Czech Republic and Slovakia have turned to the Sputnik V vaccine, despite it not being approved by the European Medicines Agency. Ed Holt reports.
Leaders in the Czech Republic and Slovakia are pushing for the use of Russia's Sputnik V vaccine, despite it not being approved by the European Medicines Agency (EMA). Both states have struggled to contain SARS-CoV-2 infections in recent months and, as of March 4, 2021, had some of the highest rates of COVID-19 mortality and SARS-CoV-2 infection rates in the world.
Ministers and health-care professionals have been keen to roll out vaccinations as quickly as possible to ease pressure on hospitals and staff, who say the health-care system is close to collapse. However, although vaccination campaigns in both countries began at the end of December, only 4·3% of the Czech population and 5·8% in Slovakia had been vaccinated as of March 1.
These low numbers have been attributed, in large part, to problems across the EU with supplies of the three vaccines—Pfizer/BioNTech, AstraZeneca, and Moderna—that have so far been approved by the EMA. These delays have led to independent calls from Czech Prime Minister Andrej Babis, and his Slovak counterpart Igor Matovic, to source vaccines elsewhere. Both have advocated the use of Sputnik V.
Sputnik V was approved in Russia in August, 2020, before the full results of phase 3 trials had been assessed, and, despite a study published in The Lancet earlier in 2021 showing high efficacy, it has not been approved by the EMA, prompting concerns among Czech and Slovak doctors about its use. Libor Grubhoffer, a virologist at the Czech Academy of Sciences, told The Lancet: “It should not be used until a proper approval procedure has taken place, for example by the EMA.”
On March 1, Slovakia received 200 000 doses of the Sputnik V vaccine as part of an order of 2 million doses. Matovic announced that these doses could be used as part of the country's vaccination programme within weeks and the health ministry issued a special dispensation for its use. Under EMA rules, national regulatory bodies can grant vaccine licences for emergency use. But on March 8, Christa Wirthumer-Hoche, chair of the EMA Management Board, urged EU members to refrain from granting national approvals for Sputnik V while the agency examines its safety and effectiveness. Hungary, another EU state, has already begun using the Sputnik V and Chinese Sinopharm vaccines.
Although groups such as the Slovak Medical Chamber said they welcomed the availability of another vaccine, even if unregistered, others were unhappy. Peter Visolajsky, chairman of the Doctors Trade Union Association in Slovakia, told The Lancet: “A vaccine should only be given to patients who have been fully informed about it. But how can they be fully informed if even we doctors do not have all the relevant information?
“If a patient came to me and asked about the Sputnik vaccine, I would say that I could not recommend it because it hasn't been through an approval process. It may be a good and effective vaccine, but it's not registered, so we don't have data [from a full regulatory body review on all aspects of its production as well as safety and efficacy] for it.” Matovic has dismissed criticism of the Sputnik V deal as political point scoring and said that people will be able to choose between the Russian vaccine or an alternative.
Matovic is confident that many people will agree to vaccination with Sputnik V, but locals who spoke to The Lancet said they would not. One, Zuzana Thullnerova, a 45-year-old who works in the capital, Bratislava, told The Lancet: “Other vaccines have gone through a process of approval with the EMA, but Sputnik V has not. I don't trust the quality of the vaccine itself, nor the conditions under which the doses might be produced, stored, or transported.”
In both countries, mistrust among parts of the population of the quality of any Russian products, medical or otherwise, dates back to the Soviet era. Others—including Slovak Foreign Minister Ivan Korcok, who described Sputnik V as a “tool of hybrid war”—are wary of geopolitical aims behind Sputnik V's distribution.
Like Matovic, Babis has emphasised that procurement of Sputnik V has nothing to do with political ideology. However, it is unclear whether he would be able, unlike his Slovak counterpart, to push through use of the vaccine in Czech Republic without EMA approval. Babis has said that approval by the Czech regulator, the State Institute for Drug Control (SUKL), would be sufficient.
However, SUKL officials have said without EMA approval it could only be used under special dispensation from the health ministry, and Health Minister Jan Blatny has said he will not authorise the use of a vaccine unless it has EMA approval.
On March 4, the EMA announced it had started a rolling review of data from trials of Sputnik V in the first step in its approval process. Rastislav Madar, an epidemiologist at the University of Ostrava, told The Lancet that EMA approval would remove many of the concerns in the Czech Republic. “If Sputnik V obtains EMA approval, where the vaccine comes from would not be so important [to people]. It could definitely work as a protective tool.”