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NEW DELHI – If the Indian government is successful, the country could launch a vaccine opposed to COVID-19 in mid-August, an incredibly short period of time that has caused controversy and led corporations to boost their progression and possible vaccine trials.
Expectations, established through the Indian Medical Research Council (ICMR), have already raised considerations as to what such an accelerated timetable for the quality of clinical trials and the vaccine itself may mean.
Human trials are already underway with Covaxin (BBV-152), a candidate vaccine developed through the ICMR National Institute of Virology (NIV) in Pune, and Bharat Biotech International Ltd., in Hyderabad.
Balram Bhargava, director of ICMR, wrote in early July to top researchers at several medical facilities and hospitals interested in the progression of Covaxin to boost trials and prepare the vaccine for launch on August 15, India’s independence day.
“It has been decided by you as a clinical trial for the COVID BBV-152 vaccine,” Bhargava wrote. “The vaccine is expected to be introduced for public fitness purposes until 15 August after the final touch of all clinical trials.”
Bhargava called on all establishments to begin patient recruitment at the time of July to lay the groundwork for the release of the vaccine before the government deadline.
“Please note that the non-compliance will be taken very seriously. Therefore, you are asked to treat this assignment with the highest priority and to comply with it without any interruption,” he added.
What followed was the fury of Indian fitness experts. A few days later, on 4 July, ICMR issued a statement that Bhargava’s letter aimed to reduce non-compulsory bureaucracy and speed up the recruitment of participants and not circumvent mandatory processes.
Randeep Guleria, director of the Indian Institute of Medical Sciences in New Delhi, one of the sites, told the media that it will take at least 3 months for the first set of knowledge to emerge.
Bharat Biotech declined to tell BioWorld if it would meet the August deadline, but the company issued a statement.
“Accelerated through national regulatory protocols, (the) company has accelerated its purpose by completing comprehensive preclinical studies. The effects of these studies are promising and show extensive protection and effective immune responses,” the company said.
Representatives of the Indian pharmaceutical industry, who called for anonymity to avoid being considered critical of the government, said it is impractical to set deadlines for vaccine launch.
Covaxin is one of two vaccines for Phase I and Phase II trials through the Indian General Drug Controller (DCGI).
A moment-in-progress vaccine is ZyCov-D, developed through Zydus Cadila Healthcare Ltd. in Ahmedabad. Both corporations began recruiting for rehearsals this month.
Covaxin is based on a lively and weakened edition of the SARS-CoV-2 virus strain. The original strain moved away from Indian patients and transferred to Bharat Biotech, which developed the inactivated virus vaccine.
ZyCoV-D by ZyDus Cadila uses a DNA vaccine platform that uses a plasmid, a small circular piece of genetic fabric that exists independently of chromosomes, the main gene-carrying structures in the nucleus of a cell. Zydus said in July that his plasmid was not reflected or integrated with the host’s genetic clothing. The company has already manufactured batches of the candidate vaccine and introduced trials this month with 1,000 patients at various sites in India.
Zydus Cadila said the screens on his DNA vaccine platform “significantly advanced the stability of the vaccine and lowered the requirements of the bloodless chain, making it less difficult to ship to the most remote parts of the country.” The platform can also be used to modify the vaccine in just a few weeks in the event of a virus mutation, to ensure that the vaccine provides protection.
Bharat Biotech is also working with the Jefferson Vaccine Institute in Philadelphia on a new candidate vaccine for COVID-19 that the institute has developed. This candidate uses an existing deactivated vaccine as a vehicle to carry coronavirus proteins, according to a joint publication. The rabies vaccine is known to “produce a strong immune reaction and is approved for the entire population, adding young people and pregnant women,” the partners said.
In April, the University of Wisconsin, Madison, Flugen Inc. and Bharat Biotech began working on the progression and testing of Coroflu, which will be based on Flugen’s flu candidate vaccine.
Four other Indian corporations are also interested in the global race for the COVID-19 vaccine. These come with the Serum Institute of India Pvt, in Pune. Ltd., which will manufacture one billion doses of the Oxford-Astrazeneca plc vaccine for low- and middle-income countries; Biological E Ltd., in Hyderabad, which uses a vaccine in a viral protein subunit; Indian Immunologicals Ltd., in Hyderabad, which works with Griffith University, Australia, to manufacture a live attenuated vaccine; and Mynvax, a startup in Bangalore, working with the Indian Institute of Science on a genetically modified vaccine.
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