BRASILIA – The National Health Surveillance Agency (Anvisa) reported on Tuesday that it had granted the definitive registration for the vaccine of the American laboratory Pfizer against Covid-19. This is the first definitive record that Anvisa grants for a vaccine against the new coronavirus. The agency has already authorized the emergency use of two other immunizers: that of CoronaVac (Sinovac Biotech / Instituto Butantan) and that of AstraZeneca / University of Oxford.
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“The immunizer at the Pfizer / Biontech Laboratory had its safety, quality and efficacy, assessed and certified by the technical team of Anvisa servers, which continues in its work to protect the health of the Brazilian citizen”, says a statement signed by the director-president of Anvisa Anvisa, Antônio Barra Torres. He added that he hoped that “other vaccines are soon being evaluated and approved.”
The definitive registration, which is the agency’s standard, allows the application in the entire population and the commercialization of the immunizer. The emergency authorization, created in December by Anvisa precisely to speed up the analysis of vaccines against the new coronavirus, allows vaccination of only a specific group. The overall effectiveness of the immunizer is 95%.
With the approval of the registration, the Pfizer vaccine can be applied to people over 16 years of age (inclusive), through 2 doses with an interval of 21 days between them. The immunizers of Sinovac and AstraZeneca, already adopted in Brazil, can only be applied to individuals over 18 years old. Last Thursday, Pfizer announced the start of testing its formula on pregnant women.
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The federal government has been negotiating the purchase of the vaccine with Pfizer since last year, but has complained about the conditions imposed by the company. President Jair Bolsonaro and Health Minister Eduardo Pazuello mainly criticize the requirement of exemption from liability in relation to possible side effects. Bolsonaro went so far as to say that the pharmaceutical company could not be held responsible if someone who took the vaccine turned into an “alligator”.
However, Pfizer said, in a meeting with senators on Monday, that it maintains the requirement of the clause. After the meeting, Senate President Rodrigo Pacheco (DEM-MG) suggested legislative changes to resolve the impasse. Among them is the possibility of allowing the participation of states, municipalities and the private sector in the acquisition of immunizers
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In January, a note released by the Ministry of Health stated that the requirements imposed by Pfizer were “leonine and abusive”. The ministry also said that the number of doses offered to Brazil was insufficient. The company’s forecast at the time was to supply two million doses in the first quarter of 2021.
The government even signed a memorandum of understanding, a step before signing the contract, with Pfizer for the acquisition of 70 million doses, but the agreement has not progressed.
Negotiation with the Civil House
On Sunday, the Ministry of Health released a note stating that it asked the Civil House for guidance on how to proceed with the deal with Pfizer and another company, Janssen. According to the folder, the expectation is that the Civil House will send a manifestation on the subject until Friday. The ministry claimed that the “lack of flexibility for companies” was holding back negotiations.
Although the Ministry of Health, when passing the baton to the Plateau, justified “legal limitations” to proceed with the negotiation with Pfizer, documents show that the government itself contradicted an internal legal opinion and excluded from a provisional measure (MP) a section that solved the issue.
In a previous version of MP 1026, which was published in January and is due to be voted on soon, the text provided that the government would be responsible for any adverse events caused by the vaccine. The wording even allowed private insurance to be taken out to cover the risks, but was excluded from the final text.
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An opinion from the Legal Counsel of the Office of the Comptroller General of the Union, sent on December 23 to support the MP, stated that the clause related to the responsibility of the Union for the risks of the vaccine was “undoubtedly constitutionality”, contradicting the recent claim by the Ministry of Health of that there would be “legal limitations” to proceed with the negotiation.
After the approval of the registration of Pfizer by Anvisa, the pharmaceutical company released a note stating that it expects the negotiations with Brazil to advance and that it received the agency’s decision with “enthusiasm”.
“We would like to congratulate the agency for the speed and professionalism it has shown in all stages of this process,” said the president of Pfizer Brasil, Marta Díez, in the statement. from the country”
Pfizer and BioNTech bet on messenger RNA (mRNA) technology, which is based on synthetic genes that can be generated and manufactured in a matter of weeks and produced on a scale faster than conventional vaccines. The RNA contained in the vaccine carries the genetic information of protein S, also known as spike, which the virus uses to invade human cells.
Once inside the body, the vaccine triggers the production of this protein that acts as an antigen, stimulating the immune system to identify and fight the virus.
According to Pfizer, the vaccine developed in partnership with BioNTech was tested 44 thousand volunteers in five countries besides Brazil: South Africa, Germany, Argentina, United States and Turkey. On Brazilian soil, 2,900 people were accompanied by the São Paulo Center for Clinical Investigation (Cepic), in São Paulo, and by the Irmã Dulce Assistance Works, in Salvador.
In December, a study published in the prestigious medical journal New England Journal of Medicine (NEJM) validated the efficacy data obtained from trials by Pfizer and BioNTech. According to the study, the immunizing agent achieved 95% protection in all groups of volunteers, regardless of gender, age, ethnicity, weight and comorbidities.
A preliminary study carried out in Scotland and published last Monday indicates that the vaccine was able to reduce hospitalizations for Covid-19 by 85% four weeks after the first dose. A second survey carried out in Israel among health professionals and published in Lancet magazine indicated an 85% protection in the first inoculation.
The formula is already adopted in dozens of countries, including South American neighbors like Chile, and is part of the Covax Facility, an initiative led by the World Health Organization (WHO). However, the need to store the vaccine in ultra-cold refrigerators at -75 ° C and transport in special boxes with dry ice represent logistical obstacles even for first world countries.
Last Friday, Pfizer and BioNTech presented to the Food and Drug Administration (FDA), the United States health regulator, complementary studies that signal the possibility of storing vaccines at higher temperatures, at -25 ° C, although still below the temperature required by the label of competitors such as CoronaVac and AstraZeneca (from 2 ° C to 8 ° C).
Transport would no longer depend on the need for dry ice and would be facilitated, in addition to allowing the allocation of a greater number of doses on airplanes, for example. The measure, however, still depends on FDA analysis.