Covid-19 roundup: In­ter­im analy­sis sug­gests Russ­ian vac­cine is 91.6% ef­fec­tive; US inks big deal with Aus­tralian com­pa­ny for its at-home coro­n­avirus test

In­ter­im Phase III da­ta sug­gest Rus­sia’s ade­n­ovirus vac­cine could be ef­fec­tive enough to ri­val mR­NA jabs from Mod­er­na and Pfiz­er.

The Sput­nik V vac­cine had an ef­fi­ca­cy rate of 91.6% based on the num­ber of Covid-19 cas­es tracked 21 days af­ter the first dose was ad­min­is­tered, ac­cord­ing to re­sults pub­lished in The Lancet. About 20,000 peo­ple par­tic­i­pat­ed in the Phase III tri­al.

While As­traZeneca/Ox­ford and John­son & John­son are al­so tak­ing an ade­n­ovirus ap­proach, they’ve re­port­ed much low­er ef­fi­ca­cy rates. As­traZeneca said the av­er­age ef­fi­ca­cy across their full study was 70%, while J&J re­cent­ly re­port­ed 66% ef­fi­ca­cy. Mod­er­na and Pfiz­er/BioN­Tech achieved 94.1% and 95% ef­fi­ca­cy rates, re­spec­tive­ly.

Sput­nik V’s pro­tec­tion ap­plied to all age groups, in­clud­ing those old­er than 60, the Lancet re­sults said. No se­ri­ous ad­verse events re­lat­ed to the vac­cine were not­ed, though 45 pa­tients in the vac­cine group ex­pe­ri­enced se­ri­ous side ef­fects un­re­lat­ed to the vac­cine, ac­cord­ing to the Gama­leya Na­tion­al Re­search Cen­ter of Epi­demi­ol­o­gy and Mi­cro­bi­ol­o­gy.

The re­searchers be­lieve pro­tec­tive im­mu­ni­ty kicks in around 18 days from the first dose.

Sput­nik V is be­lieved to re­main sta­ble at tem­per­a­tures around -18 de­grees Cel­sius, which may make it eas­i­er to dis­trib­ute than mR­NA vac­cines, which need to be kept at ex­treme­ly cold tem­per­a­tures. Pfiz­er and BioN­Tech’s jab must be shipped in -70 de­grees Cel­sius (-94 de­grees Fahren­heit) tem­per­a­tures — cold­er than Antarc­ti­ca — to re­main sta­ble.

Rus­sia reg­is­tered the vac­cine back in Au­gust — and Pres­i­dent Vladimir Putin says his daugh­ter took it — well be­fore Phase III stud­ies were com­plet­ed. The move spurred much back­lash, in­clud­ing from the As­so­ci­a­tion of Clin­ic Tri­als Or­ga­ni­za­tions, which wrote a let­ter urg­ing Russ­ian Health Min­is­ter Mikhail Murashko not to give out an un­proven vac­cine.

Af­ter claim­ing that Sput­nik V was 92% ef­fec­tive back in No­vem­ber, the Russ­ian Di­rect In­vest­ment Fund tapped South Ko­rea-based GL Rapha to pro­duce over 150 mil­lion dos­es an­nu­al­ly. The Na­tion­al Re­search Cen­ter of Epi­demi­ol­o­gy and Mi­cro­bi­ol­o­gy in Moscow said that the analy­sis was based on just 20 Covid-19 cas­es in its Phase III tri­al. In com­par­i­son, Pfiz­er an­a­lyzed 94 cas­es.

Ac­cord­ing to the new in­ter­im re­sults, 62 of 4,902 par­tic­i­pants in the place­bo group had con­tract­ed the virus at day 21, ver­sus 16 of 14,964 par­tic­i­pants in the vac­cine group.

“The de­vel­op­ment of the Sput­nik V vac­cine has been crit­i­cised for un­seem­ly haste, cor­ner cut­ting, and an ab­sence of trans­paren­cy. But the out­come re­port­ed here is clear and the sci­en­tif­ic prin­ci­ple of vac­ci­na­tion is demon­strat­ed, which means an­oth­er vac­cine can now join the fight to re­duce the in­ci­dence of COVID-19,” the Lancet study read.

