Oxford Covid-19 vaccine: Serum will start phase-III trial in India after clearances

New Delhi: At a Union Health Ministry briefing on the prevailing Covid-19 situation in the country, an ICMR official said three vaccines are at the clinical trial stage in India. The official also said that Serum Institute will start phase-III trials after the necessary clearances.

"Cadila and Bharat Biotech have completed phase-I trials. Serum Institute has completed phase II-B3 trials, and will start phase-III trial (with 1,500 patients at 14 locations) after clearances," said Balram Bhargava, DG, ICMR.

Phase-I clinical trials have revealed "excellent safety" of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with ICMR and Cadila Healthcare Ltd and their immunogenicity testing is now in progress, Minister of State for Health Ashwini Choubey informed the Rajya Sabha on Tuesday.

Their phase II clinical trials are going on, Choubey said in response to a question on the present status of the vaccine programme/clinical trials for COVID-19 undertaken by the Indian Council of Medical Research (ICMR) and other private research centres in the country.

Choubey further informed that discussions on collaborations on the recombinant vaccine developed by Russia are ongoing. However, no formal studies have been initiated.

Serum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates.

The first is ChAdOx1-S, a non-replicating viral vector vaccine developed by University of Oxford/AstraZeneca. This vaccine is undergoing phase III clinical trials in Brazil.

Late-stage trials of the vaccine were suspended last week after an illness in a study participant, casting doubts on an early rollout and sending the London-listed company's shares lower.

Global trials of the vaccine had also been paused following the UK suspension. Brazil has approved restarting the trials and the Serum Institute of India is awaiting permission from the Drugs Controller General of India.

Phase II/III bridging studies have been initiated by ICMR at 14 clinical trial sites, Choubey said. The ICMR-National Institute for Research in Tuberculosis, Chennai is the lead institution.

Choubey further informed that ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from USA.

The trial will be initiated in the second half of October after the vaccine is manufactured by SII. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune, he said.

Elaborating on the two indigenously developed candidate vaccines, Choubey said an inactivated whole virion candidate vaccine for SARS-CoV-2 has been developed by Bharat Biotech International Ltd using the virus isolate provided by ICMR-National Institute of Virology (NIV), Pune.

Characterization of the vaccine candidate has been undertaken at ICMR-NIV followed by safety and tolerability studies in small animals like rats, mice and rabbits. Phase I clinical trials along with parallel studies in large animals have been completed.

"The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress. Phase II clinical trials are ongoing," he said.

Besides, a DNA vaccine (ZyCov-D) has been developed by Cadila Healthcare Ltd, pre-clinical toxicity studies of which were conducted in small animals - mice, rats, rabbits and guinea pigs.

The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR for conduct of parallel pre-clinical studies in large animals.

"While the Government and Industry are trying their best to make available a safe and effective vaccine for COVID-19 at the earliest, it is difficult to comment on the exact timelines in view of various complex pathways involved in vaccine development," he said.

Other companies in India involved in COVID-19 vaccine development are Premas Biotech, Gennova, Mynvax, Epygen Biotech, Luxmatra Innovations, Biological Evans. All candidates are in preclinical development stages, the minister said.

Novavax Inc is doubling its COVID-19 vaccine manufacturing capacity to two billion doses under an agreement with Serum Institute of India, the U.S. company said on Tuesday.

In August, Novavax signed a deal with Serum Institute, the world's largest producer of vaccines, to produce a minimum of one billion doses of its vaccine candidate for low-and middle-income countries and India.

As part of the expanded agreement, Serum Institute will also manufacture the antigen component of the vaccine, which is dubbed NVX-CoV2373.

The U.S. company's vaccine is in mid-stage trials after an early-stage trial showed it produced high levels of antibodies against the novel coronavirus.