RIO DE JANEIRO, BRAZIL – The Covaxx, a Covid-19 vaccine under the management of the American biopharmaceutical company United Biomedical, should begin trials in Brazil in January. The phase 2 and 3 trials will be coordinated by Dasa laboratory, specialized in diagnostic medicine.
The plan is to submit an authorization request to ANVISA, Brazil’s National Health Regulatory Agency, to conduct the study in early 2021. Authorization by the agency should take no more than 72 hours in the current pandemic scenario. As soon as it is cleared, this will be the fifth vaccine in phase 3 (the most advanced) tested for Covid-19 in Brazil.
The immunizer will be tested in at least 3,000 volunteers in about five study centers in different areas of Brazil. The study will recruit adults and elderly with and without comorbidities for Covid-19. It has not yet been determined if the studies will be restricted to healthcare professionals, but there will be an exclusive trial for people with high exposure to the virus, such as public security professionals.
Thus far, approximately R$30 (US$5.6) million have been raised to conduct phase 2 and 3 trials, but this figure may increase significantly, particularly if the number of volunteers suffers a change. According to Dasa, the process is very advanced, with guidance meetings having been held with ANVISA, and with the required protocols for the submission of completed studies. Some details have yet to be completed, such as determining whether the study will involve one or two doses of the immunizer or the placebo.
To align the study terms, weekly meetings are held between the Brazilian and American companies by video call. The study is expected to run for 24 months, but preliminary results should be available in 2021. Phase 1 trials are being conducted in Taiwan. The study’s pre-clinical phases have produced promising results, says the company’s press release.
“Dasa had a relationship with United Biomedical. When they began to develop this vaccine they called us to discuss it. We think this partnership makes sense, we have a good structure for it. The moment we are experiencing will leave a legacy for the scientific community in Brazil, we will emerge from this more relevant,” says Gustavo Campana, Dasa medical director.
A total of 100 million Covaxx doses should be produced in the first four months of 2021. Around 10 million should be directed to private laboratories and 50 million to the public network. The company says that it is possible to quickly increase production because the drug does not contain parts of the novel coronavirus (which requires virus culture) in its production, as it is a synthetic immunizer, produced from peptides that trigger the body’s immune response.
United Biomedical, Inc. is located in Hauppauge, NY, and is part of the Medical & Diagnostic Laboratories Industry. The company has 285 total employees across all of its locations and generates US$22.28 million in sales.
UBI is a privately held multinational biopharmaceutical company dedicated to the discovery, development and commercialization of immunotherapeutics and vaccines for chronic and infectious diseases.
Source: Veja