NEW DELHI – If India’s government has its way, the country could launch a vaccine for COVID-19 in mid-August, an extremely short deadline that has caused controversy and pushed companies to speed up their development and the trials of prospective vaccines.

The expectation, set by Indian Council of Medical Research (ICMR), has already created concerns over what such an expedited schedule might mean for the quality of clinical trials and the vaccine itself.

Human trials are already underway on Covaxin (BBV-152), a vaccine candidate developed by the ICMR’s National Institute of Virology (NIV), in Pune, and Hyderabad-based Bharat Biotech International Ltd.

Balram Bhargava, the head of the ICMR, wrote in early July to the principal investigators of several medical institutions and hospitals involved in the development of Covaxin to fast-track trials and get the vaccine ready for launch on Aug. 15, India’s Independence Day.

“You have been chosen as a clinical trial site of the BBV-152 COVID vaccine,” Bhargava wrote. “It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials.”

Bhargava called on all institutions to begin patient enrolment during the second week of July to set the groundwork for the launch of the vaccine by the government-imposed deadline.

“Kindly note non-compliance will be viewed very seriously. Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse,” he added.

What followed was furor from Indian health experts. A few days later, on July 4, the ICMR issued a statement saying Bhargava’s letter was meant to cut unnecessary red tape and speed up the recruitment of participants and not to bypass any necessary processes.

Randeep Guleria, director of the All India Institute of Medical Sciences in New Delhi, one of the trial sites, told the media that it will take at least three months for the first set of data to emerge.

Bharat Biotech declined to comment to BioWorld on whether it would be able to meet the August deadline but the company did issue a statement.

“Expedited through national regulatory protocols, (the) company accelerated its objective in completing the comprehensive preclinical studies. Results from these studies have been promising and show extensive safety and effective immune responses,” the company said.

Indian pharma industry representatives, who requested anonymity to avoid being seen as critical of the government, said that setting deadlines for vaccine launch was impractical.

Covaxin is one of two vaccines approved for phase I and phase II trials by the Drugs Controller General of India (DCGI).

A second vaccine under development is ZyCov-D, developed by Zydus Cadila Healthcare Ltd. out of Ahmedabad. Both companies started recruitment for the trials this month.

Covaxin is based on a live, weakened version of the SARS-CoV-2 virus strain. The original strain was isolated from Indian patients and transferred to Bharat Biotech, which developed the inactivated virus-based vaccine.

Zydus Cadila’s ZyCoV-D uses a DNA vaccine platform that employs a plasmid – a small round piece of genetic material that exists independent of chromosomes, the main gene-carrying structures in a cell’s nucleus. Zydus said in a statement in July that its plasmid does not replicate and does not integrate with the host’s genetic material. The company has already manufactured batches of the vaccine candidate and launched trials this month involving 1,000 patients across multiple sites in India.

Zydus Cadila said its DNA vaccine platform shows “much improved vaccine stability and lower cold chain requirements, making it easy for transportation to remotest regions of the country.” The platform can also be used to modify the vaccine in just a couple of weeks in case the virus mutates, to ensure that the vaccine still elicits protection.

Bharat Biotech is also working with the Jefferson Vaccine Institute, of Philadelphia, on a new vaccine candidate for COVID-19 that the institute developed. That candidate uses an existing deactivated rabies vaccine as a vehicle for carrying coronavirus proteins, according to a joint release. The rabies vaccine “is known to produce a strong immune response and is approved for the whole population including children and pregnant women,” the partners said.

In April, the University of Wisconsin, Madison, Flugen Inc. and Bharat Biotech started work on development and testing of Coroflu, which will build on Flugen’s flu vaccine candidate.

Four more Indian companies are also engaged in the global COVID-19 vaccine race. These include the Pune-based Serum Institute of India Pvt. Ltd., which will make a billion doses of the Oxford University-Astrazeneca plc vaccine for low- and middle-income countries; Hyderabad-based Biological E Ltd., which is working on a vaccine based on a virus protein subunit; Hyderabad-based Indian Immunologicals Ltd., which is collaborating with Griffith University, Australia, to make a live attenuated vaccine; and Bangalore-based startup Mynvax which is working with the Indian Institute of Science on a genetically engineered vaccine.

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