A Real World Evaluation of the safety and immunogenicity of the Covishield vaccine, ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) in National Capital Region (NCR) of India: A preliminary report

  1. Sushila Kataria
  2. Pooja Sharma
  3. Vikas Deswal
  4. Kuldeep Kumar
  5. Manish Singh
  6. Sazid Alam
  7. Vaibhav Gupta
  8. Padam Singh
  9. Rashmi Phogat
  10. Smita Sarma
  11. Nipun Patil
  12. Rohit Dutt
  13. Renu Saxena
  14. Naresh Trehan

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Abstract

Background

The SARS-CoV-2 pandemic has severely impacted health systems, economic and social progress globally in 2020. The rollout of vaccines in several parts of the world is being hailed as a solution to the crisis. With newer and more virulent serotypes on the horizon and limited vaccine available, evaluation of safety and immunogenicity is critical for rationalization of vaccine use in public health.

Objective

To evaluate real world safety, and, immunogenicity of the Covishield vaccine, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) during the national vaccine roll out in the NCR, New Delhi. The safety is evaluated through Adverse Events and Serious Adverse Events reported though enhanced pharmacovigilance protocols, and, the immunogenicity by quantitative determination of anti-S1 and anti-S2 specific IgG antibodies to SARS-CoV-2 in serum samples collected before the receipt of the vaccine and 14 days after dose 1, using the fully automated LIAISON® SARS-CoV-2 S1/S2 IgG test using the chemiluminescence immunoassay (CLIA)

Results

In the two weeks after immunization with the Covishield vaccine {ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)}, none of the 1638 evaluated participants reported any serious adverse events (ie require hospitalization or emergency room visit). Solicited adverse events reported via daily diary cards included pain (62.7%) and soreness (24.1%) at injection site as most common, whereas fever (48.4%), headache (43.4%), myalgia (38.4%), fatigue (33.4%), joint pain (27.0%) and nausea (16.0%) were most common solicited systemic adverse events on day 1. Majority of local and systemic adverse events were seen in first 2 days post vaccination and thereafter they resolved. Lesser reactogenicity was observed in subjects with age >50 years. No major difference was observed in adverse events when subjects were stratified based on history of COVID 19 disease or baseline seropositivity. In our study serostatus improved from 48.2% positive at baseline to 79.0% positive 2 weeks following first dose of vaccination. After first dose of vaccination overall higher percentage (98.2%) of seropositivity rates were observed in those with past history of COVID 19 disease

Conclusion

The Covishield vaccine {ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)}, was safe and reported mild self limiting adverse events over 2-4 days and had an good early (within 2 weeks) seroresponse. This holds the promise of far reaching impact on vaccine availability for a larger population and thereby providing a widespread coverage.

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  1. Rapid Reviews Infectious Diseases

    Feng-Cai Zhu

    Review 1: "A Real World Evaluation of the safety and immunogenicity of the Covishield vaccine, ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) in National Capital Region (NCR) of India: A preliminary report"

    Reviewer: (Feng-Cai Zhu) | 📒📒📒 ◻️◻️

  2. Rapid Reviews Infectious Diseases

    Feng-Cai Zhu

    Review of "A Real World Evaluation of the safety and immunogenicity of the Covishield vaccine, ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) in Health Care Workers (HCW) in National Capital Region (NCR) of India: A preliminary report"

    Reviewer: (Feng-Cai Zhu) | 📒📒📒 ◻️◻️

  3. ScreenIT

    SciScore for 10.1101/2021.04.14.21255452: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study was approved by the Institutional Ethics Committee and was conducted in a fifteen hundred bedded tertiary care hospital in the National Capital Region of Delhi, which has treated over eight thousand hospitalized Covid-19 patients.
    Consent: The informed consent process followed by a baseline questionnaire was completed by a doctor.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line AuthenticationAuthentication: Assay ranges from 3.8 to 400 AU/mL SARS CoV-2 S1/S2 IgG. < 15 AU/mL were reported negative and those test results ≥15.0 AU/mL were reported as positive. 2.2. Lab Quality Assurance: The fully automated LIAISON® has been calibrated and validated according to the laboratory SOP, which is 3 samples (high, medium and low value) were run for 5 times a day for 5 consecutive days.

    Table 2: Resources

    Antibodies
    SentencesResources
    [Time Frame: 118±7 days post vaccination] and assessment of efficacy of the COVID-19 vaccination against severe and non-severe COVID-19 [Time Frame: Day 118±7 days] are secondary endpoints. 2.1. Laboratory Methods: The serum was tested for the quantitative determination of anti-S1 and anti-S2 specific IgG antibodies to SARS-CoV-2 in the fully automated LIAISON® SARS-CoV-2 S1/S2 IgG by Chemiluminescence immunoassay (CLIA) technology.
    anti-S1
    suggested: None
    anti-S2 specific IgG
    suggested: None
    d SARS-CoV-2 S1/S2 IgG antibody concentrations expressed as arbitrary units (AU/mL) and graded the results.
    S1/S2 IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Inter-Lab Comparison (ILC) and Repeat and split testing were conducted as per standard laboratory quality assurance protocol. 2.3. Data Analysis:
    Repeat
    suggested: (ProRepeat, RRID:SCR_006113)

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.
    • Thank you for including a protocol registration statement.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  4. Version published to 10.1101/2021.04.14.21255452v1 on medRxiv