Health
South African regulators reject Russia’s COVID-19 vaccine | Nation & World Business
Johannesburg (AP) — South African drug regulators have rejected the Russian-made coronavirus vaccine Sputnik V because of safety concerns that the manufacturer could not answer.
The South African Health Products Regulatory Authority (SAHPRA) said in a statement Tuesday that the application for approval of Sputnik V was “not approved at this time” and referred to previously unsuccessful HIV vaccines using similar technology. However, regulators added that the review process is ongoing and can accept additional safety data from Russian manufacturers.
Late study More than 20,000 participants published in The Lancet magazine last year and found that Sputnik V is safe and about 91% effective in preventing severe COVID-19 illness.
Sputnik V uses two harmless viruses called adenoviruses to carry spike proteins into the body, stimulating the immune system to produce antibodies against COVID-19. SAHPRA said concerns have been raised about the safety of adenovirus type 5 used in one of the doses of Sputnik V. Another dose contains adenovirus type 26, which is also used by Johnson & Johnson.
South African officials pointed to two unsuccessful studies that tested the HIV vaccine using adenovirus type 5 as well, and found that vaccinated men were at increased risk of becoming infected with HIV. Regulators have asked Russian manufacturers of Sputnik V to provide data demonstrating the safety of vaccines in countries with high HIV prevalence, but “applicants have failed to adequately meet (their) demands. “.
In a statement, the Sputnik V manufacturer, Gamareya Center, called concerns about vaccine vectors “totally unfounded.” Guessing the association between adenovirus type 5 and HIV infection in high-risk populations is based on “small, inconclusive studies of volunteers who are likely to behave at high risk.” .. It was noted that the same vector was also used in the Chinese CanSino vaccine, which is widely used in China.
Dr. Julian Tan, a virologist at the University of Leicester in the United Kingdom, was puzzled by South Africa’s decision to reject Sputnik V.
“It’s a strange connection,” he said, raising past concerns about the use of certain viral vectors in Sputnik V, but explaining that many remain uncertain. “We can’t blame it because it wasn’t the vector that caused HIV,” Tang said.
AstraZeneca vaccines use the associated chimpanzee adenovirus. Both it and Johnson & Johnson Shot are approved in South Africa.
The Gamareya Institute, the Russian manufacturer of Sputnik V, was not immediately asked for comment. With the widespread hesitation of vaccines in Russia, authorities are struggling to convince people to get vaccinated, and despite the availability of Sputnik V, the country’s immunization rate is about 32%. And remains stubbornly low.
Sputnik V is currently under consideration for approval by the World Health Organization and the European Medicines Agency. This shot has green lights in more than 70 countries. To date, no serious safety issues have been identified.
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AP Medical Writer Maria Cheng reported from London.
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Follow all AP stories about the coronavirus pandemic https://apnews.com/hub/coronavirus-pandemic.
Copyright 2021 AP communication. all rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.
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Sources 2/ https://lancasteronline.com/news/health/south-african-regulator-rejects-russias-covid-19-vaccine/article_b72415a4-1e9d-5fcf-9485-aaa041756423.html The mention sources can contact us to remove/changing this article |
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