An­a­lysts as­sess fall­out af­ter As­traZeneca halts PhI­II Covid-19 vac­cine dos­ing to probe a pos­si­ble se­ri­ous ad­verse event

In­ves­ti­ga­tors at As­traZeneca have or­dered a halt to dos­ing their close­ly-watched Covid-19 vac­cine in or­der to probe a po­ten­tial­ly se­vere ad­verse event — re­port­ed­ly in­volv­ing in­flam­ma­tion of the spinal cord — suf­fered by one of the tri­al par­tic­i­pants.

In a state­ment out Tues­day evening, a spokesman for the phar­ma gi­ant told End­points News that the study had been put on hold to in­ves­ti­gate an ill­ness. Lat­er Tues­day, they sent a re­vised state­ment, which not­ed that the halt is vol­un­tary, not or­dered by reg­u­la­tors. It reads:

As part of the on­go­ing ran­domised, con­trolled glob­al tri­als of the Ox­ford coro­n­avirus vac­cine, our stan­dard re­view process was trig­gered and we vol­un­tar­i­ly paused vac­ci­na­tion to al­low re­view of safe­ty da­ta by an in­de­pen­dent com­mit­tee. This is a rou­tine ac­tion which has to hap­pen when­ev­er there is a po­ten­tial­ly un­ex­plained ill­ness in one of the tri­als, while it is in­ves­ti­gat­ed, en­sur­ing we main­tain the in­tegri­ty of the tri­als. In large tri­als ill­ness­es will hap­pen by chance but must be in­de­pen­dent­ly re­viewed to check this care­ful­ly. We are work­ing to ex­pe­dite the re­view of the sin­gle event to min­imise any po­ten­tial im­pact on the tri­al time­line. We are com­mit­ted to the safe­ty of our par­tic­i­pants and the high­est stan­dards of con­duct in our tri­als.

The spokesman did not say what ill­ness was in­volved, but the New York Times re­port­ed that the halt was trig­gered by a case in the UK of trans­verse myelitis, an in­flam­ma­tion of the spinal cord that can in­ter­rupt mes­sages that spinal cord nerves trans­mit. Ac­cord­ing to Johns Hop­kins, “it is char­ac­ter­ized by symp­toms and signs of neu­ro­log­ic dys­func­tion in mo­tor and sen­so­ry tracts on both sides of the spinal cord.”

The con­di­tion can be trig­gered by a va­ri­ety of things, in­clud­ing vac­ci­na­tions.

As­traZeneca’s shares slid 6% af­ter the bell on Tues­day, a sharp drop for a Big Phar­ma of that size. Shares of Mod­er­na and BioN­Tech, the two mR­NA lead­ers in Phase III, each jumped 5%.

This is the first such pause in the fren­zied race to get a Covid-19 vac­cine to the goal line. And the in­ter­rup­tion on a Covid-19 leader like this trig­gered head­lines world­wide. As­traZeneca, like the rest of the lead­ing de­vel­op­ers work­ing on a pan­dem­ic vac­cine, has been bar­rel­ing ahead in­to late-stage piv­otal work on a jab for the coro­n­avirus that has dis­rupt­ed the world. But at every quick step, ex­ecs at the multi­na­tion­al have al­so re­peat­ed­ly as­sured all in­volved that they will not hes­i­tate to slow things down if war­rant­ed.

The next big ques­tion is how long As­traZeneca’s vac­cine could be on pause and whether there could be a spillover in­volv­ing oth­er vac­cine mak­ers.

An­drew Berens at SVB Leerink put it this way, siz­ing up the im­pact if it is trans­verse myelitis:

AZN’s vac­cine study may be post­poned by weeks to months, as the safe­ty data­base is scru­ti­nized and tri­al pro­to­cols re­vised. Fur­ther, this AE could have the po­ten­tial to slow down vac­cine de­vel­op­ment more broad­ly. Trans­verse myelitis has not been de­fin­i­tive­ly linked to any com­mer­cial vac­cines, but it has been shown to be re­lat­ed to nat­ur­al virus in­fec­tion, and a few cas­es of trans­verse myelitis were de­scribed af­ter ad­min­is­tra­tion of the MMR, vari­cel­la, and he­pati­tis B vac­cines (the mech­a­nis­tic ev­i­dence was de­ter­mined to be weak per the In­sti­tute of Med­i­cine, cur­rent­ly the Na­tion­al Acad­e­my of Med­i­cine).

