FDA au­tho­rizes Pfiz­er-BioN­Tech Covid-19 vac­cine

The first Covid-19 vac­cine has ar­rived in Amer­i­ca.

The FDA is­sued an emer­gency use au­tho­riza­tion for the Pfiz­er-BioN­Tech vac­cine late Fri­day, mark­ing a his­toric turn­ing point in the fight against a dead­ly pan­dem­ic, but that one will still leave a long road ahead as the Big Phar­ma and fed­er­al of­fi­cials try to scale up and roll out lim­it­ed dos­es while the virus con­tin­ues to rav­age the US.

The EUA comes 24 hours af­ter a com­mit­tee of out­side ex­perts vot­ed 17-4 to rec­om­mend the agency au­tho­rize the vac­cine. In a 44,000-per­son Phase III tri­al, the vac­cine was 95% ef­fec­tive at pre­vent­ing symp­to­matic Covid-19 and did not trig­ger se­ri­ous ad­verse events, al­though it did in­duce mild symp­toms such as headache and fa­tigue. The da­ta was pub­licly re­viewed by the FDA and pub­lished in The New Eng­land Jour­nal of Med­i­cine.

It is the fastest a vac­cine has ever been de­vel­oped, com­ing less than a year af­ter the nov­el coro­n­avirus broke out in Chi­na. It is al­so the first mR­NA vac­cine to ever be li­censed, po­ten­tial­ly herald­ing a new era in how vac­cines are made for a mul­ti­tude of in­fec­tions.

Al­though now au­tho­rized, a vac­cine will re­main out of reach for the vast ma­jor­i­ty of Amer­i­cans. Op­er­a­tion Warp Speed of­fi­cials have re­peat­ed­ly said they ex­pect to dis­trib­ute 20 mil­lion dos­es of the vac­cine un­til, with those first dos­es like­ly re­served for health­care work­ers and the el­der­ly. But some hos­pi­tals and out­side ex­perts have warned that such roll­outs may not be smooth, as cash-strapped states will strug­gle to get dos­es in arms and com­pa­nies may en­counter man­u­fac­tur­ing de­lays.

Still, the EUA marks a piv­otal mo­ment for a coun­try and a fed­er­al gov­ern­ment that, hav­ing failed to scale up test­ing, adopt uni­ver­sal mask-wear­ing, or fol­low oth­er re­peat­ed pub­lic health guid­ance, has come to re­ly on the ad­vent of wide­ly avail­able in­oc­u­la­tions to curb what has be­come a dai­ly of on­slaught of death.

Since the elec­tion, Pres­i­dent Trump has made scant men­tion of the dai­ly toll the pan­dem­ic is now tak­ing on the US, with up to 3,000 Amer­i­cans now dy­ing of the virus per day. But he has sought to take cred­it for the Pfiz­er-BioN­Tech vac­cine, pub­licly feud­ing with the Big Phar­ma over whether or not they were in­volved in Op­er­a­tion Warp Speed and hold­ing a “Vac­cine Sum­mit” at the White House to take cred­it for has­ten­ing de­vel­op­ment.

The FDA’s de­ci­sion Fri­day came af­ter the pres­i­dent threat­ened to fire Com­mis­sion­er Stephen Hahn if the agency did not is­sue an EUA by the end of the day.

The FDA had al­ready re­leased a state­ment say­ing they told Pfiz­er they were fi­nal­iz­ing the au­tho­riza­tion. And HHS sec­re­tary  Alex Azar had al­ready ap­peared on Good Morn­ing Amer­i­ca to an­nounce that dos­es would ar­rive in Amer­i­can arms by Mon­day or Tues­day, telling George Stephanopou­los that the agency still need­ed time to ham­mer out in­for­ma­tion for doc­tors.

It is not clear whether the ac­cel­er­at­ed de­ci­sion will re­sult in Amer­i­cans be­ing in­oc­u­lat­ed any faster.

