Covid-19 roundup: EMA ups Pfiz­er, Mod­er­na vac­cine man­u­fac­tur­ing ca­pa­bil­i­ties amid short­age

As vac­cine short­ages have caused coun­tries to scram­ble, sup­ply chain short­ages and even law­suits, the EMA has ap­proved an in­crease man­u­fac­tur­ing at Eu­ro­pean fa­cil­i­ties for both Pfiz­er-BioN­Tech and Mod­er­na’s Covid-19 vac­cines.

An in­crease in batch size at Pfiz­er’s Pu­urs, Bel­gium plant was ap­proved, in an ef­fort to suc­cess­ful­ly and safe­ly ramp up pro­duc­tion to in­crease the num­ber of dos­es avail­able. BioN­Tech CEO Ugur Sahin told Bloomberg TV last month that Pfiz­er and BioN­Tech could in­crease man­u­fac­tur­ing ca­pac­i­ty to pro­duce 3 bil­lion dos­es next year, and could cre­ate 2 bil­lion by 2021’s end. CFO Sierk Po­et­ting has al­so said that con­struct­ing new pro­duc­tion sites to keep up with de­mand is pos­si­ble.

A new man­u­fac­tur­ing line was al­so ap­proved for Mod­er­na’s site in Rovi, Spain. The line will in­crease fill-fin­ish ca­pa­bil­i­ties to keep up with a scale-up process ap­proved at Lon­za’s Visp man­u­fac­tur­ing site ap­proved in March, ac­cord­ing to a re­lease.

Pfiz­er/BioN­Tech, Mod­er­na vac­cines clear more vari­ant tests

Even as drug­mak­ers race to de­vel­op new ver­sions of Covid-19 vac­cines tai­lored to emerg­ing SARS-CoV-2 vari­ants, Pfiz­er/BioN­Tech and Mod­er­na’s orig­i­nal jabs con­tin­ue to look good enough for these new virus strains.

In the lat­est ex­am­ple, the mR­NA vac­cines have cleared pre­lim­i­nary tests against the New York vari­ant, or B.1.526, ac­cord­ing to two preprints post­ed Thurs­day. While sci­en­tists found a re­duc­tion of neu­tral­iza­tion titers in vac­cine-elicit­ed an­ti­bod­ies when pre­sent­ed with pseudovirus­es that have mu­tat­ed spike pro­teins, they note that the an­ti­bod­ies are still enough to neu­tral­ize the vari­ants.

The new re­sults add to ear­li­er ev­i­dence sug­gest­ing that the vac­cines are ef­fec­tive against the South African and UK vari­ants.

The take­away? Get vac­ci­nat­ed, with mon­i­tor­ing vari­ants and how they af­fect vac­cine and an­ti­body ef­fi­ca­cy.

“The find­ings sug­gest that cur­rent vac­cines and ther­a­peu­tic mon­o­clon­al an­ti­bod­ies will re­main pro­tec­tive against the B.1.526 vari­ants,” read a study from the NYU Gross­man School of Med­i­cine and NYU Lan­gone Vac­cine Cen­ter, re­fer­ring to Pfiz­er/BioN­Tech and Mod­er­na’s vac­cines as well as Re­gen­eron’s an­ti­body cock­tail.

Com­pared to the wild type spike pro­tein, vac­cine-elicit­ed an­ti­bod­ies still neu­tral­ized a pseudovirus with a E484K mu­tat­ed spike pro­tein but sport­ed “a mod­est 3.5-fold de­crease in titer,” they added.

The oth­er study, con­duct­ed by a coali­tion in New York, Boston and Cal­i­for­nia, not­ed that a “B.1.526 pseudovirus had a sta­tis­ti­cal­ly sig­nif­i­cant re­duced neu­tral­iza­tion titer com­pared to the D614G con­trol: for vac­ci­nee plas­ma, 4.5-fold re­duced (p = 0.00005).”

