Ursula von der Leyen, president of the European Commission (AP Images)

Covid-19 roundup: EU to sup­port vac­cine man­u­fac­tur­ing ef­forts in Africa — re­port; Sput­nik Light ap­proved for use in Venezuela

The EU is ex­pect­ed to back an ef­fort to ex­pand vac­cine man­u­fac­tur­ing in Africa, un­named of­fi­cials told the Fi­nan­cial Times. 

On­ly 1% of Covid-19 vac­cines ad­min­is­tered world­wide have been giv­en in Africa — down from 2% a few weeks ago, the WHO re­port­ed on Fri­day. The coun­try nor­mal­ly gets many of its vac­cine dos­es from the Serum In­sti­tute of In­dia, which is now di­vert­ing its Covid-19 shots for do­mes­tic use.

“We’re in a very tough spot when it comes to sup­ply,” Richard Mi­hi­go, Africa’s Im­mu­niza­tion and Vac­cines De­vel­op­ment pro­gram co­or­di­na­tor with the WHO, said in a state­ment. “What is cru­cial for Africa is that we ur­gent­ly use all the dos­es we have to pro­tect our most vul­ner­a­ble pop­u­la­tions.”

At an up­com­ing glob­al health sum­mit in Rome, EC pres­i­dent Ur­su­la von der Leyen is ex­pect­ed to sup­port pro­pos­als to es­tab­lish man­u­fac­tur­ing hubs in Africa, the FT re­port­ed. That sup­port could in­clude di­rect EU aid, and fund­ing from na­tion­al agen­cies and the Eu­ro­pean In­vest­ment Bank, un­named of­fi­cials said. Plus, Brus­sels wants to help build up the African Med­i­cines Agency, which the African Union As­sem­bly adopt­ed a treaty to es­tab­lish in 2019.

“The EU’s in­tent is gen­uine — I don’t think it is nec­es­sar­i­ly geopo­lit­i­cal. They are host­ing the glob­al health sum­mit and clear­ly they want to do a cou­ple of big things,” said Ayoade Alak­i­ja, co-chair of the Africa Vac­cine De­liv­ery Al­liance, per the FT.

Ac­cord­ing to the re­port, the coun­tries are con­sid­er­ing three sites, in­clud­ing the In­sti­tut Pas­teur in Sene­gal, and in Rwan­da and South Africa.

The EU has said in­creas­ing vac­cine pro­duc­tion is more use­ful than waiv­ing in­tel­lec­tu­al prop­er­ty rights on vac­cines, which Pfiz­er has vo­cal­ly op­posed. — Nicole De­Feud­is 

Sput­nik Light ap­proved for use in Venezuela

The sin­gle-jab ver­sion of Rus­sia’s Covid-19 vac­cine, Sput­nik Light, has been ap­proved in Venezuela, the Russ­ian Di­rect In­vest­ment Fund an­nounced. The coun­try is the sec­ond to ap­prove the sin­gle-dose ver­sion, as An­go­la ap­proved the vac­cine for use last week.

The RDIF an­nounced on May 6 that a sin­gle-shot ver­sion of the Sput­nik V vac­cine has been ap­proved by the Russ­ian reg­u­la­to­ry of­fi­cials. The Venezue­lan ap­proval will help ac­cel­er­ate the coun­try’s vac­ci­na­tion cam­paign, RDIF head Kir­ill Dmitriev said to Reuters. In Jan­u­ary 2021, the two-dose Sput­nik V vac­cine was al­so ap­proved for use in Venezuela un­der the emer­gency use au­tho­riza­tion pro­ce­dure.

Sput­nik Light has proved 79% ef­fi­ca­cy, the RDIF claims, ac­cord­ing to da­ta from 28 days af­ter the in­jec­tion was ad­min­is­tered. Vac­cine mak­ers al­so say that there were no se­ri­ous side ef­fects from the vac­cine. The study of re­al-world da­ta has gar­nered skep­ti­cism, as Russ­ian Pres­i­dent Vladimir Putin rolled out vac­cine use be­fore it cleared any safe­ty stud­ies.

Sput­nik V was al­so ap­proved in Ecuador Sat­ur­day, the RDIF an­nounced. — Josh Sul­li­van

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,100+ biopharma pros reading Endpoints daily — and it's free.