Brazilian COVID vaccine enters final phase of trials
Brazil is close to having a fully national COVID vaccine. The country has published its first scientific article on safety test results for the SpiN-TEC vaccine, which indicate that it is safe. The vaccine is now entering the final phase of clinical trials and is expected to be available to the population by early 2027.
The vaccine was developed by the Vaccine Technology Center (CT-Vacinas) at the Federal University of Minas Gerais (UFMG), in partnership with the Ezequiel Dias Foundation (Funed), and funded by the National Fund for Scientific and Technological Development (FNDCT).
Ricardo Gazzinelli, researcher and coordinator of CT-Vacinas, stated that tests showed SpiN-TEC had even fewer side effects than the vaccine developed by the American company Pfizer.
“We concluded that the vaccine is immunogenic, meaning it can induce an immune response in humans. The safety study was expanded, and this profile was maintained. In fact, it performed slightly better, causing fewer side effects than the Pfizer vaccine we currently use,” says the researcher.
SpiN-TEC uses an innovative strategy: cellular immunity. This means it prepares the body’s cells to resist infection. If infection occurs, the vaccine enables the immune system to target and destroy only the affected cells. This approach has proven more effective against COVID-19 variants in animal trials and preliminary human data.
Clinical trials
In total, the Ministry of Science, Technology, and Innovation (MCTI) invested BRL 140 million in the vaccine’s development through RedeVírus, supporting all stages of testing, from preclinical trials to clinical phases 1, 2, and 3.
Phase 1 of the study involved 36 volunteers aged 18 to 54 and aimed to assess the safety of the vaccine at different dosages. Phase 2 included 320 volunteers. Researchers are now awaiting authorization from Brazil’s national drug regulator Anvisa to begin phase 3, which is expected to involve approximately 5,300 volunteers from across Brazil.
Gazzinelli says this is also a milestone for Brazil. The country has “an almost complete vaccine ecosystem,” he adds, with research at universities, vaccine production facilities, and distribution through Brazil’s public healthcare network, the SUS.
“What we don’t have is exactly this transition from university research to clinical trials. There’s no example of this in Brazil. Clinical trials are usually conducted with products developed abroad - ideas and vaccines conceived elsewhere. This, however, is an example of a vaccine conceived in Brazil and taken to clinical trials,” he explains.
Gazzinelli points out that this is an important step for other research as well. “I believe this adds expertise we didn’t have before and is a crucial development not only in vaccine technological innovation but also for other healthcare products,” he says.
If it is approved in all phases of the study, the Brazilian vaccine is expected to be available through the SUS by early 2027, according to the researcher.
