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.

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Bob Nelsen (Photo by Michael Kovac/Getty Images)

With stars aligned and cash in re­serve, Bob Nelsen's Re­silience plans a makeover at 2 new fa­cil­i­ty ad­di­tions to its drug man­u­fac­tur­ing up­start

Bob Nelsen’s new, state-of-the-art drug manufacturing initiative is taking shape.

Just 3 months after gathering $800 million of launch money, a dream team board and a plan to shake up a field where he found too many bottlenecks and inefficiencies for the era of Covid-19, Resilience has snapped up a pair of facilities now in line for a retooling.

The company has acquired a 310,000-square-foot plant in Boston from Sanofi along with a 136,000-square-foot plant in Ontario to add to a network which CEO Rahul Singhvi says is just getting started on building his company’s operations up. The Sanofi deal comes with a contract to continue manufacturing one of its drugs.

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Amit Munshi, Arena

One of Are­na's top drugs flops in a PhI­Ib study for IBS pain. But re­searchers tease out a pos­si­ble path for­ward as CEO ex­plores 's­trate­gic op­tion­s'

Four years ago, when Arena CEO Amit Munshi cut its ties to a troubled weight drug and doubled down on the pipeline, a cannabinoid receptor 2 agonist figured prominently in the biotech’s future. On Tuesday evening, however, Munshi’s high hopes for the drug took a nasty hit after it failed a Phase IIb study for patients with irritable bowel syndrome pain.

Put through a randomized pace with 273 patients, researchers said it flat failed the primary endpoint among the large group with abdominal pain. But they quickly went on to highlight subgroup data, always a tricky and controversial ploy, where they spotlighted a positive p value for patients with moderate to severe pain who received the high dose of the drug — one of 3 provided in the study.

Af­ter bail­ing on Covid-19 vac­cines, Mer­ck will team up with J&J to pro­duce its shot as part of un­usu­al Big Phar­ma pact

Merck took a big gamble when it opted to jump into the Covid-19 vaccine race late, and made an equally momentous decision to back out in late January. Now, looking to chip in on the effort, Merck reportedly agreed to team up with one of the companies that has already crossed the finish line.

President Joe Biden on Tuesday is expected to announce a partnership between drugmakers Merck and Johnson & Johnson to jointly produce J&J’s recombinant protein Covid-19 vaccine that received the FDA’s emergency use authorization Saturday, the Washington Post reported.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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Pascal Soriot, AstraZeneca CEO (AP Images)

Pas­cal So­ri­ot cash­es in As­traZeneca’s chips on Mod­er­na for $1.2B cash in­jec­tion

While still working to prove its own Covid-19 vaccine, AstraZeneca has reportedly capitalized on the success of another.

The company has sold off its 7.7% stake in Moderna and turned it into $1.2 billion in cash, according to the Times, beefing up the reserves just as Pascal Soriot is wrapping up his $39 billion acquisition of Alexion and its rare disease pipeline.

AstraZeneca’s stock sale follows a similar move by Merck in December. But like its pharma brethren, the British giant is keeping its R&D collaborations with Moderna.

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UP­DAT­ED: Feds clear the road for J&J to start de­liv­er­ing mil­lions of dos­es of their Covid-19 vac­cine — but frets linger about run­ner-up sta­tus

All the pieces needed to trigger a third wave of Covid-19 vaccine supply to start washing over the US fell neatly into place over the weekend.

After providing for a brief mime of regulatory judiciousness, the FDA stamped their emergency approval on J&J’s Covid-19 vaccine Saturday, adding to the Biden administration’s plan aimed at ending the pandemic in the near term — at least in the US. The CDC came through on Sunday with its stamp of approval and J&J is reportedly expected to start delivering vaccine sometime in the next few days.

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Ab­b­Vie tees up a biotech buy­out af­ter siz­ing up their Parkin­son's drug spun out of Ke­van Shokat's lab

AbbVie has teed up a small but intriguing biotech buyout after looking over the preclinical work it’s been doing in Parkinson’s disease.

The company is called Mitokinin, a Bay Area biotech spun out of the lab of UCSF’s Kevan Shokat, whose scientific explorations have formed the academic basis of a slew of startups in the biotech hub. One of Shokat’s PhD students in the lab, Nicholas Hertz, co-founded Mitokinin using their lab work on PINK1 suggesting that amping up its activity could play an important role in regulating the mitochondrial dysfunction contributing to Parkinson’s disease pathogenesis and progression.

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Paul Sekhri

The next big biotech su­per­star? Paul Sekhri has some thoughts on that

It occasionally occurs to Paul Sekhri that if they pull this off, his company will be on the front page of the New York Times and a lead story in just about every major news outlet on the planet. He tries not to dwell on it, though.

“I just want to be laser-focused on getting to that point,” Sekhri says, before acknowledging, “Yes, it absolutely crossed my mind.”

Sekhri, a longtime biopharma executive with tenures at Sanofi and Novartis, is now entering year three as CEO of eGenesis, the biotech that George Church protégé Luhan Yang founded to genetically alter pigs so that they can be used for organ transplants. He led them through one megaround and has just closed another, raising $125 million from 17 different investors to push the first-ever (humanized) pig to human transplants into the clinic.

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Fi­bro­Gen shares skid low­er as a sur­prise ad­comm rais­es risks on roxa OK

FibroGen will likely have to delay its US rollout for roxadustat once again.

In an unexpected move, the FDA is convening its Cardiovascular and Renal Drugs Advisory Committee to review the NDA in an advisory committee meeting. The date is yet to be confirmed.

Just a few weeks ago, SVB Leerink analyst Geoffrey Porges predicted that the roxa approval could come ahead of the PDUFA date on March 20 — effusive despite already being let down once by the FDA’s extension of its review back in December. AstraZeneca, which is partnered with FibroGen on the chronic kidney disease-related anemia drug, disclosed regulators had requested further clarifying analyses of clinical data.