Sanofi, GSK COVID vax may work as a booster, but trial data is delayed

Dec. 15, 2021

Sanofi and GlaxoSmithKline announced positive preliminary data from their COVID-19 booster trial — but also said their long-anticipated vaccine will be delayed until 2022.

According to the partners, preliminary results from the VAT0002 clinical trial investigating the safety and immunogenicity of the protein-based adjuvanted vaccine candidate used as a booster showed neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech). But, in order to provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue into early 2022.

The same goes for the large, ongoing global phase 3 trial, VAT0008 — with a primary endpoint of the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, The trial will also have to continue into early 2022 to accrue more data.

The drugmakers were forced to restart their trial last December when the vaccine showed a low immune response in older adults. They were expected to be a major supplier of vaccines and had arrangements in place for hundreds of millions of doses in the U.S., the EU, and the U.K. Earlier this year, they pivoted to a booster trial.