As Bavar­i­an Nordic has made strides re­cent­ly to beef up its small­pox vac­cine man­u­fac­tur­ing in the wake of new mon­key­pox cas­es, the com­pa­ny is al­so get­ting ready to eval­u­ate its Covid-19 boost­er in a piv­otal study. And it’s go­ing af­ter one of the heavy­weights.

The Copen­hagen-based com­pa­ny an­nounced Thurs­day morn­ing it will be pit­ting its Covid-19 boost­er shot against Pfiz­er and BioN­Tech’s boost­er, re­design­ing its Phase III study to in­clude the com­para­tor. Bavar­i­an Nordic said the change will not im­pact its da­ta read­out time­line, ex­pect­ed be­fore the end of the year.

If all goes well, Bavar­i­an Nordic hopes to at­tain ap­proval in 2023, though it didn’t spec­i­fy where.

It’s not yet clear where the com­pa­ny sees its ad­van­tages over the al­ready-au­tho­rized Pfiz­er/BioN­Tech boost­er, but the com­para­tor ad­di­tion rep­re­sents one of the chal­lenges next-gen­er­a­tion Covid-19 vac­cine de­vel­op­ers will face. The Pfiz­er boost­er is al­ready one of the most wide­ly used around the world, mak­ing it a prac­ti­cal choice to com­pare.

But that’s al­so mil­lions of peo­ple who have al­ready re­ceived a boost­er shot who now may not be el­i­gi­ble for a Bavar­i­an Nordic boost­er. There are a hand­ful of coun­tries who have au­tho­rized sec­ond boost­ers for some parts of their pop­u­la­tions as well, but Pfiz­er, Mod­er­na and As­traZeneca con­tin­ue to have the mar­ket ad­van­tage.

Bavar­i­an Nordic may al­so face vac­cine hes­i­tan­cy, as on­ly about 47% of peo­ple in the US have re­ceived their first boost­er shot per CDC da­ta, de­spite the boost­er be­ing au­tho­rized for the gen­er­al pop­u­la­tion since last No­vem­ber. There have al­so been re­ports of low- and mid­dle-in­come coun­tries re­turn­ing their do­nat­ed Covid-19 shots af­ter be­ing un­able to dis­trib­ute them all.

Nev­er­the­less, Bavar­i­an Nordic and reg­u­la­to­ry agen­cies be­lieve this com­para­tor ap­proach is the best path for­ward to get more boost­ers out there. It’s an ap­proach that may soon see much wider up­take, as ear­li­er this week an­oth­er Covid-19 boost­er de­vel­op­er, Clover Bio­phar­ma­ceu­ti­cals, an­nounced it would mea­sure its own ex­per­i­men­tal shot against the Pfiz­er, As­traZeneca and Sino­vac boost­ers.

Thurs­day’s news comes af­ter Bavar­i­an Nordic signed mul­ti­ple con­tracts with world gov­ern­ments to pro­vide sup­plies of its small­pox vac­cine as mon­key­pox cas­es rise. Ear­li­er this week, the EU or­dered 110,000 dos­es of the small­pox shot — which helps de­fend against mon­key­pox as well — on top of 500,000 shots sold to BAR­DA last week.

So­cial: Sven Hoppe/pic­ture-al­liance/dpa/AP Im­ages

89bio said its drug was better than placebo at lessening fibrosis without worsening nonalcoholic steatohepatitis, or NASH, in two of three dose groups.

The San Francisco biotech said it thinks the Phase IIb data pave the way for a potential Phase III, following in the footsteps of another biotech in its drug class, Akero Therapeutics. To fund a late-stage study, CEO Rohan Palekar told Endpoints News 89bio “would need to raise additional capital,” with the company having about $188 million at the end of last year.

The National Institutes of Health has again declined to use so-called “march-in” rights to lower the price of Astellas and Pfizer’s prostate cancer drug Xtandi despite being invented at UCLA with grants from the US Army and NIH.

“Given the remaining patent life and the lengthy administrative process involved for a march-in proceeding, NIH does not believe that use of the march-in authority would be an effective means of lowering the price of the drug,” NIH told prostate cancer patients Robert Sachs and Clare Love, in a letter shared with Endpoints News. The institutes’ analyses found Xtandi “to be widely available to the public,” an indication that there was not a pressing need for the US to act.