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The National Health Surveillance Agency (Anvisa) authorized, on Tuesday (15), another 5,000 volunteers to participate in the step 3 of the clinical study of the Oxford vaccine in Brazil. With this permission, the country will have 10,000 volunteers in the last stage of testing the immunizer against Covid-19 developed by the university in partnership with the pharmaceutical company AstraZeneca.
The profile of the volunteers remains the same, the novelty is that now there will be no more age limit and those over 70 will have priority. Three new test application centers will also open in Brazil.
According to the Federal University of São Paulo (Unifesp), the recruitment of volunteers and the application of the vaccine will be carried out in Natal (RN), by the Centro de Investigaciones Clínicas de Natal (CPCLIN), in Porto Alegre (RS), by the Federal University. Rio Grande do Sul (UFRGS), and in Santa Maria, also in RS, by the Federal University of Santa Maria (UFSM).
The other three existing centers, in São Paulo, Rio de Janeiro and Bahia, will continue to receive volunteers.
Not there will be an exact division of the number of volunteers at each location. A free contract will be made until reaching the 5,000 selected. Adults over 18 years of age who are:
- Healthcare professionals acting directly on the front lines of the fight against covid-19
- workers working in high-risk environments exposure to the new coronavirus, such as ambulance drivers, hospital security guards, and cleaning agents in these establishments
“We include in this phase people who are known to be at increased risk of complications from Covid-19, and therefore the study may reflect reality even more. This, in addition to greatly increasing the number of participants, which will provide even more robustness in the analysis of data related to the safety and efficacy of the vaccine “, says Professor Lily Weckx, coordinator of the Reference Center for Special Immunobiologicals (Crie / Unifesp), responsible for leading the study of the Oxford vaccine in Brazil.
According to the study leader in Brazil, testing in people older than 70 years will now be prioritized because this age group was included in the survey only on August 21, after the safety of the vaccine was proven with the tests in age groups. newer.
“When the age limit passed, we were already finishing up the volunteer trials, so few older people got it,” says Lily. “It’s important that they get tested because if the vaccine comes out, we will certainly give priority to the elderly. They will be the target audience for the vaccination ”, explains the Unifesp coordinator.
- SPECIAL: Meet the Covid-19 Vaccine Candidates
With the authorization of Anvisa, starting this Tuesday, the participating centers will be able to start the process of recruiting new volunteers. As with the other 5,000 already recruited, all receive two doses of the vaccine and be closely monitored by researchers.
According to the researcher, in the next two or three months the five thousand new participants should already have received the vaccine. “We have to remember that after that, they will still be followed for a year,” says Lily.
Oxford Covid-19 vaccine tests return in Brazil on Monday, says lab
On Saturday (12), AstraZeneca announced the general resumption of the tests, which had been suspended, but did not detail the conclusions about the case of alleged adverse effects in a volunteer.
The vaccine test was suspended worldwide last Tuesday (8), after a participant presented a health condition that could be related to the vaccine.
Scientists reported that No cause and effect relationship was found between the vaccine and the patient’s symptoms..
Anvisa received official information from the British government and the laboratory on the case of volunteers on Saturday and the same day announced that the resumption of tests in Brazil was approved.
Anvisa approves the resumption of clinical trials of the British vaccine against Covid-19
Oxford University Announces Resumption of Covid Vaccine Testing
Nine vaccines in the last phase of testing
In addition to the Oxford University candidate with British pharmaceutical company AstraZeneca, eight more vaccines are in the third and final phase of human testing, the last before launch.
- Janssen Pharmaceutical Companies (USA)
- Moderna / National Institute of Allergy and Infectious Diseases (USA)
- BioNTech / Fosun Pharma / Pfizer (Germany and USA)
- Sinovac (China)
- Wuhan / Sinopharm Institute of Biological Products (China)
- Beijing Institute of Biological Products / Sinopharm (China)
- CanSino Biological Inc./ Beijing Institute of Biotechnology (China)
- Gamaleya Research Institute (Russia)
