Immunogenicity and safety of the CoronaVac inactivated SARS-CoV-2 vaccine in people with underlying medical conditions: a retrospective study

  1. Chunmei Li
  2. Ao Li
  3. Hanfang Bi
  4. Jun Hu
  5. Fan Yang
  6. Taicheng Zhou
  7. Yupeng Liang
  8. Wei Su
  9. Tianpei Shi
  10. Mei Yang
  11. Rong Wang
  12. Wanting Qin
  13. Zumi Zhou
  14. Jia Wei
  15. Zhenwang Fu
  16. Zijie Zhang

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Abstract

Background

People living with chronic disease, particularly seniors older than 60 years old, are lagging behind in the national vaccination campaign in China due to uncertainty of safety and effectiveness. However, this special population made up of most severe symptom and death cases among infected patients and should be prioritized in vaccination program. In this retrospective study, we assessed the safety and immunogenicity of the CoronaVac inactivated vaccines in people with underlying medical conditions to address the vaccine hesitation in this special population.

Methods

In this cohort study, volunteers aged 40 years and older, had received two doses of CoronaVac inactivated vaccines (3-5 weeks interval), been healthy or with at least one of the six diseases: coronary heart disease (CAD), hypertension, diabetes mellitus (DM), chronic respiratory disease (CRD), obesity and cancer, were recruited from 4 study sites in China. The primary safety outcome was the incidence of adverse events within 14 days after each dose of vaccination. The primary immunogenic outcome was geometric mean titer (GMT) of neutralizing antibodies to living SARS-CoV-2 virus at 14-28 days, 3 months, and 6 months after full two-dose vaccination. This study is registered with ChiCTR.org.cn (ChiCTR2200058281) and is active but no longer recruiting.

Findings

Among 1,302 volunteers screened between Jul 5 and Dec 30, 2021, 969 were eligible and enrolled in our cohort, including 740 living with underlying medical conditions and 229 as healthy control. All of them formed the safety cohort. The overall incidence of adverse reactions was 150 (20.27%) of 740 in the comorbidities group versus 32 (13.97%) of 229 in the healthy group, with significant difference (P=0.0334). The difference was mainly contributed by fatigue and injection-site pain in some groups. Most adverse reactions were mild (Grade 1). We did not observe any serious adverse events related to vaccination. By day 14-28 post vaccination, the seroconversion rates and GMT of neutralizing antibody showed no significant difference between disease group and healthy group, except CAD group (P=0.03) and CRD group (P=0.04) showed slight reduction. By day 90, the neutralizing antibody GMTs were significantly reduced in each group, with no significant difference between diseases and healthy group. By day 180, the neutralizing antibody continued to decrease in each group, but with slower declination.

Interpretation

For people living with chronic disease especially seniors older than 60 years, the CoronaVac vaccines are as safe as in healthy people. Although the immunogenicity is slightly different in subgroup of some diseases compared with that of the healthy population, the overall trend was consistent. Our findings highlight the evidence to address vaccine hesitancy for seniors and people living with chronic diseases.

Funding

Yunnan Provincial Science and Technology Department (202102AA100051 and 202003AC100010, China), Sinovac Biotech Ltd (PRO-nCOV-4004).

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    SciScore for 10.1101/2022.04.28.22274402: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsConsent: Written informed consent was obtained from each participant before enrolment.
    IRB: The clinical trial protocol and informed consent form were approved by the Committee on Human Subject Research and Ethics of Yunnan University (CHSRE2021021).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line Authenticationnot detected.

    Table 2: Resources

    Experimental Models: Cell Lines
    SentencesResources
    Vero cells were then added to the serum-virus mix and incubated at 36.5°C for 5 days.
    Vero
    suggested: None

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our study has a few limitations. First, the safety data of this retrospective study was collected 14-28 days after vaccination instead of daily report. The accuracy of adverse event reports could thus be somewhat affected. Second, we observed a significant reduction of neutralizing antibody titers (humoral immunity) 3 months after the second dose, but the duration of cellular immunity at this time point remains unclear. Our ongoing efforts aim to evaluate the cellular immunity against SARS-CoV-2 at the 3rd and 6th months post vaccination. Third, limited by the sample size, we only considered the rough classification of the chronic diseases for highly heterogeneous diseases. For example, some subtypes of cancer may have great impact on the immune system, resulting in an abnormal response to the vaccination. However, the assessment for safety and immunogenicity of CoronaVac on HIV positive or autoimmune rheumatic diseases (ARD) patients showed that the immunogenicity of immunosuppressed patients was significantly decreased, but remained within an acceptable range; and they all showed a good safety profile with the CoronaVac vaccines29,30. Therefore, we believe that CoronaVac will be safe in immune-related cancers but requires further efficacy and safety evaluation to provide precise vaccination guidance. In conclusion, CoronaVac vaccination showed similar efficacy and safety in individuals with and without common underlying medical conditions. Considering that individuals with ...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

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  2. Version published to 10.1101/2022.04.28.22274402v1 on medRxiv