Sanofi and GSK announce positive booster data for COVID-19 vaccine candidate
pharmafile | December 15, 2021 | News story | Research and Development |
Sanofi and GSK have announced positive preliminary booster data for their COVID-19 vaccine candidate, and continuation of their Phase III trial per independent Monitoring Board recommendation.
The trial data show that neutralising antibodies increased across all primary vaccines received (mRNA or adenovirus), in a 9- to 43-fold range, and for all age groups tested. The vaccines demonstrated a good safety and tolerability profile, similar to that of currently approved COVID-19 vaccines.
The ongoing global Phase III trial, VAT0008, includes regular reviews by an independent Data Safety Monitoring Board (DSMB). During the 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 “naïve” populations i.e participants in the third quarter of 2021, coinciding with a significant increase in the number of people infected with the Delta variant of COVID-19. The trial will continue to gather the number of events needed for analysis, in order to collate the necessary data for regulatory authorities for the booster vaccine submission.
“These preliminary data show we have a strong booster candidate, whatever primary vaccine you have received.” said Thomas Triomphe, Executive Vice President, Sanofi Pasteur. “This is consistent with our efforts to provide relevant responses to evolving public health needs. While pursuing a phase 3 trial is a challenge in a quickly shifting pandemic environment, we look forward to seeing the results to support submissions of our booster vaccine as quickly as possible.”
Roger Connor, President of GSK Vaccines, added: “As the pandemic threat continues with the current dominant Delta variant and Omicron rapidly gaining ground, booster vaccines will continue to be needed to help protect people over time. The initial booster data are promising, and we await the phase III results to determine the next steps on making protein-based adjuvanted COVID-19 vaccines available.”