Hungary can buy and distribute the Russian-made Covid-19 vaccine, but only if it invokes emergency procedures and helps keep it within its own borders, the EU warned on Monday (Nov. 30).
“The vaccine will be distributed anywhere else in the European Union other than Hungary,” European Commission spokesman Eric Mamer told reporters.
The government in Budapest could finish rolling out the Russian-made Sputnik V vaccine, named after the Soviet-era space program, without first obtaining marketing authorization from the Amsterdam-based European Medicines Agency (EMA).
The company is guilty of making sure the vaccines are effective before distributing them for wider use in the European Union.
Any biotechnology-based vaccine will also need to get approval from the company before being rolled out.
However, a Member State can forget about the company entirely, even if it invokes explicit national emergency procedures.
These emergency procedures should also be of limited duration.
“This is a resolution that will be adopted by the Hungarian government and they will be the ones who will be in charge of monitoring it,” said Stefan de Keersmaecker, spokesman for the fitness committee.
He noted that no knowledge or data has been shared about the Russian vaccine.
The EMA also won a marketing authorisation application for Sputnik V.
But he agrees with its promoter, a public institute.
Russia became the first country to approve an anti-Covid-19 vaccine in early August, but critics say approval was rushed, given that popular testing stages were not yet complete.
First, the vaccine claimed to be 92% effective. This figure increased to 95% after the announcement of similar effects of the Pfizer-Biotech and Moderna vaccines.
Sputnik V legal was based on trials involving 76 people, which later amounted to 18,000, a figure of 95%.
Hungary is the first EU state to receive the Russian vaccine, according to plans to publish clinical trials this month.
In the second part of January, larger shipments would be sent to Hungary, if the virus is deemed to be effective. Budapest also buys from Israel and China.
Nikolaj joined EUobserver in 2012 and is guilty of internal affairs. She is from Denmark, but has spent much of her life in France and Belgium. He won the King Baudouin Foundation’s investigative journalism fellowship in 2010.
Nikolaj joined EUobserver in 2012 and is guilty of internal affairs. She is from Denmark, but has spent much of her life in France and Belgium. He won the King Baudouin Foundation’s investigative journalism fellowship in 2010.