COVID-19 vaccines effectiveness against SARS-CO-V-2 infection among persons attending RT-PCR centre at a Medical College Hospital in Telangana: A case control study

  1. Nagapraveen Veerapu
  2. Dhanashree P Inmdar
  3. Baer P Ravi Kumar
  4. Basavaraju Anuradha
  5. Pavitra Guddanti
  6. Sree D Issapuri
  7. Nikhita S Ganta
  8. Arun Gopi

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Abstract

Background

In January 2021, India drug regulator issued restricted emergency approval for COVAXIN and COVISHIELD which were manufactured in India. On mid-January 2021, in India, there were 10.5million confirmed cases and 0.15 million deaths.

Objectives

The objectives were to evaluate vaccine effectiveness (VE) of India made Covid-19 vaccines against SARS-CoV-2 infection.

Methods

A test negative case control study was conducted from May 2021 to December 2021 for duration of 8months among people attending an RT-PCR centre at a medical college Hospital for RT-PCR test. The baseline characteristics and RT-PCR report; and preliminary data about vaccine status were collected from the RT-PCR centre. The exposure to vaccination was enquired via Phone call or was checked with data available with the health authorities.

Results

After applying inclusion exclusion criteria, case and control definitions, a total of 380 participants (95cases and 285 controls) were included. The adjusted VE of two doses of COVISHIED vaccine against symptomatic SARS-CoV-2 infection was 52.2% (95% CI, 41.7 to 62.1) and single dose was 40.88% (95% CI, 31.26 to 51.29). The adjusted VE of two doses of COVAXIN vaccine against SARS-CoV-2 infection was 39% (95% CI, 29.40 to 49.27). The overall VE was 48.20% (95% CI, 37.90 to 58.22) for two doses of any vaccines.

Conclusions

India made vaccines were nearly 50% effective. Similar results show by different studies with a margin of 10-25% difference. Further new studies should be conducted as new variants of SARS-CoV-2 are emerging, and we don’t know how the vaccine works against the variants and booster doses were required or not.

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  1. ScreenIT

    SciScore for 10.1101/2022.05.15.22273945: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: The persons who were 18 years and above age and who gave informed oral consent will be included in the study.
    IRB: Ethical clearance was obtained from Institutional Ethics committee.
    Sex as a biological variableThe persons who were not able co-operate, not willing to participate, pregnant women, administered with other Covid vaccines were excluded from the study.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical Analysis: First the data is entered in Microsoft Excel and then transformed into R software version 4.1.2 and analysed.
    Microsoft Excel
    suggested: (Microsoft Excel, RRID:SCR_016137)

    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:
    There were several limitations like sample size was small and some factors like covid appropriate behaviour, socio-economic status, occupation were not considered. Further, more studies should be conducted as new variants of SARS-CoV-2 like Omicron are emerging, and we don’t know how the vaccine works against the variants and whether booster doses are required or not.

    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.

  2. Version published to 10.1101/2022.05.15.22273945v1 on medRxiv