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The pharmaceutical company Pfizer said on Monday the 28th that he has no intention of presenting his vaccine against coronavirus for the evaluation of emergency use in Brazil for National Health Surveillance Agency (Anvisa). In a note, the company states that the immunizer developed in partnership with BioNTech will be featured in a “continuous shipment process”, which it believes is “the fastest at this time.”
Pfizer affirms that Anvisa’s request to analyze the specific data of the tests carried out on 3,000 Brazilian volunteers on an emergency basis “requires a specific time and statistical evaluations.” “Other regulatory agencies that have the emergency use process analyze the data from the studies in their entirety, without asking for a cut to assess specific populations,” the note says.
The company also states that it met with Anvisa on the 14th to learn about the process of sending the vaccine for emergency use and clarifies that the number of doses and the schedule required by the Brazilian agency can only be defined “in the execution of the contract. definitive “. “The conditions established by the agency require specific analysis for Brazil, which takes more time to prepare.”
Scheduled to administer 210.4 million doses of the vaccine developed by Oxford University in alliance with AstraZeneca, a Oswaldo Cruz Foundation (Fiocruz) intends to present its results for Anvisa’s evaluation next week. The laboratory also ruled out the attempt to request the emergency use of the immunizer – which only allows the application in small groups, such as health professionals – and will test the final record, which can be analyzed in up to 60 days, at most, by the Brazilian agency. .
The strategy of Butantã Institute for the vaccine developed in partnership with the Chinese pharmaceutical company Sinovac foresees the order of the two registries before Anvisa: the emergency and the definitive. “We have reached the threshold of effectiveness, which allows the emergency use application process, either here in Brazil or in China,” he said. Dimas Covas, director of the institute, last 23.
Pfizer is still in negotiations with the Brazilian government for the distribution of the vaccine in the country and has already presented the results of the phase 3 tests that, according to the company, showed a 95% effectiveness of the immunizing agent against the coronavirus. On the last day 10, the Ministry of Health He affirmed that there is already an agreement for the acquisition of 70 million doses by the pharmaceutical company for next year.
On Monday 28, the president Jair bolsonaro (without a party) affirmed that the interest in the vaccine must come from the laboratories because the country has a “huge consumer market.” On the same day, Anvisa awarded the Certificate of Good Manufacturing Practices to three of the four companies involved in the development of the Pfizer / BioNTech immunizer.
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