GENEVA – The World Health Organisation (WHO) yesterday said it is about to restart the process of approving the Sputnik V Covid-19 vaccine following a series of problems with the dossier.
WHO authorisation has been sought for the jab created by Russia’s Gamaleya research institute that is already being used in 45 countries, according to an AFP count.
Several Covid-19 vaccines have been given the WHO green light for emergency use during the pandemic: Pfizer-BioNTech, Janssen, Moderna, Sinopharm, Sinovac and AstraZeneca.
For Sputnik V, “the process was put on hold due to the lack of some legal procedures”, Mariangela Simao, WHO assistant director-general for access to medicines, vaccines and pharmaceuticals, told a press conference.
“In negotiations with the Russian government, this problem is about to be sorted out.
“As soon as the legal procedures are finished, we are able to restart the process.”
WHO emergency-use listing is the green light that gives countries, funders, procuring agencies and communities an assurance that a vaccine meets international standards.
The listing paves the way for countries to approve and import a vaccine for distribution quickly, especially states without an international-class regulator of their own.
Dossier incomplete
Sputnik V is already being used in countries including Algeria, Argentina, India, Iran, Mexico, Pakistan, the Philippines, Sri Lanka, the United Arab Emirates and Venezuela, apart from Russia itself.
“There are still issues around complete information on the dossier that has to be provided by the applicant,” said Simao.
“Then, there are also issues regarding the final finalisation of the inspections at the different manufacturers in Russia, but I’m happy to say that the process is about to be restarted.”
In June, WHO said it conducted nine inspections of Sputnik V manufacturing sites and uncovered various problems at the Pharmstandard Ufa Vitamin Plant in Ufa, southern Russia.
Moscow insists that the problems have since been resolved.
Russia is among the nations hit hardest by the coronavirus, with the fifth-highest number of recorded deaths according to an AFP tally yesterday: 213,549 fatalities out of 7,690,110 cases.
Several Russian jabs including Sputnik V have been available for months, but authorities have struggled to immunise a vaccine-sceptic population. – AFP, October 8, 2021
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