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Safety and efficacy of Sinopharm vaccine (BBIBP-CorV) in elderly population of Faisalabad district of Pakistan
  1. Iftikhar Nadeem1,
  2. Syed Ata ul Munamm2,
  3. Masood Ur Rasool3,
  4. Mufakhara Fatimah4,
  5. Muhammad Abu Bakar5,
  6. Zaid Khalid Rana6,
  7. Usman Feroze Khatana7,
  8. Louise Jordon8,
  9. Muhammad Saqlain9,
  10. Noor Mahdi1,
  11. Hilary McLoughlin10
  1. 1 Department of Respiratory Medicine, Luton and Dunstable Hospital NHS Foundation Trust, Luton, UK
  2. 2 District Health Officer, Health Medical Services, Faisalabad, Pakistan
  3. 3 Department of Respiratory Medicine, West Suffolk Hospitals NHS Trust, Bury Saint Edmunds, UK
  4. 4 Pharmacology, Sahara Medical College, Narowal, Pakistan
  5. 5 Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan
  6. 6 Galway University Hospitals, Galway, Ireland
  7. 7 Department of Respiratory Medicine, Peterborough and Stamford Hospitals NHS Foundation Trust, Peterborough, UK
  8. 8 Cambridge University, Cambridge, UK
  9. 9 Department of Endocrinology, Addenbrooke's Hospital, Cambridge, UK
  10. 10 Department of Respiratory Medicine, Portiuncula Hospital Ballinasloe, Ballinasloe, Ireland
  1. Correspondence to Dr Iftikhar Nadeem, Luton and Dunstable Hospital NHS Foundation Trust, Luton LU4 0DZ, UK; iftikharnadeem49{at}gmail.com

Abstract

Introduction The first case of novel SARS-COV-2 (COVID-19) in Pakistan was detected on 26 February 2020. Pharmacological and non-pharmacological strategies have been tried to lessen the mortality and morbidity burden. Various vaccines have been approved. The Drug Regulatory Authority of Pakistan gave emergency approval for Sinopharm (BBIBP-CorV) COVID-19 vaccine in December 2021. The phase 3 trial of BBIBP-CorV included only 612 participants aged 60 years and above. The primary aim of this study was to assess the safety and efficacy of BBIBPP-CorV (Sinopharm) vaccine within the Pakistani adult population aged 60 or above. The study was carried out in the Faisalabad district of Pakistan.

Methods A test negative case–control study design was used to assess safety and efficacy of BBIBP-CorV in individuals aged 60 and above against symptomatic infection, hospitalisations and mortality due to SARS-CoV-2 among vaccinated and unvaccinated individuals. ORs were calculated using logistic regression model at 95% CI. ORs were used to calculate the vaccine efficacy (VE) by using the following formula.

VE= (1-OR) ×100.

Results 3426 individuals with symptoms of COVID-19 were PCR tested between 5 May 2021 and 31 July 2021. The results showed that Sinopharm vaccine 14 days after the second dose was efficient in reducing the risk of symptomatic COVID-19 infection, hospitalisations and mortality by 94.3%, 60.5% and 98.6%, respectively, among vaccinated individuals with a significant p value of 0.001.

Conclusion Our study showed that BBIBP-CorV vaccine is highly effective in preventing infection, hospitalisations and mortality due to COVID-19.

  • Immunology
  • COVID-19
  • Health & safety
  • Public health

Data availability statement

All data relevant to the study are included in the article

http://dx.doi.org/10.1136/postgradmedj-2022-141649

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    Data availability statement

    All data relevant to the study are included in the article

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    Footnotes

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    • Contributors IN and SAM contributed equally as combined first author. HM was involved in writing, editing, proof reading and was the supervising consultant for the study.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.