Mumbai: Reliance Life Sciences (RLS), part of India’s largest conglomerate, is expected to start a phase I clinical study from the Indigenous Covid-19 vaccine immediately.
The Subject Expert Committee (SEC), which suggested drug regulators on vaccines and new drugs, reviewing company applications and learning to recommend it for approval on Thursday.
The formal nod to conduct a trial from the two doses is expected for the next few days, said the source to Ti.
The vaccine that is being developed is the Covid-19 vaccine based on recombinant protein protein, and is expected to be launched in the first quarter of 2022.
The company began the development process last year, with vaccines entering the pre-clinical stage in October.
Phase I tested the first sign of a vaccine tested in a small group of adults, usually between 20 to 80 people, to evaluate its safety and measure the immune response it produced.
After the success of phase I settlement, the company can approach PhaseII / III trials carried out on a series of larger people to test safety, efficacy, and immunogenicity.
Vaccines are being developed at the Navi Mumbai company, and are expected to be “competitive prices”.
Studies of pre-clinical small animals are carried out at home, in laboratory animal research facilities, as well as by partner research organizations.
While human clinical research will also be carried out through the company’s internal clinical research service organization.
Reliance Life Sciences is a niche biotechnology player with distinguished products used to treat patients in critical care, and produce biosimilar products, plasma protein and complex monoclonal antibodies.
This company increases its capacity to produce vaccines next year.
The reliance group plans to take advantage of existing businesses – pharmaceuticals, retail and technology for Covid-19 rights from the development of test kits, operating laboratory testing, to the development of vaccines, manufacture and distribution.
RLS operates the Covid-19 RT-PRC testing laboratory and high-capacity antibodies, and has developed the ‘molecular transport medium’ for the collection and transportation of Covid-19 swab samples.
MTM disables the virus in the sample and stabilizes the RNA, to make safer collection, transportation and processing.
It also dodges the need for cold chains in sample transportation.
Convention, conventional ‘viral transportation media’ may be insecure, because viruses are active in collecting tubes, and also requires cold chain transportation (2 to 8 degrees C).