Albert Bourla, Pfizer CEO (John Thys/POOL/AFP via Getty Images)

Pfiz­er CEO un­der fire from UK watch­dog over vac­cine com­ments — re­port

Pfiz­er CEO Al­bert Bourla told the BBC last De­cem­ber that he had “no doubt in my mind that the ben­e­fits, com­plete­ly, are in fa­vor” of vac­ci­nat­ing 5- to 11-year-olds for Covid-19. Al­most a year lat­er, those com­ments have re­port­ed­ly land­ed him in trou­ble with a UK phar­ma watch­dog.

Chil­dren’s ad­vo­ca­cy group Us­ForThem filed a com­plaint with the UK’s Pre­scrip­tion Med­i­cines Code of Prac­tice Au­thor­i­ty (PM­C­PA) last year ac­cus­ing Bourla of mak­ing “dis­grace­ful­ly mis­lead­ing” state­ments dur­ing the BBC in­ter­view, in­clud­ing one that “Covid in schools is thriv­ing.” At the time, UK reg­u­la­tors had not yet cleared the vac­cine for the 5 to 11 age group, though the vac­cine did have a pos­i­tive opin­ion from the EMA’s hu­man med­i­cines com­mit­tee.

On Sat­ur­day, the Tele­graph re­port­ed that PM­C­PA up­held some of those ac­cu­sa­tions, in­clud­ing that Bourla vi­o­lat­ed a British phar­ma­ceu­ti­cal code of prac­tice by mis­lead­ing the pub­lic and mak­ing un­sub­stan­ti­at­ed claims.

“It took a small team of com­mit­ted in­di­vid­u­als a year to get to this point and has tak­en grit, per­se­ver­ance and a lot of hard work,” Us­ForThem co-founder Mol­ly Kings­ley tweet­ed on Sat­ur­day.

The case is marked as on­go­ing on PM­C­PA’s web­site, and the or­ga­ni­za­tion has yet to file a full re­port. End­points News has re­quest­ed more in­for­ma­tion from PM­C­PA and Us­ForThem, and will up­date the sto­ry ac­cord­ing­ly.

“Pfiz­er is com­mit­ted to the high­est lev­els of in­tegri­ty in any in­ter­ac­tion with the pub­lic, world­wide. Through­out the pan­dem­ic, our com­mu­ni­ca­tions have been fo­cused on pro­vid­ing clar­i­ty re­gard­ing the progress of our sci­ence and sup­port­ing trans­par­ent sci­en­tif­ic ex­change in the in­ter­ests of pub­lic health,” Pfiz­er said in an email to End­points.

PM­C­PA re­port­ed­ly over­turned al­le­ga­tions that Pfiz­er en­cour­aged ir­ra­tional use of a med­i­cine, brought dis­cred­it to the in­dus­try and failed to main­tain high stan­dards, ac­cord­ing to the Tele­graph.

“We are pleased the UK’s PM­C­PA Ap­peal Board found Pfiz­er to have main­tained high stan­dards and up­held con­fi­dence in our in­dus­try, the two most se­ri­ous rul­ings in this com­plaint from a UK cam­paign group,” Pfiz­er said. “In the UK, we have al­ways en­deav­oured to fol­low the prin­ci­ples and let­ter of our in­dus­try Code of Prac­tice through­out. We will re­view the case re­port in de­tail when we re­ceive it, to in­form fu­ture ac­tiv­i­ty.”

The news comes as Pfiz­er re­ports a 66% drop in Comir­naty sales last quar­ter. While that de­cline was ex­pect­ed — due in part to de­liv­ery de­lays, in­clud­ing an amend­ment to the EU’s sup­ply deal that post­poned dos­es to the fourth quar­ter — the com­pa­ny is al­so grap­pling with slow up­take of boost­ers, es­pe­cial­ly among kids.

In the US, vac­cine cov­er­age among 5- to 11-year-olds was 20.7% in the first month af­ter the shots were rec­om­mend­ed for that age group, ac­cord­ing to re­cent­ly pub­lished CDC da­ta. As of Nov. 24, on­ly 12.1% of the en­tire US pop­u­la­tion over 5 years old had re­ceived a bi­va­lent boost­er.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

FDA re­ports ini­tial 'no sig­nal' for stroke risk with Pfiz­er boost­ers, launch­es con­comi­tant flu shot study

The FDA hasn’t detected any potential safety signals, including for stroke, in people aged 65 years and older who have received Pfizer’s bivalent Covid booster, one senior official told members of the agency’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Thursday.

The update comes as the FDA and CDC investigate a “preliminary signal” that may indicate an increased risk of ischemic stroke in older Americans who received Pfizer’s updated shot.

FDA cuts off use for As­traZeneca’s Covid-19 ther­a­py Evusheld

The FDA has stopped use of another drug as a result of the new coronavirus variants. On Thursday, the agency announced that AstraZeneca’s antibody combo Evusheld, which was an important prevention option for many immunocompromised people and others, is no longer authorized.

The FDA said it made its decision based on the fact that Evusheld works on fewer than 10% of circulating variants.

Evusheld was initially given emergency authorization at the end of 2021. However, as Omicron emerged, so did studies that showed Evusheld might not work against the dominant Omicron strain. In October, the FDA warned healthcare providers that Evusheld was useless against the Omicron subvariant BA.4.6. It followed that up with another announcement earlier this month that it did not think Evusheld would work against the latest Omicron subvariant XBB.1.5.

In­vestor 'misalign­men­t' leads to tR­NA biotech's shut­ter­ing

A small biotech looking to carve a lane in the tRNA field has folded, an investor and a co-founder confirmed to Endpoints News.

Similar to Flagship’s Alltrna and other upstarts like Takeda-backed hC Bioscience, the now-shuttered Theonys was attempting to go after transfer RNA, seen as a potential Swiss Army knife in the broader RNA therapeutics space. The idea is that one tRNA drug could be used across a galaxy of disorders and diseases.

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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