Home » Covid: phase 2 vaccine Sanofi-Gsk, ‘strong responses in adults of all ages’

Covid: phase 2 vaccine Sanofi-Gsk, ‘strong responses in adults of all ages’

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Phase 3 kicks off in the coming weeks, approval expected in the fourth quarter of 2021

Milan, May 17 (beraking latest news Health) – Positive results in clinical phase 2 for the adjuvanted recombinant Covid vaccine candidate from France’s Sanofi and Britain’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 problems. 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 will 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.”

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