India’s New COVID-19 DNA Vaccine for Adolescents and Adults Is a First | Adolescent Medicine | JAMA | JAMA Network
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Biotech Innovations
October 12, 2021

India’s New COVID-19 DNA Vaccine for Adolescents and Adults Is a First

JAMA. 2021;326(14):1365. doi:10.1001/jama.2021.16625

In August, the government of India granted Emergency Use Authorization to a COVID-19 DNA vaccine. Pharmaceutical firm Zydus Cadila, in partnership with India’s Department of Biotechnology, developed the 3-dose intradermal vaccine, called ZyCov-D, which is authorized there for use in people aged 12 years or older. The endorsement marks the first clinical use of a DNA vaccine in humans.

Ahmedabad-based Zydus in July announced interim results from a phase 3 trial involving more than 28 000 volunteers. ZyCov-D was 67% effective against symptomatic infections. No severe cases or COVID-19 deaths occurred among vaccinated individuals after the second dose and no moderate cases occurred after the third dose. The doses are given 28 days apart.

Cadila Healthcare Limited

The vaccine contains plasmid DNA, circular strands of genetic material that enter the host cells’ nuclei, where they’re converted into messenger RNA (mRNA). The mRNA then travels out of the nuclei into the cytoplasm and is translated into the SARS-CoV-2 spike protein, as in now-familiar mRNA vaccines.

No severe adverse events or deaths occurred among adults in a phase 1 trial. Tolerability was similar for adults and about 1000 adolescents enrolled in the phase 3 trial, according to the company.

A painless, needle-free injector delivers the vaccine in a narrow fluid stream into the skin. Although it’s stored in colder temperatures, ZyCoV-D is stable at 77 °F for at least 3 months, which may reduce wasted doses. A 2-dose regimen also is being evaluated.

Ten other DNA vaccines are in clinical development against the novel coronavirus, according to the World Health Organization’s COVID-19 vaccine tracker. Pennsylvania-based INOVIO is initiating a phase 3 trial of INO-4800, its plasmid DNA vaccine candidate against SARS-CoV-2. According to the company’s projections, INO-4800 should be stable at room temperature for more than a year.