“Cadila and Bharat Biotech have completed phase I trials. Serum Institute has completed phase II-B3 trials and will begin phase III trial (with 1,500 patients at 14 locations) after authorizations,” said Balram Bhargava, DG. , ICMR.
Phase I clinical trials have revealed “excellent safety” of the two candidate vaccines developed indigenously by Bharat Biotech in collaboration with ICMR and Cadila Healthcare Ltd, and their immunogenicity testing is already underway, reported the Minister of State for Cheers Ashwini Choubey to the Rajya Sabha on Tuesday.
Its phase II clinical trials are ongoing, Choubey said in response to a question about the current status of the vaccine / clinical trial program for COVID-19 conducted by the Indian Council of Medical Research (ICMR) and other private research centers in the country. .
Choubey further reported that discussions on collaborations on the recombinant vaccine developed by Russia are ongoing. However, no formal studies have been initiated.
The Serum Institute of India (SII) and the ICMR have partnered for the clinical development of two candidate vaccines globally.
The first is ChAdOx1-S, a non-replicating viral vector vaccine developed by the University of Oxford / AstraZeneca. This vaccine is in phase III clinical trials in Brazil.
Late-stage trials of the vaccine were suspended last week after an illness in a study participant, raising questions about an early launch and causing the London-listed company’s shares to slide.
Global trials of the vaccine were also halted following the UK’s suspension. Brazil approved the resumption of trials and the Serum Institute of India is awaiting permission from the Comptroller General of Drugs of India.
The ICMR has initiated phase II / III bridging studies at 14 clinical trial sites, Choubey said. The ICMR-National Institute for Tuberculosis Research, Chennai is the leading institution.
Choubey further reported that ICMR and IBS have also been associated for the clinical development of an adjuvanted nanoparticle glycoprotein subunit vaccine developed by Novavax of the USA.
The trial will begin in the second half of October after the IBS manufactures the vaccine. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune, he said.
Digging deeper into the two indigenously developed candidate vaccines, Choubey said that Bharat Biotech International Ltd has developed an inactivated whole virion candidate vaccine for SARS-CoV-2 using the isolated virus provided by ICMR-National Institute of Virology (NIV). , Pune.
Characterization of the candidate vaccine was carried out at ICMR-NIV, followed by safety and tolerability studies in small animals such as rats, mice, and rabbits. Phase I clinical trials have been completed along with parallel studies in large animals.
“The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is ongoing. Phase II clinical trials are ongoing,” he said.
In addition, Cadila Healthcare Ltd has developed a DNA vaccine (ZyCov-D), the preclinical toxicity studies of which were carried out in small animals: mice, rats, rabbits and guinea pigs.
The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR to conduct parallel preclinical studies in large animals.
“While the government and industry are doing their best to deliver a safe and effective vaccine for COVID-19 as soon as possible, it is difficult to comment on the exact timelines in view of the various complex pathways involved in vaccine development,” said.
Other Indian companies involved in COVID-19 vaccine development are Premas Biotech, Gennova, Mynvax, Epygen Biotech, Luxmatra Innovations, Biological Evans. All the candidates are in pre-clinical development stages, the minister said.
Novavax Inc is doubling its COVID-19 vaccine manufacturing capacity to two billion doses under an agreement with the Serum Institute of India, the American company said Tuesday.
In August, Novavax signed an agreement with the Serum Institute, the world’s largest vaccine producer, to produce a minimum of 1 billion doses of its candidate vaccine for low- and middle-income countries and India.
As part of the expanded agreement, the Serum Institute will also manufacture the antigen component of the vaccine, which is called NVX-CoV2373.
The US company’s vaccine is in intermediate-stage trials after an early-stage trial showed it produced high levels of antibodies against the new coronavirus.
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