British and French pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur disclosed that release of their coronavirus vaccine would be delayed until late 2021 after interim results showed “insufficient immune response” in the elderly.
“Insufficient response in older adults demonstrates the need to refine the concentration of antigen in order to provide high-level immune response across all age groups,” a joint press of two pharmas read.
The two companies said they are now planning a new phase 2b study with an improved antigen formulation in February of next year, which could be followed by a global phase 3 study potentially starting in Q2 2021. The phase 3 studies were initially expected to start this month.
The two drug makers said they have updated governments and the European Commission on the delay “where a contractual commitment to purchase the vaccine has been made.”
This summer, the French and British giants won a commitment from the US federal government to pay up to $2.1 billion to help them move forward with their proposed joint coronavirus vaccine, as part of Operation Warp Speed.