New Delhi: Sanofi and GSK have received approval for their phase 3 clinical studies in India to assess safety, efficacy, and immunogenicity from the protein-19-19-19 protein-19 vaccine candidate.
Global Phase 3 Studies, Random, Double-Blind will cover more than 35,000 volunteers aged 18 years and over in the US, Asia, Africa and Latin America, Sanofi said in a statement on Thursday.
“India participates in the Pivotal Phase 3 Study of Sanofi Pasteur, and is subject to the next agreement, we must immediately begin the study of study participants in the country,” said Sanofi Pasteur India, said Neara, Annapurna Das.
When the virus continues to evolve, “We anticipate what will be needed in the coming month and years, and therefore, has adapted our vaccine development program,” he added.
DAS said this vaccine could make an important contribution in the war against Covid-19.
“We believe the Covid-19 vaccine is ready, recombinant we can make a significant contribution to the ongoing struggle against Covid-19 and commit to starting our clinical program in India, earliest,” said the watershed.
The main endpoint of this study was the prevention of covid-19 symptomatic in adult naif sarscov-2, with a secondary end point to prevent severe covid-19 disease and prevention of asymptomatic infections, said sanofi.
In the two-stage approach, this study was initially investigating the efficacy of vaccine formulations that target the original virus strain, while the second stage will evaluate the second formulation targeting the beta variant, he added.
Phase 3 study design, conducted in various geographic diversity, also allows evaluating the efficacy of candidates to various circulating variants, the statement said.
Sanofi and GSK will also run clinical studies to assess the ability of the Covid-19-19-19-19-protein vaccine candidate to produce a strong booster response regardless of the type of vaccine which was initially received.
“In the partnership between the two companies, Sanofi gave the recombinant antigen and GSK contributed to the adjuvant pandemic, both of them set a vaccine platform that had proven successful against influenza,” said Sanofi.
Recombinant technology combined with GSK Ajuvant is designed to offer stability benefits at temperatures used for routine vaccines, so it is easily applied and easier to distribute on a global scale through infrastructure where the vaccine is stored at the temperature of the normal refrigerator, he added.
In addition to recombinant protein-based vaccines that are ready to work with GSK, Sanofi is developing a RNA envoy’s vaccine in partnership with BIO translate.