Covid-19 roundup: Flood, dead­ly fire threat­en As­traZeneca vac­cine plants; Italy won­ders aloud if it can sue Pfiz­er for vac­cine short­falls

As re­ports crop up that de­liv­er­ies of Pfiz­er and BioN­Tech’s Covid-19 vac­cine are be­ing un­ex­pect­ed­ly cut, Italy won­ders if it can take the vac­cine de­vel­op­ers to court, ac­cord­ing to the Wall Street Jour­nal. 

Af­ter its ship­ment for this week was cut by 29%, the Ital­ian gov­ern­ment con­sult­ed its at­tor­ney gen­er­al about tak­ing le­gal ac­tion, the WSJ re­port­ed. Pfiz­er and BioN­Tech had warned the EU and Cana­da last week that their al­lo­ca­tions would be re­duced as Pfiz­er up­grades its Bel­gium fac­to­ry. What Italy says it doesn’t ap­pre­ci­ate, though, is the short no­tice.

Italy isn’t the first coun­try to com­plain of vac­cine short­ages as au­thor­i­ties scram­ble to get dos­es in arms. Ger­many’s Ham­burg said they al­so re­ceived a small­er ship­ment — and they’re strug­gling to ex­tract a full six dos­es from vials.

While the vials were ini­tial­ly la­beled for five dos­es, the EU found ear­li­er this month that it was pos­si­ble to squeeze out a sixth dose. Pfiz­er and BioN­Tech said they are com­mit­ted to de­liv­er­ing a cer­tain amount of dos­es — not vials, ac­cord­ing to the WSJ. But with­out a spe­cial sy­ringe, those ad­min­is­ter­ing the vac­cine can’t quite get that sixth dose out, the pa­per re­port­ed.

Last month, sev­er­al US states al­so com­plained of sharply re­duced vac­cine al­lo­ca­tions. Wash­ing­ton Gov. Jay In­slee said the CDC told him to ex­pect 40% few­er dos­es one week, NPR re­port­ed. Iowa was ex­pect­ing a 30% short­fall. Pfiz­er said it had mil­lions of dos­es sit­ting in a ware­house, and was await­ing in­struc­tions from the gov­ern­ment. HHS Sec­re­tary Alex Azar, on the oth­er hand, blamed Pfiz­er’s pro­duc­tion ca­pac­i­ty.

The news comes as the US lags be­hind its dis­tri­b­u­tion plans. While fed­er­al pro­jec­tions had aimed to dis­trib­ute 20 mil­lion dos­es by the end of 2020, on­ly 16.5 mil­lion dos­es have been ad­min­is­tered so far, ac­cord­ing to the CDC.

Dead­ly fire strikes fa­cil­i­ties mak­ing As­traZeneca vac­cine in In­dia

A dead­ly fire broke out Thurs­day at the Serum In­sti­tute of In­dia, where hun­dreds of mil­lions of dos­es of the As­traZeneca Covid-19 are be­ing man­u­fac­tured.

Five peo­ple died in the blaze, the cause of which re­mains un­known. Serum In­sti­tute CEO Adar Poon­awal­la ex­pressed con­do­lences for the fam­i­lies and sought to as­sure that the tragedy would not im­pact vac­cine pro­duc­tion, as the in­sti­tute had 50 mil­lion dos­es in re­serve and oth­er build­ings ded­i­cat­ed to pro­duc­tion.

The fire broke out in a new build­ing the man­u­fac­tur­er was build­ing to scale pro­duc­tion of the As­traZeneca vac­cine. Murlid­har Mo­hol, may­or of Pune city, where the Serum In­sti­tute is lo­cat­ed, said the vic­tims were like­ly con­struc­tion work­ers, AP re­port­ed.

The fire was one of two dis­as­ters to threat­en fa­cil­i­ties mak­ing As­traZeneca’s Covid-19 vac­cine in the last 24 hours. A vac­cine plant in Wrex­ham, Wales sought aid from lo­cal au­thor­i­ties Wednes­day as a storm tore in­to the town, caus­ing flood­ing and evac­u­a­tions.

The fac­to­ry, though, ap­pears to have weath­ered the tu­mult. A spokesper­son told Bloomberg Thurs­day that they ex­pe­ri­enced mild flood­ing, but suf­fered no dis­rup­tions to work and pro­duc­tion is on­go­ing.

As­traZeneca, de­spite fac­ing sub­stan­tial set­backs in its vac­cine pro­gram, has pur­sued the most am­bi­tious pro­duc­tion goals of any Covid-19 de­vel­op­er, aim­ing to pro­duce 3 bil­lion dos­es world­wide by the end of 2021. The Serum In­sti­tute ac­counts for around 1 bil­lion dos­es of that to­tal.  — Ja­son Mast

US recom­mits to WHO un­der new Biden ad­min­is­tra­tion

On his first day in of­fice, Pres­i­dent Joe Biden inked a di­rec­tive recom­mit­ting the US to the World Health Or­ga­ni­za­tion, re­vers­ing the Trump’s ad­min­is­tra­tion’s calls to aban­don the agency amid the pan­dem­ic.

Ac­cord­ing to Sec­re­tary of State-des­ig­nate Tony Blinken, that means join­ing CO­V­AX, a pro­gram set up by CEPI, the WHO and Gavi to eq­ui­tably dis­trib­ute vac­cines around the world, the Wash­ing­ton Post re­port­ed.

More than 180 coun­tries had signed agree­ments to the CO­V­AX Fa­cil­i­ty as of Oct. 14, in­clud­ing France, the UK and Chi­na. The co­op­er­a­tive aims to de­liv­er 2 bil­lion dos­es by the end of 2021. The Trump ad­min­is­tra­tion, how­ev­er, re­fused to join. One White House spokesman said the coun­try won’t be “con­strained by mul­ti­lat­er­al or­ga­ni­za­tions in­flu­enced by the cor­rupt World Health Or­ga­ni­za­tion and Chi­na,” ac­cord­ing to a Bloomberg re­port.

The Trump ad­min­is­tra­tion gave no­tice of plans to with­draw from the WHO back in Ju­ly. But sev­er­ing ties with the agency isn’t that sim­ple. Ac­cord­ing to the terms of a joint res­o­lu­tion passed in 1948, the US must give a year’s no­tice and pay back debts be­fore it can leave. How­ev­er, whether Trump could do so with­out Con­gress was un­clear, and De­mo­c­ra­t­ic law­mak­ers pushed back.

Stephen Mor­ri­son, di­rec­tor of the Glob­al Health Pol­i­cy Cen­ter at the Cen­ter for Strate­gic and In­ter­na­tion­al Stud­ies, told WaPo that he thinks the WHO will wel­come the US. “But there’s go­ing to be an edge to it,” he said.

So­cial im­age cred­it: Get­ty Im­ages

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

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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.

With the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

President Biden (AP Images)

Biden in­vests $3B in­to an­tivi­ral de­vel­op­ment for Covid-19

The Biden administration on Thursday unveiled a new plan to invest more than $3 billion into speeding new antivirals to treat Covid-19.

The plan will allow NIH to evaluate, prioritize and advance antiviral candidates to Phase II clinical trials, using contractors and the NIH’s National Center for Advancing Translational Sciences laboratories to de-risk early stage development.

“New antivirals that prevent serious COVID-19 illness and death, especially oral drugs that could be taken at home early in the course of disease, would be powerful tools for battling the pandemic and saving lives,” said NIAID director Anthony Fauci.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 109,800+ biopharma pros reading Endpoints daily — and it's free.

Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.