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The Health Ministry said on Tuesday (29) that it should start vaccination between January 20 and February 10, 2021, more than need “manufacturers get registration [das vacinas da Covid-19] beside Anvisa“. The statements of executive secretary Elcio Franco come after Pfizer’s position on Monday (28), which said that Brazil requires “specific analyzes” that slow down the process. (read below).
“In the best of cases, we would be starting the vaccination from January 20. Medium term, between January 20 and February 10. And in the longer term, as of February 10, “said the executive secretary. .
“We need manufacturers to obtain registration with Anvisa, and to deliver enough doses to distribute. If the dealer gets the record and finally doesn’t have a dose to distribute … get it. The Ministry of Health as well as the Ministry of Health has done its part, we made the plan [nacional de imunização], we have the operationalization ready, preparing for this big day, but we need laboratories to request registration“.
“From the moment she [Pfizer] I don’t want to be bound by Anvisa’s rules, I can’t take Pfizer by the arm and lead him there, Pfizer, give your report to Anvisa. I can ask Anvisa for brevity, but she has to follow in his footsteps “- Elcio Franco
The statements come as dozens of countries have started their vaccination campaigns: the United States, China, Canada, Russia and the European Union. This Tuesday, Argentina began vaccinating the population. Brazil, despite having a contract with the AstraZeneca vaccine and the University of Oxford (produced by the Oswaldo Cruz Foundation), has not yet been able to approve the product and begin immunization.
Bolsonaro: ‘Didn’t we have to interest the laboratories?’
Furthermore, on Monday, Jair Bolsonaro stated that it is the laboratories that should be interested in selling the coronavirus vaccine to Brazil:
“Brazil has 210 million inhabitants, a huge consumer market for anything. Didn’t the labs have to be interested in selling to people? Why then do they not present documentation in Anvisa? People say I have to go after her. Nerd. Who wants to sell, if I am a seller, I want to present ”, said the president.
In response to the remarks, Pfizer reported in a note Monday that the National Health Surveillance Agency (Anvisa) called for a series of “specific analyzes” for the release of emergency vaccines from COVID-19 in Brazil and that, for now, will continue with the request in another format, that of continuous delivery: when the company sends documents gradually, while conducting studies and collecting data.
According to the pharmaceutical company, the note is also a demonstration that the company “does want to sell to Brazil, but that the process here requires more time.” An example of this delay in processing, according to Pfizer, is the requirement for this exclusive information on Brazil, while in other countries the data is analyzed in its entirety, without requiring further cuts.
Pfizer Responds to Bolsonaro’s Statement on Covid Vaccine
In response, the ministry said Tuesday that the documents required by Anvisa are the same as those requested by the FDA. (Food and Drug Administration), the United States regulatory agency. Pfizer has already closed the emergency use of the vaccine for Americans.
“The pronouncement that occurred yesterday made us feel strange [segunda-feira, 28] from a certain laboratory that said it was in trouble due to the great difficulty of the Anvisa orders, since the aspects requested by Anvisa are the same as those requested by the FDA in the United States, ”said Executive Secretary Elcio Franco.
Anvisa said it is at the disposal of the laboratories to discuss the requirements for the release of safe and effective vaccines for the entire population. The agency board called Pfizer for a new meeting on Wednesday (30).
The most recent Anvisa newsletter notes that both Pfizer and AstraZeneca released the partial results of the phase 3 (last stage) studies on December 5 and 22, respectively. No laboratory has yet requested the release of emergency use in Brazil, which, according to the regulatory agency, can be done with the results of the third phase of testing. Therefore, Pfizer and AstraZeneca can now place the order.
Health professional prepares doses of Pfizer / BioNTech Covid-19 vaccine. – Photo: Gil Cohen-Magen / AFP
On December 10, the Ministry of Health announced that it had signed the “Memorandum of Intent” for the purchase of 70 million doses of the Pfizer vaccine in partnership with the German company BioNTech. According to the American pharmacist, four days later a meeting with Anvisa was held on December 14. Due to the number of documents required for the emergency use request, Pfizer reported that the continuous submission format appears to be faster.
“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 explained in a note, recalling that the Brazilian government has not yet has officially signed a contract with Pfizer only demonstrated the intention to purchase. “The pharmaceutical company continues to negotiate with the federal government to supply its vaccine against Covid-19”.
On the same day it announced the “memorandum of intent” for the purchase of the Pfizer vaccine, the Ministry of Health reported that there is also a similar agreement for the use of CoronaVac, developed by the Chinese pharmaceutical company Sinovac, in association with the Butantan Institute. The vaccine has a manufacturing contract already signed with the Government of the State of São Paulo, by João Doria.
“Butantan and Pfizer are in the same state, I have memoranda of understanding, if there are records they can be inserted into the PNI (National Vaccination Plan),” said Elcio Franco, executive secretary of the Ministry of Health, on December 10.
In a note, the Butantan Institute reported that it sent Anvisa all the information available on CoronaVac, with the clinical investigation of phases 1 and 2. A team from Anvisa was at the Sinovac plant in early December and testified that the complex complies with the criteria. international best practices. The agency also authorized phase 3 clinical trials in Brazil and the importation of around 11 million doses, including ready batches and supplies for filling.
Also in a note, AstraZeneca said it was “engaged and working with Anvisa and other regulatory agencies to bring the vaccine to Brazil, and to the world, as soon as possible. The company is following the ongoing submission process together.” to Anvisa and confirms that it has submitted all available clinical efficacy and safety data to the regulatory agency in the last week. ”
The note continues: “The company continues to work with governments, multilateral organizations and employees around the world to ensure broad and equitable access to the vaccine, not for profit during the pandemic.”
