Hours after Pfizer and BioNTech obtained endorsement from an FDA panel for their mRNA vaccine, Sanofi and GSK announced that their closely monitored program to develop an adjuvanted vaccine to combat Covid-19 had suffered a major setback.
The companies announced early Friday that they were delaying their program to develop a recombinant protein-based Covid-19 vaccine with adjuvant after it failed among adults 49 and older in the study.
The researchers observed a “low immune response in older adults probably due to insufficient antigen concentration.”
The collaborators, who had expected to launch a pivotal Phase III this month, are now planning a Phase IIb study of a revised vaccine with an improved antigen formulation. They plan to start that 2-shot study in February, comparing it to an established vaccine on the market. The move will force the launch of vaccine supplies to be delayed from the first half to the fourth quarter of 2021, in the best case, after some Operation Warp Speed officials hope to see the end of the pandemic in The USA.
GSK and Sanofi had projected to bring hundreds of millions of doses of this vaccine to world markets, representing a large portion of the vaccine doses the world would need to fight the pandemic. The companies had signed an agreement to work with WHO on equitable distribution of their vaccine, offering hope for a vaccine among the world’s least wealthy countries. Their vaccine demanded a slower development approach, but used what many believed to be a more reliable technology that could distribute vaccines in bulk around the world. Now, it seems likely that Pfizer / BioNTech and Moderna will get approvals anytime soon, as AstraZeneca faces questions about the lower efficacy it had seen in its late-stage study.
Any setback like this threatens to lengthen the time it takes to beat the virus, as the first approved vaccines are likely to be in short supply for some time. It will also accelerate the ongoing virtual revolution in the vaccine industry, as traditional technology makes way for a faster and obviously more reliable mRNA approach.
Sanofi and GSK, two of the world’s leading vaccine manufacturers, remain in the race, even if they have lagged far behind the leaders.
Thomas triomphe“We have identified the way forward and remain confident and committed to providing a safe and effective COVID-19 vaccine. Following these results and the latest encouraging preclinical data, we will now work to further optimize our candidate to achieve this goal, ”said Thomas Triomphe, executive vice president and director, Sanofi Pasteur. “No pharmaceutical company can do it alone; the world needs more than one vaccine to fight the pandemic ”.
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