Ahmedabad-based Zydus Cadila is seeking emergency use authorisation for its COVID-19 vaccine ZyCov-D from the Drug Control General of India after the company revealed that the vaccine showed 66.6 per cent efficacy against SARS-CoV-2. If approved, the vaccine will be the first of many including to use plasmid DNA and to be a needleless injectable vaccine.
The indigenous vaccine is the first COVID-19 vaccine to use plasmid DNA as a technology platform against SARS-CoV-2. These plasmid DNA molecules emulate the spike protein of SARS-CoV-2 inside the body and push the body to elicit an immune response against it. While Oxford-AstraZeneca (Covishield), Sputnik V, and Johnson & Johnson vaccines use other viruses as vectors for the growth of the viral DNA, Pfizer and Moderna use mRNA, and Covaxin isolates and inactivates the original SARS-CoV-2.
If approved, ZyCov-D will become the first vaccine to be approved for the 12-18 age group in India. The company, conducted a phase III trial with 28,000 participants at 50 sites and even included adolescents between the ages of 12-18 years of age.
The vaccine is the only COVID-19 vaccine to be administered in three shots. Most of the other vaccines are to be administered in two shots while the vaccine produced by Johnson and Johnson is a one dose vaccine. Cadila Healthcare is also planning to study the effect of a two-dose vaccine against the virus and plans to manufacture close to 10-12 crore doses annually.
ZyCoV-D, according to the company, can be easily adapted to deal with mutations, making the plasmid DNA platform a lucrative and easy to use technology. The vaccine has already exhibited significant immunogenicity and tolerability and safety as reported in the Phase I/II clinical trials.
Furthermore, to reduce vaccine hesitancy among those who are afraid of using needles, this vaccine uses a needle free injection called PharmaJet which uses a spring to inject the vaccine in the intradermal area. This is another first which separates ZyCoV-D from the other COVID-19 vaccines.
The plasmid DNA needs to be stored at 2º-8ºC. It was also found to be stable at 25ºC for three months. This stability makes it easier for the transportation of the vaccine as well as storing it before it is used.
If approved, ZyCoV-D will become the fifth vaccine to receive EUA in the country. So far, only Covishield and Covaxin are currently being administered. Sputnik V has started its seven-day follow up for participants and is expected to roll out the vaccine, soon. Cipla will be importing the Moderna vaccine after it received approval on Tuesday.