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The executive secretary of the Ministry of Health, Elcio Franco, today refuted the argument of the American pharmaceutical company Pfizer about the demands of Anvisa (National Health Surveillance Agency) for the approval of the emergency use of the vaccine against covid-19.
According to the secretary, the FDA (Food and Drug Administration), the federal agency of the United States Department of Health and Human Services, has the same requirements as Anvisa regarding authorization for emergency use.
“The pronouncement caused us some kind of clarification that it was having difficulties with the Anvisa orders, since the aspects are the same with the FDA for emergency use,” he said at a press conference.
“It caused species because these labs are already licensed by the FDA and other agencies around the world. We will seek further dialogue with the laboratory. It encourages us because in the request for emergency use it is designated for specific groups ”.
Elcio Franco also stated that he does not know what was the reason for Pfizer’s eventual difficulty in presenting its vaccine against covid-19 in emergency use and said that the matter rests with the Anvisa laboratory.
According to him, questions about this difficulty should be directed to Pfizer, not to the Ministry of Health or Anvisa. “I don’t know if a sheet was missing, a document, a spreadsheet, a report. What kind of document is missing. That is not even disclosed by Anvisa on its website,” he said.
Franco added that, therefore, it is not possible to estimate when the authorization will be granted.
When asked if the ministry could interfere in this negotiation, since the Pfizer vaccine is seen as the possibility that Brazil will have an immunizer in the near future, the executive secretary estimated that it will not necessarily be the first vaccine in the country, because If Pfizer doesn’t want to abide by Anvisa’s rules, “I can’t take Pfizer by the arm, take him there and say ‘Pfizer, give your report to Anvisa.’
He stressed that Anvisa is responsible for ensuring the population a safe and effective vaccine.
The Secretary of Health Surveillance, Arnaldo Medeiros, reinforced that the ministry intends, “in the best of cases,” to start vaccination on January 20, 2021. In a longer period, as of February 10. The date depends on a number of factors, such as Anvisa authorizations, logistics and supply of doses by manufacturers, he said.
5.8 million doses of chloroquine distributed
Yesterday, President Jair Bolsonaro (without a party) used inaccurate or unfounded data to argue that “he was not wrong [em] no “pandemic measures” were taken. He also said again that he “does not have to be terrified” by the coronavirus and that he will not be vaccinated when an immunizer is available in Brazil.
Franco affirmed that the ministry had an allocation of R $ 198.1 billion in 2020 – R $ 133.9 billion provided for in the Annual Budget Law plus R $ 64.2 billion of extraordinary credits to combat covid-19 ). He cited the portfolio’s actions for the availability of beds and equipment in the intensive care unit (ICU), in addition to the purchase of drugs for intubation.
The executive secretary said that 5.8 million units of chloroquine and 302,000 units of hydroxychloroquine have been distributed to date in accordance with state demands. None of the remedies have a proven effect against covid-19.
Also 21 million units of Oseltamivir were distributed, destined to fight the H1N1 flu.
Pfizer says it had “difficulties”
Yesterday, Pfizer informed that it will not ship its vaccine, produced in association with BionTech, for emergency use in Brazil and must be supported by the so-called continuous presentation.
In a statement, the pharmaceutical company explained that it had a meeting with representatives of Anvisa to clarify doubts about the presentation process, but that it ended up facing difficulties in the Presentation Guide for Emergency Use, prepared by the Brazilian agency itself.
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.
Brazil has more than 7.5 million confirmed cases of covid-19. Since the start of the pandemic, 192,681 people have died from the disease in the country, according to data from the Ministry of Health.
