What is so special about India's needle-free Covid-19 DNA vaccine for kids, ZyCov-D?

What is so special about India's needle-free Covid-19 DNA vaccine, ZyCov-D

1. Introduction [1]

• ZyCov-D Covid-19 vaccine manufactured by Zydus Cadila, India in association with 

National Biopharma Mission, 

Biotechnology Industry Research Assistance Council (BIRAC), 

Department of Biotechnology, 

National Institute of Virology, 

Indian Council of Medical Research and 

PharmaJet®

• Received ‘emergency use authorization’ (EUA) from Drug Controller General of India (DCGI).

2. Salient features [1-3]

• It is the world's first DNA (plasmid) vaccine for Covid-19 which received ‘emergency use authorization’. 

• India's 1st vaccine for adolescent kids between age group of 12-18.

• Targeted age group: 12-18 years (adolescent) and above 18 years (adults) [1].

• The plasmid DNA platform allows easy customization to fight against new virus mutations.

• Phase I and II trail conducted between July 2020 and October 2020 in India. Peer reviewed detailed study of this trial is published in Medical Journal EClinicalMedicine [3]. 

• A double-blind, placebo controlled phase III study in 28,216 subjects aged 12 years and above is also currently ongoing and shall be published in 4-6 months [3].

• As per interim phase III trial data, its efficacy is 66.6% against the delta variant.

• Needs three shots administration, recommended gap between doses: 28d.

1st (0th day)--> 2nd (28th day) -->3rd (56th day)

• Recommended storage temp.: 2-8 deg C. Stable upto 25 deg C.

 2. Administration

• Mechanism of administration is NFIS i.e. Needle Free Injection System[3-4]. 

• NFIS technology is not new, has evolved over 50 years and is presently in use for various vaccine administration. 
  

• Solution delivery system is developed by 'PharmaJet'. NFIS technology is needle-free, painless,  intradermal vaccine delivery system. It offers at least 25% faster than a conventional needle-syringe[3-4]. 

• A narrow stream of fluid to penetrate the skin due to high pressure stream generated by the solution inside the syringe, and deliver vaccine to the proper tissue depth. 

 

 Needle vs Needle free injection

 

4. Availability

The supply of vaccines for Indian population is scheduled in September 2021. 

5. Reference

1. Press Release 'Zydus receives EUA from DCGI for ZyCoV-D, the only needle-free
COVID vaccine in the world' 

 

2. Zycov-D, India’s first COVID-19 vaccine for those above 12, gets nod

3. Momin, Taufik, et al. "Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India." EClinicalMedicine 38 (2021): 101020. https://doi.org/10.1016/j.eclinm.2021.101020

4.  'PharmaJet'. NFIS technology.