New Delhi (NVI): India’s indigenous COVID-19 vaccine candidate ‘Covaxin’ showed no side effects and enhanced immune responses during the Phase 1 trials, according to the results published in The Lancet journal.
The study evaluated the safety and immunogenicity of the vaccine candidate at 11 hospitals across India on 375 healthy adults aged between 18 to 55 years.
“This is a randomised, double-blind, multicentre, phase 1 trial to assess the safety, tolerability and immunogenicity of the whole-virion inactivated SARS-CoV-2 vaccine (BBV152) in healthy adult volunteers,” the study said.
According to the study, BBV152 led to tolerable safety outcomes and enhanced immune responses. The vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events.
It added that the most common adverse event was pain at the injection site, followed by headache, fatigue, and fever. The only serious adverse event of viral pneumonitis which was reported, has been deemed unrelated to the vaccine.
The phase 1 trials of Covaxin took place between 13 and 30 July last year. It involved 375 participants, of which 100 each were assigned to 3 different groups that were administered different vaccine doses.
Notably, these are interim results and they do not indicate the long-term safety outcomes or antibody responses. They also cannot help assess the efficacy of the vaccine, warranting and necessitating phase 3 trials, as per the study.
The vaccine which is now undergoing Phase 3 trials and had raised concerns among
experts over its emergency approval. Under the Phase 3 trials over 25,000 participants are underway, the recruitment for which was completed only in early January this year..
Earlier this month, Covaxin became India’s first indigenously produced vaccine against the coronavirus to get emergency approval for public health interest.
The vaccine has been developed by Hyderabad-based drug manufacturer Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR).