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.

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.

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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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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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.

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.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.