WINDHOEK, Oct 23 (Reuters) – Namibia will suspend its rollout of Russia’s Sputnik V COVID-19 vaccine, its health ministry said on Saturday, days after the drugs regulator in neighbouring South Africa flagged concerns about its safety for people at risk of HIV.
The Gamaleya Research Institute, which developed Sputnik V, said Namibia’s decision was not based on any scientific evidence or research.
South African regulator SAHPRA decided not to approve an emergency use application for Sputnik V for now because, it said, some studies suggested that administration of vaccines using the Adenovirus Type 5 vector – which Sputnik V does – was associated with higher susceptibility to HIV in men. Namibia’s health ministry said in a statement that the decision to discontinue use of the Russian vaccine was “out of (an) abundance of caution that men (who) received Sputnik V may be at higher risk of contracting HIV,” adding that it had taken SAHPRA’s decision into account.
Sputnik V remains one of the safest and most efficient vaccines against COVID-19 in use globally, the Gamaleya institute told Reuters. It said more than 250 clinical trials and 75 international publications confirmed the safety of vaccines and medicines based on human adenovirus vectors.
“While adenoviruses, including ad-5, are one of the most frequent causes of light common flu…, there is no evidence of increased risk of HIV infection among human population after (the) common cold,” the institute said.
“These inaccurate speculations that have since been refuted relate to unsuccessful clinical trials of another HIV vaccine by another manufacturer that simply did not seem effective enough.”
A meta-analysis of six clinical studies and their long-term follow-up in 7,092 participants showed there was no statistically significant increase of HIV-1 infection among adenovirus type-5 vectored vaccine recipients, it said.
Namibia said the suspension would last until Sputnik V receives a World Health Organization Emergency Use Listing. But it will offer people who received a first dose of Sputnik V a second to complete their immunisation course.