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Vaccines are safe as they undergo rigorous testing and approval process, says Sahpra

Sahpra officials says adverse side effects related to vaccines are still extremely rare. Picture: Ayanda Ndamane/African News Agency (ANA)

Sahpra officials says adverse side effects related to vaccines are still extremely rare. Picture: Ayanda Ndamane/African News Agency (ANA)

Published Sep 16, 2021


Cape Town - The SA Health Products Regulatory Authority (Sahpra) has reassured concerned citizens that the vaccines for the Covid-19 virus are safe as they have undergone rigorous testing and approval process.

This was highlighted during the Western Cape’s regular digital news conference to update citizens on the health platform and vaccination programme across the province, at which Sahpra’s chairperson Professor Helen Rees and Sahpra chief executive Dr Boitumelo Semete-Makokotlela were special guests.

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The health regulatory body explained that the work they do is conducted in line with the International Coalition of Medicines Regulatory Authorities and the World Health Organization.

This is done alongside regulatory authorities in the US, Australia, Canada, Europe, Nigeria and Brazil.

It also shows that the work conducted by Sahpra to ensure vaccine safety is in line with international norms and standards, and rooted in best practice.

The presentation provided by Semete-Makokotlela spoke to the rigorous process followed by Sahpra on authorisation and ensuring the safety of the Covid-19 vaccine.

This process includes:

  • Verifying that the applicant is licensed, Sahpra compliant and can oversee the necessary processes;
  • Ensuring that each production site complies with good manufacturing process and conducting the necessary evaluations;
  • Ensuring that the production process adheres to best practice and ensuring the necessary assessments are conducted;
  • Evaluating pre-clinical data to ensure that the vaccine trial meets all regulatory requirements for vaccines;
  • Assessing clinical trials in terms of safety data and providing evidence of the vaccine’s ability to prevent Covid-19;
  • Ensuring that the vaccine schedule is aligned to the clinical data, product labelling and patient information leaflet;
  • Assisting rejected applicants to appeal to the CEO of Sahpra within 20 days. They can further appeal to the health minister; and
  • Verifying lot release requirements to ensure easy accessibility of rest reports, lot summary protocol, transportation and cold chain verification.

“I cannot stress enough that we focus on the quality, safety and efficacy of the product, and also to monitor the products when they now have been authorised to hit the market,” Semete-Makokotlela said.

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“In terms of what we do, we are open to every single applicant that wants to submit – whether it’s medicine or whether it is a vaccine.

“In this case, we have created what we call pre-submission meetings wherein the applicant indicates their intention to submit; they meet with us and we tell them what the regulatory requirements are.

“We’ve met with a number of applicants – some of them have subsequently submitted, and some have not. Again, as a regulator, we cannot solicit applications, so until we have an applicant who has submitted to us (for approval), we cannot go out and solicit.”

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Semete-Makokotlela also shared which Covid-19 vaccines they are currently evaluating.

Sahpra officials also spoke of the side effects and explained that adverse side effects related to vaccines are still extremely rare.

As of 10 September 2021, the Western Cape Health Department (WCHD) found that the most common adverse side effects reported were mostly mild, including:

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  • Headaches in 18.1% of cases;
  • General body pain in 15.1% of cases; and
  • Fever over 38ºC in 9.9% of cases.

Of the reported side effects, most cases are mild and serious side effects remain extremely rare.

At a recent briefing by Sahpra, it was highlighted that while there have been reports of common adverse side-effects from Covid-19 vaccines, there have been no confirmed cases of deaths linked to the vaccine.

Between May and August 2021, following an extensive investigation by Sahpra’s experts in their field, 40 deaths required investigation and the findings by the experts confirmed 34 cases were unrelated to the vaccine and 6 cases had insufficient information to conclude.

In an analysis conducted by the WCHD between August 14 and 20, when the Western Cape was in its peak of the third wave, 96% of those over 60 years who were hospitalised were not fully vaccinated and 98.3% of those who died were not fully vaccinated.

The WCHD said that it will continue to conduct its intensive safety monitoring practices ensure that its vaccine programme continues to operate at the highest standards and that it ensures the safety of all.

Cape Argus