Covid-19 roundup: Supreme Court blocks Biden ad­min­is­tra­tion's vac­cine man­date for large busi­ness­es; South Africa study sug­gests J&J boost­er is 85% ef­fec­tive against hos­pi­tal­iza­tion 

The Supreme Court vot­ed on Thurs­day to block Pres­i­dent Joe Biden’s vac­cine-or-test­ing man­date for large busi­ness­es while up­hold­ing a vac­cine re­quire­ment for health care work­ers at fa­cil­i­ties re­ceiv­ing fed­er­al mon­ey.

The re­quire­ment would have re­quired em­ploy­ees at large com­pa­nies to ei­ther get vac­ci­nat­ed or test once a week. On Thurs­day, Biden ex­pressed his dis­ap­point­ment in the court’s de­ci­sion.

“As a re­sult of the Court’s de­ci­sion, it is now up to States and in­di­vid­ual em­ploy­ers to de­ter­mine whether to make their work­places as safe as pos­si­ble for em­ploy­ees and whether their busi­ness­es will be safe for con­sumers dur­ing this pan­dem­ic by re­quir­ing em­ploy­ees to take the sim­ple and ef­fec­tive step of get­ting vac­ci­nat­ed,” he said in a state­ment.

The court vot­ed 6 to 3 to block the man­date for large busi­ness­es, with the lib­er­al jus­tices in dis­sent, and 5 to 4 in the health care case, with chief jus­tice John Roberts Jr. and jus­tice Brett Ka­vanaugh join­ing the lib­er­al jus­tices in the ma­jor­i­ty, ac­cord­ing to the New York Times. 

When the Biden ad­min­is­tra­tion be­gan in­sti­tut­ing vac­cine re­quire­ments last Ju­ly — which ap­plied to health care work­ers, mem­bers of the Armed Forces, fed­er­al work­ers and con­trac­tors, and em­ploy­ees of large firms — 90 mil­lion Amer­i­cans were still un­vac­ci­nat­ed. Now, that num­ber is down to less than 35 mil­lion, ac­cord­ing to Biden.

The vac­cine re­quire­ment for health care work­ers ap­plies to about 10.4 mil­lion em­ploy­ees at 76,000 fa­cil­i­ties, he said in a state­ment.

In a dis­sent­ing opin­ion in the large firms’ case, jus­tices Stephen Brey­er, So­nia So­tomay­or and Ele­na Ka­gan ar­gued that reg­u­lat­ing safe­ty in the work­place is OS­HA’s job. “If OS­HA’s Stan­dard is far-reach­ing—ap­ply­ing to many mil­lions of Amer­i­can work­ers—it no more than re­flects the scope of the cri­sis,” they wrote, adding:

Un­der­ly­ing every­thing else in this dis­pute is a sin­gle, sim­ple ques­tion: Who de­cides how much pro­tec­tion, and of what kind, Amer­i­can work­ers need from COVID–19? An agency with ex­per­tise in work­place health and safe­ty, act­ing as Con­gress and the Pres­i­dent au­tho­rized? Or a court, lack­ing any knowl­edge of how to safe­guard work­places, and in­su­lat­ed from re­spon­si­bil­i­ty for any dam­age it caus­es?

South Africa study sug­gests J&J boost­er is 85% ef­fec­tive against hos­pi­tal­iza­tion 

A new study con­duct­ed in South Africa sug­gests that a boost­er dose of John­son & John­son’s Covid-19 vac­cine was 85% ef­fec­tive against hos­pi­tal­iza­tion in an area where the Omi­cron vari­ant was the dom­i­nant strain, South Africa’s Med­ical Re­search Coun­cil (SAM­RC) an­nounced.

Health care work­ers in the study were fol­lowed for about a month (from No­vem­ber to De­cem­ber), dur­ing which time the Omi­cron vari­ant in­creased from 82% of cas­es in South Africa to 98% of cas­es. When a boost­er dose was ad­min­is­tered six to nine months af­ter the pri­ma­ry dose, vac­cine ef­fi­ca­cy against hos­pi­tal­iza­tion in­creased from 63% with­in the first 13 days post-boost, to 85% at one to two months post-boost, ac­cord­ing to the SAM­RC.

In the US, it’s rec­om­mend­ed that in­di­vid­u­als who re­ceived the J&J vac­cine get boost­ed as soon as two months fol­low­ing the pri­ma­ry dose.

It’s im­por­tant to note that the da­ta have been sub­mit­ted to medRx­iv, but have not been peer-re­viewed.

“Even be­fore you fac­tor in the in­creased in­fec­tious­ness of Omi­cron, we have to re­mem­ber that health­care work­ers on the front­lines are at a great­ly in­creased risk of be­ing af­fect­ed by COVID-19 in the first place,” Glen­da Gray, pres­i­dent and CEO of the SAM­RC, said in a state­ment. “We are there­fore en­cour­aged to see that boost­ing with the John­son & John­son COVID-19 vac­cine reg­i­men pro­vides strong pro­tec­tion in a chal­leng­ing re­al-world set­ting where there is an el­e­vat­ed risk of ex­po­sure – not just to COVID-19, but to the high­ly trans­mis­si­ble Omi­cron vari­ant.”

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.

CSL is gathering its four business units under a unified brand identity strategy (Credit: CSL company site)

CSL brings Se­qirus, Vi­for un­der par­ent um­brel­la brand in iden­ti­ty re­vamp

CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.

CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.

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