GlaxoSmithKline plc (GSK) and Sanofi announced that a single booster dose of their recombinant adjuvanted Covid-19 vaccine candidate delivered consistently strong immune responses.
Preliminary results from the VAT0002 clinical trial investigating the safety and immunogenicity of the booster showed neutralising antibodies increased 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech) and for all age groups tested. The booster was well tolerated, with a safety profile similar to currently approved Covid-19 vaccines. This is the most comprehensive booster trial to date to explore boosting across different vaccine technologies used for primary vaccination.
The ongoing global phase III trial, VAT0008, includes regular reviews by an independent Data Safety Monitoring Board (DSMB). During its last review, the DSMB identified no safety concerns and recommended the trial to continue into early 2022 to accrue more data.
Regulatory authorities require phase III efficacy to be demonstrated in na
