Africa-Press – Namibia. SPUTNIK V manufacturers say the decision by Namibia’s Ministry of Health and Social Services relating to Sputnik V’s use in the country specifically cites the South Africa’s regulator’s earlier announcement and is not based on any scientific evidence or research.
The health ministry decided to discontinue the administration of the Sputnik V vaccine in Namibia. This comes after the South African Health Products Regulatory Authority (SAHPRA) last week announced that the Sputnik V vaccine has insufficient data on its safety in populations at risk for HIV infection. The Gamaleya National Centre maintains that the Sputnik V remains one of the safest and most efficient vaccines against Covid-19 in use globally.
The licensed South African applicant of the Sputnik V vaccine, Lamar International’s Naz Gamieldien said a meta-analysis of six clinical studies and their long-term follow-up in 7 092 participants showed, after rigorous statistical analysis of pooled individual participant-level data, that there was no statistically significant increase of HIV-1 infection in high-risk groups.
Gamieldien further said all the required information confirming that possible concerns about the safety of Ad5-vectored vaccines among those infected with HIV and in populations at risk for HIV infection are completely unfounded and baseless.
“While adenoviruses, including Ad-5, are one of the most frequent causes of light common flu experienced by everyone, there is no evidence of increased risk of HIV infection among the human population after common cold or conjunctivitis. There is no scientific or clinical evidence whatsoever,” Gamieldien said.
He added that inaccurate speculations relating to an unsuccessful clinical trial have since been refuted. Last week Namibian health executive director Ben Nangombe said the ministry will wait until Sputnik V has received Emergency Use Listing from the World Health Organisation.
“However, patients who received the first dose of Sputnik V will be offered their second dose to complete the vaccination schedule,” he said.
SAHPRA cited the safety of adenovirus vaccine vectors, which has been evaluated in a number of studies, including the STEP trial. The STEP trial was stopped in September 2007 due to a lack of efficacy, but evidence quickly emerged of an enhanced risk of HIV infection in a particular subgroup of participants.
Currently, 110 people in Namibia have received their first Sputnik V dose, while seven have received their second jab. This vaccine has not been approved for emergency use by the World Health Organisation, however, the British Medical Journal reported that interim results indicate that the vaccine is 91,6% effective, and 94% of reported side effects were very mild.
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