Vaccination against Covid-19 in Salvador (BA) Betto Jr/Secom/Disclosure
One of Brazilian candidates for the vaccine against Covid-19RNA MCTI CIMATEC HDT received authorization from the National Health Surveillance Agency (Anvisa) to advance to phase 2 clinical trials this Friday, 7th. The immunizing agent is being developed through a partnership between Senai Cimatec from Salvador (BA), the North American company HDT Bio Corp and Gennova Biopharmaceuticals Ltd., from India. The global development plan is supported by the Ministry of Science, Technology and Innovation (MCTI).
The immunizer uses a technology called RNA replicon (repRNA). “The repRNA platform differs from available messenger RNA (mRNA) vaccine platforms in the potential to generate more robust immune responses, inducing long-term protective immunity and at lower dose levels, with the potential for single-dose application,” he explained. , in a note, to Anvisa.
The study, which will be randomized, double early and multicenter, will compare the vaccine candidate with immunizers from Pfizer and Oxford/AstraZeneca, approved in Brazil, for the evaluation of safety and immunogenicity (ability to stimulate the production of antibodies).
At this stage of the research, the goal is to include 300 volunteers between 18 and 65 years old of both sexes. In the case of women, pregnant and lactating women will not be recruited. Phase 1 was approved in October last year and started in January of this year.
Anvisa reported that the authorization took into account data from previous stages of vaccine development, such as in vitro studies, in animals and clinical studies in progress. “The results obtained to date have demonstrated an acceptable safety profile of the candidate vaccine.”
Clinical trials, performed on humans, have three phases that assess the safety and effectiveness of a product so that it can receive regulatory agency approval for mass use.
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