The Russian maker of the COVID- 19 Sputnik V vaccine is due to submit its latest clinical data by the end of December, with factory inspections expected to follow in February, a WHO official said on Monday.
Moscow rushed to approve the shot for domestic use last year, but it hasn't been certified by the European Medicines Agency or the WHO.
Rogerio Gaspar, WHO regulation director, gave the new timelines for the vaccine made by the Gamaleya InstituteGamaleya Institute, which is seeking WHO emergency use listing, during a WHO briefing for journalists in Geneva.
He said that it was hoped that Gamaleya would complete its application in two parts, at the end of December and by the end of January.
The planning exercise for the forthcoming GMP good manufacturing practices inspections that will be necessary to look at the new data to be submitted, Gaspar said.
He said that he said that if all information is on board and the technical information is answered by the end of December, we would be able to perform GMP good manufacturing practices inspections on Sputnik in February.
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 COVAX vaccine supply for poorer countries.
The listing allows countries to expedite their own regulatory approval to import and administer COVID 19 vaccines.