Retrospective study of the immunogenicity and safety of the CoronaVac SARS-CoV-2 vaccine in people with underlying medical conditions

Background People living with chronic disease, particularly seniors (≥60 years old), made up of most severe symptom and death cases among SARS-CoV-2 infected patients. However, they are lagging behind in the national COVID-19 vaccination campaign in China due to the uncertainty of vaccine safety and effectiveness. Safety and immunogenicity data of COVID-19 vaccines in people with underlying medical conditions are needed to address the vaccine hesitation in this population. Methods We included participants (≥40 years old) who received two doses of CoronaVac inactivated vaccines (at a 3–5 week interval) and were healthy or had at least one of 6 common chronic diseases. The incidence of adverse events after vaccination was monitored. Vaccine immunogenicity was studied by determining neutralizing antibodies and SARS-CoV-2-specific T cell responses post vaccination. Results Here we show that chronic diseases are associated with a higher rate of mild fatigue following the first dose of CoronaVac. By day 14–28 post vaccination, the neutralizing antibody level shows no significant difference between disease groups and healthy controls, except for people with coronary artery disease (p = 0.0287) and chronic respiratory disease ( p = 0.0416), who show moderate reductions. Such differences diminish by day 90 and 180. Most people show detectable SARS-CoV-2-specific T cell responses at day 90 and day 180 without significant differences between disease groups and healthy controls. Conclusions Our results highlight the comparable safety, immunogenicity and cellular immunity memory of CoronaVac in seniors and people living with chronic diseases. This data should reduce vaccine hesitancy in this population. Plain language summary People living with chronic diseases, particularly those over the age of 60, are more likely to have severe symptoms and die following SARS-CoV-2 infection. However, many have not been vaccinated during the national COVID-19 vaccination campaign in China due to concerns about vaccine safety and effectiveness. Here we show that the inactivated COVID-19 vaccine, CoronaVac, is as safe in older people with chronic diseases as it is for healthy people. Also, only slightly differences are seen in the immune response of people with diseases compared to healthy people. Overall, our results highlight that the CoronaVac vaccine is safe and effective in people living with chronic diseases. Li et al. evaluate the immunogenicity and safety of the CoronaVac ina