Lancet publishes phase-3 trial data of Zydus' Covid vaccine ZyCoV-D

Zydus Lifesciences on Friday announced that the safety and efficacy analysis data from phase III clinical trial of its Plasmid DNA Covid-19 vaccine ZyCoV-D has been peer reviewed and published in The Lancet, a reputed and well known medical journal.

The double blind, placebo controlled, randomised Phase III clinical trial of the world’s first plasmid DNA vaccine, ZyCoV-D was one of the largest trials for a Covid-19 vaccine in India and was conducted on over 28,000 healthy adult volunteers at over 50 sites across the country.

An intradermal vaccine to be administered in three doses using the PharmaJet needle free applicator system, Tropis, ZyCoV-D is to be stored at 2-8 degree C but has shown good stability at temperature of 25 degree C for at least three months. The thermostability of the vaccine will help in easy transportation and storage of the vaccine and reduce any cold chain breakdown challenges leading to vaccine wastage.

According to Zydus, the plug-and-play technology of the vaccine equips it to adapt to the rapidly mutating SARS COV-2 virus.

The trial was carried out during the peak of the second wave of COVID-19 infection. The efficacy of the vaccine stood at 66.6 per cent at a time when Delta Variant of the SARS COV-2 virus was the prevalent strain across India.

The results of the Phase I part of the Phase I/II clinical trial have already been published in the EClinical Medicine Journal of The Lancet.

Commenting on the publication of phase III trials, Sharvil Patel, managing director, Zydus Lifesciences Ltd said that the peer review and publication in The Lancet attested to its compliance with global best practices and stringent peer review parameters of clinical trials.