Joe Biden (AP Images)

Covid-19 roundup: Mod­er­na has filed for vac­cine use in chil­dren; Claim­ing lead­er­ship to com­bat Covid-19, US pledges to do­nate 500M dos­es of Pfiz­er/BioN­Tech vac­cines through CO­V­AX

Just days af­ter Mod­er­na’s vac­cine was sub­mit­ted for ap­proval for use in chil­dren in the EU and Cana­da, the com­pa­ny has an­nounced it has filed for emer­gency use au­tho­riza­tion with the FDA for the ad­min­is­tra­tion in teens be­tween 12 and 18.

Mod­er­na an­nounced in May that its Phase II/III study of the vac­cine in ado­les­cents met the pri­ma­ry end­points in near­ly 2,500 pa­tients, show­ing an ef­fi­ca­cy of 100% against se­vere symp­to­matic Covid-19. Be­cause chil­dren are less like­ly to de­vel­op se­ri­ous side ef­fects, the tri­al al­so looked at milder cas­es than ex­am­ined in the adult study. The study found that the vac­cine was 93% ef­fec­tive at stop­ping mild cas­es 14 days af­ter pa­tients were dosed.

The com­pa­ny ap­pears to be on sched­ule, as it pre­vi­ous­ly said it planned to ap­ply for au­tho­riza­tion in kids in June.

Right now, Pfiz­er-BioN­Tech’s vac­cine is the on­ly one avail­able for teens in the US. Pfiz­er an­nounced this week that it will be­gin tri­als of a re­duced dosage in chil­dren be­tween the ages of 6 months and 11 years old. — Josh Sul­li­van

Claim­ing lead­er­ship to com­bat Covid-19, US pledges to do­nate 500M dos­es of Pfiz­er/BioN­Tech vac­cines through CO­V­AX

Af­ter be­ing crit­i­cized for months for hoard­ing Covid-19 vac­cines, the Unit­ed States is mak­ing a grand ges­ture.

Pres­i­dent Joe Biden has an­nounced plans to buy 500 mil­lion dos­es of the Pfiz­er/BioN­Tech vac­cine and do­nate them to low­er-in­come coun­tries in what his ad­min­is­tra­tion brands as a his­toric move to help su­per­charge the glob­al fight against the pan­dem­ic.

The do­na­tion fol­lows a sep­a­rate ini­tia­tive to give away 80 mil­lion ex­cess vac­cine dos­es al­ready in the US stock­pile for re­dis­tri­b­u­tion through the CO­V­AX mech­a­nism, co­or­di­nat­ed by the WHO, Gavi and CEPI. That batch com­prised vac­cines from Mod­er­na, John­son & John­son, and Pfiz­er/BioN­Tech.

The new pur­chase for half a bil­lion dos­es will come en­tire­ly from Pfiz­er and, giv­en the two-shot reg­i­men, be enough to vac­ci­nate 250 mil­lion peo­ple. With ship­ments start­ing in Au­gust, 200 mil­lion dos­es are slat­ed to be de­liv­ered by the end of this year, while the rest will be de­liv­ered by June 2022.

While Pfiz­er had charged the US $19.50 per dose for do­mes­tic use, it will sell these new shots at a “not-for-prof­it” price, the Wash­ing­ton Post re­port­ed.

Fol­low­ing US al­lo­ca­tion, CO­V­AX will help de­liv­er these shots to the 92 low- and low­er-mid­dle in­come coun­tries around the world el­i­gi­ble for its fa­cil­i­ty, as well as the African Union.

On top of the vac­cine do­na­tion, the US has con­tributed $2 bil­lion to the ef­fort and pledged to sup­port lo­ca­tion pro­duc­tion of Covid-19 vac­cines.

As of Tues­day, CO­V­AX has fa­cil­i­tat­ed the dis­tri­b­u­tion of about 81 mil­lion shots world­wide.

“Thanks to the suc­cess of our vac­ci­na­tion pro­gram, the Unit­ed States is beat­ing COVID-19 here at home,” a White House fact sheet reads, with 64% of adult Amer­i­cans hav­ing re­ceived at least one shot.

