Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study

Desai, Devashish; Khan, Ajmal; Soneja, Manish; Mittal, Ankit; Naik, Shailendra Singh; Kodan, Parul; Mandal, Ayan; Maher, Ganesh; Kumar, Rohit; Agarwal, Ayush; Gowda, Naveen; Vikas, H; Kumar, Praveen; Pandey, Shivam; Pandey, Ritu; Kumar, Arvind; Goel, Ayush; Jorwal, Pankaj; Nischal, Neeraj; Choudhary, Aashish; Brijwal, Megha; Madan, Kushal; Lodha, Rakesh; Sinha, Sanjeev; Dar, Lalit; Wig, Naveet; Guleria, Randeep

doi:10.1016/s1473-3099(21)00674-5

Cited by 74 publications

(71 citation statements)

References 8 publications

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“…COVID-19 vaccines have been reported to offer protection against variants, including Delta, after completion of the vaccination series, and the effect of partial uptake of vaccines has been found to be suboptimal. 24 , 25 In India, BBV152 was found to have overall efficacy of 77.8% (95% CI, 65.2%-86.4%) in a phase 3 trial. 26 Our estimate of effectiveness against reinfection was similar.…”

Section: Discussionmentioning

confidence: 99%

SARS-CoV-2 Reinfection Rate and Estimated Effectiveness of the Inactivated Whole Virion Vaccine BBV152 Against Reinfection Among Health Care Workers in New Delhi, India

et al. 2022

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IMPORTANCE A surge of COVID-19 occurred from March to June 2021, in New Delhi, India, linked to the B.1.617.2 (Delta) variant of SARS-CoV-2. COVID-19 vaccines were rolled out for health care workers (HCWs) starting in January 2021. OBJECTIVE To assess the incidence density of reinfection among a cohort of HCWs and estimate the effectiveness of the inactivated whole virion vaccine BBV152 against reinfection. DESIGN, SETTING, AND PARTICIPANTS This was a retrospective cohort study among HCWs working at a tertiary care center in New Delhi, India.EXPOSURES Vaccination with 0, 1, or 2 doses of BBV152. MAIN OUTCOMES AND MEASURESThe HCWs were categorized as fully vaccinated (with 2 doses and Ն15 days after the second dose), partially vaccinated (with 1 dose or 2 doses with <15 days after the second dose), or unvaccinated. The incidence density of COVID-19 reinfection per 100 personyears was computed, and events from March 3, 2020, to June 18, 2021, were included for analysis.Unadjusted and adjusted hazard ratios (HRs) were estimated using a Cox proportional hazards model. Estimated vaccine effectiveness (1 − adjusted HR) was reported. RESULTS Among 15 244 HCWs who participated in the study, 4978 (32.7%) were diagnosed with COVID-19. The mean (SD) age was 36.6 (10.3) years, and 55.0% were male. The reinfection incidence density was 7.26 (95% CI: 6.09-8.66) per 100 person-years (124 HCWs [2.5%], total person follow-up period of 1696 person-years as time at risk). Fully vaccinated HCWs had lower risk of reinfection (HR, 0.14 [95% CI, 0.08-0.23]), symptomatic reinfection (HR, 0.13 [95% CI, 0.07-0.24]), and asymptomatic reinfection (HR, 0.16 [95% CI, 0.05-0.53]) compared with unvaccinated HCWs.Accordingly, among the 3 vaccine categories, reinfection was observed in 60 of 472 (12.7%) of unvaccinated (incidence density, 18.05 per 100 person-years; 95% CI, 14.02-23.25), 39 of 356 (11.0%) of partially vaccinated (incidence density 15.62 per 100 person-years; 95% CI,, and 17 of 1089 (1.6%) fully vaccinated (incidence density 2.18 per 100 person-years; 95% CI, 1.35-3.51) HCWs. The estimated effectiveness of BBV152 against reinfection was 86% (95% CI, 77%-92%); symptomatic reinfection, 87% (95% CI, 76%-93%); and asymptomatic reinfection, 84% (95% CI, 47%-95%) among fully vaccinated HCWs. Partial vaccination was not associated with reduced risk of reinfection. (continued) Key Points Question What are the rate of reinfection of SARS-CoV-2 among a cohort of health care workers (HCWs) and the estimated effectiveness of the inactivated whole virion vaccine BBV152 against reinfection? Findings In this cohort study of 4978 HCWs who were infected with SARS-CoV-2 from March 3, 2020, to June 18, 2021, the incidence density of reinfection was 7.26 per 100 personyears. A protective association of 86% against reinfection was observed among HCWs who completed the 2-dose schedule of BBV152 and for whom at least 15 days elapsed without reinfection after vaccination. Meaning The results of this study suggest that complete vaccination with BBV152 amo...

