Severin Schwan, Roche CEO (Georgios Kefalas/Keystone via AP Images)

Covid-19 roundup: High­er an­ti­body counts seen in spaced-out vac­cine in­ter­vals — study; Roche CEO com­pares IP waiv­er to East Ger­man 'ex­per­i­ments'

Near the out­set of the UK’s vac­ci­na­tion cam­paign, the British gov­ern­ment out­lined plans to space out shots in larg­er in­ter­vals in or­der to get more peo­ple their first shot. Now, a study has come out say­ing the ap­proach can dri­ve a high­er an­ti­body re­sponse — at least in old­er pop­u­la­tions.

In a study with 175 peo­ple old­er than 80, the an­ti­body re­sponse was 3.5 times high­er in in­di­vid­u­als who re­ceived their sec­ond Pfiz­er/BioN­Tech shot 12 weeks af­ter their first, com­pared to those who fol­lowed the typ­i­cal three-week pe­ri­od. An­ti­body lev­els were mea­sured about two to three weeks af­ter the fol­low-up jabs.

The study was con­duct­ed by the Uni­ver­si­ty of Birm­ing­ham in the UK and joint­ly fund­ed by UK Re­search and In­no­va­tion and the Na­tion­al In­sti­tute for Health Re­search. It has been pub­lished as a preprint and has yet to be peer-re­viewed.

“Many ques­tions re­main re­gard­ing [vac­cines’] op­ti­mal de­liv­ery for pro­vi­sion of ef­fec­tive and sus­tained im­mu­ni­ty,” He­len Par­ry, NIHR lec­tur­er at Birm­ing­ham, said in a state­ment. “This is the first time an­ti­body and cel­lu­lar re­spons­es have been stud­ied when the sec­ond vac­cine is giv­en af­ter an ex­tend­ed in­ter­val.”

To con­duct the study, re­searchers took blood sam­ples from par­tic­i­pants af­ter their first vac­cine and then again two to three weeks af­ter their sec­ond vac­cine. Among the group, 99 peo­ple fol­lowed the nor­mal three-week course for the shot, and 73 got their sec­ond dose at 12 weeks.

Af­ter the sec­ond vac­cine, the av­er­age con­cen­tra­tion of an­ti­bod­ies was 4,030 U/ml in the ex­tend­ed in­ter­val group com­pared to 1,138 U/ml in the three-week group.

Re­searchers al­so looked at T cell im­mune re­spons­es in the par­tic­i­pants, where num­bers looked dif­fer­ent, how­ev­er. In in­di­vid­u­als fol­low­ing the nor­mal vac­cine course, 60% had a con­firmed T cell re­sponse two to three weeks af­ter their sec­ond shot. This num­ber fell to 15% about eight or nine weeks lat­er.

In par­tic­i­pants in the ex­tend­ed in­ter­val group, on­ly 8% showed a T cell re­sponse at five to six weeks af­ter their first shot, but the fig­ure rose to 31% in the two to three weeks af­ter their sec­ond shot. The au­thors cau­tioned that more stud­ies need­ed to be con­duct­ed in T cell re­spons­es in or­der to draw any con­clu­sions.

The Birm­ing­ham study comes as the UK con­tin­ues to see rel­a­tive­ly few new Covid-19 cas­es fol­low­ing one of the more ag­gres­sive vac­ci­na­tion cam­paigns in Eu­rope. Ac­cord­ing to Pub­lic Health Eng­land, dai­ly av­er­age cas­es re­main much low­er than the huge spike from this past win­ter, but high­er than the av­er­age from last sum­mer.

Roche CEO com­pares vac­cine waiv­er to East Ger­man ‘ex­per­i­ments’

Roche CEO Sev­erin Schwan ratch­eted up the rhetoric against the Biden ad­min­is­tra­tion’s move to waive Covid-19 vac­cine IP, com­par­ing a po­ten­tial waiv­er to the na­tion­al­iza­tion seen un­der So­vi­et-con­trolled East Ger­many.

Join­ing in on the phar­ma in­dus­try’s crit­i­cism of the waiv­er, Schwan said such a move would be “coun­ter­pro­duc­tive,” ac­cord­ing to the Fi­nan­cial Times. Though pro­po­nents of the waiv­er say it would boost vac­cine pro­duc­tion in low- and mid­dle-in­come na­tions, Schwan and the in­dus­try counter that it will lim­it the avail­abil­i­ty of raw ma­te­ri­als need­ed to make the shots.

Schwan ar­gued to FT that the waiv­er would be a “cat­a­stro­phe” akin to the na­tion­al­ized drug in­dus­try seen in East Ger­many.

“We had enough ex­per­i­ments in the 20th cen­tu­ry na­tion­al­iz­ing the in­dus­try and we know what came out of that,” he told the pa­per. He lat­er added, “This will be harm­ful for my chil­dren and grand­chil­dren when I’m not CEO any­more.”

