Sanofi and GSK to seek approval for delayed COVID-19 vaccine

The vaccine was found to be 100% effective against severe COVID-19 and hospitalization as a solo two-dose shot.

After repeated delays, Sanofi and its British partner GlaxoSmithKline are seeking regulatory approval for their COVID-19 vaccine, which may be administered as a booster as well as a solo two-dose shot. The companies said on Wednesday that they planned to submit data to regulators from a late-stage vaccine trial and a booster trial, with full results for both studies anticipated to be published "later this year." Sanofi is trying to make a comeback after slipping behind in the race for COVID-19 vaccines, while GSK has chosen to supply its adjuvant technology to developers rather than developing its own candidate. In comparison to the newer mRNA technology used in proven COVID-19 vaccines from Pfizer-BioNTech and Moderna, Sanofi-shot GSK's uses a traditional protein-based technique.

It's based on similar technology as one of Sanofi's seasonal influenza vaccines, and it's paired with GSK's adjuvant, a substance that improves a shot's effectiveness. It's also less difficult to store and transport than some of its competitors. The booster trial, which included participants who had previously received shots based on mRNA technology or adenovirus viral vectors, indicated that it might enhance neutralising antibodies by 18 to 30 times. "We are confident that this vaccine can play an important role as we continue to address this pandemic and prepare for the post-pandemic period," said President of GSK Vaccines, Roger Connor.The companies said they were in talks with regulators, the US Food and Drug Administration and the European Medicines Agency, to have their shot approved.