Vaccine-majors Sanofi and GlaxoSmithKline have received regulatory approval to undertake late-stage efficacy trials on their Covid-19 vaccine candidate in India.

The Phase III clinical studies will assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein Covid-19 vaccine candidate, Sanofi said. The global, randomised, double-blind Phase III study includes over 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America.

“India is participating in Sanofi Pasteur’s pivotal Phase III study, and subject to subsequent approvals, we should soon begin enrolment of study participants in the country,” said Annapurna Das, Country Head, Sanofi Pasteur India, in a statement.

“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 programme. We believe our Covid-19 adjuvanted, recombinant vaccine can make a significant contribution to the ongoing fight against Covid-19, and are committed to initiating our clinical programme in India, at the earliest,” she said.

As Covid-19 vaccination becomes available, study participants are encouraged to receive an approved vaccine during the study, the note clarified.

As part of the study design, all participants, including the control group, will be offered the study vaccine as soon as it is determined to be safe and effective, it added.

Cross-protection

The primary endpoint of the study is the prevention of symptomatic Covid-19 in SARSCoV-2 naïve adults, with secondary endpoints being the prevention of severe Covid-19 disease and prevention of asymptomatic infection, it said.

Two-stage approach

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). Recent scientific evidence indicated that antibodies created against the Beta variant may provide broad cross-protection against other more transmissible variants, it said.

The design of the study, conducted across a broad diversity of geographies, also allows evaluation of the efficacy of the candidate against a variety of circulating variants. The two companies will also run clinical studies to assess the ability of the vaccine candidate to generate a strong booster response, regardless of the type of vaccine initially received, it added.

In the partnership, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza. The recombinant technology, combined with GSK’s adjuvant, is designed to offer the advantages of stability at temperatures used for routine vaccines, making it easily implementable and easier to distribute at a global scale through existing infrastructure, where vaccines are stored at normal refrigerator temperature, the note explained.

Sanofi’s kitty

Sanofi is also developing a messenger RNA vaccine, in partnership with Translate Bio. In March 2021, the companies initiated a Phase 1/2 clinical trial of their mRNA Covid-19 vaccine candidate to assess safety, immune response and reactogenicity. First results are expected in the third quarter of 2021.

Sanofi also provides manufacturing support to other vaccine producers: manufacturing up to 200 million doses of Moderna’s mRNA vaccine for the US, starting September 2021; supporting BioNTech’s 125 million doses for the European Union and Johnson & Johnson’s vaccine at 12 million doses per month. Besides its two vaccines, Sanofi is the only company leveraging its manufacturing for three different Covid vaccines to support global supplies, it added.

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