ZyCoV-D to be launched in seven states first, says health ministry

Training of vaccinators complete on needle free injector system

The ZyCoV-D Covid vaccine by Zydus Cadila will be launched first in seven states including Bihar, Jharkhand, Maharashtra, Punjab, Tamil Nadu, Uttar Pradesh and West Bengal, the health ministry said.

All the seven states have been asked to identify districts where there is a high population of unvaccinated eligible people - who have not received even a single dose yet, for introduction of the new vaccine.

Cadila Healthcare (Zydus Cadila) had said in the first week of November that it had received an order to supply 10 million doses of ZyCoV-D, the world’s first Plasmid DNA vaccine, to the Centre. The vaccine has been priced at Rs 265 per dose and the needle-free applicator is being offered at Rs 93 per dose, excluding goods and services tax (GST). The vaccine has shown a 66.6 percent efficacy in interim analysis of phase 3 trials. It is a three dose regimen given on day zero, day 28 and day 56.

 Health ministry also said that the national training for administering ZyCoV-D has been completed since the vaccine is given not through an injection but using a needle free pharmjet technology.

“States should plan sessions based on pharmajet injector and identify vaccinators to be trained for using it for vaccination,” the health ministry said.

The Zydus vaccine is administered using a needle free injection system (NFIS). US startup PharmaJet has tied up with Zydus Cadila which will exclusively administer the ZyCoV-D vaccine through a needle free injection system Pharmajet Tropis. The feel of the prick is lesser than what one feels when taking an insulin pen shot.

Sharvil Patel, MD, Zydus Cadila explains: “The applicator delivers the vaccine in the dermis (skin) and not in the muscle. This makes it significantly less painful.” 

The system has two key parts-an injector which can be used multiple times, a onetime use syringe or applicator and filling adaptor. The needle free injector delivers the vaccine intra-dermally by means of a narrow stream that delivers the medicine into the skin.

The applicator takes in the metered dose – 100 micro-litre of the vaccine and delivers at the click of a button of the pen. The vaccinators need a brief training before they can use the delivery system, and even lesser skilled vaccinators can give a ZyCoV-D shot.

The pen can be used a few thousand times.

Government has asked states to ensure that the available vaccine is consumed timely and that no dose expires in both government and private facilities. According to the company, the vaccine has shown stability at temperatures of around 25 degrees for at least three months.

States have also been asked to devise targeted plans in the context of doses given in August and September 2021 to ensure coverage of all beneficiaries due for their second dose by exponentially increasing the pace of vaccination.

Zydus is getting the applicator contract manufactured at Singapore, and is assembling the product here in Ahmedabad. Soon the company may bring applicator manufacturing too in India

The total vaccine doses administered in the country has crossed 1.25 billion on Thursday. More than 84 per cent have been vaccinated with one dose while 49 per cent are now fully vaccinated according to provisional reports. Around 120 million beneficiaries are still due for their second dose in India.

So far, the firm has invested around Rs 400-500 crore for developing the DNA plasmid vaccine, including setting up of manufacturing plants. Zydus can make 10 mn monthly doses of the vaccine.

Hyderabad’s Shilpa Medicare will make the drug substance (raw material) for Cadila Healthcare’s DNA plasmid vaccine ZyCoV-D at its Dharwad facility. Shilpa Biologicals, a subsidiary of Shilpa Medicare, will manufacture the drug substance of the vaccine, while Zydus will do the filling-packaging and distribution of the vaccine.

Ahmedabad-based drug major Cadila Healthcare is currently testing if a two-dose regimen of their DNA-plasmid vaccine ZyCoV-D works instead of a three-dose one showing the similar levels of efficacy.