Tedros Ad­hanom Ghe­breye­sus

That suc­cess, though, has ex­perts wor­ried about a dis­con­nect be­tween the de­vel­oped world and vul­ner­a­ble re­gions for whom the pan­dem­ic is far from over, with new records in dai­ly new cas­es and death tolls. Tedros Ad­hanom Ghe­breye­sus, the WHO di­rec­tor gen­er­al, ap­pealed to G7 just days ago to lever­age their pow­er in meet­ing the glob­al tar­get to vac­ci­nate at least 10% of the world’s pop­u­la­tion by Sep­tem­ber, which he said would re­quire an ad­di­tion­al 500 mil­lion dos­es.

“In­creas­ing­ly, we see a two-track pan­dem­ic: many coun­tries still face an ex­treme­ly dan­ger­ous sit­u­a­tion, while some of those with the high­est vac­ci­na­tion rates are start­ing to talk about end­ing re­stric­tions,” he told re­porters.

The dos­es, the White House was sure to add, will be pro­duced at Pfiz­er’s fa­cil­i­ties in Michi­gan, Kansas, Mis­souri and Mass­a­chu­setts. — Am­ber Tong

De­moc­rats take is­sue with Pfiz­er vac­cine price

High-pro­file De­moc­rats, in­clud­ing Sen. Eliz­a­beth War­ren (MA) and Rep. Katie Porter (CA), sent a let­ter to Pfiz­er CEO Al­bert Bourla on Tues­day, ques­tion­ing the com­pa­ny’s price tag for its Covid-19 vac­cine and its ex­pect­ed tens of bil­lions in rev­enue from the vac­cine.

With an eye to­ward fu­ture price es­ca­la­tions, the mem­bers of Con­gress note that Pfiz­er could end up caus­ing pri­vate in­sur­ers to raise pre­mi­ums and in­crease tax­pay­er costs for health care.

“Does the com­pa­ny in­tend to seek ‘a nor­mal price like [it] typ­i­cal­ly get[s] for a vac­cine—$150, $175 per dose.’? If so, when does the com­pa­ny plan to im­ple­ment these in­creas­es?” they asked Bourla, in ad­di­tion to ques­tions on how much the com­pa­ny in­vest­ed in the vac­cine. The De­moc­rats al­so asked how Pfiz­er will de­ter­mine its pric­ing for the vac­cine mov­ing for­ward. — Zachary Bren­nan

Ocu­gen to no longer pur­sue an EUA for its vac­cine

Penn­syl­va­nia-based Ocu­gen, which is look­ing to bring In­dia’s Covid-19 vac­cine from Bharat Biotech to the US, says it will no longer seek an emer­gency use au­tho­riza­tion and will in­stead seek a full ap­proval.

The com­pa­ny said FDA pro­vid­ed feed­back on the mas­ter file it had pre­vi­ous­ly sub­mit­ted and rec­om­mend­ed that Ocu­gen pur­sue a BLA sub­mis­sion in­stead of an EUA ap­pli­ca­tion for its vac­cine can­di­date and re­quest­ed ad­di­tion­al in­for­ma­tion and da­ta.

The news comes as the FDA said late last month that for the re­main­der of the pan­dem­ic, it may de­cline to re­view and process fur­ther EUA re­quests for Covid-19 vac­cines, as the coun­try still tries to ad­min­is­ter mil­lions of dos­es that it’s al­ready pur­chased of the three vac­cines that have al­ready won EUAs. — Zachary Bren­nan

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.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

An­a­lysts hound Bio­gen with ques­tions over Aduhelm's $56K price point as news of Alzheimer's OK rip­ples through glob­al mar­kets

It’s been nearly 24 hours since the FDA handed down its controversial decision to approve Biogen’s Aduhelm drug for Alzheimer’s disease, and reactions from around the industry are pouring in as analysts try to size up the ramifications of Monday’s news.

Biogen hosted an investor call Tuesday morning, providing a forum for a number of topics that have been top of mind. The call came as the news of Aduhelm’s approval in the US rippled through global markets, while $BIIB stock soared to around $380 apiece (up from $286 on Friday), as Biogen’s partners at Eisai seek new approvals in Asia.

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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.