Brazil to start clinical trials for new COVID-19 jab

BRASILIA. KAZINFORM - Brazil’s drug regulator Anvisa today (Oct 3) authorized the start of clinical trials on SpiN-Tec, a potential vaccine against COVID-19. SpiN-Tec is a recombinant chimeric protein that uses the SpiN protein, developed by the Vaccine Research and Production Center of the Federal University of Minas Gerais, Agencia Brasil reports.

In its assessment, the agency reviewed data from previous stages of product development, including non-clinical in vitro and animal studies as well as preliminary figures from ongoing clinical tests. The results so far have shown an acceptable safety profile for the potential inoculation.

This is the first time the product will be tested in humans. The process will be divided into two parts—the first on dose escalation, on the safety and reactogenicity of SpiN-Tec, and phase two on its safety and immunogenicity.

«The clinical trial will include healthy participants of both sexes, aged 18 through 85, who have completed their primary vaccine scheme with Coronavac or Covishield (Astrazeneca/Oxford) and have received one or two booster doses with Covishield or Comirnaty (Pfizer) at least six months ago,» Anvisa stated.

Photo: Agencia Brasil