GENEVA, (Reuters) – The Russian maker of the COVID-19 Sputnik V vaccine is due to submit its latest clinical data by the end of December, with manufacturing site inspections expected to follow in February, a World Health Organization (WHO) official said on Monday.
Moscow rushed to approve the shot for domestic use last year and it has been exported to countries around the world, but it has still not been certified by either the WHO or the European Medicines Agency, the EU’s drug regulator.
Rogerio Gaspar, WHO regulation director, gave the new timelines for the vaccine made by the Gamaleya Institute, which is seeking WHO emergency use listing, during a WHO briefing for journalists in Geneva.
It was hoped that Gamaleya would complete submission of its data and application in two parts, at the end of December and by the end of January, he said.
“We are starting already for the planning exercise for the forthcoming GMP (good manufacturing practices) inspections that will be necessary looking at the new data to be submitted,” Gaspar said, referring to on-site inspections for quality control.
“So our planning right now, provided that all information is on board and with the technical information being answered by the end of December, we would be able to perform GMP (good manufacturing practices) inspections locally on Sputnik in February,” he said.
In the past year, the WHO has approved nine COVID-19 vaccines for emergency use listing, which assesses their quality, safety and efficacy and is a prerequisite for providing doses to the COVAX vaccine supply for poorer countries.
The listing also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines.