Safe­ty is­sues — par­tic­u­lar­ly when they could be tied to a se­ri­ous ad­verse event — loom par­tic­u­lar­ly large here. Any sug­ges­tion of a safe­ty prob­lem could raise con­cerns for all in­volved, pos­ing added prob­lems in the event they pro­voke pub­lic re­sis­tance to a shot. And there are po­lit­i­cal im­pli­ca­tions as well. As Pres­i­dent Trump has promised a vac­cine by year’s end, or even soon­er, the top vac­cines have a shot at a snap OK. Safe­ty is­sues would put a vac­cine fur­ther be­hind in the line.

Jef­feries’ Michael Yee was quick to pick up on that as­pect, writ­ing:

While we see this event as more of a short- to medi­um-term top­ic for de­bate, we do be­lieve these vac­cines will like­ly end up be­ing dif­fer­en­ti­at­ed on ef­fi­ca­cy and safe­ty in their Phase II­Is, which could dri­ve opin­ions on which is “best” and even­tu­al mar­ket up­take.

At our lat­est count, we in­clude the As­traZeneca vac­cine in 3rd place among 29 com­pa­nies in or near the clin­ic, right be­hind the mR­NA lead­ers at Pfiz­er/BioN­Tech and Mod­er­na. They’ve been work­ing with $1.2 bil­lion in pub­lic fi­nanc­ing for this work, with the Phase III get­ting un­der­way in Ju­ly. In­ves­ti­ga­tors plan to re­cruit 30,000 pa­tients in the US and 50,000 world­wide as they look for a broad pa­tient group to test safe­ty and ef­fi­ca­cy.

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

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Amidst R&D reshuf­fle, Ver­tex ex­pands its pres­ence in Boston, aim­ing to be­come num­ber one

Vertex Pharmaceuticals has been one of the buzzier names in the bustling Boston biotech scene, but now the company is looking to vault to number one status — at least in terms of physical footprint.

At a ribbon cutting on Tuesday for its new Jeffrey Leiden Center for Cell and Genetic Therapies at the Boston Seaport, Vertex announced it would embark on a new project: The company will build a 344,000 square foot facility in the seaport to accommodate the company’s growing R&D needs, especially in its cell and gene therapies program.

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Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Clay Siegall (Photo by Dimitrios Kambouris/Getty Images for Gabrielle's Angel Foundation)

UP­DAT­ED: Clay Sie­gall re­signs from Seagen amid in­ves­ti­ga­tion in­to do­mes­tic vi­o­lence claims

A week after Seagen revealed that longtime CEO Clay Siegall was on leave due to an allegation of domestic violence, he has resigned.

Since that shocking revelation, more details about the claims have emerged into the public eye. As Endpoints News reported, Siegall was arrested on April 23. A police report about that night and a subsequent temporary restraining order described a pattern of abusive behavior against his wife and a physical altercation that left her with multiple bruises. Siegall denied the claims.

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Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

Robert Califf (AP Photo/Manuel Balce Ceneta)

FDA au­tho­rizes boost­er dose of Pfiz­er and BioN­Tech's Covid-19 vac­cine in 5- to 11-year-olds

The latest wave of the pandemic — marked by Omicron and its sub-variants — has seen higher hospitalization rates for young children, health agencies have observed. That’s part of the reason why the FDA is authorizing a booster shot for kids between 5 and 11 years old.

Regulators on Tuesday OK’d a single booster dose of Pfizer and BioNTech’s mRNA vaccine for children who received their primary series with the same vaccine at least five months ago. By Pfizer’s count, that makes more than 8 million 5- to 11-year-olds eligible for another dose.