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.

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.