Closely-held PharmaJet announced that its partner, Zydus Cadila, has received Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D, the world’s first plasmid DNA vaccine for COVID-19, which is exclusively administered using the PharmaJet Tropis Needle-free Injection System.
The DCGI decision is based on data from a Phase 3 clinical trial which enrolled over 28,000 volunteers. Included in the trial were adolescents in the 12-to-18 age group, a first for a COVID-19 vaccine trial in India. ZyCoV-D exhibited robust immunogenicity, tolerability, and safety.
“We congratulate our partner Zydus Cadila for achieving this critical milestone,” Chris Cappello, president and CEO of PharmaJet, said in a statement.
The EUA is a huge step forward to help in the eradication of COVID-19. It demonstrates the power of DNA-based vaccines and broadens the use of needle-free jet injection, Mr. Cappello added.