Drug manufacturer Zydus Cadila has begun human dosing as a component of the Phase I and II human trials of its Covid-19 vaccine candidate, ZyCoV-D, the company announced Wednesday. Zydus is one of two corporations (the other is Bharat Biotech) that has so far obtained approval from the Indian Comptroller Dugs to begin human trials of its candidate anti-Covid-19 vaccines. ZyCoV-D approved on July 2.
«… Adaptive Phase I/II human clinical trials of his plasmidic DNA vaccine, ZyCoV-D, began today with the first dose in humans. The Phase I/II multicenter adaptive dose escalation test will evaluate the safety, tolerability and immunogenicity of the vaccine. Human vaccination dosing marks a key milestone since the launch of the vaccine’s accelerated progression program for Covid-9 in February 2020,” Zydus said in a statement.
Read also: India in a position to play a central role in the production of the Covid-19 vaccine, says ICMR
The candidate vaccine was found to be safe, immunogenic (immune response) and well tolerated in preclinical toxicity studies. The vaccine was able to discharge a higher point of neutralizing antibodies in animal studies. Phase I and II human trials are underway for the protection and efficacy of a new drug or vaccine.
“This is a very vital step in our combat opposite Covid-19. We recognize the … [of] the Indian government and regulatory agencies ICMR [Indian Medical Research Council] and DCGI [General Drug Controller of India] in the progression of the ZyCoV-D candidate vaccine. We looked to the adaptive phase I/II clinical studies and the collection of vital knowledge about ZyCoV-D in the coming months,” said Pankaj R Patel, president of Zydus Cadila.
Read also: India’s pharmaceutical industry is an asset to the world, says Prime Minister Narendra Modi
In the preclinical phase, the vaccine was found to cause a strong immune reaction in several animal species such as mice, rats, guinea pigs and rabbits. Antibodies produced through the vaccine were able to neutralize the virus neutralization control in the virus, indicating the protective perspective of the candidate vaccine.
No protection considerations were observed for the candidate vaccine in repeated dose toxicology studies, according to the main points shared through the company.
The platform is also known to show particularly advanced vaccine stability and reduces blood-free chain requirements, making it less difficult to send to more remote areas. In addition, the platform can be used temporarily to modify the vaccine within weeks in case the virus is mute and the vaccine still provides protection.
Zydus will recruit at least 1,000 subjects to several clinics in India and has already produced batches of clinical production practices candidate for clinical trial vaccines.
“The government is offering everything necessary to drive the vaccine progression process. India is a supplier of about 60% of the total volume of vaccines internationally and will also take the lead in manufacturing the Covid-19 vaccine even if it is being developed elsewhere in the world,” Said Dr. Balram Bhargava, ICMR’s CEO on Tuesday.
Click for full coverage of the coronavirus
“The vaccine will be the ultimate in preventing the spread of the disease, but we don’t know when an effective vaccine will be available, even if all our efforts are aimed at getting there as temporarily as possible. A smart vaccine is the ultimate cost-effective way to prevent you from disease,” said Dr. Amita Jain, Director of Microbiology, KGMU, Lucknow.
“O item.title”