The Brazilian National Regulatory Agency, Anvisa, has given approval to a Phase III clinical trial sponsored by Instituto Butantan to test the efficacy and safety of the inactivated Covid-19 vaccine developed by Sinovac Life Sciences.
This study aims to be a pivotal study to support the licensure of the vaccine.
Sinovac Life Sciences is a wholly owned subsidiary of the biopharmaceutical products provider in China.
The Brazilian regulatory agency’s process review included manufacturing and clinical information that was produced by Sinovac, and a clinical development plan and trial protocol developed by Butantan.
Given the current public health emergency, the agency fast-tracked the application.
The study will see recruitment of almost 9,000 healthcare professionals working in Covid-19 facilities in twelve clinical sites across several states of the country.
The inclusion of participants in the trial will begin this month following the receipt of ethical approval from each clinical site.
Butantan Director of Instituto Dr Dimas Covas said: “The Phase III clinical trial approval is a demonstration that the Sinovac and Butantan partnership is an efficient collaboration to move forward offering hope to save lives worldwide.”
Sinovac chairman, president and CEO Weidong Yin said: “We are pleased to advance to Phase III trials with Butantan, which will allow us one step further to our commitment to developing vaccines for global use and to our mission of supplying vaccines to eliminate human diseases.”
Sinovac Life Sciences commenced the development of an inactivated vaccine candidate against Covid-19, called CoronaVac on 28 January this year.
On 13 April, the National Medical Products Administration gave approval for Phase I and II clinical trials in China, which commenced on 16 April in Jiangsu Province.
The healthy adults, aged between 18 and 59, were given the vaccines with a 14 day schedule.
The preliminary Phase I/II results found that there was no serious adverse event after 743 volunteers in the trials were given the vaccines.
More than 90% seroconversion was found in the second phase of clinical trial, 14 days after completion of a two-dose vaccination at day zero and day 14.
A Phase II study on elderly adults is being carried out, followed by a study on child and adolescent groups.
This phase is expected to be completed at the end of this year.
The firm has teamed up with many firms outside of China for Phase III efficacy studies.