What we know about the Sputnik V approval process in Europe
The approval of certain COVID-19 vaccines is still in process. Among them are those of injections or antidotes developed in China and Russia.
In this context, apparently the approval process for Sputnik V in Europe is progressing "in a positive and professional manner," according to a statement from the Russian Direct Investment Fund (RDIF) accessed by RT.
According to the statement, the data from the clinical trials of the Russian vaccine were already provided to European specialists under the necessary measures and after an evaluation a "positive response" was received from the European Medicines Agency (EMA).
However, so far, the EMA page has not made any updates regarding what the RDIF spokesperson claims.
In March this year , the European body began the process of reviewing Sputnik V through its Committee for Medicinal Products for Human Use (CHMP). This decision was based on the results of some studies that indicated that this vaccine "triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and can help protect against COVID-19."
At the moment, what the EMA indicates is that the Russian vaccine is still in the process of "continuous review" together with its counterparts Sinovac, Curevac, Novavax. Also, in its latest updates, it granted “conditional marketing” authorization to Johnson & Johnson's Janssen vaccine.
What does the “continuous review” process mean?
It is a regulatory tool used by the EMA to accelerate the evaluation of a “promising” drug during a health emergency.
“Normally, all the data on the efficacy, safety and quality of a medicine or vaccine and all the required documents must be ready at the beginning of the evaluation in a formal application for marketing authorization . In the case of ongoing review, the EMA CHMP reviews the data as it becomes available from ongoing studies. Once the CHMP decides that sufficient data is available, the company can submit a formal application. By reviewing the data as it becomes available, the CHMP can issue an opinion on the authorization of the medicine earlier, ”the agency explains.
It also adds that it cannot give exact deadlines on when it will authorize the commercialization of the vaccine since the times depend on the developers of the drugs, in this case the vaccines, providing the necessary data for review. The agency also clarifies that it "updates the status of each drug under continuous review when the developer requests marketing authorization."If you want to know more about which COVID-19 vaccines they accept to travel to Europe, the United States and the rest of the world, we invite you to read it here .