First Real-World Study of BBV152 Vaccine against Symptomatic COVID-19 in India

The first real-world assessment of BBV152, an India-developed COVID-19 vaccine, suggests 2 doses provide 50% protection against symptomatic COVID-19 infection.

Manish Soneja, MD, researcher and additional professor of medicine at AIIMS in New Delhi, said, “Our study offers a more complete picture of how BBV152 performs in the field and should be considered in the context of COVID-19 surge conditions in India, combined with the possible immune evasive potential of the Delta variant. Our findings add to the growing body of evidence that rapid vaccine rollout programs remain the most promising path to pandemic control while public health policies must continue to include additional protective measures, such as mask-wearing and social distancing.”

The study, published today in The Lancet, included 2714 healthcare workers in Delhi, India who were RT-PCR tested for COVID-19. Of these, 1617 tested positive and 1097 tested negative. Most participants were tested for COVID-19 at the peak of the pandemic in India. The positive cases with the negative participants using a 1:1 ratio controlled for age and gender.

The study was conducted at AIIMS, a tertiary car hospital and COVID-19 treatment center. The vaccine effectiveness against symptomatic COVID-19 after 2 doses of BBV152 was 50%.

The real-world study results demonstrating 50% vaccine efficacy are lower than the 77.8% protection found in BBV152’s stage 3 clinical trial. The investigators suggested one reason for this discrepancy could be the more infectious Delta variant becoming the dominant strain in India during the April 15-May 15, 2021 study period, accounting for ~80% of all confirmed COVID-19 cases. Additionally, the study population consisted of healthcare workers, who are likely more exposed to COVID-19 infection.

BBV152 was developed in India by Bharat Biotech. It is a Vero cell-derived, inactivated, whole-virion vaccine formulated with a novel adjuvant. It is administered in 2 injections, 28 days apart.

BBV152 was approved for emergency use in India for people 18 and older. In November 2021, the World Health Organization (WHO) added BBV152 to its list of approved COVID-19 vaccines.

Professor Naveet Wig, head of medicine at AIIMS, New Delhi, noted, “Our study took place when the COVID-19 test positivity rate in Delhi was around 35% – the highest since the beginning of the pandemic. It is an important factor to consider while interpreting the impact of any vaccine. Availability of a safe and effective vaccine, addressing vaccine hesitancy to achieve good pace and coverage are cornerstone to a successful universal vaccination program.”