PODCAST: Laws regulating COVID-19 vaccine in SA

There is skeptism over the COVID-19 vaccine among South Africans as the first doses of the World Health Organisation COVAX facility is expected to be available in the country by around April.

Ipsos’s December survey shows that 47% of participants say they would refuse to get vaccinated, citing concern surrounding the treatment’s potential side effects.

Some people on social media have questioned the safety of the vaccine, a number of people say they are not going to take it, while some say they must vaccinate prominent people and politicians first to see if it works.

@PhashaMight says, “I’m definitely not taking the vaccine. I’ll use herbal treatments whenever I’m feeling ill like I usually do.

@IAmOtisJC says, “They can start with everyone else honestly. Politicians, influencers  and media that have been pushing for this vaccine must go first so we see what happens to them.

Healthcare workers are expected to be vaccinated first, followed by essential workers, persons in congregate setting, people over 60 and those with comorbidities in the second phase. People over 18 will be vaccinated in the third phase.

The ultimate aim is to vaccinate 67% of the population, which amounts to over 60 million people, to achieve herd community by the end of the year.

This Podcast outlines the regulations and statutes that will govern the procurement and distribution of the vaccine based on the Department of Health’s Vaccine Rollout Plan.

Senior Post-doctoral Fellow at the University of KwaZulu-Natal’s Health, Law and Bioethics research group, Dr Marietjie Botes, speaks about key regulatory frameworks to ensure vaccine is safe before roll out.

Botes says government cannot force citizens to take the vaccine.

“You have what we call autonomy, you can decide what happens with your body. What I foresee and what I have seen in Europe and America is that they might issue you with some kind of certificate or proof that you did receive the vaccine, to make travel or entry into the university lecture hall or churches.”

Below is the full interview:

Regulatory matters

According to the COVID-19 Vaccine Rollout Strategy, vaccines must be safe and effective Medicines and Related Substances Act 101 of 1965 and the South African Health Products Regulatory Authority (SAHPRA) put several measures in place to ensure expedited regulatory approvals of safe vaccines.

These measures include:

• Agreements with EMA, USFDA, MHRA, and TGA SAHPRA will thus be able to use their assessment reports as a reliance approach to reduce timelines in the evaluation process.
• SAHPRA has adopted a priority review approach for all COVID 19 vaccine applications since the onset of the pandemic. Thus, the process of expedited review will apply to any COVID 19 vaccine registration application.
• Flexibility in relation to labelling and packaging requirements effected in terms of effect Section 36 of the Medicines Act (exemption of medicines by the Minister of Health from certain requirements of the Medicines Act) for specific labelling and packaging requirement exemptions.
• Authorisation in terms of Section 21 of the Medicines Act where manufacturers have not submitted dossiers to SAHPRA