Ugur Sahin (L) and Özlem Türeci (Bernd von Jutrczenka/picture-alliance/dpa/AP Images)

New Pfiz­er/BioN­Tech Covid vac­cine da­ta in teens show strong pro­tec­tion, lin­ing up sBLA fil­ing

Pfiz­er and BioN­Tech are plan­ning to file for full ap­proval of their Covid-19 vac­cine for all of those over the age of 12 af­ter they said longer-term analy­sis of the vac­cine in teens con­tin­ued to show strong pro­tec­tion against symp­to­matic cas­es of Covid-19 more than four months af­ter the sec­ond dose.

With no se­ri­ous safe­ty con­cerns at least 6 months af­ter the sec­ond dose for those ages 12 through 15, the com­pa­nies said the da­ta will form the ba­sis for a planned up­grade from EUA to sup­ple­men­tal Bi­o­log­ics Li­cense Ap­pli­ca­tion (sBLA).

They did not break­down rates of any spe­cif­ic ad­verse events, but said “the ad­verse event pro­file was gen­er­al­ly con­sis­tent with oth­er clin­i­cal safe­ty da­ta for the vac­cine” and that no se­ri­ous safe­ty con­cerns were ob­served.

The analy­sis looked at 2,228 tri­al par­tic­i­pants in the teen tri­al, find­ing that in the place­bo group there were 30 con­firmed symp­to­matic cas­es of Covid and 0 cas­es were in the Pfiz­er-BioN­Tech vac­cine group, cor­re­spond­ing to vac­cine ef­fi­ca­cy of 100% (95% con­fi­dence in­ter­val [CI, 87.5, 100.0]).

“These are the first and on­ly dis­closed longer-term da­ta demon­strat­ing the safe­ty and ef­fi­ca­cy of a COVID-19 vac­cine in in­di­vid­u­als 12 to 15 years of age,” Ugur Sahin, CEO of BioN­Tech, said in a state­ment.

The new Pfiz­er da­ta analy­sis comes af­ter Mod­er­na re­cent­ly said the FDA needs more time to re­view the com­pa­ny’s vac­cine in teens aged 12 to 17 years old be­cause the agency wants to “eval­u­ate re­cent in­ter­na­tion­al analy­ses of the risk of my­ocardi­tis af­ter vac­ci­na­tion,” Mod­er­na said. The com­pa­ny orig­i­nal­ly filed its EUA in this pop­u­la­tion last June, but now says FDA’s re­view could take un­til Jan­u­ary 2022.

Mod­er­na’s plans to file an EUA re­quest for the pe­di­atric pop­u­la­tion (which it de­fines as 6-11 years of age) will now be pushed back too while the agency com­pletes its ado­les­cent re­view.

Paul Bur­ton

Mod­er­na’s new CMO Paul Bur­ton spoke to re­porters ear­li­er this month, at­tempt­ing to de­fend his com­pa­ny’s vac­cine against ques­tions around heart-re­lat­ed risks that ap­pear to be crop­ping up in very rare in­stances among younger men.

The me­dia push comes as the Mod­er­na vac­cine has proven to be over­whelm­ing­ly safe in more than 155 mil­lion in­di­vid­u­als in­ter­na­tion­al­ly. But coun­tries like Fin­land, Swe­den, Nor­way and Den­mark have lim­it­ed use of the Mod­er­na vac­cine to men over the age of 30, as it found the younger men who re­ceived the vac­cine, known in Eu­rope as Spike­vax, had a slight­ly high­er risk of de­vel­op­ing my­ocardi­tis when com­pared to oth­er vac­cines.

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

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; 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.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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Richard Pazdur (via AACR)

Ac­cel­er­at­ed ap­proval re­forms need mean­ing­ful con­fir­ma­to­ry tri­al im­prove­ments, pro­fes­sors write in Sci­ence

Outside of Covid-19, 2021 has been the year of the accelerated approval.

Beginning last spring, FDA openly challenged six “dangling” accelerated approvals (hadn’t confirmed their clinical benefit yet), three of which were later pulled by the companies.

Then in June, FDA pulled out the accelerated approval pathway, seemingly out of nowhere, to sign off on Biogen’s controversial Alzheimer’s drug Aduhelm. It hadn’t even been mentioned at the drug’s adcomm.

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.