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posted on 12/30/2020 06:00
(credit: Cris Faga / replay)
The Chemical Union, in association with the Russian Direct Investment Fund (RDIF), yesterday registered the request for approval of the clinical testing phase of the Russian vaccine against covid-19 in Brazil. The Sputnik V clinical development file (DDCM) was submitted to the National Health Surveillance Agency (Anvisa). The file is a necessary document for the testing and subsequent registration of the immunizer. The company noted, in a note, that “it has adopted all the necessary measures to comply with the requirements and demands of this process, especially the safety, efficacy and well-being of the Brazilian population.”
“All industrial, technological and scientific efforts are being made to make available as soon as possible as many doses as possible for the National Plan for the Operationalization of Vaccination against COVID-19 of the Ministry of Health,” União Química reported in a note. .
The Russian immunizer is the first registered in the world. If the document is approved by Anvisa, the production of Sputnik V, through technology transfer, will begin in January 2021, in the Chemical Union’s biotechnology, fractionation and packaging units in Brasilia (DF) and Guarulhos (SP) . . According to the pharmaceutical company, Sputnik V is the world’s first registered vaccine based on a human adenovirus-based platform.
In November, Russia even claimed that the vaccine would be 95% effective. However, days later, the country reported that, according to preliminary data from the third phase of the investigation, the effectiveness would be 92%.
The statement released by the Gamaleya Center and the RDIF says that the result was obtained from a survey of more than 16,000 volunteers, 21 days after receiving the first dose of the vaccine, which is inoculated in two doses, or placebo.
In Brazil, four other immunizers are being tested: Coronavac, Oxford / AstraZeneca, Johnson & Johnson and Pfizer / BioNTech. Anvisa has held meetings with representatives of the laboratories.
Difficulties
Lagging behind in vaccination against covid-19 in relation to at least 40 countries in the world, Brazil still faces obstacles in the search for an effective vaccine against the new coronavirus. Instead of proposing solutions, the Ministry of Health puts more obstacles by stating, yesterday, that it will not close contracts with vaccine manufacturers without an approval, either for emergency use or a definitive registration, from the National Health Surveillance Agency (Anvisa ). . The regulatory body, in turn, updated the wording of the guide that establishes the minimum requirements to request the emergency use of vaccines against covid-19 after complaints from Pfizer, one of the companies that can offer doses to Brazil.
The executive secretary of Health, Elcio Franco, indicated that the portfolio will not be able to close any contract to acquire doses without the approval of Anvisa. “What we have been asking since the beginning of December is that all (companies) request registration and request authorization for emergency use. This is the condition for us to acquire because we will have the approval of Anvisa to be able to insert (the immunizers) in the National Plan for the Operationalization of Vaccination against covid-19, ”he declared at a press conference.
On Monday, in a statement, Pfizer explained that, to request the emergency use of Anvisa, the agency requested details, such as the number of doses, which “will only be defined in the execution of the definitive contract.” For this and other reasons, the company has not yet applied to the agency. When commenting on the company’s statement, the ministry indicated that the company itself informed the folder about the possibility of supplying two million doses of the vaccine in the first quarter of 2021 and that it did not file another lawsuit for the request to be produced. emergency use.
“If data is missing to obtain authorization from Anvisa, she (Pfizer) did not ask us. Because he could have asked right away, even over the phone. And we were already starting to toast. There was no such request for the ministry, ”explained Franco, who indicated a rush to resolve the problem.
OR mail contacted Pfizer but did not receive a return until this report was published.
Data
Without having anything certain, the executive secretary of the Ministry of Health said that vaccination against covid-19 could begin on January 20, in the best scenario. If this is not possible, vaccination can begin between this date and February 10. In an even less favorable scenario, vaccination in Brazil can only start from February 10.
“This also depends on the quality of the works that are presented to Anvisa within a continuous submission process and the authorization process for emergency use. Our hope is that these processes are carried out without obstacles, with the greatest possible agility, but always seeking the safety of the Brazilian population and the effectiveness of the vaccine, ”he said.
