The European Union’s drug regulator, the European Medicines Agency EMA, has completed consulting the developer of the Russian vaccine against the Sputnik V coronavirus; now it is possible to apply for registration on the EU market, the agency told the reporters.
“At this stage, we can say that the Gamaleya National Research Center for Epidemiology and Microbiology has received scientific advice from EMA on the development of their Sputnik V vaccine to prevent COVID-19 (also known as Gam-COVID-Vac). As a next step, the company can prepare an application for a marketing authorization”, – the agency’s source said.
He explained that “the scientific consulting process is a well-established process at EMA that is available to all companies to facilitate the preparation of their development program. The EMA will advise companies based on the latest scientific advice”.
The EMA spokesman added that the agency has not yet received an application from the Sputnik V developer, the timing of obtaining approval for the EU market from the EMA can be discussed after the receipt of such an application.
“Since we have not yet received an application for registration of a vaccine, we cannot indicate the currently agreed schedule (receiving a recommendation from the EMA – ed.). As soon as we receive such an application from the company, we will inform about it”, – the representative of the European the drug regulator, answering a question from RIA Novosti about the possible time frame for obtaining a registration certificate.
If a conditional marketing authorization is issued and approved by the European Commission, the Russian vaccine can be centrally supplied to the EU. The European Union, even before the appearance of the first approved vaccines against coronavirus, made a decision on their centralized procurement. In total, contracts were signed with six manufacturers.
Currently, vaccines from Pfizer/BioNTech (purchase up to 600 million doses), Moderna (160 million doses) and AstraZeneca (up to 400 million doses) are authorized in the EU market. In addition, the EC entered into contracts for the supply of vaccines to the EU with Johnson & Johnson, Sanofi-GSK, CureVac. Until now, these developers have not yet submitted applications for the authorization of their drugs on the EU market, but an application from J&J is expected in the near future.
Thus, thanks to the contracts of the European Commission, the EU countries will be able to gain access to more than 2.3 billion doses of anti-coronavirus vaccines. The EU expects that by the end of the summer in Europe about 70% of the population will already be vaccinated.
In recent weeks, the EU has faced a number of challenges in the supply of alliance-approved vaccines from Pfizer/BioNTech and AstraZeneca. Delays in deliveries could derail Brussels’ ambitious vaccination plans.
Hungary recently approved the Russian Sputnik V vaccine for use in the country and signed an agreement with its manufacturer for the supply of the drug. More and more interest in the Russian vaccine is shown in other countries of the European Union.
Earlier, an EU official said that the union already has a sufficient portfolio of orders for vaccines against COVID-19, which allows the entire EU population to be vaccinated. At the same time, he said, Brussels does not close its doors for new vaccine manufacturers.WHO voiced their hopes for the Russian Sputnik V vaccine