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The Oswaldo Cruz Foundation (Fiocruz) articulates the import of 2 million ready-made doses of the vaccine developed by the University of Oxford and by the pharmaceutical company AstraZeneca to start the immunization schedule against covid-19 already this month. The Brazilian laboratory also informed the National Sanitary Surveillance Agency (Anvisa) that it will request the endorsement for the emergency use of the product next week.
In a letter dated December 31, 2020, Fiocruz requests Anvisa to release the exceptional import of these doses. The information was released by the magazine see and confirmed by Status. Imports of this type are generally evaluated at a meeting of the agency’s collegiate council, which is made up of five members.
The idea of the Brazilian laboratory was only to deliver ready vaccines in February. In the previous month, the pharmaceutical input for the vaccine would arrive in Brazil, which will have the final stages of production carried out at Fiocruz. The laboratory told Anvisa, however, that it is looking for ways to anticipate the delivery of the finished product, “considering the serious health situation” and the “acceleration in the number of deaths associated with covid-19.” Therefore, the strategy moved to take some fully prepared doses abroad.
The United Kingdom authorized on December 30 the emergency use of the Oxford / AstraZeneca vaccine against the new coronavirus, in a regimen of two full doses, with an interval of one to three months. In the letters sent to Anvisa, Fiocruz does not inform how many people it intends to immunize out of the two million doses, nor the expected date for the start of the campaign. The Ministry of Health says that, in the best scenario, vaccination begins on January 20 in the country.
Anvisa estimates that it will evaluate requests for the use of emergency vaccines in a maximum of ten days. The director responsible for the vaccines area, Meiruze Fritas, said, in an interview with Status, that the guarantee can be given even earlier, since the data already presented by the pharmacists will be taken into account. With this permission, it is possible to start vaccination in groups restricted by the SUS, such as health professionals or the elderly.
The vaccine that will be manufactured at Fiocruz is the commitment of the government of Jair Bolsonaro against covid-19. The idea is to distribute 210.4 million doses in 2021, which would serve to immunize more than 105 million people. The government invested about R $ 2 billion to buy doses and transfer technology to Fiocruz. In the national immunization plan, the government plans to apply doses of this vaccine to around 50 million Brazilians in priority groups in the first half of the year.
“These vaccines will be supplied by the Serum Institute of India, Fiocruz’s technological partner, PNI supplier and a central player in the global production and distribution of this vaccine, including through the COVAX initiative. However, to carry out this operation it is necessary to obtain prior authorization from Anvisa to import this vaccine in an exceptional manner ”, informs Fiocruz to the agency. When requesting the release of the import, the laboratory puts it as justification of the “health emergency situation that requires the start of vaccination in the shortest possible time.”
Lack of transparency in the disclosure of clinical trial data and a dosage error that led to two results of effectiveness of this vaccine: 62% when applied in a two full dose regimen and 90% with a half dose followed by a complete – expert generated questions.
Responsible for coordinating the clinical study of the vaccine in Brazil, said Dr. Lily Yin Weckx to the Status that the first dose of the vaccine already shows about 70% effectiveness against the disease, but in a short interval.
“We can still have an average efficiency of 70%. The study continues, we will have a segment year to see the persistence of protection, antibodies, security, etc. The important thing is that we have a safe and effective vaccine that can make a difference in the pandemic. These figures of 60%, 70%, 80% are protection against covid disease. But if we consider serious illnesses and hospitalization, the vaccine was almost 100% preventable. Among the people who were vaccinated, none had a serious illness or were hospitalized for covid. All hospitalizations occurred in the control group, ”said the doctor.
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