The approval procedure for new vaccines takes several months, despite the fact that it has already been significantly accelerated due to the pandemic. RIA Novosti was told about this by the European Medicines Agency (EMA).
It is clarified that the standard duration of the assessment of medicinal products is about 210 working days, and due to interruptions in requesting and obtaining clarifying information, the procedure may take a year. Now this period has been reduced to 150 working days, and this period can be shortened for a long time if the developer shares information at all stages of drug development.
At the beginning of February, EMA reported that the Sputnik V developer had undergone scientific consultation and could prepare an application for permission to sell the vaccine in the European Union. However, the regulator clarified that scientific advice is not a preliminary assessment of the benefits and risks of a drug, and does not guarantee that the drug will receive approval. However, in the case of
EMA recommends its support of the application to the European Commission, which makes the final decision.
Earlier on February 26, San Marino announced the start of vaccination against coronavirus with the Russian drug Sputnik V. According to the secretary for health and social security of the republic Roberto Chawatta, the first vaccinations will be given to local doctors. Vaccinations will be voluntary. Chavatta said that Italian citizens will not be able to receive the drug in San Marino, they will have to be vaccinated in their state. San Marino first entered into a vaccine supply agreement with Italy. However, since December 27, when the vaccination campaign began in 27 EU countries, not a single EU-approved vaccine has been received in the republic. The first doses of the Russian drug were delivered to San Marino on February 23.
On February 25, it became known that the cost of the Russian Sputnik V coronavirus vaccine has been halved – from 1942 to 866.81 rubles for two components, excluding value added tax. The head of the Ministry of Industry and Trade Denis Manturov indicated that the price remains the same for all production sites. It became possible to reduce it due to the development and optimization of industrial production, as well as an increase in volumes.