The World Health Organization has said it has concerns about the methods used at one plant producing the Sputnik V vaccine, as Slovakia announced it would sell or donate 160,000 of the 200,000 doses it has ordered of the Russian shot.
The WHO, which along with the European Medicines Agency (EMA) is reviewing Sputnik V for eventual approval, said in a report on Wednesday it had issues with the integrity of quality control data and test results at one of the four production sites it had seen.
The WHO review also identified concerns with cross-contamination and sterility, as well as with tracing and identifying batches of vaccines, at the Pharmstandard-UfaVITA plant in Bashkortostan, Russia, which fills vials with vaccine made elsewhere.
The company said in a statement that it had taken steps to address the issues, adding that it would welcome a further inspection. “We remain fully transparent and will continue with the WHO pre-qualification process,” it said.
The Kremlin spokesman Dmitry Peskov said all necessary corrections had been made.
The Sputnik V vaccine has been approved by more than 60 countries but has yet to be authorised by the EMA, and has been dogged by accusations that it is being deployed abroad more as a Russian propaganda tool than out of genuine solidarity.
Nor has it proved very popular at home: by 2 June, five months into the campaign, only 18 million Russians of about 144 million – one-eighth of the population – had received at least one vaccine dose, a far smaller proportion than in most western countries.
Last week, the Moscow city authorities gave employers in public services a month to ensure that 60% of their staff had been vaccinated or face a fine, while unvaccinated people are to be refused non-emergency hospital treatment and bar service.
Slovakia, whose order for 2m doses of the Russian shot triggered a political crisis leading to the resignation of the prime minister, said it planned to sell or donate 160,000 of its first batch of 200,000 vials to other countries.
A government website on Wednesday said only 14,214 people had registered to receive the vaccine, with 8,004 having had the shot. Under those circumstances, it said: “It is important to provide the possibility to use the vaccines in third countries which show interest in it.”
Slovakia is only the second EU country after Hungary to use the Russian jab, but the former prime minister, Igor Matovič, was forced to resign in March after he ignored many in his four-party coalition and struck a secret deal to buy the doses.
The government had said it would not order more than the initial 200,000 doses it had received until Sputnik V had secured EMA approval. However, Albania, Bosnia, Montenegro, North Macedonia and Argentina are all interested in its unwanted doses, the government website said.