Albert Bourla, Pfizer CEO (John Thys, Pool via AP Images)

Covid-19 roundup: Eu­rope re­serves 1.8 bil­lion dos­es of Pfiz­er vac­cines; Re­pub­li­cans slam Biden's TRIPS waiv­er sup­port

The Eu­ro­pean Com­mis­sion on Thurs­day signed a con­tract with Pfiz­er and BioN­Tech that will al­low for the pur­chase of 900 mil­lion dos­es of the cur­rent vac­cine and of a vac­cine adapt­ed to vari­ants, with the op­tion to pur­chase an ad­di­tion­al 900 mil­lion dos­es.

The EU cur­rent­ly has 600 mil­lion Pfiz­er dos­es through 2021, and the ad­di­tion­al 900 mil­lion are ex­pect­ed be­gin­ning in De­cem­ber 2021 and con­tin­u­ing in­to 2023.

In to­tal, the EU may have ac­cess to up to 2.4 bil­lion Pfiz­er dos­es, all of which are planned to be man­u­fac­tured in the EU.

Pfiz­er CEO Al­bert Bourla told Ax­ios in an in­ter­view yes­ter­day that the com­pa­ny feels “quite com­fort­able” that it’ll make 3 bil­lion dos­es of its vac­cine for the world by the end of 2021, and an­oth­er up to 4 bil­lion dos­es in 2022.

He said ap­prox­i­mate­ly 1 bil­lion dos­es will go to low- and mid­dle-in­come coun­tries this year, most of which will come in the sec­ond half of the year.

Longer re­frig­er­a­tor stor­age for Pfiz­er’s vac­cines

Fol­low­ing the Eu­ro­pean Med­i­cines Agency’s lead in al­low­ing for longer re­frig­er­a­tor stor­age (from five days to a month) of un­opened but thawed vials, the FDA did the same on Thurs­day.

Pfiz­er sub­mit­ted da­ta to the FDA to demon­strate that undi­lut­ed, thawed vials of its vac­cine are sta­ble at re­frig­er­a­tor tem­per­a­tures of 2°C to 8°C (35°F to 46°F) for up to 1 month, FDA added.

Re­pub­li­can sen­a­tors to Biden trade of­fi­cials: TRIPS waiv­er is ‘dis­as­trous de­ci­sion’

Re­pub­li­can sen­a­tors blast­ed US trade rep­re­sen­ta­tive Kather­ine Tai and Com­merce Sec­re­tary Gi­na Rai­mon­do, call­ing the Biden ad­min­is­tra­tion’s sup­port for tem­porar­i­ly halt­ing in­tel­lec­tu­al prop­er­ty pro­tec­tions for Covid-19 vac­cines a “dis­as­trous de­ci­sion.”

Sens. Tom Cot­ton (R-AR), Chuck Grass­ley (R-IA), Thom Tillis (R-NC), Mike Crapo (R-ID) and 10 oth­ers claimed the waiv­er would “force Amer­i­can com­pa­nies to give their med­ical tech­nol­o­gy and man­u­fac­tur­ing process­es to for­eign ad­ver­saries like Chi­na.”

They al­so rea­soned that there are not enough vac­cine dos­es at this time be­cause “the sup­ply chain lacks the tech­no­log­i­cal ca­pac­i­ty. Vac­cine pro­duc­tion is a com­plex tech­ni­cal and lo­gis­ti­cal process, with lim­it­ed tech­ni­cal re­sources (e.g., skilled sci­en­tists and tech­ni­cians at com­pa­nies). At best, all Pres­i­dent Biden’s give­away to Chi­na and In­dia and oth­ers will do is fos­ter un­co­or­di­nat­ed vac­cine na­tion­al­ism, as coun­tries jump in to try to co­erce tech­nol­o­gy trans­fer and man­u­fac­tur­ing lo­cal­ly.”

Pfiz­er and Mod­er­na have al­so both made clear in re­cent weeks that they are not go­ing to help any com­pa­nies try­ing to make copy­cat ver­sions of their prod­ucts, es­pe­cial­ly as they would be vy­ing for the same raw ma­te­ri­als and nec­es­sary equip­ment.

Tai, who’s re­spon­si­ble for ne­go­ti­at­ing the waiv­er at the WTO on be­half of the Biden ad­min­is­tra­tion, tes­ti­fied be­fore the Sen­ate Fi­nance Com­mit­tee last week. For coun­tries where less than 2% of their peo­ple are vac­ci­nat­ed, this is an ex­is­ten­tial cri­sis, Tai said, stress­ing the ur­gency and tem­po­rary na­ture of the de­ci­sion.

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

Adap­tive De­sign Meth­ods Of­fer Rapid, Seam­less Tran­si­tion Be­tween Study Phas­es in Rare Can­cer Tri­als

Rare cancers account for 22 percent of cancer diagnoses worldwide, yet there is no universally accepted definition for a “rare” cancer. Moreover, with the evolution of genomics and associated changes in categorizing tumors, some common cancers are now characterized into groups of rare cancers, each with a unique implication for patient management and therapy.

Adaptive designs, which allow for prospectively planned modifications to study design based on accumulating data from subjects in the trial, can be used to optimize rare oncology trials (see Figure 1). Adaptive design studies may include multiple cohorts and multiple tumor types. In addition, numerous adaptation methods may be used in a single trial and may facilitate a more rapid, seamless transition between study phases.

