The process of evaluating the drug for inclusion in an emergency registry aims to “accelerate equitable access to vaccines to save lives”
“As with other candidate vaccines, WHO is continuing to evaluate the Sputnik V vaccine at various manufacturing sites and will publish decisions on EUL status when all data is available and the review is completed”, – the WHO press office said.
Speaking about the prospects for further review of the Sputnik V approval application, the WHO referred to a statement by the organisation’s assistant director-general Mariangela Simao, who said on 7 October that the process had been “paused” but was “close to resuming”. She said “there will still be questions regarding the full information on this dossier to be provided by the applicant, the Russian Direct Investment Fund, and there are also questions regarding the completion of inspections at various facilities in Russia”.
“Any vaccine with proven safety, efficacy and quality assurance, that is, in other words, that meets the requirements of the EUL procedure, will receive a recommendation”, – the WHO assured.
The organisation explained that the process of evaluating drugs for inclusion in the register of drugs for emergency use aims to accelerate equitable access to vaccines to save lives.