Pfiz­er plans to study a third shot for its Covid-19 vac­cine in the youngest kids, push­ing back its time­line far­ther

Amer­i­can chil­dren un­der the age of five may not be vac­ci­nat­ed un­til mid-2022, as Pfiz­er said Fri­day that it’s go­ing to now test a third dose of its Covid-19 vac­cine in the tri­al.

The de­ci­sion comes as Pfiz­er an­nounced non-in­fe­ri­or­i­ty was not met for chil­dren be­tween the ages of two and five when com­pared to old­er teenagers in the cur­rent tri­al.

Pfiz­er pre­vi­ous­ly said it might ap­ply for an EUA in this youngest pop­u­la­tion by the end of De­cem­ber or ear­ly next year, but now says that if the three-dose study proves suc­cess­ful, Pfiz­er and BioN­Tech ex­pect to sub­mit da­ta to reg­u­la­tors to sup­port an EUA “in the first half of 2022.”

The shift to three dos­es was made af­ter a rou­tine re­view by the ex­ter­nal in­de­pen­dent Da­ta Mon­i­tor­ing Com­mit­tee, and the tri­al will now eval­u­ate a third dose of 3 µg at least two months af­ter the sec­ond dose in this young age group. Here’s how Pfiz­er ex­plained the non-in­fe­ri­or­i­ty is­sue with the 2- to 5-year-old group in the tri­al:

While the study is on­go­ing and re­mains blind­ed, a pre-spec­i­fied im­muno­genic­i­ty analy­sis was con­duct­ed on a sub­set of the study pop­u­la­tion one month fol­low­ing the sec­ond dose. Com­pared to the 16- to 25-year-old pop­u­la­tion in which high ef­fi­ca­cy was demon­strat­ed, non-in­fe­ri­or­i­ty was met for the 6- to 24-month-old pop­u­la­tion but not for the 2- to un­der 5-year-old pop­u­la­tion in this analy­sis. No safe­ty con­cerns were iden­ti­fied and the 3 µg dose demon­strat­ed a fa­vor­able safe­ty pro­file in chil­dren 6 months to un­der 5 years of age.

Pfiz­er and BioN­Tech are al­so shift­ing to a three-dose reg­i­men for all ages, as the com­pa­nies plan to eval­u­ate a third dose of the 10 µg for­mu­la­tion in chil­dren five to un­der 12 years of age. Ad­di­tion­al­ly, the com­pa­nies have ini­ti­at­ed a low dose sub-study of a third dose of 10 µg or 30 µg in ap­prox­i­mate­ly 600 ado­les­cents aged 12- to 17 to as­sess safe­ty and im­muno­genic­i­ty.

Ini­tial­ly, the Phase I/II/III tri­al, which en­rolled about 4,500 chil­dren aged six months to un­der 12 years in the US, Fin­land, Poland and Spain, was de­signed to eval­u­ate the safe­ty, tol­er­a­bil­i­ty and im­muno­genic­i­ty of the Pfiz­er-BioN­Tech vac­cine on a two-dose sched­ule (ap­prox­i­mate­ly 21 days apart) in three age groups: ages five to un­der 12 years; ages two to un­der five years; and ages six months to un­der two years.

In ad­di­tion to Pfiz­er, Mod­er­na is work­ing on its own Covid-19 vac­cine tri­al for those be­tween the ages of six months and 12.

Stephen Hoge, pres­i­dent of Mod­er­na, said in the com­pa­ny’s Q3 earn­ings call that the com­pa­ny sub­mit­ted da­ta from its Kid­Cove study to the FDA as well as to oth­er coun­tries.

But Hoge not­ed that the com­pa­ny was re­cent­ly no­ti­fied by the FDA that the agency “will re­quire ad­di­tion­al time to eval­u­ate our pro­posed amend­ment due to re­cent analy­sis of the risk of my­ocardi­tis af­ter vac­ci­na­tion in some pop­u­la­tions. The agency ex­pects this eval­u­a­tion may ex­tend un­til Jan­u­ary 2022.”

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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