MOSCOW (Reuters) – Developers of the Russian Sputnik V vaccine against COVID-19 on Tuesday questioned the neutrality of the European Medicines Agency (EMA) after a regulator official asked EU states to refrain from approving the vaccine for now.
EMA chief executive Christa Wirthumer-Hoche told an Austrian talk show on Sunday that she would advise European Union countries not to grant national emergency clearance for Sputnik V while the EMA was still reviewing its safety and effectiveness .
“We demand a public apology from Christa Wirthumer-Hoche of the EMA for her negative comments …, (which) raise serious questions about possible political interference in the ongoing review of the EMA,” wrote the developers in the official account of Sputnik V on twitter.
In a written response, the Amsterdam-based EMA said that its review process for possible vaccines ensures that all EU countries have “access to drugs that are evaluated effectively at the same time and ensures centralized safety monitoring throughout their life cycle”.
The EMA said this month that it would review data from ongoing vaccine tests until there was sufficient evidence for a formal application for marketing authorization.
Kremlin spokesman Dmitry Peskov found Wirthumer-Hoche’s statement regrettable and inadequate.
The developers said that Sputnik V has already been authorized by 46 countries.
It has been approved or is being evaluated for approval in three EU member states – Hungary, Slovakia and the Czech Republic – and EU officials said that Brussels could start negotiations with a vaccine manufacturer if at least four member countries so request.
Sputnik V could be manufactured for the first time in Europe, outside Russia, after an agreement to produce it in Italy was signed by the Moscow RDIF sovereign wealth fund and by the Swiss pharmaceutical company Adienne.
(Reporting by Gabrielle Tétrault-Farber; Additional reporting by Dmitry Antonov in Moscow and Bart Meijer in Amsterdam; Editing by Andrew Osborn and John Stonestreet / Mark Heinrich)