Safety and efficacy of Sinopharm vaccine (BBIBP-CorV) in elderly population of Faisalabad district of Pakistan

Abstract

IntroductionThe 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.MethodsA 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.Results3426 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.ConclusionOur study showed that BBIBP-CorV vaccine is highly effective in preventing infection, hospitalisations and mortality due to COVID-19.

BBIBP-CorV (Sinopharm) vaccination- induced immunity is affected by age, gender and prior COVID-19 and activates responses to spike and other antigens

“…In Pakistan, BBIBP-CorV vaccination was shown to reduce hospitalization, mortality under 17 USC 105 and is also made available for use under a CC0 license. and symptomatic COVID-19 in the older age group however, this was based on testing after 14 days of the second dose, or 6 weeks post-vaccination (26).…”

“…Vaccine efficacy studies of inactivated types such as, BBIBP-CorV and CoronaVac conducted in China, India, and Chile (23, 59, 60), shown that these are effective against preventing hospitalisations and severe COVID-19. In Pakistan, BBIBP-CorV vaccination was shown to reduce hospitalization, mortality and symptomatic COVID-19 in the older age group however, this was based on testing after 14 days of the second dose, or 6 weeks post-vaccination (26).…”

“…A recent study from Pakistan has shown that full vaccination with BBIBP-CorV was effective in reducing the risk of symptomatic COVID-19 infection (94.3%), hospitalisations (60.5%) and mortality (98.6%), respectively (26). Studies on immune response induced by BBIBP-CorV have shown differing results.…”

COVID-19 Vaccines, Effectiveness, and Immune Responses

“…They reported only two severe cases in the placebo group [ 82 ]. A case-control study of vaccinated elderly individuals showed that 14 days after the second dose, the Sinopharm vaccine reduced the risk of symptomatic COVID-19 infection, hospitalizations, and mortality by 94.3%, 60.5%, and 98.6%, respectively [ 83 ].…”

Comparative analysis of mRNA and inactivated COVID-19 vaccines: A study from Faisalabad district of Pakistan

“…12 Sinopharm vaccine showed a VE of 94.3% (95% CI, 92.2-95.9%) for two doses of the BBIBP-CorV Sinopharm vaccine in the prevention of symptomatic SARS-CoV-2 infection, 60.5% (95% CI, 7.9-82.9%) in reducing hospitalisation with SARS-CoV-2 and 98.6% (95% CI, 94.2-99.6%) in preventing death from SARS-CoV-2 as compared to unvaccinated individuals in an elderly cohort of Pakistani population. 13 All COVID vaccines are usually well tolerated, and adverse events associated with these vaccines are very rare and of mild severity. 14…”