Covid-19 roundup: HHS may strug­gle to ab­sorb Op­er­a­tion Warp Speed; Eu­rope has no plans for a fourth vac­cine dose

Op­er­a­tion Warp Speed, per­haps the great­est achieve­ment of the for­mer Trump ad­min­is­tra­tion, prompt­ly de­liv­ered Covid-19 vac­cine sup­plies na­tion­wide when they be­came avail­able, thanks to col­lab­o­ra­tions be­tween HHS and the De­part­ment of De­fense, while help­ing to fund and aid the man­u­fac­ture of bil­lions of dos­es.

But since the Biden ad­min­is­tra­tion took over a year ago, act­ing FDA com­mis­sion­er Janet Wood­cock tran­si­tioned out of her role as the ther­a­peu­tics lead in Warp Speed, which has been con­vert­ed in­to a new op­er­a­tion with­out the fan­cy name (now known as the “HHS-DOD COVID-19 Coun­ter­mea­sures Ac­cel­er­a­tion Group”), and as of the start of 2022, the De­part­ment of De­fense is no longer help­ing HHS on the pro­gram.

Ac­cord­ing to a new re­port from the Gov­ern­ment Ac­count­abil­i­ty Of­fice on Thurs­day, that tran­si­tion away from DOD will be tough for the HHS, which might not be equipped to take on the Warp Speed skele­ton with­out DOD re­sources and skilled per­son­nel.

“It’s un­clear whether HHS is ready to ful­ly as­sume all re­spon­si­bil­i­ties, es­pe­cial­ly those for­mer­ly led by DOD. HHS has as­sessed its work­force ca­pa­bil­i­ties, but it hasn’t ad­dressed the loss of DOD of­fi­cials with spe­cial­ized skills,” GAO said. “More­over, HHS does not have a sched­ule that is con­sis­tent with best prac­tices to help it man­age re­main­ing vac­cine-re­lat­ed ac­tiv­i­ties.”

The HHS did not con­cur with GAO’s rec­om­men­da­tion on work­force needs, and GAO said it re­vised this rec­om­men­da­tion based on up­dat­ed in­for­ma­tion, but “main­tains that it con­tin­ues to be valid.”

Mean­while, Texas Re­pub­li­can Rep. Michael Burgess in­tro­duced a bill re­cent­ly that would in­te­grate the process be­hind Warp Speed in­to the FDA. The bill al­so calls on FDA to “col­lect in­ter­im da­ta that would al­low for par­al­lel as­sess­ments of the safe­ty and ef­fec­tive­ness of mul­ti­ple drugs and bi­o­log­i­cal prod­ucts and the par­al­lel ap­proval or li­cen­sure of mul­ti­ple drugs and bi­o­log­i­cal prod­ucts, in­clud­ing through the con­duct of con­cur­rent clin­i­cal tri­als.” — Zachary Bren­nan

Eu­rope has no plans for a fourth Covid-19 vac­cine dose 

As coun­tries de­bate whether to ad­min­is­ter a sec­ond boost­er vac­cine to bat­tle Omi­cron, the Eu­ro­pean Med­i­cines Agency re­cent­ly made clear that this is not the di­rec­tion in which it’s plan­ning to move.

The EMA an­nounced ear­li­er this week that a fourth dose is — at the mo­ment — off the ta­ble for the gen­er­al pop­u­la­tion, the agency said in a se­ries of mes­sages on Twit­ter.

The EMA did ac­qui­esce slight­ly, say­ing that it would be rea­son­able for pub­lic health au­thor­i­ties to con­sid­er giv­ing a fourth dose to those with se­vere­ly weak­ened im­mune sys­tems and who have al­ready had three dos­es of a Covid-19 vac­cine.

The agency went on to ad­dress vac­cines de­signed to tar­get the Omi­cron vari­ant.

“Ap­proval of Covid-19 vac­cines with a dif­fer­ent com­po­si­tion re­quires clin­i­cal da­ta that show a su­pe­ri­or im­mune re­sponse than the one gen­er­at­ed by the boost­ers cur­rent­ly avail­able,” the agency said.

