Indian Immuno seeks approval for Covid vaccine human trials

July 7, 2021 Gubba Pharma In E News

NDDB arm hopes to apply for emergency use nod by March 2022
Indian Immunologicals Limited (IIL), an arm of the National Dairy Development Board (NDDB), is hoping to complete Phase-III trials of its Covid-19 vaccine and apply for emergency use approval by March 2022.
The company is working on a live attenuated vaccine, which will offer immunity for a longer time than those based on dead viruses.
Animal studies completed
Interacting with representatives of electronic-hardware start-ups at T-Works here, IIL Managing Director K Anand Kumar said the company has successfully completed animal studies. “We have completed all safety and efficacy studies on animals,” he said.
“We have sought permission from the government to prepare batches to begin clinical trials. After we get permission, we will begin Phase-I and Phase-II/III trials. We are looking at a March 2022 timeframe to seek ‘Emergency Use’ permission for our vaccine,” he said.
The firm entered into a research collaboration agreement with the Griffith University of Australia to develop a ‘Live attenuated SARS -CoV-2 Vaccine using the codon de-optimisation technology.
Set up by the NDDB in 1982, the Hyderabad-based firm produces inactivated to live viral vaccines, recombinant subunit, bacterial and molecular vaccines.
India first
Anand Kumar said when the company begins to produce the Covid vaccine, it would focus only on domestic needs. “We might think of exporting them only if we have enough surplus stocks,” he said.
Pointed to concerns about safety of live virus vaccines, he said live attenuated vaccines has been used for several viral diseases. “We have been using them for measles, rabies and polio. They are absolutely safe. All the safety concerns will be addressed,” he said.
Besides developing its own vaccine for Covid-19, the company has entered into an agreement with Bharat Biotech to manufacture the latter’s Covaxin from its repurposed production lines. This was part of the government’s plan to augment the vaccine production capacities in the country.

Source : thehindubusinessline

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