RIO DE JANEIRO, BRAZIL – The Brazilian health regulatory agency ANVISA on Wednesday (14) announced that it granted authorization for clinical trials in Brazil of two potential vaccines against Covid-19, one developed by the Chinese Academy of Medical Sciences’ Institute of Medical Biology and the other by AstraZeneca, a new version of the manufacturer’s immunizer currently administered in Brazil.
According to the health regulator’s note, the potential immunizer developed in China uses inactivated vaccine technology and trials will cover Phase 3 – to assess the vaccine’s efficacy, safety and immunogenicity. The immunizer will be administered in two doses at a 14-day interval.
In addition to Brazil, trials will be conducted in China and in other countries with 34,020 volunteers. There will be 7,992 volunteers in Brazil in the states of Goiás, Rio de Janeiro, Santa Catarina, and São Paulo.
The new version of AstraZeneca’s vaccine uses recombinant adenovirus vector technology, the same as its immunizer produced in partnership with Oxford University and currently used in Brazil.
The potential new vaccine is a modified version of the existing immunizer, designed to provide immunity to the coronavirus variant that emerged in South Africa, ANVISA said.
Phase 2/3 trials to determine the vaccine candidate’s safety and immunogenicity will be administered in a single dose to people who have already received two doses of AstraZeneca’s current vaccine or another immunizer using messenger RNA technology.
It will also be tested as a two-dose immunizer on people who have not yet been vaccinated and as a second dose for those who have been administered a first dose of the current vaccine.
This study will be conducted with 2,475 volunteers in Brazil, the United Kingdom, South Africa, and Poland. In Brazil, it will include 800 volunteers in the states of Bahia, Federal District, Paraná, Rio Grande do Norte, Rio Grande do Sul, and São Paulo.