Glaxo & Sanofi Suffer Setback in Coronavirus Vaccine Development: Defer Rollout To Mid 2021

 

 

Two major pharmaceutical giants, UK based GSK (Glaxo) and French based Sanofi issue a joint statement saying that their new vaccine will be available mid next year.

 

Interim results from a phase1/2 trial demonstrated a low immune response in older adults. This may be due to an insufficient antigen concentration. Adults in the age group 18-49 did get an immune response that was comparable to the response seen in recovered COVID-19 patients.

 

“The results of the study are not as we hoped,” Roger Connor, president of GSK vaccines, said in a statement. “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.”

 

They are planning to conduct a phase 2b study in February 2021. Originally phase 3 confirmatory trials were scheduled for this month but they have been deferred to the second quarter of 2021.

 

GSK and Sanofi had received a $2.1 billion U.S. Government contract for 100 million doses. The companies said that they are updating the European Commission and other governments with whom they had contracts for purchase of the vaccine.

 

The setback for these companies is unfortunate. It comes a day after the FDA panel endorsed a coronavirus vaccine Pfizer and BioNTech. The panel has made its recommendations to the FDA for emergency authorization.


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