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.”

Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Covid-19 roundup: Pfiz­er/BioN­Tech launch Omi­cron-spe­cif­ic vac­cine tri­al; UK to re­cruit thou­sands more for mol­nupi­ravir study

Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.

Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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