EU concerned as the Russia’s vaccine has not been reviewed by the European Medicines Agency
Hungary’s intention to import and use Russia’s Sputnik V COVID-19 vaccine raise safety concerns and could damage trust in potential shots, the European Commission said, opening a new front in the EU’s fraught relations with Budapest, as points out reuters.com.
Hungarian Prime Minister Viktor Orbán’s hard line against migration and what critics say is his increasingly authoritarian grip on power – an accusation he has repeatedly denied – as well as his pursuit of close relations with Russia have caused repeated disputes with the EU.
A new showdown is possible. Hungarian plans to conduct trials of and possibly produce the Russian vaccine, considered as an unprecedented step for an EU member state, deepen existing misunderstanding with Brussels.
A spokesman for the Commission said regarding this issue: “The question arises whether a member state would want to administer to its citizens a vaccine that has not been reviewed by EMA.” EMA is an agency of the European Union responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
According to the EU regulations, Sputnik V must be approved by the EMA before it can be launched on the market in any of EU-member state.
“This is where the authorisation process and vaccine confidence meet. If our citizens start questioning the safety of a vaccine, should it not have gone through rigorous scientific assessment to prove its safety and efficacy, it will be much harder to vaccinate a sufficient proportion of the population,” the Commission spokesman said.
The results of recent study of 8,000 people in the United States and Britain showed that fewer people would “definitely” take a COVID-19 vaccine than the 55% of the population which scientists estimate is needed to provide so-called herd immunity.
Experts believe that misinformation and weak safety checks on candidate vaccines are the main factors reducing confidence in vaccines’ efficacy.
Hungarian government plans importing a small number of doses that could lead to larger imports and mass-production in Hungary next year if the shot proved safe and effective.
Russia’s sovereign wealth fund stated that interim trial results showed Sputnik V is 92% effective at protecting people from the COVID-19 respiratory disease. Meanwhile vaccines developed by US firms Moderna and Pfizer – the latter in cooperation with Germany’s BioNTech – have showed better results on a much larger sample of people exposed to the virus.
The EU throws into question the import of Sputnik V by one of its member states.
The EU regulations provide that temporary import and distribution of unauthorised vaccines is allowed for emergency use in the EU territory in case of the suspected or confirmed spread of pathogenic agents, toxins, chemical agents or nuclear radiation, any of which could cause harm.
European Commission specified that this exemption has been in the top of discussions in recent months by EU experts.
“The widely supported view is that it should be considered very carefully,” the commission spokesman said. Such emergency procedures, he said, would also conflict with the EU’s current vaccine strategy.
Under that strategy, the EU has signed contracts with five vaccine makers, including Pfizer, for the supply of nearly 2 billion doses of their potential COVID vaccines and is negotiating with two other manufacturers for additional shots. It means that the 450 million combined population of all EU member-states will be covered.