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The Pfizer laboratory today pointed to the requirements of Anvisa (National Sanitary Surveillance Agency) as the main obstacle to the approval of the emergency use of its vaccine against covid-19 in Brazil. The authorization could allow the country to have doses of the immunizer available in January, since the laboratory itself has already admitted that it could supply.
The Pfizer vaccine, which was developed in partnership with German biotech company BioNTech, is being urgently applied to priority groups in the UK and the US. In Brazil, the Ministry of Health is negotiating an agreement to have 70 million doses of the immunizer, but it needs the approval of Anvisa to start applying it.
Among the Anvisa requirements mentioned by Pfizer, there is the obligation to detail the number of doses and even the vaccination schedule to be established in the country. The federal government, however, has reiterated that it cannot set a date for the start of vaccination precisely because it does not yet have any vaccine approved by Anvisa.
“The emergency use submission also requests details of the number of doses and the schedule to be used in the country, points that can only be defined at the conclusion of the final contract,” Pfizer said in a statement.
The controversy surrounding the start of vaccination even provoked a clarification note from the Ministry of Health today. In it, the federal portfolio once again stated that there is no date for the start of immunization because no vaccine has requested the definitive registration in Anvisa. However, the application is different from emergency use, which could shorten the approval process.
In view of the requirements, Pfizer anticipated that, for the time being, it is no longer considering emergency use in Brazil and will attempt the final registration by continuously sending data to Anvisa. According to the lab, “this is the fastest process at the moment.”
Meeting with Anvisa
In the statement, Pfizer also confirmed a meeting cited by the Minister of Health, General Eduardo Pazuello. Representatives of the laboratory met with Anvisa last Monday (14) to attend the request for emergency use.
According to Pazuello, Pfizer’s president in Brazil, Carlos Murillo, told the minister after the meeting that he was impressed with the demands and thought the process “was easier.”
Pfizer also cited as an obstacle to Anvisa’s approval the need for “specific analysis for Brazil, which requires more time to prepare.” The laboratory did not list what these analyzes would be, but compared the process with that of other countries.
“Other regulatory agencies that have the emergency use process analyze the study data in its entirety, without asking for a cut to assess specific populations,” Pfizer said in a note.
Definitive registration
The immunizer from the US laboratory is in phase 3 clinical studies in Brazil, the objective of which is to attest to the efficacy of the vaccine. It is the data from these tests that Pfizer will now continually send to Anvisa to attempt the definitive registration of the vaccine.
The strategy is similar to that adopted by CoronaVac, the vaccine developed and tested by the Butantan Institute in partnership with the Chinese laboratory Sinovac. Butantan, linked to the São Paulo government, decided to wait another week to present more complete results of the phase 3 studies in Brazil, thus seeking a definitive record.
