RIO DE JANEIRO, BRAZIL – The Albert Einstein Hospital’s Instituto Israelita de Ensino e Pesquisa (Israeli Institute of Teaching and Research) is expected to begin in March Phase 3 trials of the Covaxin vaccine for a period ranging from 45 to 90 days, with results scheduled for May. Approximately 3,000 volunteers will be tested in five reference centers. The vaccine is being developed in India by the Bharat Biotech laboratory.
According to Gláucia Vespa, an immunologist and researcher, Coxavin is an inactivated whole virus vaccine and presents common side effects. “Side effects will be determined in the Phase 3 clinical trials. The data observed so far suggest that the vaccine is well tolerated and safe, with the typical side effects of routine inactivated vaccines.”
The locations where the vaccine will be tested have not yet been determined. “We are finalizing a contract with five treatment centers across Brazil. There will be 3,000 volunteers, with competitive inclusion. In other words, it will depend on selection in the recruitment process and inclusion of centers,” he said.
Volunteers do not need to be healthcare professionals, only over 18 years old, with no history of Covid-19. Two doses of the vaccine will be administered, at a 28-day interval.
Despite Wednesday’s decision by the Brazilian Health Regulatory Agency ANVISA not to demand Phase 3 trials conducted in Brazil for emergency use authorization in the country, researcher Glaucia Vespa said the Institute’s goal is to establish the country as a known resource in the segment, as well as to increase access to vaccines.
“The Einstein believes that conducting clinical trials with candidate vaccines provides greater expertise to Brazilian clinical research centers, thereby establishing the country as a recognized specialist in the segment, and offers advantages to volunteers, who will be administered the vaccine immediately after completion of tests for its efficacy, as well as increasing access to vaccines for the population at this critical time of the pandemic,” said the researcher.