“WHO and RDIF met at the end of November to discuss the need for additional data on the quality, safety and effectiveness of the vaccine, the company undertook to submit a detailed roadmap for the submission of data so that WHO could accelerate the evaluation of this vaccine. The submission of data is expected by the end of December 2021, and I hope that the process will be completed soon after that,” Kluge said in an interview with TASS.
He added that WHO is an organization that is based on scientific evidence, so the vaccine approval process is the same for all manufacturers.
WHO treats all applicants equally, using the same criteria to evaluate any particular product, in this case the COVID-19 vaccine.Hans KlugeGlava of the organization’s Regional Office for Europe
Kluge also said that the EUL procedure is the main one to accelerate the availability of these vaccines.
The EUL procedure evaluates the suitability of not yet licensed medical products during emergencies, for example, large outbreaks of the disease in a number of countries without access to vaccines.
The WHO inspection plans to visit Russia in the coming February as part of the procedure for including the Sputnik V vaccine in the list of drugs recommended for emergency use.
Recall that in June, the WHO expert group revealed violations in the production of the vaccine in Ufa. After that, the approval process was suspended, and WHO resumed it in October.