[ad_1]
The pharmaceutical company Pfizer will not request the registration of emergency use of the vaccine against covid-19 in Brazil due, according to the pharmacist, to the regulations of the National Sanitary Surveillance Agency. The immunizer developed in partnership with BioNTech has already begun to be applied in the United States, Canada, Israel, Chile, the United Kingdom and countries of the European Union. The information is from CNN Brazil.
In a statement, the German pharmaceutical company said it had contacted the National Health Surveillance Agency (Anvisa) to clarify doubts about the process of emergency use of the immunizer. “The conditions established by the agency require specific analysis for Brazil, which requires more time to prepare,” the company says in a note.
“The emergency use presentation also asks for details of the amount of dose and schedule to be used in the country, points that can only be defined at the conclusion of the definitive contract,” he continues.
Also according to CNN Brazil, the pharmacist explains that, due to the “peculiarities of the Shipping Guide for Emergency Use, prepared by Anvisa”, continuous shipping is the “fastest” process at the moment.
According to the company, the results of phase 3 of the vaccine trials have already been submitted to the agency. “The pharmaceutical company continues to negotiate with the federal government to supply its vaccine against Covid-19,” he concludes.
In a new note, Pfizer removed the mention of the Shipping Guide for Emergency Use and that it “remains in negotiation” with the Brazilian government. However, he added an explanation about the specific analyzes.
“An example is the request for an analysis of the data collected exclusively on the Brazilian population, which requires time and specific statistical evaluations. Other regulatory agencies that have the emergency use process analyze the data of the studies in their entirety, without asking a cut by evaluation of specific populations, “says the statement.
Bolsonaro
This Monday (28), President Jair Bolsonaro (without a party) demanded that the pharmaceutical companies look for the Brazilian authorities to offer the immunizer. “Some say it should run after the vaccine, but the consumer market here is 210 million people. The natural thing is that the laboratory that produces the vaccine looks for Anvisa and presents here the documentation to approve the drug, “said the president, at a ceremony in Santos, in which he played soccer and celebrated a goal.
Janssen’s lab, which also develops a vaccine against Covid-19, said it was focused on the clinical development of the drug, with a phase 3 study underway in Brazil and other countries.
The Butantan Institute, which is developing a vaccine with the Chinese pharmaceutical company Sinovac, said, in a note, that it has already sent Anvisa all the available information on Coronavac and the research in phases 1 and 2. In addition, it explained that the agency has certified the international criteria. of good practices from a factory in Sinovac and authorized the conduct of phase 3 clinical trials and the importation of approximately 11 million doses. “The final results of the efficacy of the vaccine must be presented by Butantan to Anvisa until January 7,” concludes the institute.
