GOLDEN, Colo.--(BUSINESS WIRE)--PharmaJet®, the maker of innovative, needle-free injection technology, today announced that its partner Zydus Cadila has applied for Emergency Use Authorization (EUA) to the office of the Drug Controller General of India (DCGI) for its plasmid DNA Vaccine against COVID-19. The vaccine, ZyCoV-D, will be exclusively administered using the PharmaJet Tropis® Needle-free Injection System. Zydus Cadila is a global pharmaceutical company based in India, that develops, manufactures, and markets a broad range of healthcare therapies, including small molecule drugs, biologic therapeutics, and vaccines.
The ZyCoV-D vaccine is the first ever plasmid DNA vaccine for human use and represents a key milestone in scientific innovation and technology advancement. It is delivered intradermally using the PharmaJet Tropis Needle-free Injection System, which enables enhanced vaccine effectiveness in addition to being highly preferred by patients and providers over other delivery methods1. The DNA platform is ideally suited for a COVID-19 vaccine as it can be easily adapted to deal with mutations in the virus and has greater thermostability and less restrictive cold chain requirements compared with other vaccines.
ZyCoV-D administered with the PharmaJet® Tropis® Needle-free device has already established a robust immunogenicity and tolerability and safety profile with its 66.6% efficacy for RT-PCR positive cases in the interim analysis. No moderate cases of COVID-19 were observed in the vaccine arm post administration of its third dose, clocking a 100% efficacy for moderate disease. In addition to adults, the vaccine is safe for adolescents 12 to 18 years of age.
Chris Cappello, President and CEO, PharmaJet, said, “We are pleased to be partnering with Zydus Cadila as they move forward with plans to commercialize the first ever DNA vaccine for COVID-19. We are prepared operationally to supply our delivery systems to help support the fight against COVID-19 and its variants in India and beyond.”
For more information about PharmaJet visit www.pharmajet.com.
Refer to Instructions for Use to ensure safe injections and to review risks.
1 Data on file
PharmaJet’s mission is to improve people’s lives through needle-free technology. The 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.
Zydus’ Vaccine research program
The Vaccine Technology Centre of Zydus Cadila has a wide range of capabilities in developing and manufacturing viral, toxoid, polysaccharide, conjugate, and other subunit vaccines for unmet needs. In fact, Zydus was the first company in India to develop and indigenously manufacture the vaccine to combat Swine Flu during the pandemic in 2010. In the past, it has also indigenously developed numerous vaccines successfully including tetravalent seasonal influenza vaccine (first company in India to indigenously develop and commercialize), Inactivated Rabies vaccine (WHO Prequalified), Varicella vaccine (first Indian company to indigenously develop and receive market authorization), Measles containing vaccines (MR, MMR, Measles), Typhoid conjugate vaccine, pentavalent vaccine (DPT-HepB-Hib) etc. to name a few. The company also has a strong pipeline of vaccines like Measles-Mumps-Rubella-Varicella (MMRV), Human papillomavirus vaccine, Hepatitis A, Hepatitis E vaccines which are at various stages of development. For more information, visit https://zyduscadila.com/