Persistent Health Issues, Adverse Events, and Effectiveness of Vaccines during the Second Wave of COVID-19: A Cohort Study from a Tertiary Hospital in North India
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Abstract
Background There is paucity of real-world data on COVID-19 vaccine effectiveness from cohort designs. Variable vaccine performance has been observed in test-negative case-control designs. There is also scarce real-world data of health issues in individuals receiving vaccines after prior COVID-19, and of adverse events of significant concern (AESCs) in the vaccinated. Methods: A cohort study was conducted from July 2021 to December 2021 in a tertiary hospital of North India. The primary outcome was vaccine effectiveness against COVID-19 during the second wave in India. Secondary outcomes were AESCs, and persistent health issues in those receiving COVID-19 vaccines. Regression analyses were performed to determine risk factors of COVID-19 outcomes and persistent health issues. Results: Of the 2760 health care workers included, 2544 had received COVID-19 vaccines, with COVISHIELD (rChAdOx1-nCoV-19 vaccine) received by 2476 (97.3%) and COVAXIN (inactivated SARS-CoV-2 vaccine) by 64 (2.5%). A total of 2691 HCWs were included in the vaccine effectiveness analysis, and 973 COVID-19 events were reported during the period of analysis. Maximum effectiveness of two doses of vaccine in preventing COVID-19 occurrence was 17% across three different strategies of analysis adopted for robustness of data. One-dose recipients were at 1.27-times increased risk of COVID-19. Prior SARS-CoV-2 infection was a strong independent protective factor against COVID-19 (aOR 0.66). Full vaccination reduced moderate–severe COVID-19 by 57%. Those with lung disease were at 2.54-times increased risk of moderate–severe COVID-19, independent of vaccination status. AESCs were observed in 33/2544 (1.3%) vaccinees, including one case each of myocarditis and severe hypersensitivity. Individuals with hypothyroidism were at 5-times higher risk and those receiving a vaccine after recovery from COVID-19 were at 3-times higher risk of persistent health issues. Conclusions: COVID-19 vaccination reduced COVID-19 severity but offered marginal protection against occurrence. The possible relationship of asthma and hypothyroidism with COVID-19 outcomes necessitates focused research. With independent protection of SARS-CoV-2 infection, and high-risk of persistent health issues in individuals receiving vaccine after recovery from SARS-CoV-2 infection, the recommendation of vaccinating those with prior SARS-CoV-2 infection needs reconsideration.
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SciScore for 10.1101/2022.03.26.22272613: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Ethical permission: The study started after obtaining ethical permission from the Institute Ethics Committee.
IRB: Ethical permission: The study started after obtaining ethical permission from the Institute Ethics Committee.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis Sample size: The sample size estimation was based on the major primary outcome of the study i.e. vaccine effectiveness. Table 2: Resources
No key resources detected.
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 …SciScore for 10.1101/2022.03.26.22272613: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics Consent: Ethical permission: The study started after obtaining ethical permission from the Institute Ethics Committee.
IRB: Ethical permission: The study started after obtaining ethical permission from the Institute Ethics Committee.Sex as a biological variable not detected. Randomization not detected. Blinding not detected. Power Analysis Sample size: The sample size estimation was based on the major primary outcome of the study i.e. vaccine effectiveness. Table 2: Resources
No key resources detected.
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:Many of the post-approval studies have had these limitations. The maximum vaccine protection observed after excluding the participants who received any dose during the second wave (pure vaccinated vs unvaccinated cohort analysis performed in Strategy C), was close to 17%. Interestingly, ‘1’ dose recipients showed a higher rate of SARS-CoV-2 infection compared to the unvaccinated. The time to occurrence of COVID-19 in “1” dose recipients was significantly shorter, as corroborated from the findings of the Kaplan-Meier analysis. The high risk of acquisition of disease in ‘1’ dose vaccinated individuals persisted even after adjusting for potential confounders in the Cox proportional hazard model. Compared to the unvaccinated, “1” dose recipients were nearly at 1.6-times higher risk of developing COVID-19. Increased COVID-19 occurrence rate after the first dose has been observed in some other studies and has been linked to the underlying high-risk group of the participants enrolled as well as to the vaccination centers being super-spreading sites of infection.5,6 However, since majority of the observed COVID-19 infections in our study were breakthrough, a direct immunomodulatory action of COVID-19 vaccines should also be investigated as a potential cause of suboptimal vaccine protection and increased propensity towards COVID-19. Some evidence in this regard is provided by a detailed Chinese study on post-vaccination immune modulation.15 Among other factors, young individuals <40 y...
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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