The Russian Ministry of Health and the World Health Organization (WHO) announced this Saturday in Geneva. Have reached an agreement to remove all barriers that prevented the Russian vaccine Sputnik V from being registered on the emergency use list.
However, the WHO has NOT yet officially endorsed the emergency use of the Russian vaccine.
The WHO had not included the Russian vaccine in its list of emergency use
Russian Health Minister Mikhail Murashko said in this regard that his country has fully resolved, to date, all the questions posed by the WHO. This, in relation to the safety and immunogenicity characteristics of the Gamaleya Laboratory vaccine.
According to Murashko, the position of the Russian Federation on the promotion and registration of the Sputnik-V vaccine has been heard by the WHO. Which, until now, had not included the Russian vaccine in its list for emergency use. With which it facilitates the use of it at the same level.
There is no longer any obstacle to its approval …
The Russian official explained that the company that handles the registration of Sputnik V with the WHO will still have to sign a series of documents. Submit several additional papers, but there is no longer any obstacle to continue working.
Meanwhile, Ghebreyesus described the meeting with the Russian minister as constructive and thanked the senior official for his visit. For what he called a constructive meeting.
In September, Jarbas Barbosa, the deputy director of the Pan American Health Organization, a region where the Russian drug is applied in several countries. He announced that the approval of Sputnik V by the WHO was on hold pending a new inspection of the producer’s plant.
In mid-June, a group of WHO experts detected irregularities related to environmental protection and emission control in the production of Sputnik-V in a laboratory in Ufa (Russia).
As for the vaccine, it did NOT pass the validation procedure.
About the procedure
The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for evaluating and listing in vitro diagnostics (IVD).
As well as drugs and vaccines that do not have a strict regulatory evaluation and that are intended to be used mainly during public health emergencies of international concern.
“The emergency use list procedure is used to assess the suitability of new medical devices during public health emergencies. The objective is that medicines, vaccines and diagnostic tests are available as quickly as possible to face the emergency, while respecting strict criteria of safety, efficacy and quality ”, explains the WHO.
What Happens During a Pandemic
During these times, communities and public health authorities may be willing to tolerate less certainty about the quality, safety, and performance of products, given the morbidity and / or mortality of the disease and the need for diagnoses.
THE PROCESS IS BASED ON AN ESSENTIAL SET OF AVAILABLE DATA OF QUALITY, SAFETY AND PERFORMANCE.
* Hopefully the Sputnik vaccine will get its validation very soon. Since Mexico has received 6,900,000 biologicals, that is, almost seven million samples.
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