The Ahmedabad-based Zydus Cadila group is working out a plan to test its ZyKov-D vaccine for Covid-19 for children between 5 to 12 years of age.
The ZyKov-D is plasmid DNA vaccine that falls under the category of ‘nucleic acid’ vaccines. Recently, Zydus Cadila carried out over 800 clinical trials for the vaccine for adults and children aged between 12 and 18 years.
The company is looking to get the regulatory nod for the emergency use of its vaccine in adults by June-end or July.
Dr Sharvil Patel, managing director, Cadila Healthcare Limited, told The Times of India, “We will have a good amount of data on children in this age group. If everything goes well in terms of safety, the vaccine will potentially be approved for use in children aged 12 to 18 years.”
“The vaccine development always happens in phases. Obviously, it starts with adults, followed by children in the 12-18 year age group and then you go towards younger kids aged five and above,” he said
“This platform will be more useful for children because it will be devoid of any side effects that you get to see in many other vaccines. Another benefit of our vaccine is that it involves ‘needlefree’ administration,” he added.
Recently, Zydus Cadila said it is seeking permission from Drugs Controller General of India (DCGI) to initiate human clinical trials for monoclonal antibodies cocktail for treatment of COVID-19.
“Zydus is currently seeking permission to initiate phase 1/3 human clinical trials from the DCGI… ZRC-3308, a cocktail of two SARS-CoV-2-neutralizing monoclonal antibodies (mAbs) can emerge as one of the main treatments for mild COVID 19,” Cadila Healthcare said in a regulatory filing.
Cadila Healthcare is the listed entity of the group. ZRC-3308 has been found to be safe and well tolerated in animal toxicology studies.
Zydus said it is the only Indian company to have developed a neutralizing monoclonal antibody based cocktail for the treatment of COVID-19.