“We’re not see­ing big dif­fer­ences,” Michel Nussen­zweig, an im­mu­nol­o­gist at Rock­e­feller Uni­ver­si­ty in New York who was in­volved in that sec­ond study, told the New York Times.

EU seals sup­ply deal for 1.8B Pfiz­er/BioN­Tech dos­es while snub­bing J&J, As­traZeneca — re­port

The EU has re­port­ed­ly sealed its third con­tract with Pfiz­er and BioN­Tech, clinch­ing the sup­ply of 1.8 bil­lion dos­es over the next cou­ple of years while de­clin­ing to take up the ex­tra 300 mil­lion dos­es it’s pre­vi­ous­ly re­served from As­traZeneca and J&J.

Reuters cit­ed se­nior of­fi­cials in re­port­ing both moves. Amid long­stand­ing ten­sion with As­traZeneca and in­ves­ti­ga­tions on the safe­ty of J&J’s vac­cine, the Eu­ro­pean bloc has open­ly put its faith in the mR­NA vac­cine, with EC pres­i­dent Ur­su­la von der Leyen of­fer­ing a pub­lic shoutout to Pfiz­er-BioN­Tech and prais­ing the two com­pa­nies as a “re­li­able part­ner” that de­liv­ers on its com­mit­ments.

So far, the EU has or­dered 300 mil­lion from As­traZeneca and 200 mil­lion dos­es from J&J, with the op­tions to pur­chase an ad­di­tion­al 100 mil­lion and 200 mil­lion, re­spec­tive­ly.

“There is no need to ex­er­cise the op­tions” for those ex­tra dos­es, an of­fi­cial di­rect­ly in­volved in talks with vac­cine mak­ers told Reuters.

Here’s what a PhI­II tri­al for a sec­ond-gen Covid-19 vac­cine looks like 

French vac­cine mak­er Val­ne­va has of­fi­cial­ly made the leap to Phase III with its Covid-19 vac­cine can­di­date. But it may look a bit un­fa­mil­iar.

In­stead of en­rolling tens of thou­sands of vol­un­teers and giv­ing half of them place­bos to tease out the pro­tec­tive ef­fect of its vac­cine, Val­ne­va’s piv­otal tri­al will in­volve around 4,000 par­tic­i­pants. They will re­ceive ei­ther two shots of ei­ther VLA2001 or Vaxzevria, As­traZeneca and Ox­ford’s con­di­tion­al­ly ap­proved vac­cine. In­ves­ti­ga­tors will then com­pare the im­mune re­spons­es (i.e. an­ti­body titers) elicit­ed by each of the jabs, with an eye to su­pe­ri­or­i­ty.

While Val­ne­va sug­gest­ed that the tri­al re­sults, if pos­i­tive, would sup­port reg­u­la­to­ry ap­proval in the UK, they wouldn’t be enough for an emer­gency use au­tho­riza­tion in the US based on cur­rent FDA re­quire­ments. As­traZeneca’s shot isn’t cur­rent­ly cleared for use in the US.

No­tably, Val­ne­va is go­ing with a 4-week reg­i­men. As­traZeneca has sug­gest­ed that its ade­n­ovirus-based vac­cine is more ef­fec­tive when giv­en 12 weeks apart.

Thomas Lin­gel­bach

The on­ly Eu­ro­pean play­er to test an in­ac­ti­vat­ed vac­cine — a pop­u­lar ap­proach in Chi­na — Val­ne­va has struck a sup­ply deal with the UK, where the tri­al will take place, and is man­u­fac­tur­ing its shots in Scot­land.

“We be­lieve that VLA2001 has an im­por­tant role to play in­clud­ing boost­ers or po­ten­tial mod­i­fi­ca­tions to the vac­cine to ad­dress vari­ants,” CEO Thomas Lin­gel­bach said in a state­ment. “While Cov-Com­pare is pro­gress­ing we are plan­ning to con­duct ad­di­tion­al, com­ple­men­tary tri­als.”

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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