China-based COVID-19 vaccine developer Sinovac Biotech Ltd. (NASDAQ: SVA) inked a clinical development collaboration agreement with a Brazilian producer of immunobiological products called Instituto Butantan to advance clinical trials of CoronaVac, Sinovac’s inactivated vaccine candidate targeting SARS-CoV-2 to Phase III.
TrialSite News provides a breakdown of this material news.
Recently, the company shared promising preclinical results regarding CoronaVac in the peer-reviewed academic journal called Science. The article stated that the vaccine candidate was safe and offers protection to rhesus macaques (monkeys) through an animal challenge study.
What is the experimental vaccine’s status?
The company received approval from China’s National Medical Products Administration (NMPA) to conduct Phase I/II human clinical trials in China to determine the vaccine candidate’s safety, tolerance, dosage, and immunization schedule.
What is the status of vaccine production?
The company is now building a commercial vaccine production plan in China that is expected to manufacture up to 100 million doses of CoronaVac annually.
What does this collaboration involve?
With this deal in place, Instituto Butantan will sponsor Phase III clinical trials in Brazil. The first in a series of agreements, this broader collaboration will also entail technology licensing, market authorization, and commercialization of CornaVac in Brazil should the vaccine prove safe and effective, assuming it ultimately is approved by regulators.
What is the impact of COVID-19 in Brazil?
It is bad. Brazil is second only to the United States in the total number of cases (831,064) and deaths (41,942).
What is the profile of Instituto Butantan?
This Brazilian public institution is a producer of Immunological products and vaccines. They carry out a number of missions domestically and abroad through the Pan American Health Organization, the World Health Organization, UNICEF, and the United Nations. Instituto Butantan collaborates with other agencies in Brazil, such as the Sao Paulo State Secretariat and Brazilian Ministry of Health, for the improvement of overall health in Brazil.
Instituto Butantan partners with various universities, research institutions, pharma companies, and non-profit charitable groups such as the Bill & Melinda Gates Foundation for the achievement of institutional objectives.
Call to Action: Interested in exploring partnerships in Brazil? Visit them at www.butantan.gov.br