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The US pharmaceutical Pfizer said today that it will not send its vaccine, produced in association with BionTech, for emergency use in Brazil and that it must rely on the so-called continuous presentation. This, in practice, would simplify the protocol.
In a statement, Pfizer explained that it had a meeting with representatives of Anvisa (National Health Surveillance Agency) on December 14 to clarify doubts about the submission process, but that it ended up running into difficulties in the Presentation Guide for Emergency Use. prepared by the Brazilian agency itself.
“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 “, argues Pfizer. “We understand that continuous submission is the fastest process at the moment,” he later noted. (See company statement, in full, below)
The continuous submission is not yet the application for registration of the vaccine, but a way to speed up the analysis of data by Anvisa. In this procedure, the results of the clinical test phases are presented as they are ready and not only at the end of the investigation.
Anvisa received data regarding clinical and non-clinical studies of phases 1 and 2 of the COVID-19 vaccine developed by Pfizer in late November. Once received, the agency would have 20 days, counted from the date of the protocol, to analyze these data.
In the same statement, the pharmaceutical company says that it continues “in negotiations with the federal government to supply its vaccine against covid.”
Called BNT162, the Pfizer / BioNTech vaccine is made with messenger RNA technology, which carries genetic information to the body to make a viral protein and activate the immune system to generate an antibody response against the pathogen.
The studies involved about 43,000 volunteers. The effectiveness analysis was performed when the number of infected in the group of participants reached 170. When opening the blinding of the investigation (that is, verifying how many of the infected were in the vaccinated group and how many in the placebo group), the Researchers found that 162 infections occurred among those who did not take the immunizer, thus achieving 95% effectiveness.
Although modern and easy to produce, RNA vaccines are sensitive and require refrigeration at -70 ° C. Pfizer and BioNTech say that while they await authorization for emergency use, they are already taking care of the logistical preparations for product distribution, including a special box that uses dry ice to keep the immunizer at the proper temperature for up to 15 days.
Bolsonaro: “The laboratory must go after”
Previously, President Jair Bolsonaro (without a party) once again minimized the delay in the release and acquisition of vaccines by the government. According to him, in the face of a “huge” consumer market in the country, the laboratories should be interested in Anvisa’s authorization requests and in selling the vaccine to Brazil.
“Brazil has 210 million inhabitants, a huge consumer market for anything. Didn’t the laboratories have to be interested in selling us? Why don’t they present documentation in Anvisa?” Bolsonaro asked a group of supporters in Palacio. da Alvorada, in Brasilia (DF). “People say that I have to go after them. Who wants to sell (who has),” he amended.
Bolsonaro repeated again the story that the vaccine leaflets indicate that the consumer is responsible for the use of the drug and the possible side effects, and also that he will not be vaccinated, since he has already contracted covid-19.
According to the president, he has already signed “the check for R $ 20 billion” for the purchase of vaccines.
Bolsonaro’s statement comes at a time when several countries, including Latin America, announce the start of immunization against covid-19, and Brazil does not even have a date.
Complete version
Regarding the negotiations with the Brazilian government and the presentation of the emergency use of the BNT162 vaccine, developed by Pfizer and BioNTech, we clarify:
- On December 14, Pfizer held a meeting with Anvisa to clarify doubts about the shipping process for emergency use.
- The conditions established by the agency require specific analysis for Brazil, which takes more time to prepare.
- An example is the request for an analysis of 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 study data in its entirety, without asking for a cut to assess specific populations.
- The presentation for emergency use also requests details of the amount of dose and schedule that will be used in the country, points that can only be defined at the signing of the final contract.
- Therefore, based on current regulations defined for emergency use, the company believes that the continuous shipping process is the fastest at this time.
- Pfizer has already sent Anvisa, through the continuous submission process, the results of our Phase 3 study, which is another step towards the approval of our vaccine.
