Sanofi, GlaxoSmithKline set to start Phase 3 trials for COVID-19 vaccine after earlier setback

A COVID-19 vaccine developed by Sanofi and GlaxoSmithKline showed a robust immune response in early-stage clinical trial results, enabling them to move to a late-stage study, the companies announced on Monday.

France’s Sanofi and U.K.-based GSK said a global Phase 3 trial would start in the coming weeks and involve more than 35,000 adults. The goal is for the vaccine to be approved by the fourth quarter after having initially targeted the first half of this year before a setback.

The delays were announced late last year, when the companies discussed their intention to improve the shot’s effectiveness in older adults.

The companies said in December that early trials showed the vaccine produced an “insufficient” immune response in people over 60 because it didn’t contain enough of the material that triggers the production of disease-fighting antibodies. The drugmakers said they planned to reformulate the vaccine and do more testing.

Since then, the COVID-19 vaccine candidate has achieved a strong antibody-based immune system response across all adult age groups during the Phase 2 study involving 722 volunteers, a finding in line with what has been measured in people who have recovered from COVID-19, Sanofi announced Monday.

The shot, developed through technology from both companies, combines a spike protein-based antigen with an adjuvant, a substance that enhances the immune system’s response to the presence of an antigen.

The latest data suggests the vaccine’s potential to “play a role in addressing this ongoing global public health crisis,” Thomas Triomphe, executive vice-president and global head of Sanofi, said in a statement.

Canada has an agreement for up to 72 million doses of the vaccine, pending Health Canada authorization.

Earlier this year, Sanofi also announced investments to boost Canadian vaccine manufacturing, facilitating the creation of hundreds of jobs and millions in funding annually for research and development.

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