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

Sanofi and GSK announced that they have received the approval for the Phase 3 clinical study of their adjuvanted recombinant-protein COVID-19 vaccine candidate in India. Read all you need to know.

Created On: Jul 8, 2021 19:13 ISTModified On: Jul 8, 2021 19:14 IST

Sanofi, a French pharmaceutical company and GlaxoSmithKline (GSK), a British pharmaceutical company on July 7, 2021, announced that they have received the approval for the Phase 3 clinical trials in India for their adjuvanted recombinant-protein COVID-19 vaccine candidate.

Both companies will assess the efficacy, safety, and immunogenicity of their vaccine candidate through Phase 3 clinical trials.

“India is participating in Sanofi Pasteur’s pivotal Phase 3 study, and subject approvals, we should soon begin enrollment of study participants in the country,” said Annapurna Das, Country Head, Sanofi Pasteur India.

The Phase-3 study will be conducted on more than 35,000 volunteers aged 18 and above across the US, Latin America, Africa, and Asia.

Apart from the partnership with GSK, Sanofi has also partnered with Translate Bio to develop a messenger RNA vaccine.

Sanofi-GSK COVID-19 study: Key focus

• The first focus point of the Phase 3 study by Sanofi and GSK of their COVID-19 vaccine candidate is the prevention of symptomatic COVID-19.

• The second focus point of the study is the prevention of severe COVID-19 and asymptomatic COVID-19 infection.

Sanofi-GSK COVID-19 study: Process

• The study will be conducted in a two-stage process. The first stage will investigate the efficacy of the vaccine formulation on the original COVID-19 virus strain.

• The second stage will investigate the efficacy of a second formulation on the Beta variant. The geographical spread designed for the Sanofi-GSK Phase 3 study will help in gathering data on the efficacy of the vaccine candidate.

• The companies will also conduct clinical studies to evaluate the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate at generating a strong booster response, no matter what type of vaccine was initially administered.

What is recombinant protein COVID-19 vaccine?

• The recombinant protein COVID-19 vaccine incorporates the same technology as Sanofi’s influenza vaccines. The new recombinant protein COVID-19 vaccine candidate 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 infection.

• Sanofi’s recombinant antigen technology has been combined with GSK’s adjuvant to achieve stability in terms of temperatures used for vaccines so that the vaccine candidate is easier to store at normal refrigerator temperature and distributed at a global scale.

 

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