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One step closer. Sanofi and GSK Announce Today They Have Commenced Phase 1/2 Clinical Trial for Their Own in Over 400 Participants vaccine Covid-19 adjuvant. The candidate vaccine, jointly developed by the two companies, uses the same recombinant protein-based technology as one of Sanofi’s seasonal flu vaccines with the pandemic adjuvant technology established by GSK. Preclinical studies – explained in a note – “show promising safety and immunogenicity.” Pending any positive data from Phase 1/2, the companies emphasize that they are ready to move to Phase 3 by the end of 2020 and are increasing production of the antigen and adjuvant with the goal of producing up to 1 billion doses by 2021.
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The companies explain how the Phase 1/2 “clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, reactogenicity (tolerability), and immunogenicity (immune response) of the candidate vaccine. COVID-19. A total of 440 healthy adults were enrolled in the study at 11 trial sites in the United States. The first results – they explain – could be available in early December 2020, which would allow the start of a phase 3 trial in December 2020. If the data is sufficient for the license application, the objective is to request regulatory approval in the first half of 2021. Sanofi explains how the ‘preclinical data showed a profile of acceptable reactogenicity and data based on two injections of the adjuvanted recombinant vaccine showed elevated levels of neutralizing antibodies that are comparable to levels in humans who have recovered from Covid-19 infection. The preclinical results will be published at the end of the year. ‘
SANOFI PRECISE
The French laboratory Sanofi will continue to work in the search for a vaccine against Covid-19. The announcement made by the same laboratory about the discontinuation of the phase 3 trial of the anti-rheumatoid arthritis antibody Kevzara, for not giving the desired results, has nothing to do with the research activity of a new vaccine, which will continue with regularity.
Last updated: 17:12
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