File Photo by Olga MALTSEVA / AFP)
File Photo by Olga MALTSEVA / AFP)

No Sinopharm and Moderna vaccines application, no approval, says Saphra

By Thobeka Ngema Time of article published Jun 22, 2021

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DURBAN - PRESSURE is mounting on the South African government to procure other types of Covid-19 vaccines as infections and Covid-related deaths rise, while the country is constantly moved to different levels of the national lockdown.

This prompted the SA Health Products Regulatory Authority (Sahpra) to release a statement on Monday saying it did not approve any product if an application had not been submitted to the authority.

This comes after frustration over the pace of South Africa’s vaccination rollout, with many calling for the procurement of the Sputnik V and Sinopharm vaccines to be administered to South Africans. Only a little over 2 million South Africans have been vaccinated.

A graphic illustrating South Africa’s new Covid-19 cases between June 14 and June 20. Graphic: Thobeka Ngema

The EFF said it would march to Pretoria on Friday to demand that Sahpra include Russian Sputnik V and Chinese Sinovac vaccines for use.

Sahpra said thus far it had approved the Johnson & Johnson (J&J) and Pfizer vaccines.

“Sahpra has also received applications for Coronavac (manufactured by Sinovac) and the Sputnik V (manufactured by the Gamaleya Research Institute) vaccines. The evaluation of the Coronovac application is at a very advanced stage,” Sahpra said.

“Furthermore, reports recently made available by the World Health Organization (WHO) that articulate the basis for the Emergency Use Listing are being considered. The Sputnik V application is a rolling review, thus as data becomes available to the applicant, it is submitted to Sahpra.”

The authority said there was no decision on the Sinopharm and Moderna vaccines which had a WHO Emergency Use Listing, as there had not been any applications for these vaccines in South Africa.

Also of concern was the prevalence of variants such as the Beta variant in South Africa. This required that Sahpra ensured efficacy against such variants and therefore information on studies supporting efficacy would be expected to be provided by the applicant.

Sahpra chief executive Dr Boitumelo Semete-Makokotlela said: “Sahpra is committed to prioritising all Covid-19-related health products, including vaccines, as the world and South Africa grapple with ending the scourge of a pandemic of mammoth proportions. Sahpra will not be pressured to allow the public access to any product that has not met the necessary regulatory requirements.”

Health portfolio committee member Naledi Chirwa asked Kubayi-Ngubane about the status of acquiring the Sinopharm vaccine from China.

Kubayi-Ngubane had said Sahpra required an applicant (manufacturer or importer) of a medicine to file a registration dossier with the regulator for a medicine to be considered for registration and subsequent use in the country.

“Sinopharm does not have a presence in the country, neither does it have an agreement with any local company to act as the importer. The department has met with Sinopharm to discuss access to the vaccine, however in the absence of registration approval from the regulator, it would be difficult to pursue a procurement discussion with Sinopharm,” said Kubayi-Ngubane.

“Additionally, it is important to understand the performance of the Sinopharm vaccine against the dominant variant in South Africa. However, to date, there has been no data provided on this matter.”

A graphic illustrating KwaZulu-Natal’s new Covid-19 cases between June 14 and June 20. Graphic: Thobeka Ngema

Chirwa had also asked Kubayi-Ngubane when the Sputnik V and Sinopharm vaccines would be rolled out, the number of doses that had been secured and what would be required for vaccination.

In response, Kubayi-Ngubane had said the department could only procure vaccines once Sahpra had assessed and approved the vaccines for use in SA based on efficacy, safety and quality.

Neither the Sputnik nor the Sinovac vaccine had been approved by Sahpra as yet. Once these vaccines were approved, Sahpra would approach the National Treasury for concurrence regarding the procurement of these vaccines.

Dr Sophie Thembekwayo asked Health Minister at the time, Dr Zweli Mkhize why he could not speed up the procurement of Sputnik V for South Africa in light of a peer-reviewed study published in the medical journal The Lancet, where trial results showed that the Russian-developed Covid-19 vaccine had shown efficacy of 91% and was deemed safe.

“The Gamaleya Institute was still undergoing investigations into the effectiveness of the Sputnik V in the presence of the 501Y.V2 (B.1.351, or Beta) variant, which is the main circulating strain of Covid-19 in South Africa. The published results do not represent the effectiveness of this vaccine against this variant.

“Also, concern was raised with regards to the second booster dose which uses the Ad5 vector, where previous work in the Phamibili study showed that using this vector may increase the acquisition of HIV, particularly in males,” said Mkhize.

“The Ministerial Advisory Committee on Covid-19 Vaccines has been engaging with the Gameleya Institute to investigate these matters further.”

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