The World Health Organization (WHO) recently granted emergency use authorization to BBV152. Vero cell-derived inactivated whole virion vaccine developed by Bharat Biotech for people aged 18 and up. The vaccine is made with a new adjuvant and is given in two doses, separated by 28 days. With a 28-day multi-dose open vial policy, the vaccine can be stored and transported between 2 and 8°C.
The BBV152 COVID-19 Vaccination Is Safe And Effective In Phase 3
The devastation caused by coronavirus is yet not over, and its new variants keep on spreading the same with double efficiency and speed. Hence for the vaccine makers, it has been a big challenge to create a vaccine that can offer the desired effect on each of its variants. This new vaccine is believed to be safer compared to its previous versions, which is noted by the experts while analyzing the results.
The findings, which were published in The Lancet, show that BBV152 elicits a strong antibody response. There were no serious vaccine-related adverse events or deaths among the trial participants. The bulk of the side effects such as headaches, weariness, fever, and injection site soreness were minor and occurred within seven days following immunization.
According to preliminary data from a phase 3 trial of BBV152, an Indian-developed COVID-19 vaccine, two doses provide 77.8% protection against symptomatic COVID-19.
Among 16 973 originally seronegative subjects, the researchers conducted an effectiveness study based on 130 laboratory-confirmed participants symptomatic for COVID-19. These incidents were documented at least two weeks after the second dose was given to the individuals. Researchers discovered 24 positive cases among 8 471 vaccine recipients and 106 positive cases among 8 502 placebo recipients implying vaccine effectiveness of 77.8% overall.
The researchers conducted a preliminary analysis of efficacy against the delta variant and discovered that BBV152 was 65 percent effective against symptomatic COVID-19 infection caused by the delta variant. However, the researchers caution that this data should be viewed as preliminary and that more research is needed to confirm clinical efficacy against the delta and other variants.
Sixteen cases of severe symptomatic COVID-19 disease defined as respiratory failure evidence of shock major acute renal hepatic or neurologic dysfunction admission to an intensive care unit or death were found in the effectiveness analysis population.
One case out of 8 471 individuals in the vaccination group and 15 cases out of 8 502 people among placebo recipients. However, the authors point out that this is preliminary data. More study with a bigger sample size is needed to determine efficacy in preventing severe disease and hospitalization.
The researchers discovered no significant variations in immune responses between people aged less than 60 and those aged over 60. The trial’s oldest participant was 97 years old.
Jing-Xin Li and Feng-Cai Zhu of the Jiangsu Provincial Center for Disease Control and Prevention, who were not involved with the study, write in a linked comment: “The introduction of BBV152 could help other SARS-CoV-2 vaccine platforms meet their ultra-cold chain requirements increase finite global manufacturing capacity and address vaccine shortages that disproportionately affect low- and middle-income countries.
The next phase in BBV152 research should be to look for epidemiological changes in SARS-CoV-2 as well as long-term vaccine efficacy against symptomatic COVID-19 and asymptomatic illness to see if the vaccine still protects VOC replacement.”
The data and safety monitoring board (DSMB) and the research team chose to un-blind that placebo. Individuals who were eligible to receive an approved COVID-19 vaccine after satisfying the pre-defined effectiveness success criteria.
Even though the trial was meant to vaccinate and follow participants for one year following the second dose, given the nature of the epidemic in India and the emergency use authorization for BBV152.
