Sanofi, GlaxoSmithKline Launch Phase 3 COVID Vaccine Trial

Sanofi and GlaxoSmithKline have begun enrolling participants in a global phase 3 trial of their COVID-19 vaccine candidate that could potentially lead to a regulatory approval in the fourth quarter of 2021.

The drugmakers said they tailored their vaccine development strategy to the ever-changing coronavirus, and the pivotal trial is using a two-stage design that will evaluate the vaccine candidate against both the original virus and the South African variant.

The Sanofi/GSK shot can remain stable at temperatures used for routine vaccines, making it potentially viable as a global option for COVID-19 vaccination.

The phase 3 trial, which will enroll more than 35,000 patients aged 18 years and up in the U.S., Africa, Asia and Latin America, will be supplemented by a booster study set to start in the coming weeks. That program will assess how well the adjuvanted vaccine candidate serves as a booster dose regardless of the initial vaccine administered. The companies believe their vaccine could be powerful as a booster, given their phase 2 trial findings that showed it provided a high immune response after one dose in patients previously infected.

"Our phase 2 data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge and the need for effective and booster vaccines, which can be stored at normal temperatures, increases,” said Thomas Triomphe, executive vice president and head of Sanofi’s vaccines unit. — James Miessler