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Sanofi, GSK Delay COVID-19 Vaccine Program Due To Low Immune Response In Elderly People

Sanofi (SNYNF,SNY) and GlaxoSmithKline Plc. (GSK.L,GSK) said Friday that they have delayed their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immune response in older adults.

The delay in the vaccine program will push the vaccine availability to the fourth-quarter of 2021 from the earlier targeted deadline of mid-2021.

According to the companies, in the phase I/II study of the COVID-19 vaccine candidate in adults aged 18 to 49 years, the immune response was comparable to patients who recovered from COVID-19. But in older adults, the immune response was low, probably due to an insufficient concentration of the antigen.

The companies have now planned to conduct a phase IIb study of the COVID-19 vaccine candidate with an improved antigen formulation, which is expected to start in February 2021, with support from the Biomedical Advanced Research and Development Authority (BARDA).

The study will include a proposed comparison with an authorized COVID-19 vaccine. If all goes well as planned, a global phase III study could be started in the second quarter of 2021, and if the results are positive, a regulatory filing could be made in the second half of 2021, hence delaying the vaccine's potential availability from mid-2021 to the fourth-quarter 2021.

Sanofi and GlaxoSmithKline were earlier hoping to initiate the pivotal phase III study before the end of the year and had planned to request for regulatory approval in the first half of 2021.

In September, Sanofi and GSK signed a final agreement with the European Commission to supply European countries with up to 300 million doses from their European industrial network.

In July 2020, Sanofi and GSK announced a collaborative effort with the U.S. government to supply up to 100 million doses of their COVID-19 recombinant protein-based vaccine. The U.S. government has a further option to discuss the purchase of up to 500 million doses longer term.

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