Effectiveness of BBV152 vaccine against SARS-CoV-2 infections, hospitalizations and deaths among healthcare workers in the setting of high delta variant transmission in New Delhi, India

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Abstract

Background

Delta variant transmission resulted in surge of SARS CoV-2 cases in New Delhi, India during the early half of year 2021. Health Care Workers (HCWs) received vaccines on priority for prevention of infection. Real life effectiveness of BBV152 vaccine against severe disease including hospitalization and death was not known.

Objective

To estimate effectiveness of BBV152 vaccine among HCWs against SARS CoV-2 infection, hospitalization or death

Design

Observational study

Setting

a multi -speciality tertiary care public funded hospital in New Delhi, India.

Participants

12,237 HCWs

Interventions

BBV152 vaccine (Covaxin, Bharat Biotech limited, Hyderabad, India); whole virion inactivated vaccine; two doses four weeks apart

Measurements

vaccine effectiveness after receipt of two doses of BBV152 protecting against any SARS CoV-2 infection, symptomatic infections or hospitalizations or deaths, and hospitalizations or deaths.

Results

The mean age of HCWs was 36(±11) years, 66% were men and 16% had comorbidity. After adjusting for potential covariates viz age, sex, health worker type category, body mass index, and comorbidity, the vaccine effectiveness (95% Confidence Interval) in fully vaccinated HCWs and ≥14 days elapsed after the receipt of second dose was 44% (37 to 51, p<0.001) against symptomatic infection, hospitalization or death due to SARS CoV-2, and 61% (37 to 76, p<0.001) against hospitalization or death, respectively.

Conclusions

BBV152 vaccine with complete two doses offer a modest response to SARS CoV-2 infection in real life situations against a backdrop of high delta variant community transmission. Efforts in maximizing receipt of full vaccines should be invested for HCWs, who are at higher occupational risk for infection.

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  1. SciScore for 10.1101/2022.01.22.22269701: (What is this?)

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

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variableDemographic and clinical variables such as age (<25, 25-44 and ≥45 years), sex (male and female), health care worker category (student/ administrative/clerical staff, faculty/scientist/research staff, nursing staff, junior/senior resident, paramedical/ support staff), Body Mass Index (BMI<18.5, 18.5-24.9 and ≥ 25 kg/m2) and comorbidity status (none and any comorbidity) with respect to SARS-CoV-2 infection and vaccination status was compared using Pearson’s chi-square test.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Definitions: Statistical analyses: Data management and statistical analysis was done using Stata/SE 15.0 (StataCorp LLC, College Station, TX, USA).
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    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 had few limitations. In this observational study, some of the confounding due to residual covariates could not be omitted, though we adjusted our VE estimates for the known confounders including age, sex, type of health care worker, body mass index, and comorbidity status. There could be additional covariates like risk averse behaviour adopted by HCWs, that were not measured and reported, but could possibly influence effectiveness estimates. Vaccination status and other data were based on self-reports; however, sufficient details were captured and data were validated to authenticate the exposure and outcome data. We did not perform genomic analysis of SARS CoV-2 infections following vaccination reported in our study, though evidence from other studies was correlated and the delta variant was predominant lineage in transmission during the study period. We did not collect information about source of exposure of infection in our study HCWs. Also, some of the asymptomatic infections might be missed out, owing to lesser chances of them being tested. We anticipate in our setting that HCWs due to continuous exposures would get themselves tested more due to ready availability of testing and screening facilities within our Institute, though the possibility of varying rates of testing among different categories of HCWs could not be ruled out. HCWs are at increased risk of SARS CoV-2 infection due to occupational exposure and our results apply to them. The estimates for VE mig...

    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.


    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.