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Brazilian health authorities reported this Wednesday of the death of a volunteer participating in the trials of the vaccine against Covid-19 at the University of Oxford and the AstraZeneca laboratory, although they did not specify in what form, or if he received the dose or a placebo.
The National Sanitary Surveillance Agency (Anvisa), linked to the Brazilian Ministry of Health, noted in a note that was “formally informed” of the event last Monday and that your “evaluation” will follow.
“Based on the ethical confidentiality commitments provided for in the protocol, the regulatory agencies involved receive partial data regarding the investigation” carried out by the International Committee on Evaluation and Safety, the body indicated.
The president of Anvisa, Antonio Barra, said in a press conference that “At this time” clinical trials of the British vaccine “continue” in the country.
Clinical trials of the potential British vaccine began in Brazil in June with the idea of involving some 10,000 people, and only suffered a small interruption in September, when an adverse reaction from a volunteer was reported.
Finally, Oxford explained in a statement that the death was the subject of a “careful evaluation” in which no elements were found that raise concerns about the safety of the vaccine.
“The independent review, in addition to the Brazilian regulator, have recommended that you follow the trial“, highlighted the university in its note.
Experts working on this vaccine are optimistic that it could receive regulatory approval by the end of the year, allowing UK adults to be vaccinated by April 2021, the newspaper reported. The times.
Your identity is kept secret
The Federal University of Sao Paulo (Unifesp), which coordinates the vaccine tests in the country -which is in the last phase of testing and is one of the most promising-, according to the World Health Organization, has not yet stated about the death of the volunteer, about which no details are known.
“Anvisa reiterates that, according to the national and international regulations of Good Clinical Practices, data on clinical research volunteers must be kept secret, in accordance with the principles of confidentiality, human dignity and protection of the participants, “he stressed.
Due to its continental dimension and the high incidence of the virus within the national territory, Brazil has become fertile ground for the testing of candidate vaccines against Covid-19, which is why those developed by the Johnson & Johnson laboratories and the consortium formed by BioNTech (Germany) and Wyeth / Pfizer (United States), as well as the one manufactured by the Chinese company Sinovac.
