April 07, 2021 – 12:51
The European Union’s drug regulator will next week launch an investigation into clinical trials conducted by Russia for the Sputnik V coronavirus vaccine.
The Financial Times reports that research will focus on whether Russia has followed best security practices during clinical trials.
The UK-based newspaper quoted anonymous sources as having knowledge of the European Medicines Agency (EMA) approval process.
The investigations come as there have been ethical concerns about testing the Sputnik V, while preparing for its use.
The newspaper quotes the head of the Russian Investment Fund, Kirill Dimitriyev, as saying that “there was no pressure on the test participants and Sputnik V is in line with all practices”.
The European regulator will base its assessment on whether or not to approve the Sputnik-V vaccine, following the results of a clinical trial investigation conducted by Russia.
Russian President Vladimir Putin ran a race to approve a vaccine in August 2020, before completing a third phase of clinical trials that typically involves a larger number of volunteers.
Sputnik V is being widely used in Russia and dozens of other countries, despite early doubts about the confidentiality and reliability of the data.
A study published in February by The Lance, a UK-based science journal, allayed some international concerns by saying Sputnik V “looks safe and effective”.
However, this vaccine has not been approved by either the US or the EU, although two EU member states, Hungary and Slovakia, have purchased it.