Anvisa (National Health Surveillance Agency) granted the definitive registration for the use of the Pfizer / BioNTech vaccine against covid-19 in Brazil. According to the agency, studies and clinical tests showed the “Safety, quality and effectiveness” of the immunizer.
The decision was announced on Tuesday (23. Feb. 2021) in a meeting with the directors of Anvisa. This is the 1st vaccine to obtain definitive registration in the country. However, it is not in use in Brazil because the federal government does not yet have an agreement for the purchase of doses with Pfizer.
In January, the Jair Bolsonaro government refused to buy 2 million doses of the immunizer. In the same month, Health Minister Eduardo Pazuello complained about the laboratory’s purchase conditions.
“Everyone already knows about Pfizer’s clauses. I don’t think I need to repeat it, but I’ll be succinct: complete disclaimer for side effects from today to infinity. That simple”, Said the minister on January 11.
On Monday (Feb. 22) Pfizer informed Senate President Rodrigo Pacheco (DEM-MG) that it does not accept the conditions of the Brazilian government for the sale of the vaccine against covid-19 in the country. The clause that generated the dispute and fought the negotiations was the one that passes to the Brazilian government the responsibility for eventual disputes in the Court because of adverse effects caused by the immunizer.
Currently, the Pfizer vaccine is applied in 69 countries. Brazil is the 3rd to grant the definitive registration to the immunizer.
The laboratory asked for the definitive registration in early February. According to a note released by Anvisa, the agency’s technical analyzes were carried out in 17 days. The deadline was 60 days, but the agency has been under pressure to carry out technical procedures more quickly during the pandemic.
Anvisa’s CEO, Antonio Barra Torres, celebrated the speed and release for use of the Pfizer vaccine. The Oxford / AstraZeneca immunizer is also being analyzed by the agency for final use. “We hope that other vaccines are soon being evaluated and approved. This is our commitment”, Torres said in a note.
The Brazilian vaccination campaign uses vaccines from AstraZeneca and CoronaVac. But it has been facing a shortage of doses and a shortage of immunizers, especially in the capitals. The Pfizer vaccine could help solve this problem, as preliminary studies have shown that the 2nd dose of this immunizer can be delayed without impairing safety and effectiveness.
Negotiations between Brazil and Pfizer await the assessment of the Planalto Palace to proceed. Congressmen were also involved in the issue and are talking to the laboratory. Senator Randolfe Rodrigues (Rede-AP), present at the Pacheco meeting with the company this 2nd (Feb. 22), has already indicated that the National Congress is looking for a solution of its own.
“We are going to open the necessary dialogue with the Chamber of Deputies. A bill is being prepared based on all the conditions that are necessary for the entry of these companies ”said Randolfe.