Pfizer CEO Albert Bourla (L) and BioNTech CEO Ugur Sahin (AP Images)

Covid-19 roundup: FDA au­tho­rizes Pfiz­er/BioN­Tech vac­cine for 12- to 15-year-olds; No­vavax shares sink as com­pa­ny de­lays vac­cine time­line

Back-to-school sea­son could look much dif­fer­ent this year, as Pfiz­er and BioN­Tech’s Covid-19 vac­cine has be­come the first in the US to be au­tho­rized for chil­dren as young as 12 years old.

On Mon­day, the FDA ex­pand­ed its emer­gency use au­tho­riza­tion for the jab — which was orig­i­nal­ly OK’d for those 16 years and old­er — based on ef­fi­ca­cy da­ta from 190 ado­les­cents which showed their im­mune re­sponse to the vac­cine was at least as good as the re­sponse seen in old­er par­tic­i­pants.

Pfiz­er and BioN­Tech al­so con­duct­ed an analy­sis sev­en days af­ter the ado­les­cents were giv­en their sec­ond dos­es. No Covid-19 cas­es were found among 1,005 12- to 15-year-olds who re­ceived the vac­cine, ver­sus 16 cas­es in the place­bo group, sug­gest­ing the vac­cine was 100% ef­fec­tive.

Side ef­fects ex­pe­ri­enced by a group of 2,260 ado­les­cents who were test­ed for safe­ty — pain at the in­jec­tion site, tired­ness, headache, chills, mus­cle pain, fever and joint pain — were con­sis­tent with old­er groups, ac­cord­ing to the agency. More than half of the par­tic­i­pants were fol­lowed for at least two months af­ter their sec­ond dose, ac­cord­ing to the com­pa­nies.

Pe­ter Marks, di­rec­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search (CBER), told re­porters in a me­dia brief­ing that the dos­es won’t be ad­min­is­tered to 12- to 15-year-olds un­til Thurs­day (af­ter the CDC holds an Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices meet­ing).

“We rec­og­nize that the next crit­i­cal step is hav­ing vac­cines avail­able for use through­out the pe­di­atric pop­u­la­tion,” Marks said in a state­ment on Mon­day.

Both the Mod­er­na and John­son & John­son vac­cines are cur­rent­ly au­tho­rized for adults 18 years and old­er, though Mod­er­na said last month that its Phase II/III Teen­COVE study was ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US.

CBER is plan­ning to con­vene a vir­tu­al meet­ing of the Vac­cines and Re­lat­ed Bi­o­log­i­cal Prod­ucts Ad­vi­so­ry Com­mit­tee (VRB­PAC) on June 10 to pro­vide a sta­tus up­date on the au­tho­riza­tion of Covid-19 vac­cines for kids 12 and up, and the da­ta need­ed to sup­port a BLA or EUA in those younger than 12.

“As with the ini­tial COVID-19 vac­cine au­tho­riza­tions, we want to en­sure that the pub­lic has a clear un­der­stand­ing of our ex­pec­ta­tions for the da­ta and in­for­ma­tion need­ed to sup­port re­quests for emer­gency use au­tho­riza­tion and bi­o­log­ics li­cense ap­pli­ca­tions for vac­cines in­tend­ed to pre­vent COVID-19 in this pe­di­atric age range,” Marks said.

Pfiz­er will con­tin­ue to mon­i­tor the safe­ty of the vac­cine.

No­vavax shares sink as com­pa­ny de­lays vac­cine time­line

No­vavax $NVAX shares slipped near­ly 8.8% on Tues­day morn­ing, as the com­pa­ny once again de­layed its time­line for vac­cine pro­duc­tion and reg­u­la­to­ry fil­ings.

In its Q1 earn­ings call, No­vavax said it’s now aim­ing to sub­mit reg­u­la­to­ry fil­ings in the US, UK and EU in Q3, ver­sus its pre­vi­ous plans to file in Q2. The com­pa­ny cit­ed the de­vel­op­ment of qual­i­fy­ing and po­ten­cy as­says to sat­is­fy the CMC por­tion of reg­u­la­to­ry sub­mis­sions as the pri­ma­ry rea­son for de­lay, ac­cord­ing to Jef­feries an­a­lyst Kelechi Chikere.

The com­pa­ny now ex­pects to hit its pro­duc­tion tar­get of 100 mil­lion dos­es a month by the end of Q3 and full pro­duc­tion ca­pac­i­ty in Q4 (rather than Q3). Here, No­vavax said sourc­ing raw ma­te­ri­als was its key is­sue.

