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WHO and EMA to inspect Sputnik V manufacturing in May – WHO – Metro US

WHO and EMA to inspect Sputnik V manufacturing in May – WHO

A man receives a vaccine against the coronavirus disease in
A man receives a vaccine against the coronavirus disease in a vaccination centre located at a shopping mall in Almaty

GENEVA (Reuters) – Technical experts from the World Health Organization are due to start the next round of their review of Russia’s Sputnik V vaccine against COVID-19 jointly with the European Medicines Agency on May 10, the WHO said on Thursday.

Russia is seeking WHO emergency-use listing for the vaccine developed by Gamalaya Institute. So far COVID-19 vaccines made by Pfizer AstraZeneca and Johnson & Johnson have been listed – an endorsement of their safety and efficacy that helps guide countries’ regulatory systems.

“Inspections for good manufacturing practices will take place from 10 May to 1st week of June,” the WHO told Reuters in reply to a query.

A joint team from the WHO and EMA are currently carrying out inspections for good clinical practices related to Sputnik, it said.

Asked about clinical data from Sputnik vaccine trials, the WHO said: “We are still receiving information from the producer.”

Russian deputy health minister Sergei Vershinin held talks in Geneva on Tuesday with WHO director-general Tedros Adhanom Ghebreyesus, who later wrote on Twitter: “@WHO appreciates Russia’s efforts to fulfill the Emergency Use Listing criteria for vaccines”.

(Reporting by Stephanie Nebehay; Editing by Gareth Jones and Hugh Lawson)