Sputnik V will submit vaccine data to WHO by the end of December

Moscow rushed to approve the shot for domestic use last year and it has been exported to countries around the world, but it still hasn’t been certified by the WHO or the European Medicines Agency, the European Union’s drug regulator.

WHO regulation director Rosario Gaspar gave new deadlines for a vaccine made by the Gamalia Institute, which is seeking the WHO’s emergency use list, during a WHO briefing for journalists in Geneva.

He said it was expected that Gamalaya would submit his data and application in two parts by the end of December and the end of January.

Referring to on-site inspections for quality control, Gaspar said, “We are starting planning exercises for upcoming GMP (Good Manufacturing Practices) inspections, which will be necessary given the new data to be submitted.”

“So our plan right now, provided that all information is on board and technical information is being responded to by the end of December, we will be able to conduct GMP (good manufacturing practices) inspections locally on Sputnik in February,” he said. .

In the past year, WHO has approved nine COVID-19 vaccines for emergency use list, which assesses their quality, safety and efficacy and is a prerequisite for providing doses for COVAX vaccine supplies to poor countries .

The listing allows countries to expedite their own regulatory approvals for the import and administration of COVID-19 vaccines.

(Reporting by Stephanie Nebbe and Emma Farge; Editing by Alison Williams)

This story has been published without modification in text from a wire agency feed. Only the title has been changed.