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SA wants Chinese and Russian vaccines for 10 million people – but regulators say not yet

South Africa Covid-19 vaccines

Ampoules with the Gam-COVID-Vac (Sputnik V) vaccine at a mobile Covid-19 vaccination site outside the Viktoria shopping center. (Photo by Vitaly NevarTASS via Getty Images)

  • Covid-19 vaccines developed in China and Russia could be introduced in South Africa if they get approval from the Health Products Regulatory Authority.
  • Health minister Zweli Mkhize confirmed government’s intention to acquire enough of Russia’s Sputnik V and China’s Sinovac doses to vaccinate 10 million people.
  • But both vaccines have shown diminished efficacy in combatting Covid-19 variants, particularly 501Y.V2.
  • And Sputnik V has already been shelved in Brazil due to fears surrounding its “dangerous” adenovirus vector.
  • For more stories, go to www.BusinessInsider.co.za.

South Africa’s health department is looking to procure Covid-19 vaccines developed in Russia and China. But before Sputnik V and Sinovac can be included in the local rollout, South Africa’s Health Products Regulatory Authority (Sahpra) needs to give its stamp of approval – and that is not looking like a sure thing.

South Africa’s vaccination drive currently hinges on jabs produced by Johnson & Johnson (J&J) and Pfizer.

To date, 298,153 J&J doses have been administered to frontline healthcare workers who form part of the first phase of the rollout. A further three million doses – out of a total 31 million already ordered – are due to arrive before June.

An equal number of doses developed by Pfizer, including 1.4 million shots supplied via the COVAX programme, are due to vaccinate approximately 15.7 million South Africans in 2021. The first shipment of Pfizer shots is due to arrive in the country on 3 May.

If all the ordered doses are delivered and administered, it’s estimated that almost 47 million South Africans will be vaccinated against Covid-19. This exceeds government’s plans to vaccinate 67% of the population to achieve herd immunity.

But constraints impacting the global supply chain have the potential to delay the delivery of vaccines. New studies concerning side-effects, like isolated reports of blood clots with the J&J jab, and diminished efficacy relative to new variants, which halted the use of AstraZeneca doses in South Africa, can also disrupt the rollout in future.

Despite South Africa having ordered enough doses to reach its vaccination goals, health minister Zweli Mkhize this week confirmed interest in acquiring Russia’s Sputnik V and China’s Sinovac. In a presentation to parliament’s portfolio committee on health, Mkhize said that 10 million doses of each shot – enough to vaccinate 10 million people – would be procured.

The final decision to purchase vaccines produced by these manufactures relies entirely on the results of safety and efficacy studies conducted by Sahpra. The regulatory body received Sputnik V’s application on 24 February and is still conducting its analysis. Sinovac’s Coronavac submission was lodged on 10 March, and is also still being considered.

The viral vector vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology, Sputnik V, has been ordered by more than 50 countries, with India set to manufacture 850 million doses through support from the Russian Direct Investment Fund (RDIF).

The RDIF and Gamaleya institute report that the two-dose vaccine has shown 97.6% efficacy. Earlier results from a Phase 3 study place Sputnik V’s efficacy at 91.6%, as reported by Lancet medical journal.

But like the AstraZeneca dose, which is also viral vector vaccine, Sputnik V has a “markedly reduced” efficacy in combatting new Covid-19 variants like 501Y.V2, which is dominant in South Africa.

This diminished efficacy doesn’t bode well for Sahpra’s approval which places emphasis on vaccines’ ability to neutralise the 501Y.V2 variant.

“The key question is about the availability of data around efficacy on the 501Y.V2 variant,” said Sahpra CEO Dr Boitumelo Semete-Makokotlela in an interview with SAfm.

Brazil’s health regulator recently rejected the use of Sputnik V, arguing that the vaccine’s adenovirus vector poses a serious threat to people with weaker immune systems. Semete-Makokotlela noted that Sahpra “aligns itself with the views of various regulators” with regards to health and safety standards.

The Coronavac vaccine, developed by the Chinese pharmaceutical company Sinovac Biotech – not to be confused with the Sinopharm jab created by the state-owned China National Pharmaceutical Group Corporation (CNPGC) – also faces a significant hurdle in gaining Sahpra’s approval.

The vaccine’s overall effectiveness has been found to be as low as 50.4%. Brazilian researchers have determined that the two-dose vaccine, when administered shorter than three weeks apart, was only 49.1% effective. This is lower than the 50% efficacy threshold set by the World Health Organisation.

Sinovac’s use also made headlines in Thailand earlier in April, when six medical personnel reported “stroke-like” side effects – including drowsiness and numbness in the limbs – after receiving the Coronavac jab. Thailand’s Department of Disease Control said these isolated incidents would not, however, lead to the suspension of the Sinovac vaccine.

Sahpra has not yet indicated when its analysis of the Sputnik V and Sinovac vaccines would be completed.

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