Bengaluru: The Covid-19 vaccine developed by India’s Bharat Biotech is safe and has shown high levels of antibody response in a mid-stage trial, but follow-up studies are needed to evaluate the shot for children and the elderly, a peer-reviewed review. The study showed.
The vaccine, India’s first successful home-made vaccine against Covid-19, has attracted interest from more than 40 countries. The company said last week it had shown an 81% effectiveness in preventing Covid-19 symptoms, based on an interim analysis of its late-stage trials.
In the study published in a medical journal, the researchers said that the dual dose vaccine showed equivalent antibody responses significantly higher in the second phase than in the first stage due to the difference in dose regimens that changed to a four-week injection schedule from a two-week course. The Lancet on Monday.
But she said the phase two trial, which had 380 participants, enrolled a small number of participants between the ages of 12-18 years and 55-65 years and follow-up studies are required to establish immunity in children and the elderly.
She also said that while the trial included participants from nine Indian states, the study population lacks ethnic and gender diversity, “underscoring the importance of assessing BBV152 (the vaccine) in other populations.”
Participants, for example, represent only a quarter of the study participants.
Bharat Biotech said last week that its Phase 3 study involved 25,800 participants between the ages of 18 and 98 and included more than 2,400 people over the age of 60.
The peer-reviewed study is another positive for Bharat Biotech, which was criticized in January after the Indian government approved a vaccine, called Covaxin, for emergency use without any effective data.
Government data showed that less than 9% of the more than 18.2 million Indians vaccinated so far against Covid-19 had taken Covaxin as of Tuesday.
Many politicians in India, including Prime Minister Narendra Modi, have chosen to vaccinate the local vaccine rather than the competing vaccine developed by AstraZeneca Plc and the University of Oxford.
India, the world’s largest vaccine producer, aims to vaccinate 300 million of its 1.35 billion people by August. It has reported 11.24 million cases of Covid-19, the highest number in the world after the United States, with 157,930 deaths.