The National Health Surveillance Agency (Anvisa) authorized, this Friday (7), the second phase of the clinical development of the Brazilian vaccine candidate for Covid-19, technically named as RNA MCTI Cimatec HDT.
The immunizer is part of a global development plan that includes the companies HDT Bio Corp (United States), Gennova Biopharmaceuticals (India) and Senai Cimatec (Salvador – BA), supported by the Ministry of Science, Technology and Innovation (MCTI).
The first phase of the study was authorized by Anvisa in October 2021 and started in January this year. According to Anvisa, the schedule for carrying out the clinical development, including the start of each phase of the study, is the responsibility of the developers.
The vaccine candidate uses replicon RNA (repRNA) technology capable of encoding the coronavirus Spike protein, developed by US company HDT Bio Corp.
repRNA technology 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.
The approved clinical trial will make it possible to evaluate the safety and ability to generate an immune response (immunogenicity) compared to two vaccines approved in Brazil, Pfizer and AstraZeneca.
The study must have the participation of 300 volunteers, between men and women, aged between 18 and 65 years and who meet the eligibility criteria of the study.
Criteria for authorization
Anvisa states that, in order to define approval, data from previous stages of product development were analyzed, including non-clinical laboratory studies (in vitro) and in animals, as well as preliminary data from ongoing clinical studies.
According to the agency, the results obtained to date have demonstrated an acceptable safety profile of the vaccine candidate.
About clinical trials
Clinical trials are studies of a new drug or vaccine performed in humans. The clinical phase serves to validate the relationship between efficacy and safety of the product and also to validate new therapeutic indications.
Within this trial, there are three phases (I, II, III), where information on activity, functioning and safety is collected so that the product can be released to the market and used in patients along with the standard treatment of the research.
In order to carry out any clinical research involving human beings, the approval of the Research Ethics Committees (CEPs) or the National Research Ethics Committee (Conep) is mandatory.
Source: CNN Brasil
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