Hungary must keep Russian vaccine within borders, says EU

The government in Budapest may end up rolling out the Russian-made vaccine Sputnik V, named after the Soviet-era space programme, without first getting market authorisation from the Amsterdam-based European Medicines Agency (EMA).

The agency is tasked to ensure vaccines are safe and effective before they are distributed for wider use in the European Union.

Any vaccine based on biotechnologies must also first secure approval from the agency prior to roll out.

However, a member state may skip the agency altogether - but only if it invokes specific national emergency procedures.

Such emergency procedures also have to be limited in duration.

"It is a decision which will be taken by the Hungarian authorities and they are the ones who will assume full responsibility for follow up," said Stefan de Keersmaecker, the commission's spokesperson on health.

He noted that no data or information on the Russian vaccine has so far been shared.

Nor has the EMA received a request for Sputnik V market-authorisation.

But it is holding discussions with its developer, a state-run institute.

Russia became the first country to approve an anti Covid-19 vaccine, in early August. But critics say the approval was rushed, given it had not completed standard testing phases.

The vaccine initially claimed to be 92 percent effective. The figure increased to 95 percent following announcement results of similar vaccines by Pfizer-Biotech and Moderna.

Sputnik V was licensed based on trials involving 76 people, which then increased to 18,000, leading to the 95 percent figure.

Hungary is the first EU state to secure the Russian vaccine, amid plans to launch clinical trials this month.

Larger shipments to Hungary would then be sent in the second half of January, if the virus is deemed effective. Budapest is also mulling purchases from Israel and China.