Re­search on the ef­fec­tive­ness of a fourth dose against Omi­cron has been spot­ty. A study among health­care work­ers in Is­rael found that while the fourth dose does in­crease an im­mune re­sponse, it’s like­ly not enough to pre­vent in­fec­tion from Omi­cron, though it could boost pro­tec­tion against se­vere dis­ease. — Paul Schloess­er

Bio­mark­er 'roadmap­s' and the fu­ture of can­cer R&D; Cur­tain rais­es on #AS­CO22; Pfiz­er, No­var­tis tack­le drug ac­cess; 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.

While this was not a week for earth-shattering news, there were certainly a lot of interesting tidbits. If you found this recap helpful, please recommend it to your friends and colleagues. We’ll see you on the other side of the long weekend.

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Keep­ing pres­sure on Am­gen, Mi­rati draws mixed re­views on lat­est cut of KRAS da­ta

As the close runner-up to Amgen’s Lumakras in the KRAS race, any data cut from Mirati’s adagrasib continues to draw scrutiny from analysts. And the latest batch of numbers from ASCO is a decidedly mixed bag.

While a quick comparison suggests that adagrasib spurred slightly more responses and led to a longer overall survival than Lumakras among a group of non-small cell lung cancer patients, its duration of response appears shorter and the safety profile continues to spark concern.

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Switzer­land to de­stroy over 600,000 ex­pired dos­es of Mod­er­na Covid vac­cine

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

Ann is one of ViiV Healthcare's newest spokespeople as the retired school administrator speaks up about her HIV status.

GSK's Vi­iV de­buts next evo­lu­tion in HIV med Dova­to cam­paign with new spokes­peo­ple and new mes­sage

When Ann saw the first TV commercials for HIV medicine Dovato, she didn’t see herself represented. So the 74-year-old retired school administrator who’s been living with HIV since 1998, reached out to GSK’s ViiV Healthcare and asked why not?

Now Ann is one of three people starring in ViiV’s latest Dovato campaign called “Detect This.” The next-step evolution in the branded campaign plays on the word “detect” — often used in describing HIV status under control as undetectable — but in this case, uses the word as a directive for people to understand they can use fewer medicines.

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Tran­si­tion to new Eu­ro­pean clin­i­cal tri­als in­fo sys­tem starts slow­ly

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

Covid-19 roundup: CDC study shows good pro­tec­tion from mR­NA boost­er plus J&J's sin­gle-dose vac­cine; White House launch­es test-to-treat Paxlovid site

Concerns about rare but life-threatening blood clots have limited the use of J&J’s Covid-19 vaccine — once pitched as the only one-shot option in the mix — with the FDA cutting it off except in limited circumstances. Yet there’s some good news for those who did receive it: A single booster dose of an mRNA vaccine for recipients of a single priming dose of Ad26.COV2.S (the J&J vaccine) provided protection close to that of a three-dose mRNA vaccine regimen.

Nassim Usman, Catalyst Biosciences CEO

Af­ter $60M Ver­tex deal, group of Cat­a­lyst share­hold­ers claims biotech could’ve sold as­sets three years ago

Catalyst Biosciences was down to five employees in March, and the biotech needed to do something after two rounds of layoffs, a nixed collaboration and a culling of its hemophilia program.

In came Vertex, with $60 million to buy up the South San Francisco biotech’s preclinical complement drugs, which target the system that bridges the body’s innate and adaptive immune response and a class most known for Ultomiris and Soliris. The deal includes CB 2782-PEG, the dry AMD drug that Biogen no longer wanted in March.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP Images)

Pile-on over PBMs con­tin­ues with FTC com­ments and a new bi­par­ti­san Sen­ate bill

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

Pharma brands are losing their shine with US consumers who are now thinking about the economy and inflation instead of Covid. (Credit: Shutterstock)

Phar­ma brands fade in an­nu­al Har­ris con­sumer vis­i­bil­i­ty poll: Mod­er­na drops off and Pfiz­er dips

As Covid-19 concerns are fading in the US, so is biopharma visibility. The annual Axios Harris Poll survey to determine and rank the 100 most top-of-mind brands in the US finds Moderna, which was No. 3 last year, not on the list at all for 2022, and Pfizer sinking 37 spots.

However, it’s not that Moderna or Pfizer did anything wrong, it’s just that Americans have moved on to other worries beyond Covid.

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