Safety Profile of Sinopharm COVID-19 Vaccine and Breakthrough Infections in Pakistan

  1. Wajiha Rizwan
  2. Ahmad Uzair Qureshi
  3. Muhammad Nasir Rana
  4. Mubeen Nazar Duggal
  5. Muhammad Sohaib
  6. Masood Sadiq

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Abstract

Background: To determine the safety profile of Sinopharm COVID-19 vaccine and identify breakthrough infections. Method: The study design was analytical cross sectional. An online questionnaire was filled by 1033 respondents between 16th and 22nd April 2021. Adults who had received both doses of Sinopharm COVID-19 vaccine more than a week ago or only a single dose with serious side effect were included in the study. The frequency and severity of vaccination related side effects were assessed and breakthrough infection identified. Results: The mean age of participants was 36.7 ± 12.91(18 – 92) years. Ninety one percent of participants (n=946) were health care professionals. One fifth (n=225/1033, 21.8%) had suffered from COVID-19 infection prior to vaccination, confirmed using the nasal RT-PCR test. None of the participants reported serious (grade III) or life threatening (grade IV) adverse reactions after either of the two doses. The most common side effects after the first dose were pain at injection site (20.3%), fatigue (20.3%), headache (13.9%), myalgia (12.5%) and fever (9.3%) whereas after the second dose were fatigue (16.8%), pain at injection site (15.8%), myalgia (14%) and fever (6.7%). The side effects were more common in participants who had previous history of COVID-19 infection. Of 225 previously infected participants, 97(43.1%) (p value=0.020) and 90 (40%) (p value=0.001) participants had side effects after 1st and 2nd dose respectively. 16 participants (1.55%) developed PCR positive COVID-19 infection two weeks after the second dose while 3(0.29%) participants had a re-infection. There was one case of probable severe COVID-19 infection, 2 weeks after the second dose and recovered completely with treatment. Conclusion: Our study shows that Sinopharm COVID-19 vaccine is generally safe with no serious side effects. The side effects were however, more common in inviduals who already had COVID-19 infection. The COVID-19 breakthrough infection and reinfection could occur after the vaccination.

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  1. Version published to 10.21649/akemu.v27i4.4884
  2. ScreenIT

    SciScore for 10.1101/2022.01.18.22268965: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: A cross-sectional study (online survey) was conducted from 16th April to 22nd April 2021 after taking ethical permission and approval from institutional review board of The Children’s Hospital and Institute of Child Health, Lahore (Ref.
    Consent: The form requested participants to give consent for study assuring that their confidentiality will be maintained.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisThe sample size was 631, calculated through OpenEpi software after considering frequency of side effects after Sinopharm COVID-19 vaccine 39% according to phase II trail data12 and confidence level 99%.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    The data was analyzed using Statistical Package for the Social Sciences (SPSS) version 25.
    Statistical Package for the Social Sciences
    suggested: (SPSS, RRID:SCR_002865)
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    The limitation is lack of facility for viral genome sequencing and comparative genome analysis was not conducted in these 3 doctors. Our data supports that everyone should get vaccinated with same recommended doses irrespective of history of past COVID-19 infection. One of our participant reported a probable severe COVID-19 infection after 2 week of second dose. She was admitted in COVID-ICU and received in addition to oxygen for 10 days remedisvir, steroids, intravenous antibiotics and oral anti-coagulant. She recovered completely. As her PCR was negative and currently to report it as breakthrough infection positive SARS-CoV-2 PCR is essential we reported it as probable case. This is also the concern showed by NA alwan15 that as some patients who fulfill clinical criteria for COVID-19 but either having negative PCR or not get tested are at present not included as confirmed COVID-19 cases during surveillance so our surveillance system might be underestimating the burden of COVID-19 pandemic and even missing reporting of breakthrough infections. Even though vaccines have good efficacy but breakthrough cases are being reported. Although majority of these are non-serious infection but very few deaths have also been reported among people fully vaccinated 21with Food and Drug Administration(FDA) approved vaccines. Yet, COVID-19 cases and deaths that are being prevented among vaccinated person have far exceeded the breakthrough cases. 21 There are few limitations of our study. Firs...

    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

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  3. Version published to 10.1101/2022.01.18.22268965v1 on medRxiv