Covid-19 live updates: Germany, France Italy suspend AstraZeneca vaccinations; safety agency says blood clot incidence is low

MOSCOW — Russia’s sovereign wealth fund said Monday that it has agreements with companies in Italy, Spain, France and Germany to produce its Sputnik V coronavirus vaccine for the European Union, signaling Moscow’s confidence that the immunization will soon receive regulatory approval from the European Medicines Agency.

“We are now actively working with EMA as part of the rolling review procedure,” the head of the Russian Direct Investment Fund, Kirill Dmitriev, said in a statement. “In addition, RDIF and partners are ready to start supplies to those EU countries that independently authorize Sputnik V.”

Though Sputnik V has been approved for use in 51 countries, according to the investment fund, E.U. approval would be seen as validation from the West in Russia’s efforts to expand its vaccine reach. Medical journal the Lancet in February published a peer-reviewed study that the vaccine was safe and had an efficacy rate of 91.6 percent.

European governments have been under pressure over their slow rollout of vaccines. The E.U. has registered three vaccines: the ones developed by Pfizer and BioNTech, Moderna, and AstraZeneca and Oxford.

Countries could also choose to individually approve Sputnik V, as Hungary did.

Christa Wirthumer-Hoche, the chair of the European Medical Agency’s management board, recently said on Austrian television that E.U. members approving Russian and Chinese vaccines via emergency national procedures is “partly comparable with Russian roulette.” The vaccines were widely criticized for their hasty rollout, starting vaccination programs in their countries before completing Phase 3 trials.

The Russian Direct Investment Fund demanded a public apology from Wirthumer-Hoche, saying that her comments “raise serious questions about possible political interference in the ongoing EMA review.”

In an interview with Rhineland Post newspaper last week, Thomas Mertens, the head of Germany’s vaccine oversight committee described Sputnik as a “cleverly built” vaccine.

“It’s a good vaccine that will probably be approved in the E.U. at some point,” he said.

Expanding further in a news conference he said that data on Sputnik published in the Lancet looked “good.”

“But this data is not sufficient for the EMA for approval,” he said. “For this to happen, so to speak, other data must also be provided by the manufacturers, so that an EMA approval assessment can be made.”

The German Health Ministry declined to comment.

Following a similar announcement from the RDIF last week, a spokesman for France’s Industry Ministry said he was unaware of any such deal with a French manufacturer.

Source: WP