Anvisa authorizes clinical study by Inovio Pharmaceuticals

The National Health Surveillance Agency (Anvisa) authorized today a clinical trial of the INO-4800 vaccine against covid-19 in Brazil. The clinical trial is sponsored by the American Biotechnology company Inovio Pharmaceuticals and the immunizing agent will be administered intradermally (ID).

According to the regulatory agency, the trial is a Phase 3, placebo-controlled trial. One in three volunteers will receive a placebo to assess the vaccine candidate’s safety, immunogenicity, and efficacy. At the vaccine application site, a facilitation technique for DNA entry into cell tissue (electroporation) with a specific device will be used.

The study foresees the application of two doses with an interval of 28 days in volunteers over 18 years old. The protocol estimates the participation of 350 volunteers in Brazil distributed among the states of Rio de Janeiro, São Paulo, Santa Catarina and Rio Grande do Sul.

In addition to Brazil, the trial has 7,116 participants also distributed in Argentina, Colombia, United States, Philippines, Mexico, Peru, Poland, Czech Republic and Thailand. Initial Phase 1 and 2 studies were conducted in the United States, South Korea and China.