Sanofi, GSK receive approval for Phase 3 trial of COVID vaccine in India

French pharmaceutical company Sanofi and its British partner GSK (GlaxoSmithKline plc) received approval for their Phase 3 clinical study in India, to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. In order to vaccinate a large number of the country’s adult population of nearly one billion people by the end of the year, the government has fast-tracked the approval for vaccines developed in other countries, including the USA, European Union, Russia, and Japan, writes ETV Bharat Deputy News Editor Krishnanand Tripathi.

New Delhi:French pharma giant Sanofi and British drugmaker GSK have received the regulatory approval to conduct phase-3 efficacy trials of the COVID-19 vaccine candidate in India, said the French drug-maker on Thursday. The clinical trial to assess the safety, efficacy, and immunogenicity of an adjuvanted, recombinant-protein COVID-19 vaccine candidate will have more than 35,000 volunteers from several countries, including the USA and India, in addition to several other countries in Asia, Africa, and Latin America. It will be a global, randomized, double-blind Phase-3 study that will be conducted on people above the age of 18 years.

New vaccine to tackle virus mutations

“As the virus continues to evolve, we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development program,” said Annapurna Das, the Country Head of Sanofi Pasteur India. In a statement sent to ETV Bharat, Das said the company believed its COVID-19 adjuvanted, recombinant vaccine could make a significant contribution to the ongoing fight against COVID-19.

The primary objective of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 in adults, with secondary endpoints being the prevention of severe COVID-19 disease and the prevention of asymptomatic infection. In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus strain (D.614), while a second stage will evaluate a second formulation targeting the Beta variant (B.1.351).

Citing a study, the French pharma giant said it showed that antibodies created against the Beta variant might provide broad cross-protection against other more transmissible variants. The company said the phase-3 trial conducted across different regions also allows evaluation of the efficacy of the candidate against a variety of circulating variants. Sanofi and GSK will also run clinical studies to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of the type of vaccine initially received, it said.

The Phase-3 study follows global interim Phase-2 results which showed that the adjuvanted recombinant COVID-19 vaccine candidate achieved high rates of neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates. "After a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine," said the company.

Boosting availability of vaccines

In order to vaccinate a large number of the country’s adult population of nearly one billion people by the end of the year, the government has fast-tracked the approval for vaccines developed in other countries, including the USA, European Union, Russia, and Japan. At present, three vaccines are administered in the country. Locally developed vaccine Covaxin produced by Hyderabad based Bharat Biotech, Covishield produced by Pune based Serum Institute of India, and Russian vaccine Sputnik V.

On Tuesday, the Russian Direct Investment Fund (RDIF) Russia’s sovereign wealth fund announced that it has started test production of the Sputnik V vaccine in Himachal Pradesh. RDIF has partnered with an Indian pharma company Morepen Laboratories to produce the vaccine developed by Gamaleya Institute. The first batch will be sent to the Gamaleya Center for quality control. Also, RDIF and Morepen had signed a cooperation agreement last month for the transfer of technology.

Sputnik V was granted an emergency use authorization in India in April this year. RDIF has already partnered with other leading pharmaceutical companies in India such as Gland Pharma, Hetero Biopharma, Panacea Biotec, Stelis Biopharma, and Virchow Biotech to produce more than 850 million doses of Sputnik V in the country per year.