Anvisa (National Health Surveillance Agency) declares that it is analyzing as a priority the proposal to start a phase 3 clinical trial for SpiN-Tec, the first vaccine against Covid entirely developed on Brazilian territory.
According to the agency, the technical sector maintains permanent contact with the UFMG (Federal University of Minas Gerais) to offer advice so that the proposal can be adjusted to meet regulatory requirements that prove safety and effectiveness.
SpiN-Tec is produced by CT Vacinas (National Vaccine Center) and is coordinated by UFMG, with financial support from the Ministry of Science, Technology and Innovation and the City of Belo Horizonte.
The phase 3 clinical trial is the final and most comprehensive step before regulatory approval. The study is expected to involve around 5,000 volunteers in the country to assess the safety of the vaccine on a large scale.
The phase 3 protocol has been under analysis at Anvisa since May, but on the 17th, Finep (financier of studies and projects), linked to the Ministry of Science, Technology and Innovation, and the pharmaceutical company Hipolabor, which is leading the project with CT Vacinas/UFMG, signed a contract that unlocks the resources of 121 million BRL which will be used to carry out phase 3. The resources come from the National Fund for scientific and technological development (FNDCT), managed by Finep.
The innovation agency’s award of the proposal was conditional on proof of completion of Phase 1 and 2 clinical trials and submission of a consent request from Anvisa to start the Phase 3 trial.
According to Finep, the first stages of phase 3 are underway, such as preparation for the production of the IFA (Active Pharmaceutical Ingredient) and the manufacture of the immunizer. The application of the vaccine to volunteers is planned for the second half of 2026.
For the future production of the vaccine, Hipolabor will invest approximately 150 million reais in the construction of a new area at its production plant in Montes Claros (MG).
Phase 2 evaluated the immunogenicity – that is to say the ability to generate an immune response – of the vaccine in a single dose booster regimen after a complete initial regimen with the currently available monovalent vaccines against Covid (Coronavac, Pfizer and AstraZeneca) or with a bivalent booster at least six months ago.
During the studies, which required monitoring 320 volunteers for 12 months, with blood samples and medical consultations, half of the volunteers received a dose of Spin-Tec and the other half of bivalent Pfizer.
SpiN-Tec is formulated from a viral protein, the Spike (molecular hook used by the virus to penetrate cells) modified to induce the production of antibodies without causing infection.
According to those responsible for developing the vaccine, the manufacturing cost of the vaccine produced by CT Vacinas is lower than that of other vaccines on the market, because it is a technology already known to Brazilian public and private pharmaceutical companies.
Another advantage highlighted is the data which indicates that the vaccine remains stable for up to two years in the refrigerator, without requiring logistical costs and storage in freezers.
If phase 3 testing is successful, SpiN-Tec should be made available to Brazilians starting in 2028, according to UFMG.
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