Tuesday, 28 September, 2021
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SAHPRA: Russian and Chinese vaccine authorisations a rigorous process

In the wake of continued political pressure from the Economic Freedom Fighters on the issue, the SA Health Products Regulatory Authority (SAHPRA) has stressed in a Sunday Times Daily report that it would only authorise the use of Russia’s Sputnik V and China’s Sinopharm COVID-19 vaccines if the jabs passed stringent safety and efficacy requirements.

SAHPRA CEO Dr Boitumelo Semete-Makokotlela said the authority had received two applications to roll out the Russian vaccine, and “we have engaged with these applicants”, she said.

Currently, only the Pfizer-BioNTech and Johnson & Johnson (J&J) vaccines are authorised for use in SA, but she added that applications were pending for the Sputnik V and Sinopharm vaccines.

Sputnik V, developed by Russia’s Gamaleya Research Institute of Epidemiology and Microbiology, was the world’s first registered COVID-19 vaccine to market after being registered in August 2020.

The Sinopharm jab, manufactured by Chinese state-owned enterprise China National Pharmaceutical Group Corporation, is being used in China and various other countries after the go-ahead from the World Health Organisation (WHO) in May.

Delays to those applications were the result of compliance queries at the respective manufacturing sites and because neither vaccine is produced in SA. Also, said Semete-Makokotlela, in some cases, the reports had to be translated, as SAHPRA had made it “very clear we operate in English”. Waiting for clinical data or lab-based data on the variants of concern caused further delays, she added. “When applicants don’t have that information ready, they do what we call a rolling review submission.”

Regarding deaths among people who had been vaccinated that SAHPRA had investigated, she stressed the vaccine had not been the cause of death. “In probably 98% of these 30 [cases] they were elderly who received their vaccines when we were focusing on those 60 and above.” SAHPRA had yet to see any of the adverse reactions seen in certain age groups in other countries, but was monitoring this, she said. “We are not seeing anything alarming that is a cause of concern.”

According to the Sunday Times Daily report, another example that proved the agency’s concern with safety was the decision to delay releasing the J&J vaccine after reports of contamination at the manufacturing stage.

“We aligned ourselves with the FDA (US Food and Drug Administration) and the European Medicines Agency, and the three of us agreed that these batches should not be released to the public.”

SAHPRA’s rigorous processes added further safety, she said.
“Other countries will fully rely on a decision that is made by another authority or maybe by the WHO. Because of the nuances we see locally in terms of the epidemic and the variants of concern, we evaluate every single dossier. We do our own assessments.”

SAHPRA had evaluators who looked at quality aspects, as well as experts who investigated the safety aspects and clinical efficacy of vaccines: vaccines need to have a minimum efficacy of 50% before being authorised.

“We have also articulated the minimum phase three trial data that is required and until we get the full data, these vaccines would be under emergency use only.”

 

Sunday Times Daily article – SA in discussions about Russian and Chinese Covid-19 vaccines (Open access)

 

See more from MedicalBrief archives:

 

EFF: SAHPRA refusal to allow Sinovac and Sputnik condemned

 

Sputnik V vaccine efficacy against SARS-CoV-2 variants — Small Argentina study

 

Despite safety fears, China inoculates with experimental vaccines

 

Russia’s Sputnik V about 90% effective against Delta variant — Developer

 

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