After a letter by the Indian Council for Medical Research (ICMR) chief urging medical research centres to produce an "Indian vaccine" by August 15 raised suspicions of politics driving science, the body on Saturday issued a statement saying the vaccine has been fast-tracked by "cutting unnecessary red tape, without bypassing any necessary process".
Experts say that an inactivated vaccine involving live SARS-CoV-2 should be produced only in a BSL-3 containment facility due to a high risk of contamination or inadvertent release.
The ICMR has selected 12 institutes, including one from Odisha, for clinical trial of the country's first indigenous Covid-19 vaccine, an official said on Thursday. The letter claims that they are expecting the launch of the vaccine for public health use latest by August 15th completing all clinical trials.
The ICMR warned that any kind of non-compliance to the order will be viewed "very seriously".
The trial hospitals are in Belgaum, Bhubaneswar, Chengalpattu, Goa, Gorakhpur, Hyderabad, Kanpur, Nagpur, New Delhi, Patna, Rohtak, and Visakhapatnam. Whether the vaccine will be approved for general use depends on the outcomes of those trials, he said.
DNA vaccines use genetically engineered plasmids-a type of DNA molecule-that are coded with the antigen against which the immune response is to be built.
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Separately on Friday, Indian drugmaker Zydus Cadila said it had secured regulatory approval to start human trials on its own COVID-19 vaccine contender.
Once the initial phases are over, the vaccine will move into the third and final stage of human trials, where it will be tested on thousands of people. The letter, accessed by News18, was also marked to Bharat Biotech. "We basically check on the changes of Immunoglobulin in the body", he said.
A new drug or vaccine usually takes about 10-12 years to complete its journey from lab to market, with development costs surpassing $2.6 billion. Indian pharmaceuticals company, Bharat Biotech International Limited which is engaged in the manufacturing of bio-therapeutics, vaccines, and health care products developed a vaccine to treat coronavirus, the COVAXIN. It said results from these studies have been promising and show extensive safety and effective immune responses.
As per the recent update, the drug regulator's approval for Zydus' ZyCoV-D comes days after Bharat Biotech got a similar nod for human trials for its vaccine candidate as India has listed as the world's fourth worst-hit country. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic.
Developing nations are eager to pare their dependence on other nations and foreign drugmakers in securing vaccines.
"Furthermore, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection", it added.