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New Delhi: Drug maker Zydus Cadila has started human dosing as part of phase I and II human trials of its Covid-19 vaccine candidate, ZyCoV-D, the company said on Wednesday. Zydus is one of the two companies (the other is Bharat Biotech) that have so far received the Indian dugs controller’s approval to begin human trials for their anti-Covid-19 vaccine candidates. ZyCoV-D was granted the approval on July 2.
“…the Adaptive Phase I/ II human clinical trials of its plasmid DNA vaccine, ZyCoV-D commenced today with the first human dosing. The Adaptive Phase I/II dose escalation, multi-centric study will assess the safety, tolerability and immunogenicity of the vaccine. The human dosing of the vaccine marks a key milestone since the launching of the accelerated vaccine development programme for Covid-9 in February 2020,” said Zydus in a statement.
The vaccine candidate was found to be safe, immunogenic (generating immune response) and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit a high level of neutralizing antibodies in animal studies. Phase I and II human trials are conducted to determine the safety and efficacy of a new drug or vaccine.
“This is an all-important step in our fight against Covid-19. We acknowledge the support of… [the] government of India and regulatory agencies ICMR [Indian Council of Medical Research] and DCGI [Drug Controller General of India] in the development of ZyCoV-D vaccine candidate. We look forward to the Adaptive Phase I/II clinical studies and gathering important data on ZyCoV-D in the months ahead,” said Pankaj R Patel, chairman, Zydus Cadila.
In the pre-clinical phase, 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 neutralize the virusin virus neutralization assa,y indicating the protective potential of the vaccine candidate.
No safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies, according to the details shared by the company.
The platform is also known to show much-improved vaccine stability and lower cold chain requirements, making it easy for transportation to the remotest regions. Also, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection.
Zydus will be enrolling at least 1,000 subjects across multiple clinical study sites in India and has already produced clinical manufacturing practice batches of the vaccine candidate for the clinical trials.
“The government is providing all support needed to fast-track the vaccine development process. India is about 60% supplier of total vaccine volume to the world, and will also take the lead in manufacturing the Covid-19 vaccine even if it’s developed elsewhere in the world,” said Dr Balram Bhargava, director general, ICMR, on Tuesday.
“The vaccine will be ultimate to check the disease spread but we don’t know when will an effective vaccine be available for use even though all our efforts are being directed towards making it happen as soon as possible. A good vaccine is the most cost-effective way of preventing a disease,” said Dr Amita Jain, head, microbiology department, KGMU, Lucknow.
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