Needle-free delivery shown to have significantly fewer local side effects
GOLDEN, Colo. — June 7, 2022 — PharmaJet®, a biotech company that has developed a more effective way of administering drugs and biologics with their innovative, needle-free injection technology, today announced that the phase 3 clinical study sponsored by their partner, Zydus Lifesciences, has been published in The Lancet. The peer-reviewed article, entitled Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomized, double-blind, placebo-controlled study in India, features ZyCoV-D, the world’s first plasmid-DNA vaccine approved for use in humans, delivered exclusively by the PharmaJet Tropis® Intradermal Needle-free Injection System.
This study, one of the largest trials for a COVID-19 vaccine in India, included over 28,000 healthy adult volunteers in over 50 sites during the peak of the second wave of COVID-19 when the Delta strain was dominant. The overall efficacy of the vaccine was 66.6%, while it was 100% effective against severe and moderate COVID-19 cases which puts it on par with commercialized peer-group vaccines tested in the same period. The unique plasmid DNA platform allows the rapid development of new constructs to deal with virus mutations. It has also shown good stability at a temperature of 25 degrees Celsius for a couple of months. This means it can be easily transported and stored with reduced reliance on cold chain systems and with less vaccine wastage. The vaccine was delivered intradermally, with the PharmaJet Tropis Needle-free Injection System, which resulted in a significant reduction in local side effects typically associated with needle use e.g., injection site pain.
Chris Cappello, President and CEO of PharmaJet, added, “ We congratulate our partner in the publication of their phase 3 clinical trial results in The Lancet and on their Emergency Use Authorization in India which further demonstrates the importance of the first DNA-plasmid vaccine for COVID.”
For more information about PharmaJet visit www.pharmajet.com.
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PharmaJet’s mission is to enable greater access to life improving pharmaceuticals. PharmaJet Needle-free Systems provide increased vaccine effectiveness, a preferred patient and caregiver experience, and a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or subcutaneously. The Tropis® System has CE Mark and WHO PQS certification for intradermal injections. For more information visit www.pharmajet.com. Follow us on LinkedIn.
The Zydus Group, with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 23,000 people worldwide and is driven by its mission to unlock new possibilities in life-sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through path-breaking discoveries. For more details visit: www.zyduslife.com