Bob Kramer, Emergent

The man­u­fac­tur­ing hold at Emer­gen­t's Bal­ti­more Bayview plant could be com­ing to an end — re­port

Mary­land’s Emer­gent BioSo­lu­tions has been forced to sit on its own hands for more than a month af­ter shut­ting down pro­duc­tion at a Bal­ti­more plant blast­ed for screw­ing up mil­lions of dos­es of two Covid-19 vac­cines. Now, with a laun­dry list of qual­i­ty is­sues ap­par­ent­ly solved, Emer­gent is re­port­ed­ly days away from get­ting its lines rolling once again.

J&J is ex­pect­ed to an­nounce that con­t­a­m­i­na­tion prob­lems at Emer­gent’s Bal­ti­more Bayview plant have been re­solved and pro­duc­tion is set to re­sume, The Wall Street Jour­nal re­port­ed Fri­day.

The deal with the FDA could free up al­ready man­u­fac­tured dos­es of the vac­cine that have been in quar­an­tine, and al­low for the pro­duc­tion of new ones. Dos­es of the vac­cine have been in lim­bo af­ter the FDA took over the plant in April, and Emer­gent an­nounced it would cease man­u­fac­tur­ing in light of the in­spec­tion tied to a vi­ral vec­tor mix­up.

That was on April 16, and soon af­ter the US saw the num­ber of dos­es al­lo­cat­ed for states fall from near­ly 5 mil­lion to 785,000. Cal­i­for­nia, Texas and Flori­da were slat­ed to re­ceive the dos­es, Reuters re­port­ed.

As a part of the arrange­ment, 60 mil­lion dos­es of the J&J jab could be cleared for use, the WSJ re­ports. Be­cause the jab is sin­gle-dose, that means 60 mil­lion peo­ple are el­i­gi­ble to be ful­ly vac­ci­nat­ed once dos­es be­come avail­able. An ad­di­tion­al 60 mil­lion dos­es of the As­traZeneca shot could be­come avail­able as well, ac­cord­ing to the WSJ, ready to vac­ci­nate 30 mil­lion peo­ple.

The mix­up wasn’t Emer­gent’s first. Ear­li­er in the man­u­fac­tur­ing process, the com­pa­ny was forced to trash mil­lions of ma­te­ri­als tied to As­traZeneca’s vac­cine, some­thing Kramer blamed on a flawed man­u­fac­tur­ing process sent over by the drug­mak­er.

A Form 483 from the FDA re­vealed un­san­i­tary con­di­tions at the plant and half-heart­ed at­tempts at keep­ing it clean. Mold, paint chip­ping off the walls and un­known black and brown sub­stances were all present, and some em­ploy­ees failed to de­con­t­a­m­i­nate bags of waste be­fore drag­ging them through the ware­house.

In an April 21 state­ment, Emer­gent said:

We deeply val­ue the re­la­tion­ship we have with our man­u­fac­tur­ing part­ners and with the FDA. The FDA’s feed­back will help us con­tin­ue to im­prove and strength­en the sup­ply chain for John­son & John­son’s COVID-19 vac­cine. While we are nev­er sat­is­fied to see short­com­ings in our man­u­fac­tur­ing fa­cil­i­ties or process, they are cor­rectable and we will take swift ac­tion to rem­e­dy them.

Kramer had pre­vi­ous­ly of­fered mixed mes­sages on what ex­act­ly hap­pened to lead to the mix­up, but clar­i­fied in front of a House sub­com­mit­tee in May that J&J qual­i­ty con­trol em­ploy­ees at its Lei­den, Nether­lands fa­cil­i­ty caught the mix­up. The cross con­t­a­m­i­na­tion oc­curred as a re­sult of ma­te­r­i­al ex­it­ing out of a fa­cil­i­ty and com­ing in close vicin­i­ty with me­dia pre­pared for a J&J run.

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.

Ugur Sahin, AP Images

Covid-19 man­u­fac­tur­ing roundup: BioN­Tech an­nounces plans to pro­duce mR­NA vac­cines in Africa; As­traZeneca de­liv­er­ies from Thai­land de­layed

BioNTech, Pfizer’s partner on its Covid-19 vaccine, will look to establish mRNA vaccine production facilities in Africa, the Financial Times reported Wednesday.

The move is a part of a larger push to tackle diseases beyond Covid-19, and as the EU looks to up its manufacturing capacity on the continent. Right now, Africa imports over 99% of the vaccines it uses, the FT reports. The plan was outlined in a call between CEO Ugur Sahin and European Commission President Ursula von der Leyen before the G7 summit.

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.