French company Sanofi and UK-based GSK have said a global Phase 3 trial will start in the coming weeks and involve more than 35,000 adults. The goal is for the vaccine to be approved in the fourth quarter after initially targeting the first half of this year before a setback. The delays were announced late last year, when companies discussed plans to improve shooting efficiency in the elderly.
The companies said in December that the first trials had shown that the vaccine produced an “insufficient” immune response in people over 60 because it did not contain enough material that triggers the production of anti-disease antibodies. Drugmakers have said they plan to reformulate the vaccine and do more testing.
Since then, the COVID-19 vaccine candidate has achieved a strong antibody-based immune system response in all adult age groups during the Phase 2 study involving 722 volunteers, a finding consistent with what has was measured in people who have recovered from COVID- On 19, Sanofi announced on Monday.
The shot, developed using technology from the two companies, combines an advanced 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 director of Sanofi, said in a statement.
Canada has reached an agreement for up to 72 million doses of the vaccine, pending approval from Health Canada.
Earlier this year, Sanofi also announced investments to boost vaccine manufacturing in Canada, facilitating the creation of hundreds of jobs and millions of dollars in annual funding for research and development.