Sanofi, GSK Kick Off Phase 1/2 COVID-19 Vaccine Trial in the U.S.

Sanofi and GlaxoSmithKline (GSK) have launched a phase 1/2 trial of their COVID-19 vaccine candidate in the U.S.

The trial will compare the vaccine vs. a placebo in 440 healthy adults. It will study the vaccine’s safety and tolerability and its ability to induce an immune response. Data from the trial are expected by December, when the companies also plan to begin a phase 3 trial.

Sanofi and GSK plan to file for approval of the vaccine in the first half of 2021.

The companies partnered in April to develop the vaccine, which uses the recombinant, protein-based technology from Sanofi’s seasonal flu vaccine and GSK’s adjuvant technology. They are scaling up manufacturing to be able to produce 1 billion doses in 2021.

The drugmakers landed a $2.1 billion contract from the U.S. government for 100 million doses of their vaccine, with an option for 500 million more, and are in negotiations with the European Commission to supply 300 million doses for the European Union (DID, Aug. 3).

The companies have also reached an agreement with the British government to supply up to 60 million doses for the UK. (DID, July 30). 

The phase 1/2 trial puts Sanofi and GSK behind several of their competitors. Moderna, Pfizer, and AstraZeneca have already launched phase 3 trials in the U.S., each aiming to enroll around 30,000 participants (DID, Sept. 1).

Johnson & Johnson has already begun phase 1/2 trials of a vaccine and is expected to begin the largest late-stage trial to date for a COVID-19 vaccine this month (DID, Aug. 21). — Jordan Williams