Sanofi and GSK Commence Phase 3 Study of COVID-19 Vaccine Candidate

Sanofi (SNYNF) announced that together with GlaxoSmithKline, it has begun enrolment in their Phase 3 clinical study to examine the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate.

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The primary endpoint of the study is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints being the prevention of severe COVID-19 disease and the prevention of asymptomatic infection.

Notably, the study will include 2 stages. In the first stage, it will investigate the efficacy targeting the original D.614 virus (Wuhan) while in the second, it will examine a second formulation targeting the B.1.351 (South African) variant.

Over 35,000 volunteers aged 18 and above from several countries will participate in the study that will evaluate the efficacy of the candidate against a variety of circulating variants. (See Sanofi stock analysis on TipRanks)

The Phase 3 study follows the interim Phase 2 results that showed the COVID-19 vaccine achieved strong antibody responses in all age groups, with 95 to 100% conversion rates.

The vaccine is subject to positive outcomes as well as certain regulatory approvals and is expected to receive authorizations in Q42021.

Both the companies also intend to start clinical studies to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of the initial vaccine platform received in the coming weeks.

Sanofi’s EVP and Global Head of Sanofi Pasteur, Thomas Triomphe commented, “We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting. This trial is a testament to the urgency and agility in our approach to help overcome the ongoing impact of this pandemic.”

On May 21, Kepler Capital analyst David Evans maintained a Buy rating and a price target of EUR105.00. ($127.88). This implies approximately 20% upside potential over the next 12 months.

Overall, the stock has a Moderate Buy consensus rating with 6 Buys, 3 Holds, and 1 Sell. The average analyst price target of $119.48 implies 12.4% upside potential from current levels.