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Sanofi and GSK postpone COVID-19 vaccine due to lower immune response of seniors
Sanofi and GSK postpone COVID-19 vaccine due to lower immune response of seniors. On December 11, Sanofi announced on its global official website that it and GlaxoSmithKline (GSK) announced the postponement of the adjuvant-based recombinant protein COVID-19 vaccine plan.
The two companies said that the interim results of the phase 1/2 study of the COVID-19 vaccine show that the immune response generated by the vaccine is comparable to that of patients who have recovered from COVID-19 pneumonia among adults aged 18 to 49. However, due to insufficient antigen concentration, the elderly The immune response of the vaccine is low, and the purpose of delaying the vaccine plan is to improve the immune response of the vaccine in the elderly.
According to the official statement, the two companies plan to use the improved antigen preparation for phase 2b research, which will start in February 2021, including comparison with authorized COVID-19s, and is expected to provide products in the fourth quarter of 2021.
In April of this year, Sanofi and GlaxoSmithKline (GSK) announced that the two sides have signed a letter of intent to cooperate in the development of a COVID-19 vaccine containing adjuvants. When Pfizer, Moderna and other vaccine research and development companies announced the good news, the research and development progress of the two giants has been stuck on September 3, and they jointly announced on this day that they started 1/2 of their adjuvant COVID-19 vaccine on the same day. Phase clinical trials.
According to the previous statements of the two companies, the cooperative COVID-19 vaccine is expected to obtain its first results in early December this year, which will support the launch of phase 3 clinical trials in December this year, and plans to apply for regulatory approval in the first half of 2021.
The announcement of the postponement of the research plan means that the above timetable has been disrupted.
Thomas Triomphe, Executive Vice President and Global Head of Sanofi Pasteur, said that he is disappointed with the extension announced today, but all decisions will always be driven by science and data. The company has determined the way forward, remains confident and Committed to providing a safe and effective COVID-19 vaccine, based on these results and the latest encouraging new preclinical data, the candidate vaccine will be further optimized.
Roger Connor, president of GlaxoSmithKline Vaccines, said that the results of this study are not what we hoped for. Based on past experience and other collaborations, it is believed that GSK’s pandemic adjuvant system combined with the COVID-19 antigen can produce acceptable results. A powerful immune response characterized by reactogenicity.