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- The South African drug regulator has rejected the Russian-made coronavirus vaccine Sputnik V
- The reason being given is safety concerns, which the manufacturer wasn’t able to respond with cogent reasons
- The South African Health Products Regulatory Authority (SAHPRA), said that the request for Sputnik V to be authorized could “not be approved at this time.
The South African drug regulator has rejected the Russian-made coronavirus vaccine Sputnik V. The reason being given is safety concerns, which the manufacturer wasn’t able to respond with cogent reasons.
The South African Health Products Regulatory Authority (SAHPRA), said that the request for Sputnik V to be authorized could “not be approved at this time. Earlier, South Africa did not approve the HIV vaccines that used a similar technology. Authorities pointed out that the decision was not final since a review process was going on.
The journal Lancet found that last year more than 20,000 participants found that Sputnik V was safe and about 91% effective in preventing people from becoming severely ill with COVID-19.
Sputnik V uses two types of harmless viruses known as adenoviruses to carry the spike protein into the body. The vaccine then primes the immune system to produce antibodies against COVID-19. Concerns have been raised about the safety of Adenovirus Type 5, which is used in one of the Sputnik V doses. The other dose contains Adenovirus Type 26. This is also used by Johnson & Johnson.
South African officials pointed to two failed research studies testing an HIV vaccine also using Adenovirus Type 5, which found men who were vaccinated had a higher risk of being infected with HIV. The regulators said they had asked the Russian makers of Sputnik V to provide data proving the vaccine’s safety in a country with high rates of HIV. But the applicant did produce any adequate data.
The Gamaleya Center- Sputnik V’s manufacturer- termed the concerns about the vaccine “completely unfounded,” and said speculation about the link between Adenovirus Type 5 and HIV transmission in high-risk populations was based on “small-scale inconclusive studies among volunteers with highly probable risky behaviour.”
Sputnik V is currently also being tested by the World Health Organization and the European Medicines Agency. The shot has been approved in more than 70 countries. Importantly, the vaccine did not show any significant safety problems till date.
