A statement from the South African Health Product Regulatory Authority (SAHPRA) stated that the use of the Sputnik V vaccine in South Africa, where HIV prevalence and incidence are extremely high, "may increase the risk of vaccinated males contracting HIV."
As the report stated, the company that had submitted an application for the use of Sputnik V in South Africa had provided no evidence that the formula was safe "in environments with a high HIV prevalence."
In addition, the FDA stated that "the rolling evaluation of the Sputnik V vaccine would remain available for the submission of relevant safety data in support of the application."
The Gamaleya Centre in Russia, which was responsible for the development of Sputnik V, stated that it would provide facts to demonstrate that SAHPRA's fears were "absolutely unjustified."
As stated in a release, "Speculation on the association between adenovirus type-5 vectored vaccines and HIV transmission in high-risk groups has been based on small-scale studies," the organization noted.
Adenovirus type-5 vectored vaccine recipients did not experience a statistically significant increase in HIV-1 infection, according to several clinical studies conducted on more than 7,000 participants, according to the institute. "When all study participants and follow-up time were considered, there was no statistically significant increase in HIV-1 infection among adenovirus type-5 vectored vaccine recipients," the institute concluded.
South Africa, the African country that has been hit the hardest by the pandemic, also has the highest number of individuals living with HIV in the world.
It has been dealing with vaccination hesitancy for some time.
To yet, only little more than a quarter of the 40 million people who are expected to be vaccinated by early 2022 have received their vaccinations in full.
Children as young as 12 will be vaccinated in South Africa starting this week, and certain immuno-compromised citizens will be offered booster vaccinations as well.
There are two vaccines available at the moment: the single-dose Johnson & Johnson vaccine (which contains an adenovirus, but one of a different type) and the rMNA Pfizer/BioNTech vaccine.
The Sinovac, which is manufactured in China, has also been approved.
Sputnik V has not yet been approved for use in an emergency situation by the World Health Organization, despite the fact that it is being administered in at least 45 nations.
Coronavirus COVID-19 Sputnik is discussed in this article.
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