Sanofi and GSK’s Adjuvanted Recombinant COVID-19 Vaccine Candidate Elicits Strong Neutralizing Antibody Responses Across All Adult Age Groups in Phase 2 Trial

May 18, 2021 /BioonBIOON/ -- Currently, the COVID-19 epidemic overseas continues to spread rapidly. According to Baidu's "Real-time Novel Coronavirus Pneumonia EpidemicBig DataReport》, as of 23:00 on May 17, 2021,Global cumulative confirmed cases exceed 160 million (163.75 million)., with over 3.39 million deaths.

Recently, Sanofi (SNF) andGlaxoSmithKline(GSK) announcedAdjuvanted Recombinant COVID-19 Candidate VaccineData from a Phase 2 study. The study was conducted in 722 healthy adults aged 18 years and older, including adults with high-risk medical conditions, evaluated2-dose immunization schedule (21-day interval), the safety, reactogenicity, and immunogenicity of 3 antigen dose levels [5, 10, 15 μg]). The results showed that,Across all adult age groups, neutralizing antibody response rates were high and consistent with those observed in COVID-19 convalescents.. A global pivotal Phase 3 study is expected to commence in the coming weeks.

Interim results from the Phase 2 study showed that, following the second dose across all age groups (18-95 years) and all dose levels,The seroconversion rate is 95%-100%., demonstrated acceptable tolerability with no safety concerns. Overall, the robust neutralizing antibody levels elicited by the candidate vaccine were comparable to those induced by natural infection, with higher levels observed in younger participants (18–59 years).Following a single injection, evidence indicates that subjects previously infected with SARS-CoV-2 developed high levels of neutralizing antibodies., this demonstrates the development of this vaccineStrong Potential as a Booster Vaccine。

Based on these positive interim results from the Phase 2 study, Sanofi andGlaxoSmithKlineA global Phase 3 randomized, double-blind study is planned to be initiated in the coming weeks to evaluate a 10-μg antigen dose combined with GSK's pandemic adjuvant. This Phase 3 trial is expected to enroll more than 35,000 adults from multiple countries worldwide.Ginsengparticipants, and will evaluate the efficacy of two vaccine formulations, including the D614 (Wuhan) and B.1.351 (South Africa) variants.

Meanwhile, both parties plan to conduct booster studies on various formulations to evaluate the ability of low-dose vaccines to elicit a robust booster response, regardless of the initial vaccine platform. If Phase 3 studies yield positive results and are submitted for regulatory review, the vaccine is expected to receive approval in the fourth quarter of 2021.

Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said: “Our Phase 2 study data confirms the potential of this vaccine to play a role in addressing the current global public health crisis. We recognize the need for multiple vaccines, particularly as variants continue to emerge, and the demand for effective booster vaccines that can be stored at room temperature is growing. With these favorable results, we will proceed with a global Phase 3 efficacy study. We look forward to generating more data and collaborating with partners worldwide to make our vaccine available as soon as possible.”

Roger Connor, President of GSK Vaccines, stated: “These positive data demonstrate the potential of this protein-based adjuvanted vaccine in the context of the COVID-19 pandemic, including the need to address variants and provide booster doses. We believe this vaccine candidate can make a significant contribution to the ongoing fight against COVID-19. We will advance to Phase 3 studies as soon as possible to achieve our goal of making the vaccine available by the end of the year.” (Bioon.com)

Original Source: Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial