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.

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. No thanks to all those who cast us as the ‘mis­in­for­mants’ dur­ing that time. https://t.co/4Pe­vAQub97

— Mol­ly Kings­ley (@lensiseethrough) No­vem­ber 26, 2022

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.

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.

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.

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.

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.