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.

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

In the search for a better Covid-19 therapeutic, GlaxoSmithKline and Vir have partnered up on two antibodies they hope have a chance. GSK is also testing its own in-house antibody, and early results may have shut the door on its widespread use.

A combination of GSK’s monoclonal antibody otilimab plus standard of care couldn’t best standard of care alone in preventing death and respiratory failure in hospitalized Covid-19 patients after 28 days, according to data from the Phase IIa OSCAR study unveiled Thursday.

Despite having already received an emergency use authorization for its Covid-19 antibody in non-hospitalized patients last November, Regeneron continued to conduct trials to evaluate the cocktail’s effectiveness. Now, the big biotech has received some good news from their IDMC.

On the IDMC’s recommendation, Regeneron will be shutting down enrollment in the placebo group of a Phase III outpatient trial for their REGN-COV program — a mix of casirivimab with imdevimab — after investigators found “clear clinical efficacy” in both doses compared to the control, the company announced Thursday. CSO George Yancopoulos also said in a statement that the cocktail can neutralize emerging strains of the novel coronavirus.

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.