RIO DE JANEIRO, BRAZIL – Sinovac Biotech announced Wednesday, June 30, that its Covid-19 vaccine Coronavac – manufactured in Brazil by Instituto Butantan – is safe in children 3 years of age and older and also elicits a strong immune response in 96% of participants.
The combined Phase 1 and Phase 2 trial, which used a randomized double-blind design, enrolled 552 young volunteers aged 3 years and older, with two doses given 28 days apart.
The Chinese pharmaceutical company’s test results were published in the journal The Lancet Infectious Diseases.
China previously granted emergency approval of the vaccine for the 3-to-17-year-old group on June 3 last year. Most adverse effects were mild to moderate and recorded 7 days after each dose. The most common reaction was pain at the injection site (13%).
Coronavac is a first-generation vaccine and uses as its technology the virus itself in an inactivated form, producing an immune response from the body.
The vaccine was approved by the Brazilian National health regulator ANVISA on January 17, making it the first vaccine against Covid-19 to be approved and used in Brazil. On June 2, the World Health Organization (W.H.O.) approved the vaccine.
The Brazilian government has purchased 100 million doses of Coronavac from the Butantan Institute, which has supplied about 60 million so far. Coronavac accounts for nearly 60% of the total Covid-19 vaccines used in the country, with 98 million doses administered in Brazil.