Covaxin ph 2 data shows vaccine safe

NEW DELHI: The Lancet on Tuesday published interim phase 2 trial results of Bharat Biotech’s Covid-19 vaccine — Covaxin— that shows a two-fold increase in antibody titres than phase 1. Side-effects were observed in 10-12% of participants, which is six times less than other Covid-19 vaccines in use.

Also, the phase 1 study follow-up showed durable antibody and T-cell response for three months post-vaccination.

The phase 1 trial results published in The Lancet in January showed the vaccine was well tolerated in all dose groups with no related serious adverse events.

For phase 2 trials, two intramuscular doses were administered four weeks apart to 380 participants across nine hospitals in nine states in a doubleblind, randomised, and multicentre manner to evaluate the immunogenicity and safety of Covaxin.

Covaxin had initially raised concerns among experts over its emergency approval by India’s drug regulator.

The latest study comes a week after Bharat Biotech announced that the vaccine has shown 81% efficacy in the third phase of clinical trials, the results of which are yet to be published.

Bharat Biotech has developed the whole-virion inactivated SARS-CoV-2 vaccine candidate (BBV152) in collaboration with the Indian Council of Medical Research (ICMR).

The virus strain (NIV-2020770) containing the Asp614Gly mutation, isolated from a Covid-19 patient who came in from Wuhan (China), and sequenced at the ICMR-National Institute of Virology (NIV), was provided to Bharat Biotech in May last year.

The vaccine was approved for use in India on January 3 based on its safety and immunogenic