Russia, WHO differ on when approval will come for Sputnik V

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Russia is ready to provide up to 300 million doses of its Sputnik V vaccine to the UN-backed COVAX initiative, a top Russian official promoting the shot says, even though the World Health Organization hasn't yet signed off on it and production issues have fanned customers' concerns worldwide.

Russian Direct Investment Fund CEO Kirill Dmitriev and the World Health Organization had vastly different takes Wednesday on when the Russian vaccine would get WHO's stamp of approval.

But Dr. Mariangela Simao, the WHO's assistant director-general for access to health products, wouldn't make any commitment to that timetable. She said the approval process for Sputnik V is currently on hold, and once the legal procedures are sorted out, "we will reopen the assessment, which includes the submission of the data in the dossier -- it's still incomplete -- and resuming the inspections in the sites in Russia.

Dmitriev argued that "there is not one vaccine manufacturer in the world that didn't have vaccine delivery issues." including Russian plants making Sputnik V. The European Medicines Agency's expedited approval for Sputnik V began in March. Experts from the EMA visited some of Sputnik V's manufacturing sites earlier this year and the agency said further visits could be required depending on additional data submitted.

The Kremlin has attributed the mounting contagion and deaths to a lagging vaccination rate. Prime Minister Mikhail Mishustin said Tuesday that about 43 million Russians, or 29 per cent of the country's nearly 146 million people, were fully vaccinated. Experts say vaccine skepticism and vaccine disinformation are widespread in Russia.

Source: Healthcare Press (healthcarepress.net)

 

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