Sanofi-Gsk vaccine, phase 2 results ok: when it arrives

Positive results in clinical phase 2 for the adjuvanted recombinant Covid vaccine candidate from France’s Sanofi and UK’s GlaxoSmithKline, which has been shown to produce “a strong immune response in adults of all age groups”. This was announced by the two companies, which plan to start the phase 3 trial “in the coming weeks”. The green light is expected “in the fourth quarter of 2021”. The phase 2 trial, which began last February, enrolled 722 volunteers in the US and Honduras. Intermediate data indicate “a seroconversion of 95% to 100% after the second injection in all age groups (18 to 95 years) and with all doses” tested, in the face of “acceptable tolerability, without safety concerns. Overall – reads a joint note by Sanofi and Gsk – the vaccine candidate elicited strong levels of neutralizing antibodies, comparable to those generated by natural infection, with higher levels observed in younger adults (18-59 years). After a single injection, “the shield product induced” high levels of neutralizing antibodies in participants with evidence of previous Sars-CoV-2 infection, suggesting a strong development potential “of the candidate as a” booster vaccine “. The phase 3 study will recruit more than 35,000 adults in a wide range of countries and evaluate the efficacy of two vaccine formulations, including coronavirus variants D614 (Wuhan) and B.1.351 (South African), the two partners specify. In parallel, the two companies intend to conduct “booster studies with various formulations” against multiple “variants, in order to evaluate the ability of a lower dose of the vaccine to generate a strong booster response, regardless of the initial vaccine platform received.” that this vaccine candidate can make a significant contribution to the ongoing fight against Covid-19. It will move to Phase 3 “clinical trials” as soon as possible, to achieve our goal of making it available by the end of the year, “says Roger Connor , president of Gsk Vaccines, on the occasion of the announcement of the positive clinical phase 2 data of the vaccine co-developed by the British GlaxoSmithKline and the French Sanofi. The results communicated by the two groups show “the potential of this protein-based adjuvanted vaccine candidate in the broader context of the pandemic – underlines Connor – including the need to address” Sars-CoV-2 “variants and provide booster doses. “.” Our Phase 2 data confirms the potential of this vaccine to play a role in addressing the ongoing global public health crisis, as we know more products will be needed, especially as “viral” variants continue to emerge and increases the need for effective, booster vaccines that can be stored at normal temperatures, ”said Thomas Triomphe, executive vice president and global head of Sanofi Pasteur. “With these favorable results – he adds – we are ready to move to a global Phase 3 efficacy study. We look forward to producing additional data and working with our partners around the world to make our vaccine available. as quickly as possible “.

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