Hungarian authorities have completed the final steps of authorizing the emergency use of the Gamaleya Research Institute’s Russian vaccine. While Hungary no longer faces any obstacles in using Sputnik V, the rest of the European Union needs to wait until the European Medicines Agency authorizes its use, a process which has not yet begun.
Minister of Human Resources Miklós Kásler posted on his Facebook page saying that the National Public Health Center (NNK) has licensed the use of the Russian Sputnik V vaccine. Kásler said “from a medicinal efficacy perspective, the vaccine meets the specifications of the producer, and from an immunobiological perspective, it is usable on humans.”
The minister pointed out that there are now four vaccines available for use in Hungary: Pfizer/BioNtech, Moderna, AstraZeneca, and Sputnik V.
Chief Medical Officer Cecília Müller said that Hungary expects to receive enough of the Russian vaccine to inoculate one million people, and insists that all the vaccines authorized by Hungarian authorities are effective against the coronavirus.
NKK testing was the final step in licensing Gamaleya’s vaccine in Hungary, after the National Institute of Pharmacy and Nutrition authorized its use at the end of January.
Hungary is the first EU member state to fully authorize the vaccine, while the European Medical Agency has yet to begin the authorization process of Sputnik V. Many leaders within the union are eager for its approval, but only through the union agency.
EU Leaders Confident in the Russian Vaccine’s Authorization
Jens Spahn, Germany’s Federal Minister of Health, told Frankfurter Allgemeine Sonntagszeitung that Russian and Chinese vaccines are just as relevant in the fight against the coronavirus, since it is not the serum’s location of origin which matters, but its efficacy and safety. Spahn believes that there is no obstacle to any vaccine if it is licensed by the European Union.
The minister’s statement comes after German Chancellor Angela Merkel spoke with Russian President Vladimir Putin, offering Germany’s Paul Ehrlich Institute to help with the vaccine’s authorization in the European Union.
Chancellor of Austria, Sebastian Kurz, told Welt am Sonntag that he would like it if the Russian Sputnik V and China’s Sinopharm vaccines would be manufactured in Austria. Regarding licenses, the chancellor would prefer to wait until the European Medicines Agency (EMA) authorizes the use of the vaccine.
Minister of Foreign Affairs of the European Union Josep Borrell announced that the Sputnik V vaccine is “good news for the whole of mankind,” AP news reports. Borrell hopes that the vaccine is approved in the European Union as soon as possible.
While EU leaders are hopeful, there are still many steps remaining in the authorization process. An important factor which the EMA is looking into before licensing the vaccine for the European market is the producer’s capacity to manufacture the vaccine in the EU.
A Slow Authorization Process Within the European Union
The European Union has already signed six contracts for more than two billion doses of various vaccines, but only three of those have been approved for use, and there have been production delays.
Regarding Hungary’s separate authorization of the Sputnik V vaccine, European Commission President Ursula von der Leyen said that the responsibility over potential consequences no longer falls on the manufacturer, but the country authorizing the vaccine’s use.
The commissioner believes too much effort was put towards the development of vaccines, and too little towards the challenges of mass production.
Liberal news portal 444.hu asked the European Medicines Agency about whether they have been working on the licensing of the Russian Sputnik V vaccine. The organization said that they had negotiated with Gamaleya, the vaccine’s producer, two weeks ago about the documentation required to authorize Sputnik V in Europe.
Gamaleya has yet to submit the necessary documentation, meaning that the authorization of the vaccine has not even reached the first step of authorization.
Proof of the Russian Vaccine’s Safety Still a Topic of Discussion
Hungary is the only EU member state to order vaccines which have not been authorized by the EU: Sputnik V and Sinopharm. So far there are enough vials of the Sputnik V vaccine for 23 thousand people.
Opposition politicians, such as Ákos Hadházy, have been critical of the Russian vaccine, warning of its alleged dangers and suspicious documentation.
Non-OGYÉI specialists in Hungary have also challenged the vaccine’s documentation, but before they received a response from the National Institute of Pharmacy and Nutrition (OGYÉI), the organization had already authorized the use of the vaccine.
The head of the Hungarian Medical Chamber, Dr. Gyula Kincses, told MTI that vaccines should only be administered “with no concern” over their properties. Kincses mentioned that his organization had been promised further documentation around the Russian vaccine.
The debate around the Russian vaccine will obviously continue, but in Hungary it will continue under the circumstances that Sputnik V is being used in full for the mass inoculation of 10 million people.
Featured photo illustration by MTI/RFPI