US inks big deal with Aus­tralian com­pa­ny for its at-home coro­n­avirus test

Ex­perts have warned time and time again that ear­ly de­tec­tion of asymp­to­matic Covid-19 cas­es is key to curb­ing the pan­dem­ic. On Mon­day, the US gov­ern­ment inked a $231.8 mil­lion deal to help an Aus­tralian dig­i­tal di­ag­nos­tics com­pa­ny man­u­fac­ture its rapid, at-home coro­n­avirus tests state­side.

El­lume reached an agree­ment with the DOD and HHS to de­liv­er 8.5 mil­lion Covid-19 home tests and es­tab­lish a US-based fa­cil­i­ty from which it could pro­duce up to 19 mil­lion tests per month. The tests got an EUA back on Dec. 15, and were pre­vi­ous­ly be­ing made at an Aus­tralian site, which is on track to pump out 200,000 tests per day this quar­ter. Un­til the US fa­cil­i­ty is ready for ac­tion, El­lume will de­liv­er 100,000 tests per month from Aus­tralia.

“We will ful­fill the or­der for these tests at the same time as we ramp up the out­put across our pro­duc­tion fa­cil­i­ties, cre­at­ing more pos­si­bil­i­ties for re­tail and pri­vate in­sti­tu­tion use in the fu­ture,” CEO Sean Par­sons said of the US deal.

El­lume de­vel­oped its tests with the help of a $30 mil­lion grant from the NIH’s RADx ini­tia­tive, which was cre­at­ed to speed up the pro­duc­tion of new test­ing ca­pa­bil­i­ties. The agency is call­ing on re­searchers to de­vel­op in­ex­pen­sive, wide­ly ac­ces­si­ble tests to over­come cur­rent test­ing bar­ri­ers.

El­lume’s nasal test can be done at home, with self-swab­bing ma­te­ri­als, pro­cess­ing flu­id and a Blue­tooth an­a­lyz­er that sends re­sults to your phone with­in 15 min­utes. The re­sults are al­so sent to lo­cal health au­thor­i­ties through a se­cure cloud con­nec­tion us­ing your zip code.

The tests cost $30 each, but Par­sons told the Wash­ing­ton Post that the price could come down once US man­u­fac­tur­ing kicks in — one rea­son be­ing that the tests would no longer have to be shipped in from Aus­tralia.

“We know there are ef­forts to cre­ate even low­er cost and more in­no­v­a­tive ap­proach­es and we wel­come those,” Andy Slavitt, Pres­i­dent Biden’s se­nior ad­vis­er for Covid-19 re­sponse, said at a brief­ing, per the Post.

As­traZeneca kept dos­ing er­ror from par­tic­i­pants — re­port

An­oth­er lay­er of con­tro­ver­sy has sur­round­ed As­traZeneca and Ox­ford Uni­ver­si­ty’s dos­ing mishap in their late-stage Covid-19 vac­cine tri­al.

Ac­cord­ing to doc­u­ments ob­tained by Reuters, the part­ners kept the mis­take from around 1,500 of the par­tic­i­pants who were giv­en the wrong dose. The phar­ma sent let­ters to par­tic­i­pants in June pre­sent­ing the mix-up as an op­por­tu­ni­ty for Ox­ford to learn how well the vac­cine works at dif­fer­ent dos­es, mak­ing no men­tion that a mis­take was made, Reuters re­port­ed.

Pas­cal So­ri­ot As­traZeneca

The par­tic­i­pants had been giv­en a half dose fol­lowed by a whole dose, as op­posed to two full dos­es. As­traZeneca re­port­ed bet­ter re­sults for this co­hort — up to 90% ef­fi­ca­cy ver­sus an av­er­age ef­fi­ca­cy of 70% across the full study. But it was lat­er learned that the half-dose co­hort had an age cap of 55 years old.

While the vac­cine has been au­tho­rized in a num­ber of coun­tries in­clud­ing the UK and EU, Ger­many rec­om­mend­ed the vac­cine should on­ly be giv­en to those un­der 65 years old, ac­cord­ing to Reuters. And the EU low­ered its re­port­ed ef­fi­ca­cy rate to 60%.

As­traZeneca CEO Pas­cal So­ri­ot promised back in No­vem­ber to put an end to the ques­tions around its in­ter­im Phase III vac­cine da­ta by con­duct­ing a new in­ter­na­tion­al study. In mid-De­cem­ber, the com­pa­ny be­gan pur­su­ing a sur­pris­ing ap­proach: com­bin­ing their vac­cine with the Russ­ian-backed Sput­nik V vac­cine.

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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