BRAZIL. KAZINFORM – Brazilian drug regulator Anvisa (October 3) authorized the start of clinical trials of SpiN-Tec, a potential vaccine against COVID-19. SpiN-Tec is a recombinant chimeric protein that uses the SpiN protein, developed through the Vaccine Research and Production Center of the Federal University of Minas Gerais, reports Agencia Brasil.
In its evaluation, firm knowledge of past stages of product development, adding non-clinical in vitro and animal studies, as well as initial figures from ongoing clinical trials. So far, the effects have shown an adequate protective profile for prospective inoculation.
This is the first time the product will be tested in humans. The procedure will be divided into two parts: the first on dose increase, on the protection and reactogenicity of SpiN-Tec, and two on its protection and immunogenicity.
“The clinical trial will come with healthy participants of both sexes, aged 18 to 85, who finished their number one vaccination program with Coronavac or Covishield (Astrazeneca/Oxford) and gained one or two booster doses with Covishield or Comirnaty (Pfizer) at least six months ago,” Anvisa said.
Photo: Agencia Brasil