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The United States drug regulatory agency, FDA, approved on Friday night (11/12) the emergency use of the pharmacist Pfizer’s vaccine against the new coronavirus.
Studies show that the immunizing agent is approximately 95% effective in preventing COVID-19.
With the endorsement of the organ, the doses should begin to be applied from next week, first in the elderly who live in nursing homes and in health professionals who work on the front line in the fight against the pandemic.
Although the United Kingdom, Canada and Mexico have taken the lead in the approval of the vaccine by their regulatory bodies, the scientific community around the world awaited the outcome of the FDA process because the agency’s work is seen as a benchmark for the work of investigative agencies. other countries.
Approval in 72 hours in Brazil?
And although this week the Minister of Health of Brazil, General Eduardo Pazuello, said that the approval of an immunizer would take 60 days to go through the analysis stages by the Sanitary Surveillance Agency (Anvisa), the expectation of specialists is that the result of the FDA also facilitates the process of approval of immunizations in Brasilia.
As a general rule, registration of a drug or immunizer by Anvisa takes from four months to a year to complete. But this period would not apply to COVID-19 treatments and immunizations. This is due to the fact that this year the National Congress approved a law that requires Anvisa to respond within 72 hours to an emergency registration request of an immunizer against covid-19 that has already been evaluated by one of the regulatory agencies. in the U.S. Europe, Japan or China.
The FDA, therefore, is subject to the law. If Anvisa does not position itself, the release of the immunizer would be automatic.
However, there is an issue that is subject to interpretation in the legislation that can cause difficulties. According to the wording of the law, Anvisa would have to evaluate the release of the vaccine if it had obtained a definitive record of another foreign body. In the case of the Pfizer vaccine, what the US agency granted was an authorization for the emergency use of the immunizer, a faster release and less bureaucratic than the full registry.
However, for the epidemiologists and public health specialists heard by BBC News Brazil, Anvisa should have no doubts about what to do.
“This interpretation that only with the definitive registration could there be this quick release does not make sense. Did Congress pass a law to streamline the processes of fighting the pandemic and then would we have to wait another two months before the FDA completed its final registration? The logic of that? ”Asks the doctor and lawyer Daniel Dourado, researcher at the Health Law Research Center of the University of São Paulo (USP).
According to Dourado, the expedient provided for in the law came to be applied when the United States sent some million doses of hydroxychloroquine to Brazil, which the federal government announced it would use to treat patients with Covid-19.
At that time, hydroxychloroquine had an emergency use authorization issued by the FDA to treat patients with the new coronavirus, which weeks later ended up being revoked by the agency itself due to evidence that the drug did not work for this purpose and exposed patients at risk. additional. With emergency approval from the FDA, hydroxychloroquine was imported and distributed in Brazil.
How did the FDA conduct its evaluation?
“An FDA approval tends to greatly facilitate approval by Anvisa. First, because it is a highly credible body, and although they have given the name of emergency for the registry, the truth is that they did not take any shortcut in evaluating the data. , because in the pandemic situation in which we find ourselves, it is unacceptable to wait 60 days for approval ”, evaluated the epidemiologist from BBC News Brasil Denise Garrett, vice president of Applied Epidemiology Programs at the Sabin de Vacinas Institute.
According to Garrett, the FDA was the only agency to date that required Pfizer, like other vaccine-producing pharmaceuticals, to accompany research volunteers with immunizers for eight weeks after the second dose was applied.
“They did this because virtually all of the known side effects from vaccines occur up to the sixth week after dosing. Therefore, they have surrounded themselves with care to ensure safety,” Garrett says.
Another feature of FDA analysis is the data analysis mode. Rather than just analyzing final manufacturers’ reports, US regulators verify raw test data and recalculate results, replicating thousands of page reports from scratch.
“We are one of the few regulatory agencies in the world that really looks at raw data,” FDA Director Stephen Hahn said this week, justifying why the agency’s work took longer than that of its British peers. and Canadians.
That was exactly the work that was done with the Pfizer vaccine. Microbiologist Natalia Pasternak, president of the Questão de Ciência Institute, followed part of the FDA evaluation process.
