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This is an unprecedented step by an EU member state, which has escalated disagreements with Brussels after the country, along with Poland, blocked the long-standing EU budget and recovery fund.
According to European Union regulations, the Sputnik V vaccine must be authorized by the European Medicines Agency in order to be marketed in any of the 27 countries of the bloc. For Budapest, the importation of the Sputnik V vaccine is part of a larger plan. This could lead to larger-scale imports and mass production within the country next year if the vaccine proves safe and effective.
“They (vaccine doses) were transported in very special conditions: they were flown, kept constantly in a 10 degree cold, and the temperature was controlled by a special device. In this way, it was transported to a Hungarian state laboratory, where Hungarian experts will have the opportunity to test the vaccine in the near future and make an informed decision about its possible suitability for use and approval, ”said the Minister of Foreign Affairs of Hungary, Peter Szijjarto.
The government did not answer questions about whether it was trying to license the Sputnik V vaccine domestically or through the process required by the EU. Russia expects Sputnik V to be tested and manufactured by other countries as well: Brazil, Mexico, the Philippines and the United Arab Emirates.
Russia’s Independent Property Fund reported last week that interim studies show that the Sputnik V vaccine is 92 percent effective in protecting against COVID-19, and the country is preparing for mass vaccination.
Russia boasts that Sputnik V is 92% effective, although Western experts have serious suspicions.
In addition, Russia has already applied to the World Health Organization (WHO) for expedited registration and pre-approval of the Russian Sputnik V vaccine against COVID-19, Russia’s independently owned fund said it was funding the process.
Russia announced in August that it had developed the world’s first vaccine against COVID-19.
Russia’s direct investment fund said accelerated vaccine registration would make Sputnik V available faster than usual around the world.
“The Russian Federation was one of the first to apply to WHO for prior approval of a coronavirus vaccine,” the fund said in a statement.
The WHO, for its part, states that such requests are confidential.
According to the Russian Foundation, “successful pre-approval would allow the Sputnik V vaccine to be included in drug lists used by international procurement agencies and states, which provide guidelines for purchasing drugs.”
Meanwhile, some Western scientists are warning against a Russian vaccine because approving the vaccine too quickly could be dangerous.
“If the product submitted for evaluation meets the criteria, WHO will make these results public. So far, WHO has not approved any vaccine against COVID-19,” WHO said in a statement.
Hungary’s plans to import and likely use Russia’s widely offered COVID-19 vaccine Sputnik V raise safety concerns and could undermine confidence in future vaccines, says the European Commission, which has opened a new front for strained relations. of the EU with Budapest.
When asked about these plans, a spokesman for the European Commission said: “The question is whether an EU member state wants to vaccinate its citizens with a vaccine that has not been approved by the European Medicines Agency.”
As Reuters recalls, EU regulations require Sputnik V to first obtain permission from the European Medicines Agency. Only then will it be available for sale in any of the 27 states of the block.
“This is where the vaccine approval process and confidence in the vaccine come into play.” If our citizens question the safety of a vaccine that has not been scientifically tested and evaluated to demonstrate its safety and effectiveness, it will be much more difficult. vaccinate a sufficient proportion of the population, “a spokesman for the European Commission said in a statement.
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