An activist installs a Brazilian flag for the victims of Covid-19, in Rio de Janeiro, on December 23. Antonio Lacerda / EFE
The US pharmaceutical company Pfizer will not request the emergency use of its vaccine against covid-19, BNT162, developed together with BioNTech, in Brazil.
In a statement released last Monday, the laboratory reported having met on December 14 with representatives of the National Health Surveillance Agency (Anvisa) to clarify doubts about the process, but that it encountered obstacles created by the agency's own protocol.
The statement was a response to President Jair Bolsonaro, who reminded the laboratories that they had to present the registration of their vaccines in Anvisa.
"The conditions established by the agency require specific analyzes for Brazil, which requires more time to prepare," explained Pfizer.
Pfizer's claim is one more example of the problems that laboratories have that must negotiate approval of their vaccines with Bolsonaro, a denier of the pandemic.
The Pfizer / BioNTech vaccine was the first coronavirus immunizer used in the world.
First in the United Kingdom, and then in the United States, Canada, Mexico, Chile and Costa Rica.
Argentina began this Tuesday to immunize its population with the Russian vaccine, Sputinik V. Thus, Brazil will be the only large American country that has not started with vaccination.
It hasn't even submitted a start date.
Bolsonaro has said that he does not "care" or feel pressured by what his neighbors are doing.
Bureaucratic problems
Among the requirements demanded by Anvisa to approve the emergency use of a vaccine, Pfizer mentions "the request for an analysis of the data collected exclusively from the Brazilian population, which requires time and specific statistical evaluations."
In a clear criticism of the bureaucracy created by Anvisa, the pharmaceutical company recalls that "other regulatory bodies that have the emergency use process analyze the data from the studies in their entirety, without requesting a cut-off for the evaluation of specific populations."
"Pfizer has already presented to Anvisa, through the continuous submission process, our results from phase 3 of the studies, which is a further step towards the approval of our vaccine," said the laboratory.
The Ministry of Health did not plan to use the Pfizer / BioNTech vaccine, made with RNA technology that requires temperatures to -70ºC to maintain its effectiveness.
However, a law passed earlier this year that establishes rules to deal with the pandemic states that Anvisa has 72 hours to grant an authorization if the immunizer has achieved registration in Japan, the United States, Europe or China.
If the body does not manifest itself, the authorization must be granted automatically.
However, for Bolsonaro, the responsibility for making vaccines available rests with the laboratories, not with him or his government.
“Brazil has 210 million inhabitants.
So, shouldn't the laboratories be interested in selling us?
Why then don't they present all the documentation to Anvisa? ”, He affirmed last Monday.
The president also noted that any vaccine approved by Anvisa will be available to Brazilians in five days.
"Once Anvisa certifies, in five days the vaccine will reach all Brazilians, for all, no ... you cannot have 100 million doses instantly, but they will be distributed equitably to all Brazilian states," Bolsonaro stressed .
The pressure on the Brazilian government to start a vaccination program grows when more than 30 countries have already begun to immunize their populations.
Members of the European Union, who see a new strain of the coronavirus spreading through their territory, began to immunize health professionals and the elderly.
The application of the first doses of the vaccine in Latin America during the last week has brought hope to the region most affected by the pandemic.
Brazil, meanwhile, is in the middle of a political battle between Bolsonaro and the governor of São Paulo, João Dória, in the race for a vaccine.
The country initially focused on the AstraZeneca vaccine, the so-called "Oxford vaccine."
The Federal Government signed an agreement to carry out immunization tests for phase three of the vaccine, with technology transfer and the promise of the production of millions of doses by Fiocruz, a local laboratory.
São Paulo, however, says that it will begin its immunization on January 25 with the vaccine from the Chinese laboratory Sinovac, which has signed a cooperation agreement with the Butantan Institute.