Is Covaxin safe? Hyderabad-based Bharat Biotech's Covaxin is “safe, immunogenic with no serious side effects,” according to a study published on Tuesday in the medical journal The Lancet.
It has published the phase 2 results. The first phase of mass vaccination drive was launched in India on January 16. Two coronavirus vaccines – Serum Institute’s Covishield and Bharat Biotech’s Covaxin — have been granted approval for emergency use in the country.
The Lancet report, which enrolled a small number of participants aged 12-18 years and 55-65 years in the study, claimed that efficacy cannot be determined by phase 2 trials, but Covaxin (codenamed BBV152) showed "better reactogenicity and safety outcomes, and enhanced humoral and cell-mediated immune responses compared with Phase 1 trial. The 6g with Algel-IMDG formulation has been selected for the Phase 3 efficacy trial." It also claimed that further validation with Phase 3 safety results was needed, as per the report.
Preliminary results show Covaxin has an efficacy of 81% in phase 3 clinical trial.
Faheem Younus, Chief of Infectious Diseases at the University of Maryland Upper Chesapeake Health, US, tweeted:
“We report interim findings of the phase 2 trial on the immunogenicity and safety of BBV152, with the first dose administered on day 0 and the second dose on day 28,” the report said.
The study further clarified that the response to the vaccine was "substantially better in the phase 2 trial" than the phase 1 trial. “BBV152 (developed using a well established manufacturing platform) was safe, immunogenic (persisting for 3 months), and can be stored at 2–8°C, which is compatible with the immunisation cold chain requirements of most countries. Follow-up studies to assess efficacy and immune responses in older adults and in people with comorbidities are underway,” it added.
IMF Chief Economist Gita Gopinath on Monday hailed India’s vaccination drive as she said the country is leading the fight against the coronavirus pandemic. India “really stands out” in its vaccination approach, Gopinath spoke at a program organised for the Inaugural Dr Hansa Mehta Lecture on International Women’s Day. “If you look at where exactly is one manufacturing hub for vaccines in the world – that will be India. India has been at the forefront in fighting this pandemic,” she stated supporting other neighbouring countries like Bangladesh, Nepal and Myanmar.
PM Modi gets vaccine:
Earlier this month, Prime Minister Narendra Modi was the first one to receive the first dose of Covaxin at the All India Institute of Medical Sciences (AIIMS) New Delhi, as the second phase of the inoculation drive kick-started in India on March 1. He was administered by sister P Niveda, from Puducherry, who was the main nurse who gave him the jab.
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