After weeks of dubious hesitation, necessity prevailed over mistrust. Vaccines are needed and they are needed quickly. L'Ema has therefore decided to start the rolling review process (continuous review, in Italian) of the Russian vaccine Sputnik v. The announcement came today from the European Medicines Agency itself through an article in which he clarifies that "although EMA is not able to predict the general timing, it should take less time than usual to evaluate a possible application due to the work carried out during the progressive review".
Immediately after the communication from the EMA, the Russian authorities made it known that they were ready to supply 50 million doses of vaccines to Europeans starting in June.
The rolling review is a tool that allows regulatory authorities to speed up the normal evaluation process of drugs and vaccines. Simply put, if in normal situations companies present all the data on the product (efficacy, safety, quality, etc.) when they request authorization to market the drug or vaccine, with the continuous review these data are examined earlier, already during the experimentation phase. By analyzing the data when it is available and not at the end, the EMA will gain time and will have the opportunity to decide more quickly whether the vaccine can be used or not. The currently distributed vaccines (Moderna, Pfizer and Astrazeneca) have also undergone continuous review and currently so is the serum of the German pharmaceutical company Novavax, whose arrival is scheduled for May.
Returning to Sputnik, "the EMA - reads the agency's note - will evaluate the data as soon as they are available for decide whether the benefits outweigh the risks. The rolling review will continue until sufficient evidence is available for a formal marketing authorization application."
The vaccine will be tested on the basis of the “usual EU standards on efficacy, safety and qualityand the agency will let you know when "the marketing authorization application for the vaccine has been submitted."
The Russian serum was developed by Gamaleya, the Russian National Center for Epidemiology and Microbiology, but the request for revision came from R-Pharm, the German branch of the Russian pharmaceutical group. It's about a viral vector vaccine administered in two doses (each with a different viral vector). According to Mosca the serum would have an effectiveness against Covid equal to 90%. The same data was published in The Lancet, one of the most authoritative scientific journals in the world.
Currently the vaccine is already used, as well as in Russia, also in Argentina, Bolivia, Venezuela, Hungary, Serbia, Algeria, Palestine and Belarus.
Meanwhile, news on vaccines also comes from Italy. Italy is the first EU country to refuse the export of AstraZeneca vaccine doses. According to what is learned in Brussels, on Friday the Italian authorities notified the European Commission of the decision to block the export of a shipment of vaccines from the pharmaceutical company to Australia.
Meanwhile, through a circular, the general directorate of prevention of the Ministry of Health has established that those who have contracted Covid at least three to six months before receiving the vaccine will be administered only one dose and not two.
"Given the opinion expressed by the Permanent Group on SARS-Cov-2 infection of the Superior Health Council", we read, "in accordance with that expressed by Aifa on 23/02/2021, it is represented that it is possible to consider the administration of a single dose of SarsCoV-2/Covid-19 vaccine in subjects with previous SARS-CoV-2 infection (ran symptomatically or asymptomatically), provided that the vaccination is performed at least 3 months after the documented infection and preferably within 6 months of it".
However, the novelty will not apply to subjects with immunodeficiency conditions, primary or secondary to pharmacological treatments.