Covid-19 roundup: Pfiz­er im­pos­es vac­cine man­date for US work­ers; WHO calls for mora­to­ri­um on boost­ers, while some coun­tries make plans any­way — re­port

As the US struggles to keep pace with the fast-spreading Delta variant, big companies like Walmart and Disney are imposing vaccine mandates for some workers. It may come as no surprise that Pfizer — the Big Pharma behind the US’ first authorized Covid-19 vaccine — is joining them.

Pfizer will start requiring all US employees and contractors to get vaccinated, or participate in weekly Covid-19 testing, spokesperson Pamela Eisele told Reuters. Workers outside the US are strongly urged to get a vaccine if they can, according to the report. And those with medical conditions or religious objections can seek accommodations.

Marianne De Backer (L) and Jeff Hatfield

Bay­er nabs star biotech Vi­vid­ion with a $2B buy­out and an ‘arms-length’ pact, pulling a part­ner out of the IPO con­ga line

Vividion is canceling that IPO it filed. Instead of following the industry-wide migration to Nasdaq, the biotech that has captured considerable attention for its still-preclinical work finding cryptic pockets to bind to on proteins is going to work for Bayer now.

The pharma giant is putting out word today that it has bought out Vividion for $1.5 billion in cash and another half-billion dollars in milestones.

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Tadataka Yamada (Photographer: Kiyoshi Ota/Bloomberg via Getty Images)

Sci­ence pi­o­neer, phar­ma re­search chief, glob­al health ad­vo­cate and biotech en­tre­pre­neur Tadata­ka ‘Tachi’ Ya­ma­da has died

Tadataka Yamada, a towering physician-scientist who made his name in academia before transforming drug development at GlaxoSmithKline and developing vaccines for malaria and meningitis at the Gates Foundation, died unexpectedly of natural causes at his home in Seattle Wednesday morning.

He was 76. Frazier Healthcare Partners’ David Socks confirmed his death.

Known widely by the mononym “Tachi,” Yamada had a globetrotting career and arrived in industry relatively late in life. A 2004 Independent article noted GSK had asked Yamada to stay on beyond his approaching 60th birthday, the company’s usual retirement age. Yamada would continue working for the next 17 years, steering the Gates Foundation’s global health division for 6 years, funding Jim Wilson’s gene therapy work when few would touch it, launching Takeda Vaccines and co-founding a series of high-profile biotechs.

Tien Lee, Aardvark Therapeutics CEO

Emerg­ing from stealth mode, Aard­vark rounds up enough cash to put its lead drug through Prad­er-Willi PhII

When Aardvark Therapeutics CEO Tien Lee started his work on the biotech’s lead candidate, appetite suppression was the goal for the small molecule.  Soon after, his team started to see added benefits with lower blood glucose levels and anti-inflammatory activity. On the tail end of that, the company has emerged from stealth mode and announced today that they’ve raised enough cash in the B round to cover mid-stage development work.

Josh Hoffman, outgoing Zymergen CEO (Zymergen)

UP­DAT­ED: Syn­bio uni­corn Zymer­gen jet­ti­sons found­ing CEO, cuts guid­ance as cus­tomers re­port lead prod­uct does­n't work

Zymergen, just months off a $500 million IPO that put the synthetic bio firm in rarified air, has now ejected its founding CEO and downgraded its revenue forecasts after customers reported its lead film product doesn’t work as advertised, the company said Tuesday afternoon.

CEO Josh Hoffman will leave his role and sacrifice his board seat immediately in favor of Jay Flatley, the former CEO of Illumina who will take the lead role on an interim basis as the company conducts a search for its next leader.

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UK re-in­ves­ti­gates Pfiz­er's eye-pop­ping price goug­ing on an epilep­sy drug

When a drugmaker raises the price of a drug in the US by more than 2,000% overnight, and without any particular reason for that increase, nothing typically happens to the company. No fines, no court orders, just business as usual.

Martin Shkreli’s decades-old anti-parasitic drug Daraprim was the perfect example — massive price spike on an old drug, lots of media attention, public outcry, congressional committees dragging his former company through multiple hearings, and at the end of it? Nothing happened to the price or the company (until generic competition came).

Thomas Lingelbach, Valneva CEO

A small vac­cine de­vel­op­er fa­vored by the UK gov­ern­ment in Covid-19 touts a PhI­II first in chikun­gun­ya

Before Valneva garnered the favor of the UK government as a potential supplier of Covid-19 vaccines, the French biotech prided itself on being the first company to bring a chikungunya vaccine into Phase III.

It now has positive pivotal results to back up the breakthrough therapy designation the FDA granted just weeks ago.

There are currently no approved jabs to prevent chikungunya virus infection despite decades of R&D efforts, a fact that underscores just how arduous traditional vaccine development can be, particularly for neglected tropical disease. In a absence of a major commercial market, the US government and NGOs such as CEPI have deployed various grants and incentives to spur on a small crew of academics and industry players, with Merck, via its acquisition of Themis, claiming a spot in that race.

Zymergen co-founders Zach Serber, Josh Hoffman, and Jed Dean (Zymergen via website)

Zymer­gen's sud­den im­plo­sion shocked biotech. A lin­ger­ing loan could make things even worse

As former synbio unicorn Zymergen picks up the pieces from its spectacular implosion Tuesday, an outstanding loan from Perceptive Advisors — the only blue-chip biotech crossover investor to touch Zymergen’s fundraising efforts — could make the situation worse, according to public documents.

In December 2019, more than a year before Zymergen filed for what would eventually become a $500 million IPO, the “biofacturing” firm signed a $100 million credit facility with Perceptive to help supplement the nearly $700 million the company had raised across four VC rounds.