Alliance for Pandemic Preparedness

April 2, 2021

Interim Report Safety And Immunogenicity Of An Inactivated Vaccine Against Sars-Cov-2 In Healthy Chilean Adults In A Phase 3 Clinical Trial

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  • [Pre-print, not peer-reviewed] Interim results for the phase 3 clinical trial (n=397) of the SARS-CoV-2 inactivated-virus vaccine CoronaVac (SinoVac BioTech) conducted in Chile indicate the vaccine is safe to use and induces neutralizing antibody production against the SARS-CoV-2 spike protein. Among participants receiving two doses of the vaccine (n=239) or placebo (n=80) 2 weeks apart, no serious adverse events were reported up to 28 days after the second dose, and symptoms resolved within two days. Seroconversion for anti-spike IgG among vaccinated individuals aged 18-59 years was 48% at day 14 and 95% at day 42. Among individuals aged ≥60 years old, seroconversion was 18% at day 14 and 88% at day 42. Neutralizing antibodies were not detected among vaccinated individuals at day 14, but were detected at day 42 in 97% individuals aged 18-59 years and 100% of those age ≥60 years. No significant differences in cell-mediated immunity were observed between the two age groups.

Bueno et al. (Apr 1, 2021). Interim Report Safety And Immunogenicity Of An Inactivated Vaccine Against Sars-Cov-2 In Healthy Chilean Adults In A Phase 3 Clinical Trial. Pre-print downloaded Apr 2 from https://doi.org/10.1101/2021.03.31.21254494