Health products regulator at advanced stage evaluating Sinovac vaccine

The SA Health Products Regulatory Authority (Sahpra) said on Thursday that it was at an advanced stage of evaluating the CoronaVac vaccine, manufactured by Sinovac.

Sahpra CEO Dr Boitumelo Semete-Makokotlela said the process of assessing and approving vaccines was rigorous and “intricate”.

Sahpra is evaluating CoronaVac and reviewing applications for one of the Sinopharm vaccines and for the Sputnik V vaccine, manufactured by the Gamaleya Research Institute.

It said it had not received applications for the registration of the vaccines manufactured by Moderna or Novavax.

“Sahpra is not mandated to effect procurement of any medicine or vaccine. Our role focuses largely on the regulatory oversight of these health products,” said Semete-Makokotlela.

Sahpra’s mandate included looking at the manufacturing company and whether it was registered, she said.

“We look at whether the companies comply with production practices. Is the product of good quality? We look at the safety and efficacy of the product. We are then able to approve the vaccine. We also assess the product once it is made available on the market.”

Semete-Makokotlela said they had to assess whether the product had any adverse side effects.

“We look at compliance with manufacturing practices. Where there is non-compliance, we are then able to say this product is not safe and therefore cannot be released.

“It’s an intricate assessment process. When it comes to Covid-19 vaccines, there is guidance that the vaccines must have a minimum threshold of 50% efficacy.”

The applicant needed to demonstrate that they had a clear risk management assessment plan that was contextualised to the SA environment, she said. “Does their risk management plan speak to how they will be able to assess the efficacy of the vaccine against the variants of concern?”

Sahpra also announced that it had reduced the time taken to register Covid-19 vaccines to less than three months where the required standard of data was available. This it did while continuing to adhere to strict guidelines to ensure the safety of South Africans.

“The medicines’ approval process entails a rigorous process of assessment, where all information provided by the applicant is carefully evaluated by experts in their respective fields.

“While we have drastically reduced our usual time frames for the registration of Covid-19 vaccines, we have not cut back on the checks required to ensure that they are safe and effective. We will not compromise on the safety of South Africans and we will not endanger South African lives,” said Semete-Makokotlela.

In addition to reviewing Covid-19 vaccines, Sahpra said it had also been approving other health products required for the testing and care of Covid-19 patients, such as ventilators, diagnostic tests and repurposed medicines.

“Our mandate is not only confined to medicine. It also encompasses the approval of medical devices and diagnostics tests, as well as overseeing clinical trials.

“Our staff have been working around the clock to ensure that we meet this mandate in the shortest possible time given the monumental challenge confronting South Africa. We have to do so with the primary objective of ensuring the safety of South Africans. We understand that lives depend on us and we hold this responsibility sacrosanct.”

The authority was dismayed by allegations that it was dragging its feet in registering Covid-19 vaccines, she said.

“As a regulator with integrity, which places the interests of the country it serves and its people at the forefront of its decision-making, Sahpra is committed to acting responsibly and in accordance with its mandate at all times.

“Sahpra strives to be responsive in this time of crisis, ensuring that health products are timeously and appropriately assessed and authorised. We welcome any endeavour by civil society and political parties which can constructively assist Sahpra in meeting its mandate.

“We will authorise Covid-19 vaccines which meet the necessary standards of safety, quality and efficacy as soon as is possible.”

TimesLIVE