Zydus Cadila to begin human trials of COVID-19 vaccine next week; targets early 2021 launch

KEY HIGHLIGHTS

• Zydus Cadila's vaccine candidate has received DGCI nod for human trials

• No safety concerns were also observed for the vaccine candidate in repeat dose toxicology studies

• DCGI was was fast to take all measures for clearance, including conducting an audit

• Zydus Cadila company hopes the vaccine to hit the market by early 2021

Pharma major Zydus Cadila announced on Friday its plasmid DNA vaccine candidate for COVID-19 developed indigenously at its Vaccine Technology Centre in Ahmedabad has successfully completed the preclinical phase and received permission from the Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II (combined) human clinical trials. This makes it the second indigenous vaccine candidate to get DCGI approval for human trials, after Bharat Biotech-ICMR candidate.

Zydus Cadila, which claims to have achieved this after extensive animal studies, says in a note that the vaccine was found to elicit strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralisation assay, indicating the protective potential of the vaccine candidate. No safety concerns were also observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.

Zydus sources tell BusinessToday.In, the company hopes to begin human trials in a week and if, all goes well, then conclude the Phase I/II trials on over 1,000 people by October-November, and thereafter start phase III. The company hopes to hit the market by early 2021. The DCGI was was fast to take all measures for clearance, including conducting an audit, inspection and a holding a committee meeting.

The company has already manufactured clinical GMP batches of the vaccine candidate for clinical trials to be held across multiple sites in India on over 1,000 subjects.

The note issued by the company says, "with ZyCoV-D, the company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe. Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1). The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country."

What is also important, it says, is that "the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection." Zydus Cadila now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.

A senior official of the company, not wanting to be quoted, told BusinessToday.In that what stands out about the company is its track record as it was the first company in India to develop and indigenously manufacture the vaccine to combat swine flu in 2010. The vaccine technology centre of Zydus Cadila has wide range of capabilities in developing and manufacturing viral, toxoid, polysaccharide, conjugate and other subunit vaccines.

Candidate for COVID-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, India has successfully completed the preclinical phase and has now received permission from the Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II (combined) human clinical trials in India. This makes it the second indigenous vaccine candidate to get the DCGI approval for human trials, after the Bharat Biotech- ICMR candidate.

Zydus Cadila, which claims to have achieved this after extensive animal studies, says in a note that in animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate. No safety concerns were also observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.

Zydus, sources tell Businesstoday.in, hopes to begin human trials in a week and if, all goes well, then hopes to conclude the Phase I/II trials on over 1000 people by October / November and thereafter get into phase III and hopefully hit the market by early 2021. According to sources in the company, the DCGI was quite nimble footed while looking at this and also attending to the  rigorous exercise required, including  conducting an audit, inspection and a committee meeting apart from all the other measures required.

The company has already manufactured clinical GMP batches of the vaccine candidate for the clinical trials now to be held across multiple sites in India in over 1000 subjects.

The note issued by the company says, "with ZyCoV-D, the company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe. Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1). The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country." What is also important, it says, is that "the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection."

Zydus Cadila now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand.

A senior official of the company, not wanting to be quoted, tells Businesstoday.in that what stands out about the company in the vaccine development is also its track record as it was the first company in India to develop and indigenously manufacture the vaccine to combat Swine Flu during the pandemic in 2010. The vaccine technology centre of Zydus Cadila has wide range of capabilities in developing and manufacturing viral, toxoid, polysaccharide, conjugate and other subunit vaccines for unmet needs.