Steven Brandenburg, (Ozaukee County Sheriff via AP, File)

Covid-19 roundup: Phar­ma­cist who tam­pered with Mod­er­na vac­cines sen­tenced to 3 years in jail; FDA says J&J shelf life may be ex­tend­ed

A Wis­con­sin hos­pi­tal phar­ma­cist who told a judge he was skep­ti­cal of the Covid-19 vac­cines, es­pe­cial­ly Mod­er­na’s, will spend three years in prison af­ter he ad­mit­ted to at­tempt­ing to de­stroy hun­dreds of dos­es that were lat­er ad­min­is­tered to pa­tients.

Steven Bran­den­burg, 46, re­moved a box of Mod­er­na vials from a re­frig­er­a­tion unit at the hos­pi­tal he worked at dur­ing two overnight shifts in De­cem­ber 2020. He left the vac­cines out for sev­er­al hours a night, then re­turned them to the re­frig­er­a­tor to be used at the clin­ic the next day, the US De­part­ment of Jus­tice said, and the vac­cines were ad­min­is­tered to 57 peo­ple be­fore hos­pi­tal em­ploy­ees learned about his con­duct.

Bran­den­burg plead­ed guilty to two counts of at­tempt­ing to tam­per with con­sumer prod­ucts and was sen­tenced to 3 years of su­per­vised re­lease and or­dered to pay $83,800 in resti­tu­tion to the hos­pi­tal on top of his up­com­ing prison stint.

“The FDA has en­sured that the Mod­er­na COVID-19 vac­cine meets the agency’s rig­or­ous stan­dards for safe­ty, ef­fec­tive­ness, and man­u­fac­tur­ing qual­i­ty,” FDA in­ves­ti­ga­tor Cather­ine Hermsen. “Those who know­ing­ly tam­per with this vac­cine place Amer­i­can pa­tients’ health at risk. To­day’s an­nounce­ment should serve as a re­minder that this kind of il­lic­it tam­per­ing ac­tiv­i­ty will not be tol­er­at­ed.”

An “ad­mit­ted con­spir­a­cy the­o­rist,” Bran­den­burg be­lieved the vac­cine could harm peo­ple and change their DNA, po­lice in Grafton, WI told The New York Times. The box he re­moved con­tained 570 vials of the vac­cine, though it ap­pears that the vac­cines he tam­pered with re­mained ef­fec­tive, US At­tor­ney Richard Frohling said in a state­ment.

FDA says J&J shelf life may be ex­tend­ed

If you have some soon-to-ex­pire J&J vac­cines, Pres­i­dent Joe Biden’s ad­min­is­tra­tion wants you to hang on to them.

Janet Wood­cock, the act­ing com­mis­sion­er of the FDA, told state of­fi­cials dur­ing a White House call Tues­day that they could store the dos­es un­til new da­ta is re­leased that shows whether the vac­cines are still safe to use, Kaiser Health News re­port­ed. Un­til now, health of­fi­cials have warned against us­ing ex­pired dos­es, but FDA of­fi­cials are op­ti­mistic that the ex­pi­ra­tion dates could be ex­tend­ed.

There have been 21.4 mil­lion dos­es of that vac­cine de­liv­ered to the states, but just about half have been ad­min­is­tered, ac­cord­ing to the CDC. Louisiana health of­fi­cer Joseph Kan­ter has said that in Louisiana alone, there are 14,000 J&J dos­es that set to ex­pire in June. In Ohio, Gov. Mike DeWine said 200,000 J&J dos­es will ex­pire on June 23 and the state has no le­gal way to send them else­where.

The sin­gle-dose jab can last for three months if re­frig­er­at­ed, and two years if frozen. Through Pres­i­dent Don­ald Trump’s Op­er­a­tion Warp Speed, J&J was giv­en a $1 bil­lion con­tract to de­liv­er 100 mil­lion dos­es of the shot.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, 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.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

As it ex­pands its foot­print, Mod­er­na reach­es deal to man­u­fac­ture Covid-19 vac­cine dos­es in Mid­dle East

While the UAE leads the world with the highest percentage of residents vaccinated, neighboring Saudi Arabia — home to nearly 35 million people — has lagged behind significantly. On Friday, Moderna announced that it has partnered with the Saudi pharmaceutical company Tabuk to manufacture its jab and future variant-specific boosters in the country.

Tabuk will hold marketing authorization for the vaccine in Saudi Arabia, and the agreement gives them the possibility of distributing future Moderna mRNA products.

Covid-19 roundup: 60 mil­lion J&J dos­es from Emer­gent to be tossed; EMA up­dates As­traZeneca vac­cine warn­ings

After a two-month hold on millions of doses of the J&J vaccine, the FDA will announce that it is releasing 10 million doses and trashing 60 million that were made at a troubled Baltimore plant, The New York Times scooped on Friday morning.

Emergent BioSolutions reported that the doses were contaminated after drug material intended for the AstraZeneca vaccine came in close contact with media prepared for a J&J run. As a result, the doses were held from distribution, causing a shakeup in early availability.

Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Valeriano Di Domenico)

An­a­lysts hound Bio­gen with ques­tions over Aduhelm's $56K price point as news of Alzheimer's OK rip­ples through glob­al mar­kets

It’s been nearly 24 hours since the FDA handed down its controversial decision to approve Biogen’s Aduhelm drug for Alzheimer’s disease, and reactions from around the industry are pouring in as analysts try to size up the ramifications of Monday’s news.

Biogen hosted an investor call Tuesday morning, providing a forum for a number of topics that have been top of mind. The call came as the news of Aduhelm’s approval in the US rippled through global markets, while $BIIB stock soared to around $380 apiece (up from $286 on Friday), as Biogen’s partners at Eisai seek new approvals in Asia.

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Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.