Hours af­ter Pfiz­er and BioN­Tech won the back­ing of an FDA pan­el for their mR­NA vac­cine, Sanofi and GSK an­nounced that their close­ly watched pro­gram to de­vel­op an ad­ju­vant­ed vac­cine to com­bat Covid-19 had hit a ma­jor set­back.

The com­pa­nies an­nounced ear­ly Fri­day that they were de­lay­ing their de­vel­op­ment pro­gram for an ad­ju­vant­ed re­com­bi­nant pro­tein-based Covid-19 vac­cine af­ter it failed among adults old­er than 49 in the study.

The re­searchers not­ed a “low im­mune re­sponse in old­er adults like­ly due to an in­suf­fi­cient con­cen­tra­tion of the anti­gen.”

The col­lab­o­ra­tors, who had been hop­ing 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 get that 2-shot study start­ed in Feb­ru­ary, com­par­ing it to an es­tab­lished vac­cine on the mar­ket. The move will force a de­lay on launch­ing sup­plies of the vac­cine from H1 un­til the 4th quar­ter of 2021, at best, af­ter some of­fi­cials in Op­er­a­tion Warp Speed ex­pect to see the end of the pan­dem­ic in the US.

GSK and Sanofi had pro­ject­ed get­ting hun­dreds of mil­lions of dos­es of this vac­cine out to world mar­kets, rep­re­sent­ing a large por­tion of the vac­cine dos­es the world would need to fight the pan­dem­ic. The com­pa­nies had signed a deal to work with the WHO on eq­ui­table dis­tri­b­u­tion of their vac­cine, of­fer­ing hope of a vac­cine among the world’s less af­flu­ent coun­tries. Their vac­cine de­mand­ed a slow­er ap­proach to de­vel­op­ment, but uti­lized what many be­lieved was a more re­li­able tech­nol­o­gy that could de­liv­er vac­cine in bulk around the world. Now, it ap­pears like­ly that Pfiz­er/BioN­Tech and Mod­er­na will get ap­provals in the near term, 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 van­quish the virus as the first ap­proved vac­cines are like­ly to be in short sup­ply for some time. It al­so will ac­cel­er­ate the vir­tu­al rev­o­lu­tion now un­der­way in the vac­cine in­dus­try, as tra­di­tion­al tech makes way for a faster and ev­i­dent­ly more re­li­able mR­NA ap­proach.

Sanofi and GSK, two of the world’s lead­ing vac­cine mak­ers, are stay­ing in the race, even if they’ve fall­en well be­hind the lead­ers.

Thomas Tri­om­phe

“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 op­ti­mize our can­di­date to achieve this goal,” said Thomas Tri­om­phe, ex­ec­u­tive vice pres­i­dent and head of Sanofi Pas­teur. “No sin­gle phar­ma com­pa­ny can make it alone; the world needs more than one vac­cine to fight the pan­dem­ic.”

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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