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CoronaVac, an inactivated whole-virus COVID-19 vaccine, was widely distributed in national campaigns worldwide based on Phase 1 and 2 clinical trial data. In a Phase 3 trial in Turkey, >10,000 participants in two cohorts (healthcare workers and the general community; age range, 18–59) were randomized to receive two doses of vaccine or placebo 28 days apart. Starting 14 days after the second dose (median follow-up, 43 days), 32 and 9 cases of symptomatic SARS-CoV-2 infection occurred in the placebo and vaccine groups, respectively (efficacy, 83%). Six COVID-19 cases were hospitalized, all in the placebo group. The vaccine was generally well tolerated, and 90% of participants had detectable receptor-binding domain–specific antibodies after two doses.
In a study in Chile (where CoronaVac was the predominant vaccine in the national campaign), investigators assessed the vaccine's effectiveness at preventing COVID-19 and its sequelae. In a prospective observational cohort including 80% of the Chilean population, all persons aged ≥16 were enrolled and categorized by receipt of one, two, or no doses vaccine. From February to May of 2021 among those who received two doses, CoronaVac's preventive effectiveness was 66% (COVID-19), 88% (hospitalization), 90% (intensive care unit admission), and 86% (death); all percentages were somewhat higher among those who sought SARS-CoV-2 testing.
Tanriover MD et al. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): Interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet 2021 Jul 8; 398:213. (https://doi.org/10.1016/S0140-6736(21)01429-X)
Jara A et al. Effectiveness of an inactivated SARS-CoV-2 vaccine in Chile. N Engl J Med 2021 Jul 7; [e-pub]. (https://doi.org/10.1056/NEJMoa2107715)
Comment
The efficacy study was conducted primarily in young, healthy persons, raising questions about generalization (especially regarding older patients and those with underlying illnesses). The effectiveness study included older, sicker patients and the vaccine was shown to be effective; however, it was administered and evaluated at a time when the Alpha and Gamma variants circulated in Chile. Moreover, given the relatively low levels of antibodies elicited by CoronaVac, continued vigilance is needed. More data from other countries will help public health authorities understand this vaccine's future role as resistant SARS-CoV-2 variants emerge.