French Sanofi announced on Friday a delay in the development program for its COVID-19 vaccine developed with the British GlaxoSmithKline (GSK) due to an insufficient immune response in the elderly, which is a major setback for the pharmaceutical group in the global race for a vaccine against the new coronavirus. “The results of the study do not live up to our expectations,” GSK Vaccines President Roger Connor said in a statement.
“In adults aged 18 to 49 years, the interim results of the phase I / II study showed an immune response comparable to that of patients who recovered from COVID-19 infection, but a weak immune response in older adults, potentially attributable to an insufficient concentration of antigens, ”the two groups explained in a statement.
Therefore, the two companies will launch a new phase IIb study which is expected to start in February 2021. If the data is positive, phase III – the final phase of development – would start in the second quarter of 2021. In case of positive results, the Submission of approval requests to regulatory authorities would take place in the second half of 2021, which will have the effect of pushing back the potential availability of the vaccine to the fourth quarter of 2021, which was originally scheduled for the start of the second half of 2021.
“The strategy to be followed has been identified, and we are confident and firmly resolved to develop a safe and effective vaccine against COVID-19”, declared Thomas Triomphe, executive vice-president and head of Sanofi Pasteur. The vaccine candidate developed by the two groups is based on the same classic technology used by Sanofi against seasonal influenza. It is associated with an adjuvant, a product intended to stimulate its action, developed by GSK.
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