BRASILIA (Reuters) – Brazilian health regulator Anvisa on Wednesday gave the go-ahead for the ButanVac COVID-19 vaccine in development by Sao Paulo’s Butantan Institute biomedical center to be used on volunteers in clinical trials.
Anvisa in a statement said the vaccine will be applied in two doses, 28 days apart. Phase I of ButanVac’s clinical trial will involve 400 volunteers, and the first two phases are expected to involve 6,000 volunteers in total.
In a separate statement, Butantan said the tests will begin in the coming days in Riberao Preto, a city in the state of Sao Paulo.
Butantan said it has around 10 million doses of the ButanVac shot in stock, which will be used to assess the vaccine’s safety and efficacy in the trials. It hopes to have 40 million shots ready for use by October, it added.
The protein-based vaccine uses a chimeric recombinant Newcastle disease virus engineered to carry coronavirus spike proteins that was developed by researchers at the University of Texas at Austin and Icahn School of Medicine at Mount Sinai with support from the U.S. National Institutes of Allergy and Infectious Diseases Vaccine Research Center.
Newcastle, a poultry virus, grows well in egg-based flu vaccine manufacturing facilities, and the vaccine vector, known as NDV-HXP-S, is being produced and tested in several countries under royalty-free licensing agreements. In addition to ButanVac in Brazil, the vaccine is in development in Mexico as the Patria vaccine, and in Thailand where a phase 1/2 trial began recruiting in March.
Brazil registered 54,022 new COVID-19 cases and 1,648 new deaths in the past 24 hours, the Health Ministry said on Wednesday. This brings the total in Brazil to nearly 18.9 million cases and 528,540 deaths.
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