MUMBAI: Reliance Life Sciences (RLS), part of India’s largest conglomerate, is expected to start phase I clinical studies of its indigenous Covid-19 vaccine soon.
The Subject Expert Committee (SEC), which advises the drug regulator on vaccines and new drugs, reviewed the company’s application and is learnt to have recommended it for approval on Thursday.
A formal nod to conduct trials of the two-dose jab is expected over the next few days, sources told TOI.
The vaccine under development is a recombinant protein-based Covid-19 vaccine, and is expected to be launched by the first quarter 2022. The company started the development process last year, with the vaccine entering the pre-clinical stage in October.
Phase I testing marks the first time the vaccine is tested in a small group of adults, usually between 20 to 80 people, to evaluate its safety and measure the immune response it generates.
After the successful completion of Phase I, the company can approach for PhaseII/III trials which are conducted on a larger set of people to test its safety, efficacy and immunogenicity.
The vaccine is being developed at the company’s Navi Mumbai facility, and is expected to be “competitively priced”.
Pre-clinical small animal studies were conducted in-house, at the laboratory animal research facility, as well as by partner research organisations. While human clinical research will also be conducted through the company’s in-house clinical research services organisation.
Reliance Life Sciences is a niche biotechnology player with differentiated products used to treat patients in critical care, and manufactures biosimilar products, plasma proteins and complex monoclonal antibodies. The company is augmenting its capacity to manufacture vaccines next year.
The Reliance group plans to leverage its existing businesses — pharmaceuticals, retail and technology for Covid-19 right from developing test kits, operating testing laboratories, to vaccine development, manufacturing and distribution.
RLS is operating a high capacity Covid-19 RT-PCR and antibody testing laboratory, and has developed a ‘molecular transport medium’ for collection and transportation of Covid-19 swab samples.
MTM inactivates the virus within the sample and stabilizes the RNA, to make collection, transportation and processing safer. It also obviates the need for a cold chain in transportation of samples.
In contrast, the conventional ‘viral transport medium’ may not be safe, as the virus is active in the collection tube, and also requires cold chain (2 to 8 deg C) transportation.
Reliance gets nod to start Covid-19 vaccine trials – Times of India