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.

IDC: Life Sci­ences Firms Must Em­brace Dig­i­tal Trans­for­ma­tion Now

Pre-pandemic, the life sciences industry had settled into a pattern. The average drug took 12 years and $2.9 billion to bring to market, and it was an acceptable mode of operations, according to Nimita Limaye, Research Vice President for Life Sciences R&D Strategy and Technology at IDC.

COVID-19 changed that, and served as a proof-of-concept for how technology can truly help life sciences companies succeed and grow, Limaye said. She recently spoke about industry trends at Egnyte’s Life Sciences Summit 2022. You should watch the entire session, free and on-demand, but here’s a brief recap of why she’s urging life sciences companies to embrace digital transformation.

Paul Hudson, Sanofi CEO (Eric Piermont/AFP via Getty Images)

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Sanofi is officially giving up on its oral SERD.

The French drugmaker put out word Wednesday morning that it will discontinue the global development program of amcenestrant, the selective estrogen receptor degrader once billed as a top late-stage prospect. Having already failed a Phase II monotherapy test earlier this year, a combo with the drug also missed the bar in a second trial for breast cancer, triggering the decision to drop the whole program.

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Tom Barnes, Orna Therapeutics CEO

UP­DAT­ED: 'We have failed to fail': Mer­ck gam­bles $250M cash on a next-gen ap­proach to mR­NA — af­ter punt­ing its big al­liance with Mod­er­na

Merck went in deep on its collaboration with Moderna on new mRNA programs, and dropped them all over time, including their RSV partnership. But after writing off what turned out as one of the most successful infectious disease players in the business, Merck is coming in this morning with a new preclinical alliance — this time embracing a biotech that hopes to eventually outdo the famously successful mRNA in a new run at vaccines and therapeutics.

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Bayer's first DTC ad campaign for chronic kidney disease drug Kerendia spells out its benefits

Bay­er aims to sim­pli­fy the com­plex­i­ties of CKD with an ABC-themed ad cam­paign

Do you know the ABCs of CKD in T2D? Bayer’s first ad campaign for Kerendia tackles the complexity of chronic kidney disease with a play on the acronym (CKD) and its connection to type 2 diabetes (T2D).

Kerendia was approved last year as the first and only non-steroidal mineralocorticoid receptor antagonist to treat CKD in people with type 2 diabetes.

In the TV commercial launched this week, A is for awareness, B is for belief and C is for cardiovascular, explained in the ad as awareness of the connection between type 2 and kidney disease, belief that something can be done about it, and cardiovascular events that may be reduced with treatment.

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James Mock, incoming CFO at Moderna

Mod­er­na taps new CFO from PerkinElmer af­ter for­mer one-day CFO oust­ed

When Moderna hired a new CFO last year,  it didn’t expect to see him gone after only one day. Today the biotech named his — likely much more vetted — replacement.

The mRNA company put out word early Wednesday that after the untimely departure of then brand-new CFO Jorge Gomez, it has now found a replacement in James Mock, the soon-to-be former CFO at diagnostics and analytics company PerkinElmer.

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Etleva Kadilli, director of UNICEF’s supply division

GSK lands first-ever UNICEF con­tract for malar­ia vac­cine worth $170M

GSK has landed a new first from UNICEF the first-ever contract for malaria vaccines, worth up to $170 million for 18 million vaccine doses distributed over the next three years.

The vaccine, known as Mosquirix or RTS,S, won WHO’s backing last October after a controversial start, but UNICEF said these doses will potentially save thousands of lives every year.

“We hope this is just the beginning,” Etleva Kadilli, director of UNICEF’s supply division, said. “Continued innovation is needed to develop new and next-generation vaccines to increase available supply, and enable a healthier vaccine market. This is a giant step forward in our collective efforts to save children’s lives and reduce the burden of malaria as part of wider malaria prevention and control programmes.”

Joe Jonas (Photo by Anthony Behar/Sipa USA)(Sipa via AP Images)

So­lo Jonas broth­er car­ries Merz's new tune in Botox ri­val cam­paign

As the lyrics of his band’s 2019 pop-rock single suggest, Joe Jonas is only human — and that means even he gets frown lines. The 33-year-old singer-songwriter is Merz’s newest celebrity brand partner for its Botox rival Xeomin, as medical aesthetics brands target a younger audience.

Merz kicked off its “Beauty on Your Terms” campaign on Tuesday, featuring the Jonas brother in a video ad for its double-filtered anti-wrinkle injection Xeomin.

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Marisol Peron, Genmab SVP of communications and corporate affairs

Gen­mab launch­es cor­po­rate cam­paign am­pli­fy­ing its ‘knock your socks off’ an­ti­bod­ies

Genmab often talks about its “knock-your-socks-off” antibodies — and now the term is getting its own logo and corporate campaign.

The teal and purple logo for the acronym KYSO — Genmab pronounces it “ky-so” — debuts on Wednesday and comes on the heels of Genmab’s newly announced 2030 vision. That aspiration aims to expand Genmab’s drug development beyond oncology to include other serious diseases, while also doubling down on its own drug development.

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Joel Dudley, new partner at Innovation Endeavors (Bosch Health Campus)

For­mer Google CEO’s VC is mak­ing a big­ger push in­to the biotech world, hir­ing promi­nent Ther­a­nos skep­tic

Venture capital firm Innovation Endeavors has mainly had its focus on investments across the tech space, but it has been slowly turning its attention to the biotech world. Now, a new partner is coming into the fold showing that its interest in biotech is likely to grow further.

The Silicon Valley-based company, which is headed up by former Google CEO Eric Schmidt, has brought on Joel Dudley as a partner. According to Dudley’s LinkedIn page, he is joining Innovation Endeavors after serving as the chief science officer of biotech startup Tempus Labs since 2020.

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