Albert Bourla, Pfizer CEO (Evan Vucci/AP Images)

Covid-19 roundup: Pfiz­er to sup­ply US with 200M more vac­cines as UK study finds high­er an­ti­bod­ies in 8-10 week in­ter­vals

The US gov­ern­ment has pur­chased 200 mil­lion more dos­es of the Pfiz­er/BioN­Tech vac­cine, the com­pa­nies an­nounced Fri­day morn­ing.

Pfiz­er and BioN­Tech ex­pect to de­liv­er 110 mil­lion of the ad­di­tion­al dos­es by Dec. 31, with the re­main­ing 90 mil­lion dos­es to be de­liv­ered no lat­er than April 30, 2022.

“Un­der this con­tract, the U.S. Gov­ern­ment is pay­ing ~$24 a dose for the Pfiz­er-BioN­Tech COVID-19 Vac­cine. The price for this or­der ac­counts for the ad­di­tion­al in­vest­ment nec­es­sary to pro­duce, pack­age and de­liv­er new for­mu­la­tions of the vac­cine, as well as the in­creased cost as­so­ci­at­ed with de­liv­er­ing the vac­cine in small­er pack sizes to fa­cil­i­tate de­liv­ery at in­di­vid­ual provider of­fices, in­clud­ing pe­di­a­tri­cians,” a Pfiz­er spokesman told End­points News.

The US gov­ern­ment has the op­tion to ac­quire an up­dat­ed ver­sion of the vac­cine to ad­dress po­ten­tial vari­ants, as well as new for­mu­la­tions of the vac­cine, if avail­able and au­tho­rized.

The Pfiz­er vac­cine is like­ly to con­vert its EUA in­to a full ap­proval some­time soon, po­ten­tial­ly in Au­gust or Sep­tem­ber, ac­cord­ing to FDA’s top vac­cine of­fi­cial Pe­ter Marks. Pres­i­dent Biden made a sim­i­lar time­line es­ti­mate dur­ing a CNN town hall on Wednes­day evening.

The US has now pur­chased 500 mil­lion dos­es of the Pfiz­er vac­cine for do­mes­tic use, and an­oth­er 500 mil­lion for do­nat­ing to the world’s poor­est coun­tries and oth­er al­lies.

El­i­gi­ble US res­i­dents will con­tin­ue to re­ceive the vac­cine for free, Pfiz­er said. — Zachary Bren­nan

Pfiz­er/BioN­Tech shots pro­duce high­er an­ti­bod­ies af­ter 8-10 week in­ter­vals — study

The UK is tout­ing the re­sults of a new study that it says vin­di­cates the coun­try’s de­ci­sion to space out Covid-19 vac­cine dos­es ear­li­er in the pan­dem­ic.

An in­ter­val of eight to 10 weeks be­tween Pfiz­er/BioN­Tech shots re­sults in high­er neu­tral­iz­ing an­ti­body lev­els than the three-week span test­ed in clin­i­cal tri­als, ac­cord­ing to a Bloomberg re­port. Though the find­ings have yet to be peer-re­viewed, re­searchers found dou­ble the an­ti­bod­ies af­ter 10 weeks com­pared to three weeks.

Fund­ed by the UK’s De­part­ment of Health and So­cial Care, the study looked at the im­mune re­spons­es of 503 British health­care work­ers. About three quar­ters of the par­tic­i­pants were women.

The find­ings come af­ter Britain orig­i­nal­ly ap­proved the Pfiz­er/BioN­Tech shot in ear­ly De­cem­ber 2020 ahead of the FDA and oth­er reg­u­la­to­ry au­thor­i­ties, and sub­se­quent­ly rolled out a plan to space out vac­cine dos­es in or­der to get as many peo­ple as it could their first shots.

Re­gard­ing the best in­ter­val be­tween dos­es, “eight weeks is prob­a­bly the sweet spot,” Uni­ver­si­ty of Ox­ford study lead Su­san­na Dunachie said at a news con­fer­ence, per Bloomberg. In ad­di­tion to boost­ing an­ti­body lev­els, the study al­so re­port­ed­ly found an im­proved re­sponse from helper T cells.

But the find­ings al­so re­lat­ed one sig­nif­i­cant draw­back as the UK and oth­er coun­tries face an­oth­er pan­dem­ic wave amidst the delta vari­ant’s surge: In­di­vid­u­als saw a de­cline in an­ti­body lev­els be­tween their first and sec­ond shots, par­tic­u­lar­ly against Delta. Re­gard­less, both the short and long in­ter­vals in be­tween dos­es lead to strong re­al-world pro­tec­tion against the virus, re­searchers said. — Max Gel­man

Japan’s prime min­is­ter press­es Bourla for more vac­cines

As the Sum­mer Olympics get un­der­way in Japan on Fri­day, the coun­try’s prime min­is­ter is press­ing Pfiz­er to speed up vac­cine de­liv­er­ies.

