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Zydus seeks emergency-use nod for plasmid DNA vaccine

Our Bureaus Ahmedabad | Updated on July 01, 2021

Interim results from Phase III trials show safety and efficacy among 12-18 age group

Zydus Cadila’s plasmid DNA vaccine, ZyCoV-D, has inched closer to the finish line, with the company applying to the Drug Controller General of India (DCGI) for emergency-use authorisation.

DNA vaccines are non-infectious, said Zydus Managing Director Dr Sharvil Patel, on the dermal vaccine that would be a first, globally. Vaccine hesitancy is due to the fear of needles, among other things, and that’s the benefit of this vaccine, he said. It is administered in a needle-free way, intradermally, using the PharmaJet applicator for painless vaccine delivery.

Interim results

The company has presented the interim results from its late-stage Phase III clinical trials in over 28,000 volunteers across 50 centers in India. The interim trial data demonstrated safety and efficacy, he said. Since the trial was done during the peak infection period – April to June – he said the vaccine was also seen to be effective against variants. According to sero-surveys, 99 per cent of the infections were from the Delta variant. The vaccine will be adapted to tackle “new variants of concern”, he added.

The vaccine was also tested in about 1,000 children over 12 years and was found to be safe and well tolerated, he added.

To scale-up production

Zydus was also at the cusp of scaling up manufacturing to ensure the product was available, said Dr Patel. The company expects to produce about a crore doses a month by mid-August-September, he said, and by December, they expect to have about five crore doses.

The company is investing in a new plant to manufacture about 10-12 crore doses annually. It has a 20 crore production target on the applicator used to administer this vaccine. The company has invested about ₹500 crore till date, between trials and manufacturing.

As for manufacturing, he said they were looking for partnerships. At present, the focus is on supplying to India, he said, indicating that Zydus was not looking at the overseas markets just yet.

With data on its three-dose vaccine as well as its two-dose one being given for regulatory evaluation, he said the deciding factor on which one would make the cut will depend on discussions with the regulatory authorities.

Vaccine pricing

Pricing of the vaccine will be decided once the approvals come through, he indicated.

While he did not comment on the issue of indemnity, a concern being raised by other vaccine-makers, he said the government will act in a balanced manner for both local and foreign players.

Efficacy

Plasmid DNA vaccine, when injected, produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from disease as well as viral clearance. It has shown primary efficacy of 66.6 percent for symptomatic RT-PCR positive cases in the interim analysis.

No moderate case of Covid was observed in the vaccine arm post-administration of the third dose, suggesting 100 per cent efficacy for moderate disease.

Published on July 01, 2021

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