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Anvisa approves definitive registration of Pfizer / BioNTech vaccine – Prime Time Zone

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Immunizing is the first to have registration for widespread use in America; Ministry of Health faces difficulties to close agreement with the pharmaceutical company

ADRIANA TOFFETTI / A7 PRESS / ESTADÃO CONTENT – 10/17/2020 ADRIANA TOFFETTI / A7 PRESS / ESTADÃO CONTENT – 10/17/2020

A National Health Surveillance Agency approved, this Tuesday morning, the 23rd, the definitive registration of the vaccine against Covid-19 of Pfizer/BioNTech in Brazil. The approval was informed by Anvisa’s CEO, Antonio Barra Torres. “I inform you with great satisfaction that, after a seventeen-day analysis period, the General Management of Medicines, of the Second Directorate, granted the first vaccine registration against Covid 19, for wide use, in the Americas”, celebrated Barra Torres. In Brazil, CoronaVac, developed by the Chinese company Sinovac and produced in Brazil by Fiocruz, and the Oxford / AstraZeneca vaccine have already received authorization for emergency use and are already being applied in the country. Sinovac and AstraZeneca, however, have not yet requested Anvisa to register, for widespread use, the immunizers. Barra Torres said he hopes other vaccines will soon be approved by the agency.

“The immunizer from the Pfizer / Biontech laboratory had its safety, quality and effectiveness, assessed and certified by the technical team of Anvisa servers”, says the note. According to a study carried out on seven thousand health professionals who work at Hospital Sheba, in Israel, two weeks after being applied, the first dose of Pfizer vaccine is capable of reducing infections by 75% coronavirus. This suggests that it is possible to postpone the administration of the second dose in countries with a shortage of vaccines, so that more people can be inoculated earlier. The results were released last Friday, 19 by the prestigious scientific journal The Lancet. The survey also showed an 85% reduction in the number of people who had symptoms of Covid-19. In addition, Pfizer and BioNTech announced that their vaccine can be stored and transported between -15 ° C and -25 ° C, temperatures reached by common freezers. Until then, the orientation was that the immunizers should be kept between -60 ° C and -80 ° C, which required the use of sophisticated equipment and made it difficult to purchase the vaccine by Ministry of Health.

Imbroglio involving the acquisition of the Pfizer vaccine by the Ministry of Health

In addition to the difficulty in transporting and storing the immunizer due to the requirements, the Minister of Health, Eduardo Pazuello, in session of Federal Senate, stated that Pfizer imposed “leonine” issues in negotiations with the Brazilian government. The problems, according to the minister, would be in three clauses: that the federal government should be responsible “until eternity” for the side effects of the vaccine, and that Brazilian assets abroad should be available to Pfizer to cover as collateral actions abroad and that the Brazilian Justice should give up its ability to judge the company. The clauses, according to the Executive Secretary of the portfolio, Elcio Franco, go beyond the legal limits of the Ministry of Health. For this reason, the ministry asked for help for the Planalto Palace on Wednesday, 17. In a note, the ministry said it requested guidance from the Civil House and waiting for a response by Friday, 26.

A Chamber of Deputies vote on Tuesday, a Provisional Measure (MP) that facilitates the purchase of vaccines and supplies. Among other points, the MP dispenses bidding and provides for more flexible rules for contracts. With that, the acquisition of the vaccine from Pfizer can be unlocked. The senator Randolfe Rodrigues introduced an amendment that authorizes the Union to take responsibility for any side effects of immunizers. “Both Pfizer and Janssen need this device. It is a device that was even highlighted by the president of Pfizer for Latin America, which since June has been offered to the Brazilian government, as well as to other governments in the world. ” Pfizer, however, informed that 69 countries signed a contract with the company, following the same conditions presented to Brazil, and that it intends to follow the negotiations only with the federal government.

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Anvisa approves definitive registration of Pfizer / BioNTech vaccine - Prime Time Zone