Roche does not pro­duce Covid-19 vac­cines and Schwan did not spec­i­fy what ex­per­i­ments he was re­fer­ring to. But in­ves­ti­ga­tions by the Ger­man mag­a­zine Der Spiegel in 2012 and 2013 re­vealed that sev­er­al big-name West­ern drug­mak­ers — in­clud­ing Roche — paid East Ger­man hos­pi­tals to use pa­tients as “un­wit­ting guinea pigs” in un­der-the-ta­ble clin­i­cal tri­als.

The So­vi­et-con­trolled bloc al­so re­port­ed­ly ran a mass-dop­ing scheme for Olympic ath­letes, forc­ing com­peti­tors to take an­a­bol­ic steroids and oth­er per­for­mance-en­hanc­ing drugs. More than 150 for­mer ath­letes sued an East Ger­man drug­mak­er in the 2000s, with the com­pa­ny chip­ping in to a gov­ern­ment-backed set­tle­ment fund, ac­cord­ing to re­ports from the time.

De­spite its lack of vac­cine pro­duc­tion, Roche does con­tribute its Actem­ra drug as part of a col­lab­o­ra­tion with Re­gen­eron for a mon­o­clon­al an­ti­body cock­tail. The orig­i­nal waiv­er pro­pos­al in­clud­ed oth­er Covid-19-re­lat­ed prod­ucts.

Britain re­thinks an­ti­body deal with As­traZeneca

The UK gov­ern­ment is re­port­ed­ly re­think­ing plans to pur­chase 1 mil­lion dos­es of As­traZeneca’s Covid-19 an­ti­body ther­a­py cur­rent­ly un­der de­vel­op­ment.

Part of the rea­son for the shift has to do with Britain’s re­sponse to the pan­dem­ic, un­named of­fi­cials told Bloomberg News. The UK still has not of­fi­cial­ly placed any or­ders and is won­der­ing if the an­ti­body ther­a­pies will be need­ed in the coun­try at all.

Alok Shar­ma, the UK’s for­mer busi­ness sec­re­tary, said in No­vem­ber that the coun­try had pro­cured dos­es pend­ing tri­al re­sults, but these were non-bind­ing deals. The US, on the oth­er hand, in­creased its or­der for the treat­ment by 500,000 dos­es in March, bring­ing their po­ten­tial sup­ply to 700,000.

As­traZeneca is ex­pect­ed to re­port new tri­al re­sults for the ther­a­py by the end of June, look­ing at the treat­ment’s func­tion as a pro­phy­lac­tic among those who have been ex­posed to Covid-19. It’s one of five on­go­ing late-stage tri­als for the ther­a­py, which com­bines two an­ti­bod­ies to pos­si­bly pre­vent and treat Covid-19 in mild, mod­er­ate and se­vere/hos­pi­tal­ized cas­es.

Sev­er­al com­pa­nies have been de­vel­op­ing an­ti­body treat­ments for Covid-19, in­clud­ing Re­gen­eron, Eli Lil­ly and Glax­o­SmithK­line and Vir. But in the UK, more than half of the pop­u­la­tion has al­ready re­ceived its first vac­cine dose.

Sam­sung Bi­o­log­ics de­nies Mod­er­na man­u­fac­tur­ing deal

A Ko­re­an news­pa­per re­port­ed that the biotech arm of Sam­sung and Mod­er­na had agreed to pro­duce its Covid-19 vac­cine at a Song­do plant, and cit­ed un­named sources. But Sam­sung has said that no de­ci­sion has been reached yet, Reuters re­ports.

Sam­sung’s shares jumped up as much as 8.7% to­day, to $833.18 af­ter the re­port from the Chosun Il­bo. The com­pa­ny al­so de­nied re­ports that it had struck a deal with Pfiz­er to man­u­fac­ture its vac­cine, co-de­vel­oped with Ger­man BioN­Tech.

Mod­er­na’s jab hasn’t been ap­proved in South Ko­rea, but it Thurs­day it was rec­om­mend­ed for emer­gency use ap­proval af­ter safe­ty and ef­fi­ca­cy tri­als in the US. If the deal is ap­proved, it would be Mod­er­na’s first pro­duc­tion of the vac­cine in Asia. Ear­li­er this week, BioN­Tech struck a deal with Sin­ga­pore to pro­duce a wide range of mR­NA vac­cines and ther­a­peu­tics.

Mod­er­na’s an­nounced a string of man­u­fac­tur­ing ex­pan­sions in the last 2 weeks, af­ter an an­nounce­ment that it would pro­duce up to 3 bil­lion dos­es in 2022. Thurs­day, the com­pa­ny an­nounced a deal with the Aus­tralian gov­ern­ment that would pro­vide 25 mil­lion dos­es, in­clud­ing some of a boost­er that will pro­tect against vari­ants of the virus, to the coun­try in which not many of its res­i­dents are vac­ci­nat­ed. It’s al­so an­nounced a 50% in­crease in pro­duc­tion at its Mass­a­chu­setts site, and dou­bled pro­duc­tion in Switzer­land and Spain at sites run by Lon­za and Rovi,

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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