Sanofi and GlaxoSmithKline (GSK) have delayed their COVID-19 vaccine program after phase I/II results found a coffee immune reaction in older adults who received their investigational vaccine.
In a phase I/II study of Sanofi/GSK’s adjuvanted recombinant protein-based vaccine, interim results found the jab induced an immune reaction like recovered COVID-19 patients in adults aged 18 to 49 years.
However, the results also found that the vaccine didn’t have an equivalent effect in older adults, who demonstrated low immune responses – likely thanks to an ‘insufficient concentration of antigen’, consistent with the Sanofi/GSK.
The companies have now decided to plan a phase IIb study, expected to start in February 2021, to check an improved antigen formulation which recently showed promise during a recent challenge study in non-human primates.
In this challenge study, the improved antigen formulation demonstrated protection against lung pathology and cause rapid viral clearance from the nasal passages and lungs within two to four days.
‘These results increase the businesses confidence within the capacity of the adjuvanted recombinant platform to deliver a highly efficient vaccine for all adults,’ the businesses commented during a statement issued today.
The phase IIb study, additionally to testing the improved antigen formulation, will include a proposed comparison with an authorised COVID-19 vaccine.
If the info during this mid-stage study is positive, Sanofi/GSK expect a that a phase III clinical trial study could start within the second quarter of 2021.
Depending on the leads to phase III clinical trial , regulatory submissions might be expected within the last half of 2021, which can delay the vaccine’s potential availability from the previously anticipated mid-2021 to the top of 2021.
“The results of the study aren’t as we hoped. supported previous experience and other collaborations, we are confident that GSK’s pandemic adjuvant system, when including a COVID-19 antigen, can elicit a strong immune reaction with a suitable reactogenicity profile,” said Roger Connor, president of GSK Vaccines.
“It is additionally clear that multiple vaccines are going to be needed to contain the pandemic. Our aim now’s to figure closely with our partner Sanofi to develop this vaccine, with an improved antigen formulation, for it to form a meaningful contribution to preventing COVID-19,” he added.
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