Over the sum­mer, the US signed a pur­chase or­der for 100 mil­lion Pfiz­er vac­cines and have an op­tion to or­der 500 mil­lion more, but they may find it to dif­fi­cult to ac­quire any of those ad­di­tion­al dos­es be­fore the sum­mer. For­mer FDA Com­mis­sion­er and Pfiz­er board mem­ber Scott Got­tlieb told CN­BC this month that the gov­ern­ment turned down an of­fer from Pfiz­er to buy more dos­es af­ter their ini­tial ef­fi­ca­cy da­ta came out. (Azar de­nied the ac­count, say­ing Pfiz­er nev­er said how many ex­tra dos­es they could of­fer).

The EUA is like­ly to be fol­lowed by a sec­ond EUA for the Mod­er­na vac­cine, which showed 94.5% ef­fi­ca­cy in its own Phase III tri­al. An FDA ad­vi­so­ry com­mit­tee hear­ing is sched­uled for Thurs­day. J&J is al­so ex­pect­ed to read out on their vac­cine in Jan­u­ary, with the As­traZeneca shot be­hind them.

It is pos­si­ble that Mod­er­na’s mR­NA shot be­comes the dom­i­nant vac­cine in the US. HHS ex­er­cised an op­tion to pur­chase an ad­di­tion­al 100 mil­lion dos­es of the vac­cine to­day, giv­ing the US enough Mod­er­na and BioN­Tech shots to vac­ci­nate 150 mil­lion Amer­i­cans by June.

The EUA is al­so a turn­ing point for BioN­Tech, a Ger­man mR­NA biotech run by a hus­band-and-wife sci­en­tists who long op­er­at­ed with less flash and less ven­ture cap­i­tal than their mR­NA ri­vals in Cam­bridge. The com­pa­ny ap­proached their pan­dem­ic ef­fort with sim­i­lar in­con­spic­u­ous­ness, dis­clos­ing the pro­gram in a sin­gle line in the mid­dle of an SEC doc­u­ment in Feb­ru­ary. They now stand as one of the most fa­mous biotechs in the world.

It is al­so a win for Pfiz­er and CEO Al­bert Bourla, who bet big on BioN­Tech’s tech­nol­o­gy and chose to go alone, re­ject­ing gov­ern­ment funds and ul­ti­mate­ly suc­cess­ful­ly de­vel­op­ing the first proven Covid-19 vac­cine. And it marks the cul­mi­na­tion of decades of work from aca­d­e­mics who worked to tame a mol­e­cule that much of the in­dus­try didn’t want to touch but which they saw as the fu­ture of vac­cines and drug de­vel­op­ment. That in­cludes Katal­in Karikó and Drew Weiss­man at the Uni­ver­si­ty Penn­syl­va­nia, who li­censed their tech to Mod­er­na and BioN­Tech and who now work for the lat­ter.

The UK and Cana­da au­tho­rized the vac­cine ear­li­er this week.

Even though its now au­tho­rized, stud­ies on the vac­cine will con­tin­ue, as Pfiz­er con­tin­ues to mon­i­tor vol­un­teers in its tri­al and the CDC and oth­er branch­es of the fed­er­al gov­ern­ment roll out plans to mon­i­tor vac­cine re­cip­i­ents across the coun­try.

Robert Bradway (Photographer: Scott Eisen/Bloomberg via Getty Images)

UP­DAT­ED: Am­gen snaps up can­cer drug play­er Five Prime, adding PhI­II-ready FGFR2b drug in $2B M&A play

Amgen is making a long-awaited move on the M&A side, buying South San Francisco-based Five Prime $FPRX for close to $2 billion and adding a slate of new cancer drugs to the pipeline.

Amgen is paying $38 a share, putting the deal value at $1.9 billion. The stock closed at $21.26 last night, giving investors a 78% premium.

