Anvisa (National Health Surveillance Agency) published this Monday (3) approval for a clinical trial that will study SpiN-Tec, a vaccine candidate for Covid-19. SpiN-Tec is a recombinant (masked) chimeric protein that uses the SpiN protein developed by CT Vacinas at UFMG (Center for Vaccine Research and Manufacturing at the Federal University of Minas Gerais).

New immunization candidate to enter human trial phase — Photo: Ricardo Wolffenbüttel/Secom/Disclosure/ND

The Agency considered data from earlier stages of product development, including non-clinical in vitro and animal studies, as well as preliminary data from ongoing clinical trials, for approval.

According to Anvisa, these are clinical trials in which the investigational product will be used in humans for the first time.

The trial will consist of two parts: “Phase 1 clinical trial with dose escalation to test the safety and reactogenicity of the product; and another Phase 2 clinical trial to study the safety and immunogenicity of SpiN-Tec.”

“The clinical trial will involve healthy participants of both sexes aged 18 to 85 years who have completed a course of primary vaccination with Coronavik or Covischild (Astrazeneca/Oxford) and received one or two booster doses of Covischild or Comirnati (Pfizer) for at least six months.” , Anvisa said.

The study will be funded by UFMG, MCTI (Ministry of Science, Technology and Innovation), Fiocruz (Fundação Oswaldo Cruz) and the city of Belo Horizonte.

The UK has a better scenario for dealing with Covid-19

Santa Catarina continues to record an improvement in the Covid-19 pandemic. As in the previous period, the third week of September recorded the best epidemiological scenario in 2022, according to the Necat/UFSC newsletter (Núcleo de Estudos de Economia Catarinense at the Federal University of Santa Catarina).

Between September 17 and 23, the SES (Santa Catarina Health Department) detected 2,640 new cases of Covid-19, 718 fewer entries than the previous “best moment” week.

According to Agência Brasil