EU Drug Regulator Completed Scientific Consultations With Developers of Russia’s Sputnik V

(FILES) In this file photo vials of undiluted Pfizer Covid-19 vaccine are prepared to administer to staff and residents at the Goodwin House Bailey's Crossroads, a senior living community in Falls Church, Virginia, on December 30, 2020. - Sales of the Covid-19 vaccine developed by Pfizer and BioNTech could reach up to $15 billion in 2021 and go higher if Pfizer signs additional supply contracts, Pfizer said on February 2, 2021. The projections came as Pfizer reported fourth-quarter and full-year profits and released forecasts for 2021. Pfizer projected full-year 2021 sales of between $44.4 to $46.4 billion, excluding sales for the Covid-19 vaccine. (Photo by Brendan Smialowski / AFP) (Photo by BRENDAN SMIALOWSKI/AFP via Getty Images)

BRUSSELS (Sputnik) – The European Medicines Agency (EMA) told Sputnik that it completed scientific consultations with Russia’s Gamaleya research centre that developed the Sputnik V coronavirus vaccine, which means that Moscow can now submit an application for vaccine authorization for the EU market.

“The Gamaleya National Centre of Epidemiology and Microbiology has received scientific advice from EMA for the development of its Sputnik V vaccine (formerly known as Gam-COVID-Vac) for the prevention of COVID-19 … As a next step the application for a marketing authorisation could then be prepared by the company,” a EMA spokesperson said.

The scientific consultations are a well-established process, available for all companies and meant to facilitate their development programs, a EMA spokesperson explained.

“EMA will provide advice to companies taking into account the latest regulatory and scientific guidance,” the agency assured.

The EU drug regulator has not yet received a marketing authorization request from the Sputnik V developers.

“We cannot point to an agreed timetable at the moment. As soon as we receive an application from the company, we will communicate about this,” the spokesperson noted.

The Russian Direct Investment Fund (RDIF) told Sputnik on Tuesday that it had an official confirmation that the European Medicines Agency (EMA) accepted all paperwork for registration of Russia’s Sputnik V vaccine in the EU market.

RDIF, Sputnik V vaccine developers and the EMA held a scientific consultation on the vaccine on 19 January, the fund recalled.

“On 29 January 2021, the RDIF submitted an application for Sputnik V vaccine registration in the European Union, it started presenting information to the EMA through the rolling review procedure. The fund has an official confirmation from the EMA that the application was accepted. The speed of application approval is determined by the EMA,” the RDIF said.

If a conditional marketing authorization is issued and the vaccine is approved by the European Commission, it will be possible to deliver Sputnik V to the EU through centrally-managed procedures. The bloc made decisions on centralized vaccines procurement even before the first vaccines were approved. The EU signed contracts with six coronavirus vaccine manufacturers. Thanks to these contracts, the EU countries will have access to over 2.3 billion doses of vaccines. The EU expects around 70 percent of European citizens to be vaccinated by the end of summer.

However, in recent weeks, the EU faced shipment delays and reductions in the number of doses that were initially agreed upon with AstraZeneca and Pfizer.

Sputnik V, developed by the Gamaleya Epidemiology and Microbiology Centre, was the world’s first vaccine against COVID-19 and was registered by the Russian health ministry on 11 August.



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