Russia's Sputnik V COVID-19 Vaccine Developer Questions Neutrality Of EU Regulators

JAKARTA - The developer of the Russian COVID-19 vaccine, Sputnik V, has both criticized and questioned the neutrality of the European Union's medical regulator, the European Medicines Agency (EMA).

The criticism followed by this apology, related to the 'suggestion' not to authorize the emergency use of the Sputnik V vaccine, was issued Tuesday, March 9 local time.

"We demand a public apology from EMA Christa Wirthumer-Hoche for her negative comments in EU countries which directly approve of Sputnik V," wrote the vaccine developer on the official Sputnik V vaccine Twitter account.

"His comments raise serious questions about possible political interference in the ongoing EMA review," the statement continued.

The developer added that the vaccine has been approved by 46 countries.

"After delaying the review of Sputnik V for months, the EMA has no right to undermine the credibility of the 46 other regulators who reviewed all the necessary data," said developer Sputnik V.

Christa Wirthumer-Hoche is the head of the EMA management board. In the Austrian talk show ORF on March 7, he advised EU countries against giving Sputnik V national emergency authorization, while the EMA is still reviewing the safety and effectiveness of the Russian vaccine.

For information, Sputnik V has been approved or is being assessed for approval in three member states of the European Union, namely Hungary, Slovakia and the Czech Republic. EU officials said they could start negotiations with vaccine makers if at least four member states requested it.

Kirill Dmitriev, head of Russia's RDIF sovereign wealth fund, which markets Sputnik V abroad, told Italian television on Sunday that it is working with pharmaceutical company Adienne to produce a vaccine in Italy.

The Italian-Russian Chamber of Commerce later said there were plans for production to begin in Italy in June. The deal paved the way for creating Europe's first Sputnik V production facility.

The EMA earlier this month said it would review data from ongoing COVID-19 vaccine trials until there is sufficient evidence for a formal marketing authorization application.