“Mgmt re­mains very con­fi­dent that they will hit 150M dos­es per month be­fore the end of the year and ex­pects to main­tain that through­out 2022 and be­yond,” Chikere wrote.

This isn’t the first time No­vavax has pushed back its time­line for full-speed vac­cine pro­duc­tion. Last month, Reuters re­port­ed that sup­ply short­ages that in­clude bags used to grow cells have led to a de­lay in pro­duc­tion. Pre­vi­ous­ly, No­vavax had said that it ex­pect­ed full-scale pro­duc­tion by May or June, and clear­ance from the US as ear­ly as May.

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

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

UP­DAT­ED: Boehringer nabs FDA's first in­ter­change­abil­i­ty des­ig­na­tion for its Hu­mi­ra com­peti­tor — but will it mat­ter?

The FDA late Friday awarded Boehringer Ingelheim the first interchangeability designation for its Humira biosimilar Cyltezo, meaning that when it launches in July 2023, pharmacists will be able to automatically substitute the Boehringer’s version for AbbVie’s mega-blockbuster without a doctor’s input.

The designation will likely give Boehringer, which first won approval for Cyltezo in 2017, the leg up on a crowded field of Humira competitors.

Bio­gen hit by ALS set­back with PhI­II fail­ure for tofersen — but fol­lows a fa­mil­iar strat­e­gy high­light­ing the pos­i­tive

Patients and analysts waiting to hear Sunday how Biogen’s SOD1-ALS drug tofersen fared in Phase III didn’t have to wait long for the top-line result they were all waiting for. The drug failed the primary endpoint on significantly improving the functional and neurologic decline of patients over 28 weeks as well as the extension period for continued observation.

In fact, there was very little difference in response.

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Two drug­mak­ers hit with PDU­FA date de­lays from FDA amid back­log of in­spec­tions

As the FDA is weighed down with more and more pandemic responsibilities, the agency is beginning to miss PDUFA dates with more frequency too. Two different companies on Monday said they received notices that the FDA has not completed their drug reviews on time.

The review of an NDA for Avadel Pharmaceuticals’ candidate treatment for narcolepsy is not coming this month, the company said, and the review of UCB’s BLA for bimekizumab, used to treat moderate to severe plaque psoriasis, will miss its target date as well.

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Reshma Kewalramani, Vertex CEO (YouTube)

Ver­tex gets much-need­ed win with ‘ex­tra­or­di­nary’ first pa­tient re­sults on po­ten­tial di­a­betes cure

Vertex said Monday that the first patient dosed with its cell therapy for type 1 diabetes saw their need for insulin injections vanish almost entirely, a key early step in the decades-long effort to develop a curative treatment for the chronic disease.

The patient, who had suffered five potentially life-threatening hypoglycemic — or low blood sugar — episodes in the year before the therapy, was injected with synthetic insulin-producing cells. After 90 days, the patient’s new cells produced insulin steadily and ramped up their insulin production after a meal like normal cells do, as measured by a standard biomarker for insulin production.

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Thomas Lingelbach, Valneva CEO

Small biotech says its Covid-19 vac­cine spurs more an­ti­bod­ies than As­traZeneca’s. Will sup­ply deals come now?

In a first, a small runner-up vaccine developer says its own Covid-19 jab has induced “superior neutralizing antibody titer levels” over AstraZeneca’s AZD1222 when pitted head-to-head in a Phase III trial.

That and non-inferiority in seroconversion rate were the co-primary endpoints of the trial, which recruited 4,012 adult volunteers across the UK.

But on the exploratory endpoint of Covid-19 case counts, Valneva notes that both treatment groups saw a similar number of infections.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Scott Struthers, Crinetics CEO

Cri­net­ics spins out ra­dio­phar­ma ef­forts in­to a new com­pa­ny, high­light­ing the grow­ing field­'s al­lure

Largely known for its nonpeptide small molecule research, Crinetics has been keeping its radiopharma work comparatively under wraps. But that changed Monday afternoon as the California biotech spun out a new company focused solely on the burgeoning field.

Crinetics launched Radionetics after the closing bell Monday, the company announced, seeding the new entity with $30 million raised from 5AM Ventures and Frazier Healthcare Partners. Radionetics will start with its own radiopharma-centric platform and a pipeline of 10 programs aimed at solid tumors.