“The Pfizer clinical trial was exquisite and the FDA evaluation was extremely rigorous, looking at every detail. It is an emergency use approval because we are in an emergency, but the data is clearly solid,” Pasternak told BBC News Brazil.
Additionally, according to Daniel Dourado, the FDA has established a scheme with manufacturers to continuously submit data for the past few months. Therefore, by the time the information from phase 3 of Pfizer’s immunization tests reached the agency, regulators had already evaluated all the material from phases 1 and 2.
“Brazil only started requesting this type of continuous data submission in Anvisa from November, so we are behind in the process,” says Dourado.
Finally, before the agency’s approval, the Pfizer vaccine was submitted to a committee of independent experts, who on Thursday recommended that the immunizer be approved.
‘Release the damn vaccines NOW’
This whole process that made the FDA one of the most respected regulatory agencies in the world also took time and made the United States the only Western country to have the vaccine available. This infuriated President Donald Trump, who just over a month ago lost re-election to Democrat Joe Biden.
During the campaign, Trump even promised that the vaccine would reach the population before Americans go to the polls on November 3. Therefore, the Republican was accused of trying to make political use of immunizers.
On Twitter this Friday, Trump wrote, addressing the FDA leader Stephen Hahn: “Get the damn vaccines NOW. Stop gambling and start saving lives.”
In the same message, Trump also said that “while my effort to drench the money with the FDA saved us five years to approve numerous vaccines, the FDA is a big, old, slow turtle.”
The pressure didn’t stop there. According to information from the American newspaper The Washington Post, confirmed by other American media, Trump’s chief of staff, Mark Meadows, spoke with Hahn and would have conveyed the message that if the approval did not come out on Friday the 11th, the management expected have the head of the FDA present his resignation letter
“It is important to say that the FDA approval did not come out because Trump ordered it, but because the data is very clear,” says Natalia Pasternak.
For Denise Garrett, it is “very unfortunate” to see Trump’s actions.
“Both the FDA and Anvisa have to be exempt from any political interference, so that the population can trust their conclusions. Trump’s action is extremely harmful to the cause of the vaccine, and I see a parallel in the behavior of Bolsonaro and Doria , in Brazil, who subject the immunizer to their personal interests, “said Garrett.
The doctor refers to the confrontation between the president and the governor of São Paulo over the vaccine in recent days. On the one hand, the federal government signed a contract only with the manufacturer Astrazeneca, whose tests had errors, which should delay the completion of the investigation and the release of the immunizer by months.
On the other hand, the government of São Paulo partnered with the Chinese company Sinovac to manufacture Coronavac at the Butantan Institute. And although there are no results yet from Coronavac phase 3, Doria has already promised that vaccination will begin in São Paulo on January 25 and guaranteed that the doses will be distributed to any Brazilian who goes to the state.
Doria’s statements infuriated not only Bolsonaro, but the other governors. This Friday, the governor of Goiás, Ronaldo Caiado, affirmed that the Ministry of Health is studying measures to confiscate doses from São Paulo and redistribute them throughout the country.
In the middle of the dispute, it will be up to Anvisa to release or not Coronavac from Doria. Recently, the agency’s permanent employees published an open letter in which they said they did not act for political reasons.
“But it is impossible to deny that Anvisa ended up in the middle of this dispute between Doria and Bolsonaro,” says Dourado.
The president sees the governor of São Paulo as his main opponent in the 2022 elections.
The arm wrestling, according to Dourado, can be brought back to the Federal Supreme Court (STF).
“There is already an action by the Brazilian Bar Association that asks the Supreme Court to release the vaccine if Anvisa takes a long time to release it. But it is more likely that the agency will take a little longer, but end up launching it.” says Dourado.
For Natalia Pasternak, the political episodes surrounding vaccines in both the United States and Brazil are cause for alarm, especially at a time when the population needs to depend on and receive immunization.
“With vaccines, we are seeing the beginning of the end of the pandemic. Science is becoming politicized and these agencies cannot give in to pressure in the name of the reliability of their work,” he says.
