Sanofi/GSK COVID-19 vaccine development delayed after failing to induce strong response in over-50s
pharmafile | December 11, 2020 | News story | Medical Communications, Research and Development | COVID-19, GSK, Sanofi, Vaccine
Sanofi and GlaxoSmithKline have taken the decision to delay the development programme for their adjuvanted recombinant protein-based COVID-19 vaccine after it failed to show an adequate response in older patients over the age of 50.
Data from the Phase 1/2 study showed that the two-dose vaccine generated comparable levels of neutralising antibody titers to those seen in patients who have recovered from COVID-19 infection, but only in patients between the ages of 18 and 49. In participants over the age of 50, these levels were insufficient – a fact which the investigators believe was due to “an insufficient concentration of the antigen”.
“The results of the study are not as we hoped. Based on previous experience and other collaborations, we are confident that GSK’s pandemic adjuvant system, when coupled with a COVID-19 antigen, can elicit a robust immune response with an acceptable reactogenicity profile,” remarked Roger Connor, President of GSK Vaccines. “It is also clear that multiple vaccines will be needed to contain the pandemic. Our aim now is to work closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to make a meaningful contribution to preventing COVID-19.”
The candidate was also tested in a challenge study in non-human primates, and was shown to protect against lung pathology and rapidly clear the virus from the lungs and nasal passages within two to four days, bolstering the developers’ confidence for “the adjuvanted recombinant platform to deliver a highly efficient vaccine for all adults”.
“We care greatly about public health which is why we are disappointed by the delay announced today, but all our decisions are and will always be driven by science and data,” said Thomas Triomphe, Executive Vice President and Head of Sanofi Pasteur. “We have identified the path forward and remain confident and committed to bringing a safe and efficacious COVID-19 vaccine. Following these results and the latest encouraging new preclinical data, we will now work to further optimise our candidate to achieve this goal.”
He added: “No single pharma company can make it alone; the world needs more than one vaccine to fight the pandemic.”
Both companies now plan to launch a Phase 2b study in February next year in partnership with the US Government’s Biomedical Advanced Research and Development Authority (BARDA), potentially comparing the candidate to an already authorized COVID-19 vaccine. Looking further, a Phase 3 study could commence in the second quarter of the year should previous trials succeed.
Matt Fellows
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