Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfiz­er CEO Al­bert Bourla has inked a deal with Harp­er Busi­ness for a book to tell the “be­hind-the-scenes” sto­ry of the com­pa­ny’s race to de­vel­op a vac­cine, the As­so­ci­at­ed Press re­ports.

The book is ti­tled “Moon­shot: In­side Pfiz­er’s Nine-Month Race to Make the Im­pos­si­ble Pos­si­ble” and is set to be re­leased Nov. 9. Bourla plans to do­nate the pro­ceeds to char­i­ty, the AP re­port­ed.

Bourla helped dri­ve Pfiz­er’s un­prece­dent­ed race to an emer­gency use au­tho­riza­tion in just nine months, a pre­vi­ous­ly un­heard-of pace for vac­cine de­vel­op­ment. And since, he’s worked to pro­tect the in­tel­lec­tu­al prop­er­ty that un­der­gird­ed that work.

“I am shar­ing the sto­ry of our moon­shot — the chal­lenges we faced, the lessons we learned, and the core val­ues that al­lowed us to make it hap­pen — in hopes that it might in­spire and in­form your own moon­shot, what­ev­er that may be,” Bourla, 59, said in a state­ment ob­tained by the AP.

Last week, the com­pa­ny an­nounced that it gen­er­at­ed $26 bil­lion in 2021 rev­enue, which is more than $10 bil­lion than ini­tial­ly ex­pect­ed. That’s more mon­ey than any drug or vac­cine has ever gen­er­at­ed, and good for 30% of the com­pa­ny’s to­tal ex­pect­ed rev­enue in 2021. It’s al­so more than dou­ble the ex­pect­ed cost of R&D in 2021.

In a re­cent LinkedIn post, Bourla wrote a let­ter to em­ploy­ees op­pos­ing the use of IP waivers, em­pha­siz­ing that there had been no in­fra­struc­ture in place to cre­ate mR­NA-based med­i­cines or vac­cines at the start of the pan­dem­ic, and claim­ing Pfiz­er had to build such a sys­tem from scratch. Rough­ly 280 dif­fer­ent com­po­nents or raw ma­te­ri­als go in­to mak­ing the vac­cines, Bourla wrote, and open­ing the flood­gates could pro­vide a chase for raw ma­te­ri­als that could put dos­es at risk.

Pfiz­er’s part­ner BioN­Tech be­gan work on the de­vel­op­ment of the coro­n­avirus when CEO Ugur Sahin read about a new virus that ap­peared in Wuhan, Chi­na. In March, the col­lab­o­ra­tion was an­nounced.

A Chi­nese mR­NA vac­cine preps for Mex­i­co late-stage test

A Chi­nese-de­vel­oped mR­NA Covid-19 vac­cine will un­der­go late-stage clin­i­cal tri­als in Mex­i­co lat­er this month, ac­cord­ing to Reuters. 

The Phase III tri­al for the jab from Wal­vax Biotech­nol­o­gy will start on May 30 with 6,000 vol­un­teers, for­eign min­is­ter Marce­lo Ebrard said on his Twit­ter ac­count.

Wal­vax is work­ing with the Acad­e­my of Mil­i­tary Sci­ence and Suzhou Abo­gen Bio­sciences to joint­ly de­vel­op AR­CoV. It’s the first Chi­nese mR­NA vac­cine to en­ter Phase III tri­als. Dos­es can be stored in re­frig­er­a­tors be­tween 2 and 8 de­grees Cel­sius for six months, the com­pa­ny claims, much longer than the 30 days Mod­er­na’s vac­cine is ap­proved for.

Mex­i­co al­ready has dos­es of vac­cines from Sino­vac and CanSi­no Bi­o­log­ics, two oth­er Chi­nese drug­mak­ers, and has plans to or­der shots from Sinopharm.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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