New Delhi: Zydus Lifesciences has announced that 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 28000 healthy adult volunteers in over 50 sites across the country.
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% at a time when Delta Variant of the SARS COV-2 virus was the prevalent strain across India.
ZyCoV-D is a three dose intradermal vaccine administered using a needle-free applicator. The plug-and-play technology of vaccine equips it to adapt to the rapidly mutating SARS COV-2 virus. 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.
Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd
said “We are pleased that the outcomes of the Phase III trial of ZyCoV-D have been peer
reviewed and published in The Lancet. This attests to the compliance with the global best
practices and stringent peer review parameters of clinical trials.”
The peer reviewed article can be accessed using the following link: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)00151-9/fulltext
Facts about ZyCoV-D
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ZyCoV-D is an intradermal vaccine, administered in three doses. It is administered using The PharmaJet® needle free system, Tropis®, which leads to a significant reduction in local side effects.
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ZyCoV-D is 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.
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The Plasmid DNA platform also allows generating new constructs quickly to deal with mutations in the virus, such as those already occurring.
