965 as amended), on 31 May and 6 June 2022, respectively. SAHPRA has also authorised, with conditions, the importation of Molnupiravir 200 mg capsules (Lagevrio).

Monitoring vaccine impact

One of the tools used to monitor vaccine effects is the Med Safety Application (app), which was designed for the public and healthcare professionals to report suspected ADRs and adverse events following im-

O V E R V I E W O F C O V I D - 1 9 V A C C I N E D A T A

W W H H A A T T D D O O T T H H E E S S T T A A T T S S S S A A Y Y ? ?

Data period: 17/05/2021 - 30/04/2022

5 893 AEFIs

There was a total of 5 893

Adverse Events Following Immunisation

(AEFIs) reported, for both the J&J and Pfizer vaccines, from over 34 million administered doses.

The more data SAHPRA collects, the better they can understand and monitor the impact of the various vaccinations being rolled out in the country.

Data period: 17/05/2021 - 30/04/2022

6,000 AEFIs reported Highest numbers according to ages

4,000

2,000

0

J & J Pfizer

In terms of the most affected age group, which was between 40 – 49 years, there were 331 and 961 AEFIs reported for J&J and Pfizer vaccinations respectively.