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Section: Discussionmentioning

confidence: 99%

SARS-CoV-2 Reinfection Rate and Estimated Effectiveness of the Inactivated Whole Virion Vaccine BBV152 Against Reinfection Among Health Care Workers in New Delhi, India

et al. 2022

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“…Among them, inactivated vaccines possessed the largest market share and were the most frequently administered [5]. An Indian case-control study published in November 2021 showed that the adjusted effectiveness of the two-dose BBV152 (inactivated vaccine) at least 14 days before testing was 47% and suggested that the relatively low effectiveness might be due to the high prevalence of the circulating delta variant in India [6]. Infectious disease experts have carefully weighed the need for booster shots for certain vulnerable groups or the entire population to protect against the circulating new variants and improve immunity level, as the duration of protection remains unknown [7].…”

Section: Introductionmentioning

confidence: 99%

Public Perceptions and Acceptance of COVID-19 Booster Vaccination in China: A Cross-Sectional Study

et al. 2021

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Coronavirus disease 2019 (COVID-19) booster vaccination has been proposed in response to the new challenges of highly contagious variants, yet few studies have examined public acceptance of boosters. This study examined public acceptance of COVID-19 booster vaccination and its influencing factors by using the data from a self-administered online cross-sectional survey conducted in June 2021 in China. Multiple logistic analysis was used to examine the influencing factors of booster acceptance based on the health belief model (HBM). Among 1145 respondents, 84.80% reported to accept COVID-19 booster vaccination. Having COVID-19 vaccination history, perceiving high benefits and low barriers to booster vaccination, being younger (18–30 vs. 41–50), having a lower education level, being employed, and belonging to priority groups for vaccination were associated with increased odds of booster acceptance. The primary reason for refusing booster vaccination was concern about vaccine safety. The vast majority (92.8%) of respondents reported an annual willingness to pay between 0 and 300 CNY (0–46.29 USD) if the booster was not free. Our findings suggest that the acceptance rate of booster vaccination is relatively high in China, and the HBM-based analysis reveals that more efforts are needed to increase perceived benefits and reduce perceived barriers of vaccination to design effective and proper vaccination extension strategies when boosters become widely recommended.

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“…Our study found modest effectiveness of BBV152 (two doses) as 44% against any SARS CoV-2 infection and 61% against hospitalization or death in real life situation in a background setting of delta variant spread. The Phase 3 trial of BBV152 vaccine reported 65% efficacy against the delta variant (7) and a recent test-negative, case-control study reported 50% (17).…”

Section: Discussionmentioning

confidence: 99%

“…Estimates of ChAdOx1 vaccine effectiveness are available in different settings, including for delta variant, both in India and other countries (14-16). There is no previous real time study reporting BBV152 vaccine effectiveness against hospitalization and death due to SARS-CoV-2 (17). We aimed to report effectiveness of BBV152 vaccine against SARS CoV-2 infections, hospitalizations and deaths among health care workers, in a setting of predominant transmission due to delta variant.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of BBV152 vaccine against SARS-CoV-2 infections, hospitalizations and deaths among healthcare workers in the setting of high delta variant transmission in New Delhi, India

Malhotra

Kalaivani

Lodha

et al. 2022

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Background: Delta variant transmission resulted in a surge of SARS CoV-2 cases in New Delhi, India during the early half of the year 2021. Health Care Workers (HCWs) received vaccines on priority for the prevention of infection. The real-life effectiveness of the BBV152 vaccine against severe disease including hospitalization and death was not known. Objective: To estimate the effectiveness of BBV152 vaccine among HCWs against SARS CoV-2 infection, hospitalization, or death Design: Observational study Setting: a multi-specialty tertiary care public-funded hospital in New Delhi, India. Participants: 12,237 HCWs Interventions: BBV152 vaccine (Covaxin, Bharat Biotech Limited, Hyderabad, India); whole virion inactivated vaccine; two doses four weeks apart Measurements: vaccine effectiveness after receipt of two doses of BBV152 protecting against any SARS CoV-2 infection, symptomatic infections or hospitalizations or deaths, and hospitalizations or deaths. Results: The mean age of HCWs was 36(11) years, 66% were men and 16% had comorbidity. After adjusting for potential covariates viz age, sex, health worker type category, body mass index, and comorbidity, the vaccine effectiveness (95% Confidence Interval) in fully vaccinated HCWs and two weeks elapsed after the receipt of the second dose was 44% (37 to 51, p<0.001) against symptomatic infection, hospitalization or death due to SARS CoV-2, and 61% (37 to 76, p<0.001) against hospitalization or death, respectively. Conclusions: BBV152 vaccine with complete two doses offers a modest response to SARS CoV-2 infection in real-life situations against a backdrop of high delta variant community transmission. Efforts in maximizing receipt of full vaccines should be invested for HCWs, who are at higher occupational risk for infection.

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Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study

Cited by 74 publications

References 8 publications

SARS-CoV-2 Reinfection Rate and Estimated Effectiveness of the Inactivated Whole Virion Vaccine BBV152 Against Reinfection Among Health Care Workers in New Delhi, India

SARS-CoV-2 Reinfection Rate and Estimated Effectiveness of the Inactivated Whole Virion Vaccine BBV152 Against Reinfection Among Health Care Workers in New Delhi, India

Public Perceptions and Acceptance of COVID-19 Booster Vaccination in China: A Cross-Sectional Study

Effectiveness of BBV152 vaccine against SARS-CoV-2 infections, hospitalizations and deaths among healthcare workers in the setting of high delta variant transmission in New Delhi, India

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