WHO says Russia does not need its approval to register the vaccine

The World Health Organization (WHO) said on Tuesday (11) that will need access to the research data of the Russian laboratory Institute Gamelaya to evaluate the efficacy and safety of the vaccine developed in the country to approve it, but that Russia does not need the approval of the entity to make the registration.
Russia announced on Tuesday morning that it was the first country in the world to register a coronavirus vaccine. Little is known about the research that underlies this vaccine.
WHO monitors the development of vaccines. By the entity's last record, on July 31, the Russians are still in phase 1, and it would be necessary to complete phase 3 to register (see below for what each phase consists of). The entity considers that a vaccine should only be used in the population after it has been approved in these three stages.
In an interview, Tarik Jasarevic, a spokesman for (WHO), said the agency maintains the information contained in the monitoring. However, he also stated that the document is updated weekly, and the last information is from July 31.
Countries do not need WHO approval to apply vaccines in their territories. "[Vaccine] producers ask who for a pre-qualification because it is a kind of quality seal. And then there is a process of reviewing and evaluating the safety and efficacy data that were collected in the clinical trials. Who would do that for any candidate vaccine."
He said the organization is in contact with Russia's regulatory agency. There are discussions about a possible WHO pre-qualification of the vaccine, but for this it is necessary to make a rigorous analysis and evaluation of all data on efficacy and safety.
The protocol for researching the development of a vaccine is as follows:
- Phase 1: preliminary assessment of the safety of the immunizer, made with a small number of volunteers. With it, it is understood what type of response the immunizer produces in the body. It is applied to dozens of experiment participants.
- Phase 2: expanded clinical study, has hundreds of volunteers. The vaccine is given to people with characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. At this stage, vaccine safety, immunogenicity (or protection capacity), dosage and how it should be administered are evaluated.
- Phase 3: large-scale trial with thousands of individuals. It is necessary to provide a definitive assessment of its efficacy and safety in larger populations. In addition, made to predict adverse events and ensure the durability of protection. Only after this phase can you make a health record.