Japan leader Yoshi­hide Suga re­port­ed­ly met with CEO Al­bert Bourla ear­ly Fri­day in or­der to ask for an ac­cel­er­at­ed vac­cine sched­ule to the coun­try, per a Reuters re­port on Japan­ese me­dia. Suga is at­tempt­ing to se­cure shots that were orig­i­nal­ly sched­uled to ar­rive in Oc­to­ber, with lo­cal gov­ern­ments around the coun­try strug­gling with sup­ply.

Ac­cord­ing to the Reuters vac­cine track­er, on­ly 35% of Japan’s pop­u­la­tion has re­ceived their first vac­cine dose, a slow­er start com­pared to oth­er high-in­come na­tions.

The re­port comes with Japan kick­ing off the Olympics open­ing cer­e­mo­ny Fri­day amidst a swath of con­tro­ver­sies and lo­gis­ti­cal is­sues. Af­ter orig­i­nal­ly post­pon­ing the Games by a year due to the pan­dem­ic, Japan has seen a sig­nif­i­cant rise in cas­es re­cent­ly due to the Delta vari­ant. Though the coun­try had orig­i­nal­ly planned to al­low a lim­it­ed num­ber of spec­ta­tors, the Olympics are now tak­ing place in large­ly emp­ty sta­di­ums and are­nas.

More than 110 ath­letes and Olympics work­ers have al­so test­ed pos­i­tive in the days lead­ing up to the Games, ac­cord­ing to the New York Times, and Japan was forced to dis­miss its open­ing cer­e­mo­ny cre­ative di­rec­tor af­ter footage emerged of him mak­ing fun of the Holo­caust in a 1990s standup rou­tine.

A brouha­ha has al­so emerged over the card­board beds Japan has set up in the Olympic Vil­lage, in what it says is an ef­fort to lim­it in­ti­ma­cy be­tween ath­letes while the pan­dem­ic surges. — Max Gel­man

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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As­traZeneca, Mer­ck cull one Lyn­parza in­di­ca­tion in heav­i­ly pre­treat­ed ovar­i­an can­cer pa­tients

Just one day after blockbuster Lynparza got access to another indication in China, its Big Pharma owners have decided to withdraw it in certain patients after reviewing Phase III data.

The two companies that work together on Lynparza decided to recall one of the indications several weeks ago in a specific type of ovarian cancer, Lynparza’s first indication when it was first FDA-approved in 2014. Initial data showed that rates of overall survival in patients with at least three rounds of chemo before getting on the PARP inhibitor were lower than in patients with less previous chemo treatment.

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Fu­ji­film con­tin­ues CD­MO ex­pan­sion, break­ing ground on $435M UK site

Fujifilm’s CDMO arm, Fujifilm Diosynth, has been on a roll this month as the company has recently broken ground on a major project in Europe and it appears to be keeping up the momentum.

Fujifilm Diosynth announced that it has kicked off an expansion project for its microbial manufacturing facility at its campus in the town of Billingham, UK, in the northeast of England.

The 20,000 square-foot, £400 million ($435 million) expansion will add clean rooms, purification suites and a packing area along with more space for the manufacturing itself.

An­oth­er Cipla site lands a Form 483 over clean­ing is­sues and QC con­trols

A Cipla drug manufacturing site in India has once again landed in the crosshairs of FDA inspectors.

The facility in question is Cipla’s drug manufacturing facility in the village of Verna, in the state of Goa in India’s southwest. In a sign that foreign inspections might ramp up again, the FDA’s visit from Aug. 16 to Aug. 22 uncovered six observations.

The 11-page report noted that environmental monitoring at the site did not properly ensure that microbial contaminants were not making any impact in the aseptic filling areas. It also found that procedures meant to stop microbial contamination were not adequately conducted in aseptic areas of the facility.

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FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s Oncologic Drugs Advisory Committee on Friday voted 8-4 against the benefit-risk profile of Secura Bio’s PI3K inhibitor Copiktra (duvelisib), which won approval in September 2018 as a third-line treatment for relapsed or refractory CLL or SLL, but updated pivotal trial results raised safety questions.

In addition to the serious and fatal toxicities of duvelisib, FDA speakers at the ODAC meeting pointed to an evolved treatment landscape for CLL and SLL, with targeted BTK or BCL2 inhibitors (front-line or second-line), and data pointing to a “potential detriment” in overall survival for duvelisib. But some ODAC members noted that the detriment was likely small and that there is some efficacy even as the data are difficult to interpret.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.