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Russia announced on Tuesday that it had applied for approval for emergency use of one of its Covid-19 candidate vaccines, Sputnik V, from the World Health Organization (WHO). The entity released the criteria for evaluating candidates for possible emergency use in late September.
The Russian state fund that coordinates the production of the vaccine has submitted applications for expedited registration on the Emergency Use List (EUL) and prequalification of the immunizer.
The fund’s director, Kirill Dmitriev, commented on the application, saying that it “will allow Sputnik V to be included in the list of medical products that meet the main standards of quality, safety and efficacy.”
The Russian candidate is expected to be produced and tested in phase 3 in Brazil, in a partnership signed with the state of Paraná.
Sputnik V, developed by the Gamaleya Institute in Moscow, was the world’s first registered vaccine against Covid-19. About two weeks ago, Russia announced a second registry, EpiVacCorona, developed by the Vector Institute in Siberia.
Russia registers the first vaccine against Covid-19: 5 points to understand
The first Russian candidate, Sputnik V, is based on a platform (manufacturing process) of viral vector, where a modified virus (in the case of the Russian vaccine, two types of adenovirus) is used to introduce some of the coronavirus genetic material into the body and induce the body to produce antibodies.
The viral vector platform is also used in the vaccine developed by the University of Oxford, currently in phase 3 trials in several countries, including Brazil.
The Sputnik V registration announcement was widely criticized by experts, among other reasons, due to the low number of people tested before approval. Immunization was tested in phases 1 and 2 before being recorded, steps in which dozens of people are tested (see details further down in this article).
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The second Russian candidate, EpiVacCorona, is based on peptides (pieces of protein from the new coronavirus) synthetically produced. The intention is that the body can recognize the virus and build a defense from these protein fragments.
According to the Russian government, the second candidate was tested with 100 volunteers, aged between 18 and 60, in the city of Novosibirsk, in Siberia. In the trials, 57 people received the immunization and the other 43 received an inactive substance (the placebo). This type of study is used to compare the results between the volunteers who received the immunization and those who did not.
In a statement, the Vector Institute, which developed the second vaccine, said there were no side effects among the volunteers. Like Sputnik V, it was also recorded without phase 3 studies.
How the 3 phases work
When testing a vaccine, usually divided into phases 1, 2 and 3, scientists try to identify serious adverse effects and whether the immunization was able to induce an immune response, that is, a response from the body’s defense system.
- STAGES: Why Phase 3 Clinical Trials Are Essential to Vaccine Safety and Success
Phase 1 trials generally involve dozens of volunteers; those of phase 2, hundreds; and phase 3, thousands. These phases are generally carried out separately, but due to the urgency of finding a Covid-19 vaccine, several companies have taken more than one step at the same time.
Before testing in humans, vaccines are tested in animals, usually mice and then monkeys.