The jewel in the crown of this deal is bemarituzumab, which Amgen describes as a first-in-class, Phase III-ready anti-FGFR2b antibody. Amgen was drawn to the bargaining table by Five Prime’s mid-stage data on gastric cancer, satisfied by PFS and OS data helping to validate FGFR2b as a target. Amgen researchers will now expand on the R&D program in other epithelial cancers, including lung, breast, ovarian and other cancers.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

David Liu (Casey Atkins Photography courtesy Broad Institute)

David Liu has a new big idea: pro­teome edit­ing. It could one day shred tau, RAS and some of the worst dis­ease-caus­ing pro­teins

Before David Liu became famous for inventing new forms of gene editing, he was known around academia in part for a more obscure innovation: a Rube Goldberg-esque system that uses bacteria-infecting viruses to take one protein and turn it into another.

Since 2011, Liu’s lab has used the system, called PACE, to dream up fantastical new proteins: DNA base editors far more powerful than the original; more versatile forms of the gene editor Cas9; insecticides that kill insecticide-resistant bugs; enzymes that slide synthetic amino acids into living organisms. But they struggled throughout to master one of the most common and powerful proteins in the biological world: proteases, a set of Swiss army knife enzymes that cut, cleave or shred other proteins in everything from viruses to humans.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

Cedric Francois, Apellis CEO (Apellis)

Apel­lis joins the grow­ing num­ber of bio­phar­mas scrap­ping a failed Covid-19 pro­gram af­ter an ear­ly flop

The global pandemic set off a frenzy of R&D activity as biotechs around the world scrambled to see if they could come up with a new medication or vaccine to help fight back. But even as the mRNA standouts are highlighting the market El Dorado open to successful teams, the failures are starting to pile up.

Thursday afternoon it was Apellis’ $APLS turn to deep-six a new drug.

The biotech reports that their C3 therapy APL-9 had failed to move the needle on mortality when combined with standard of care, as compared to SOC alone.

No­var­tis pairs up with Cure­Vac to help dri­ve Covid-19 shot pro­duc­tion but may miss the show in the US, EU

With the pandemic potentially entering its later stages, major drugmakers like Merck have jumped in to aid in the gargantuan task of manufacturing other companies’ vaccines. Now, after a relatively quiet year, Novartis is teaming up with one of the mRNA players to help the production crunch.

Novartis will help manufacture bulk drug substance for CureVac’s mRNA-based Covid-19 shot, dubbed CVnCoV, at its Kundl, Austria site with plans to produce up to 50 million doses by the end of 2021, the Swiss drugmaker said Thursday.

In the lat­est big in­vest­ment in gene ther­a­py man­u­fac­tur­ing, Bio­gen com­mits $200M to a ma­jor new fa­cil­i­ty in NC

You’d be forgiven for thinking that the only R&D effort of any consequence at Biogen belongs to aducanumab, its controversial Alzheimer’s drug. But behind the uproar around that drug, the big biotech has a full scale pipeline in play that includes a growing focus on developing gene therapies.

Now Biogen plans to build up the kind of manufacturing muscle that will give it an advantage in gaining FDA approvals — where CMC is always key — and then marketing them around the world.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: EMA starts rolling re­view of Rus­si­a's Sput­nik V; No­vavax says shot is 51% ef­fec­tive against vari­ant in South Africa 

The EMA has started a rolling review of Sputnik V, the Russian vaccine that holds the dubious title of the world’s first registered jab for Covid-19.

Seven months after the controversial clearance in Russia, Europe’s human medicines committee says it’s convinced to start looking at the application by data indicating that the adenovirus-based vaccine triggers the production of antibodies and immune cells against the SARS-CoV-2 coronavirus.

Eli Lil­ly claims a TKO in its long-run­ning ti­tle fight with No­vo Nordisk for the block­buster di­a­betes mar­ket — but there’s a hitch

Eli Lilly isn’t just gunning for a better diabetes drug in tirzepatide. They want to cut ahead of Novo Nordisk’s blockbuster rival Ozempic (semaglutide) on the obesity front as well. But a newly-claimed win in a head-to-head Phase III showdown over reducing A1C while shedding pounds — complete with clear evidence of superiority over the approved rival — could prove a tough sell right now.

Let’s start with the latest data from Lilly.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 102,700+ biopharma pros reading Endpoints daily — and it's free.