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RIO DE JANEIRO (Reuters) – The president of Pfizer in Brazil was in Anvisa (National Health Surveillance Agency) to submit an application for approval for the emergency use of the vaccine developed by the company against covid-19 in Brazil, but he said he had encountered difficulties. said Thursday the Minister of Health, Eduardo Pazuello.
“I am in favor of emergency use, I even picked up the phone and spoke with the CEO of Pfizer on Sunday (13) and asked him on Monday (14) to be in Anvisa to request emergency use, and there it was”, Pazuello said at a Senate hearing on covid vaccination.
“And the answer was: ‘I thought it was simpler, but the agency is very detailed.’ Well, you have to comply with the regulatory details, “added Pazuello, referring to the conversation he had with the president of Pfizer in Brazil, Carlos Murillo.
The Pfizer vaccine was the first to receive approval for emergency use in Western countries and is already being applied in places like the United Kingdom, the United States and Canada.
In the Brazilian case, a negotiation between the company and the federal government is still underway, with the expected purchase of 70 million doses, but only 2 million in the first quarter: 500 thousand in January, 500 thousand in February and 1 million in March. .
Yesterday, the company delivered to Anvisa the documents related to the Phase 3 tests of its vaccine, one of the prerequisites for submitting an authorization request for the emergency use of its immunizer.
According to Anvisa, the data provided were primary safety and effectiveness results of Phase 3, which were presented within the Continuous Presentation process that has been used by laboratories to present partial data on vaccine development.
“These are not yet the complete data necessary to evaluate the safety, efficacy and quality of a vaccine for registration,” the agency said in a note, recalling that, to date, no pharmaceutical company has requested the definitive registration of the vaccine. or emergency use in Brazil.
The regulatory agency approved last week the procedure to grant temporary authorization for the emergency use of experimental vaccines against Covid-19 during the epidemic.
At the Senate hearing, Pazuello also stated that Pfizer filed several lawsuits to close the sale of immunizers to Brazil, including the total exemption of any responsibility of the company for possible side effects of the vaccine and the refusal to be tried in the courts of the country.
“And surprisingly, we are thinking of accepting,” he added.
Upon request, Pfizer said it submitted a proposal for a possible acquisition of the company’s vaccine to the Ministry of Health, which formally expressed interest. “We are working on negotiating the terms and conditions of the supply contract,” he said.
The company added that it cannot comment on ongoing negotiations with the government, but cited that, due to the “risks associated with developing a vaccine,” several governments are passing laws that provide protection to manufacturers.
(Additional reporting by Gabriel Stargardter)
