Reliance Life Sciences to conduct trials of its recombinant protein-based COVID-19 vaccine

Reliance Life Sciences (RLS), part of India’s biggest conglomerate Reliance Industries, will be conducting the trials of its recombinant protein-based COVID-19 vaccine candidate after the country’s drug regulatory authority on August 26, 2021, approved the company’s application.

The Subject Expert Committee (SEC) gave its approval after reviewing the application at a meeting on August 26, 2021. Reliance Life Sciences is required to approach the Drug Controller General of India seeking permission for conducting Phase-1 trials for its proposed two-dose recombinant protein-based COVID-19 vaccine.

What is recombinant protein COVID-19 vaccine?

The recombinant protein COVID-19 vaccine uses the spike protein of SARS-CoV-2 as the antigen that helps the human body to recognize and develop a strong booster response to fight off the COVID-19 infection.

What will Phase-1 trials of Reliance Life Sciences include?

The Phase-1 trials by Reliance Life Sciences of its recombinant protein-based COVID-19 vaccine will aid in obtaining data on the safety, pharmacokinetics (PK), tolerability, and mechanism of action of drugs with the objective of determining the maximum tolerated dose (MTD).

The Phase-1 trials will be conducted for 58 days to study the tolerated strength of its vaccine dose. Once the Phase-1 trials will be completed successfully, the company will apply for Phase-2/3 trials.

Where will Phase-1 trials be conducted?

The Phase-1 trials by Reliance Life Sciences of its recombinant protein-based COVID-19 vaccine will be conducted across 10 sites in India across Delhi, Maharashtra, Tamil Nadu, and Andhra Pradesh.

Other recombinant protein COVID-19 vaccine trials

Sanofi, a French pharmaceutical company, and GlaxoSmithKline (GSK), a British pharmaceutical company in July 2021 also received the approval to conduct Phase-3 trials of their adjuvanted recombinant protein Covid-19 vaccine candidate to assess its safety, efficacy, and immunogenicity.

Hyderabad-based company Biological E has also been developing CORBEVAX, a recombinant protein subunit COVID-19 vaccine.

Also read: COVID-19 Vaccine: Sanofi, GSK receives approval for Phase 3 trials in India

COVID-19 vaccines approved in India

So far, India has six COVID-19 vaccines that got Emergency Use Authorization (EUA). Zydus Cadila’s three-dose mRNA COVID-19 vaccine ZyCoV-D became the 6^th vaccine that got approval on August 21, 2021, and is now India’s first vaccine for children between 12 to 18 years old. Other vaccines being administered in India are Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Russia’s Sputnik V, Moderna, and Johnson & Johnson.

Also read: ZyCoV-D: Zydus Cadila to begin vaccine trials for children aged 3-12 years