Hungarian drug regulator approves Sputnik V vaccine - website

Hungary moved one step closer to being the first EU member to receive Russia's Sputnik V vaccine after its drug regulator gave the green light to the shot on Wednesday, the Index.hu website reported. Hungary's foreign minister, who is due to visit Moscow this week, said the government had received a draft contract to buy the vaccine from Russia's RDIF sovereign wealth fund, although he stopped short of confirming the Index.hu report.

Hungary moved one step closer to being the first EU member to receive Russia's Sputnik V vaccine after its drug regulator gave the green light to the shot on Wednesday, the Index.hu website reported.

Hungary's foreign minister, who is due to visit Moscow this week, said the government had received a draft contract to buy the vaccine from Russia's RDIF sovereign wealth fund, although he stopped short of confirming the Index.hu report. Peter Szijjarto said in a statement that if the Hungarian regulator approves the Russian vaccine "then the contract can be signed and ... Hungary could receive a large supply of safe vaccine".

Index.hu, citing unnamed sources, said the regulator, the National Institute of Pharmacy and Nutrition, had in fact already approved the vaccine after studying its documentation. Hungarian experts have been in Moscow for days. Another website, Origo.hu, said the regulator had also approved the AstraZeneca vaccine.

The Hungarian regulator was not immediately available for comment. The government spokesman was not reachable either. Scientists have raised concerns about the speed at which Moscow has worked, giving the regulatory go-ahead for the shot at home and launching mass vaccinations before full trials to test its safety and efficacy had been completed.

Moscow has said Sputnik V is 92% effective at protecting people from COVID-19 based on interim results, but it has not yet released the full dataset for the trials. Russia on Wednesday filed for registration of the Sputnik V vaccine in the European Union ahead of a review by the European Medicines Agency (EMA) next month.

Hungary's nationalist government has sharply criticised the EU for what it said were tardy vaccine purchases and deliveries that now threatened economic recovery. Last week it said it had reached a deal with China's Sinopharm 1099.HK to buy its vaccine.

Hungary would be the first EU country to accept a Chinese vaccine if approved by Hungarian authorities. Under EU rules it would have to give an ultra-fast emergency use approval, rather than waiting for the EMA to give the go-ahead for the vaccine.