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July 2, 2021

Zydus reports positive Phase III data of first DNA Covid-19 vaccine

The Phase III trial is the first to study a Covid-19 vaccine in adolescent subjects in India.

Zydus Cadila has reported positive interim results from the Phase III clinical trial of its plasmid DNA Covid-19 vaccine candidate, ZyCoV-D.

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Based on these data, the company is seeking emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for the vaccine.

On administration, ZyCoV-D generates the SARS-CoV-2 spike protein and triggers cellular and humoral immune responses. It is a three-dose vaccine to be given intradermally using the PharmaJet needle-free applicator.

Performed at more than 50 centres to date, the Phase III trial is considered the largest Covid-19 vaccine study in India.

It is also the first to evaluate a Covid-19 vaccine in adolescent subjects aged 12-18 years in the country.

With 1,000 participants recruited in this age group, ZyCoV-D was safe and well-tolerated. The interim data also showed a tolerability profile similar to that observed in adults.

The primary efficacy of the vaccine was 66.6% in symptomatic patients who tested positive using reverse transcription-polymerase chain reaction (RT-PCR).

Furthermore, the trial did not report any moderate Covid-19 cases in the vaccine group after the third dose, indicating 100% effectiveness against moderate disease.

No Covid-19-related severe cases or deaths were seen following the second dose of ZyCoV-D.

In previous adaptive Phase I/II trials, the vaccine demonstrated strong immunogenicity and tolerability and safety profile. The Phase I/II and Phase III trials were reviewed by an independent Data Safety Monitoring Board (DSMB).

Cadila Healthcare managing director Dr Sharvil Patel said: “As the first-ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety and efficacy profile in our fight against Covid-19.

“The vaccine when approved will help not only adults but also adolescents in the 12 to 18 years age group.”

The company expects to produce 100 to 120 million doses of its Covid-19 vaccine a year.

Separately, Zydus assessed a two-dose regimen of ZyCoV-D with a 3mg dose administered per visit.

Data showed an immunogenicity equivalent to the three-dose regimen, the company said. This can decrease the full course vaccination duration.

In May 2021, Zydus sought regulatory approval to conduct Phase I/III trials of its drug candidate, ZRC-3308 (Covimabs), for the treatment of mild Covid-19.

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COVID-19 has already affected our lives forever. The way we work, shop, eat, seek medical advice, and socialize will all be different in the future. Quite how different remains to be seen, but all industries must plan for multiple eventualities. Are you interested in actionable insights on the business challenges induced by the pandemic? GlobalData's cross-sector report analyzes the significance of this major disruptive theme across industry verticals. It provides side-by-side research of alternative datasets to present you with unique quantitative analysis of the effects of COVID-19 and how these differ across sectors. Additionally, it offers qualitative analysis of each sector and analyzes COVID-19’s impact on leading companies. Whatever your company’s imminent strategic plans, the long-lasting impact of COVID-19 must not be overlooked. Find out how to futureproof your business operations – download our report today.
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