Zydus to soon start work on developing a vaccine for Delta variant

Also plans trials for children aged three years and above. Its needle-free injection is to be assembled in India

Apart from expecting to deliver 30-50 million doses of ZyCoV-D — India’s first vaccine for children aged 12-18 between October and January — Zydus Cadila will now start work on developing a version for the Delta variant and start trials on children aged three years and above.

Given that the delivery system of this vaccine is significantly more expensive, compared to the conventional injection-needle system, sources close to the development claimed that the price could be lower than Covaxin in the private market. 

ZyCoV-D will be delivered using a special injector that will use a specialised syringe or ‘applicator’. While each injector could be used thousands of times, the applicator is new for each shot. The cost of the injector roughly works out to be around Rs 5-7 per dose, sources claimed. The applicator price is additional. The company did not wish to comment on the pricing strategy. Zydus Cadila has said it will work closely with the government to deliver as many doses as it requires and the balance would go to the private sector.

Speaking with Business Standard, Zydus Cadila Healthcare Managing Director Sharvil Patel said that the deoxyribonucleic acid plasmid vaccine platform is a plug-and-play type, where developing a targeted vaccine for a specific variant is easy. It can be easily adapted to change the virus strain or the genes of the antigens injected.

“We are planning to develop variants specific to the Delta variant. Work will begin soon,” said Patel, adding that the vaccine can be tweaked in a month’s time or so to target any variant of concern.

Meanwhile, the company also plans to start work on trials on children aged 3-11 years and is developing the protocol. Patel feels this could be an ‘open label’ trial if the regulator approves, which means that no child will get a placebo. Such trials, in which everyone receives a vaccine shot, can be completed quickly. Each dose of ZyCoV-D will be two shots in two arms using a needle-free injection system.

US start-up PharmaJet has tied up with Zydus Cadila, which will exclusively administer the vaccine through a system called PharmaJet Tropis needle-free injection system. The feel of the prick is even less than the feel of an insulin pen shot. “The applicator delivers the vaccine in the dermis (skin) and not in the muscle.

“This makes it significantly less painful,” said Patel. The system comprises an injector which can be used multiple times, a one-time use applicator and a filling adaptor. The applicator takes in the metered dose — 100 microlitre of the vaccine — and delivers it at the click of a button of the pen. Vaccinating staff will need some brief training before they can use the delivery system.

Zydus is having the applicator contract manufactured in Singapore and is assembling the product in Ahmedabad. It may soon bring the applicator manufacturing to India too.

Experts in the syringe industry say the syringe is not cheap, but say it is possible the price could be lower, given the large volumes required in India. While very little details on the pricing are known, some reports say that the injector costs around $100 in the international market and the applicator (which is designed differently from a normal one-time needle syringe) costs anything between 30 cents and $1.

For the ZyCoV-D vaccine, the injector can be used between 10,000-20,000 times, depending on what the regulator approves. This brings the cost per dose down to Rs 5-7. To this, the cost of the applicator needs to be added (two applicators are needed for one dose as it is given in both arms).

In contrast, the cost of a syringe currently being used to administer Covaxin and Covishield is priced at only Rs 2 (without taxes). Together with the injection, the cost of one shot of either of these vaccines works out to be Rs 7-12. Patel did not comment on the price of the device or the syringe. The applicator and injector will not come free with the vaccine. As for the government procurement price, talks are on. The Centre will have to add the cost of the device to the price per dose calculations.

Zydus is not the only company in India which will be using PharmaJet Tropis. In 2017, the company partnered the Serum Institute of India for commercialising the needle-free delivery of the measles-mumps-rubella vaccine using the same system. 

The system is also being tried out in other countries, such as Australia, where it is under trials for delivery of Covid-19 vaccines. It has also been used extensively as part of polio eradication in Somalia, Pakistan, Cuba, and Gambia, among others.

Taking the ouch out of vaccines

· Needle-free injection system (NFIS) costs $100 in international markets

· Specialised needle or applicator price ranges between 30 cents and $1

· Indian price could be lower with large volumes

· ZyCoV-D NFIS is from PharmaJet; needle is made in Singapore

· Zydus assembles the device in India

· Cost of conventional injection needle is Rs 7-12 per dose; NFIS is Rs 5-7 per dose

· Each dose needs two applicators at an additional cost

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ZyCoV-D: Giving it the best shot

· Open-label trials in smaller children likely

· Everyone gets the vaccine, no placebos

· Supplies mainly to government channel

· Private market price could be less than Covaxin