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BRASÍLIA – The National Sanitary Surveillance Agency (Anvisa) authorized the inclusion of more than 5,000 volunteers in studies of the Oxford vaccine in Brazil. As a result, the total number of test participants in the country could reach 10,000 people. The trials are expected to spread to two more states: Rio Grande do Norte and Rio Grande do Sul. Today, studies of the Oxford vaccine in Brazil involve around 5,000 participants in Rio de Janeiro, São Paulo and Bahia.
Anvisa also authorized the extension of the age range of volunteers to more than 69 years. The request to expand the participants was made by AstraZeneca, the laboratory that sponsors the development of the vaccine.
The tests were even suspended on the last day 6 after a possible reaction presented by a volunteer in the United Kingdom. On Saturday, however, the University of Oxford, which is conducting the experiments, announced the resumption of the tests. Anvisa also authorized the continuity in Brazil the same day.
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Anvisa stated, in a note, that requests for volunteer expansion and other changes in clinical trials are common. The agency cites as an example an alteration authorized last week in another vaccine investigation, conducted by Pfizer-Wyeth, which requested the inclusion of a new manufacturing site for the substances used in the tests.
“These changes are related to the objective of the research, which is to produce solid data on the performance of each product and better understand its effects on different population groups,” highlights Anvisa.
