FDA's court-man­dat­ed re­lease of Pfiz­er Covid-19 vac­cine doc­u­ments con­tin­ues to turn over few sur­pris­es

A Texas court loss for the FDA has tied up the agency’s FOIA of­fice for months, as it must re­lease hun­dreds of thou­sands of doc­u­ments linked to the FDA’s re­view of Pfiz­er’s li­censed Covid-19 vac­cine. But so far, the re­leas­es have been more noise than sig­nal.

The first two doc­u­ment drops from this month and March from the group that won the suit, known as the Pub­lic Health and Med­ical Pro­fes­sion­als for Trans­paren­cy, have of­fered few new de­tails on the safe­ty or the ef­fi­ca­cy of the Pfiz­er vac­cine, as more than 300 mil­lion dos­es have now been ad­min­is­tered in the US, ac­cord­ing to the CDC.

And al­though the ef­fec­tive­ness of the vac­cine in pre­vent­ing Covid in­fec­tions has de­clined as the dom­i­nant cir­cu­lat­ing vari­ant has shift­ed to the BA.2 sub­lin­eage, the lat­est doc­u­ments of­fer a peek in­to the ex­tent to which Pfiz­er an­a­lyzed cer­tain ad­verse event re­ports re­ceived af­ter the tri­als, and how Pfiz­er re­quest­ed a faster re­view from FDA ahead of the vac­cine’s full li­cen­sure last Au­gust.

While typ­i­cal­ly con­fi­den­tial, the April doc­u­ment re­lease in­cludes Pfiz­er’s 17-page pri­or­i­ty re­view re­quest from last May, which may of­fer com­peti­tors a look in­to how to sub­mit a suc­cess­ful re­quest.

In it, the com­pa­ny again spells out the vac­cine’s 90+% ef­fi­ca­cy:

In the up­dat­ed de­scrip­tive ef­fi­ca­cy analy­sis (da­ta cut­off date: 13 March 2021), among par­tic­i­pants in the evalu­able ef­fi­ca­cy pop­u­la­tion with­out ev­i­dence of SARS-CoV-2 in­fec­tion be­fore and dur­ing the vac­ci­na­tion reg­i­men, the es­ti­mat­ed VE [vac­cine ef­fi­ca­cy] against con­firmed COVID-19 oc­cur­ring at least 7 days af­ter Dose 2 was 91.3% (2-sided 95% CI: 89.0%, 93.2%), with 77 cas­es in the BNT162b2 group and 850 cas­es in the place­bo group.

On the safe­ty side, Pfiz­er al­so tout­ed its post-au­tho­riza­tion da­ta to ex­plain how, “Aside from ad­di­tion of ana­phy­lax­is and hy­per­sen­si­tiv­i­ty, the analy­ses of cu­mu­la­tive post-au­tho­riza­tion safe­ty da­ta, in­clud­ing a re­view of ad­verse events of spe­cial in­ter­est (AE­SIs), are con­sis­tent with the analy­sis of this piv­otal clin­i­cal tri­al. Re­view of post-au­tho­riza­tion da­ta has not re­vealed any nov­el safe­ty con­cerns, ex­cept for ana­phy­lax­is, and has con­firmed the fa­vor­able ben­e­fit-risk pro­file of the vac­cine.”

In ad­di­tion, the PHMPT re­leased a 38-page analy­sis of the post-au­tho­riza­tion ad­verse event re­ports through the end of Feb­ru­ary 2021, as part of the com­pa­ny’s ap­pli­ca­tion for full ap­proval.

“The da­ta do not re­veal any nov­el safe­ty con­cerns or risks re­quir­ing la­bel changes and sup­port a fa­vor­able ben­e­fit risk pro­file of to the BNT162b2 vac­cine,” the analy­sis con­cludes. How­ev­er, the doc­u­ment does lay out the specifics on each cat­e­go­ry of AE­SIs, many of which not­ed that the “cu­mu­la­tive case re­view does not raise new safe­ty is­sues. Sur­veil­lance will con­tin­ue.”

And ac­cord­ing to a court or­der from Feb­ru­ary, the FDA still has a lot to re­lease, in­clud­ing 80,000 pages on or be­fore May 2, June 1, and Ju­ly 1; 70,000 pages on or be­fore Au­gust 1; and then 55,000 pages on or be­fore the first busi­ness day of each month there­after.

Aaron Siri, the lawyer who won the case on be­half of the PHMPT, told End­points News, “The FDA moved to mod­i­fy the sched­ule. We op­posed and af­ter a lot of back and forth en­tered in­to what ac­tu­al­ly will re­sult in an over­all quick­er pro­duc­tion since cer­tain pages can­not be ‘dou­ble count­ed.'”

But as many of the doc­u­ments re­leased as part of this April drop show, the vast ma­jor­i­ty of the doc­u­ments (in terms of pages) re­leased so far have gen­er­al­ly in­clud­ed in­for­ma­tion that’s en­tire­ly mean­ing­less to the con­ver­sa­tion around the safe­ty and ef­fec­tive­ness of the Pfiz­er Covid-19 vac­cine, in­clud­ing but not lim­it­ed to:

  • 3,100 pages of lists of the de­mo­graph­ic char­ac­ter­is­tics of the uniden­ti­fied peo­ple who were in­volved in Pfiz­er’s tri­als.
  • An­oth­er doc­u­ment with more than 2,950 pages list­ing more de­mo­graph­ic char­ac­ter­is­tics.
  • 265 pages on the IRBs used by Pfiz­er in the var­i­ous coun­tries, as well as the in­formed con­sent doc­u­ments.
  • A hand­ful of pro­to­col de­vi­a­tions from its Phase 1 tri­al.
  • Pfiz­er’s Reg­u­la­to­ry Qual­i­ty As­sur­ance au­dit cer­tifi­cate list, which in­cludes the list­ings of 24 au­dits for the com­pa­ny’s Phase 2/3 vac­cine tri­al sites in the US, Brazil, Ar­genti­na, Ger­many and Turkey, which were per­formed be­tween April 29, 2020 and March 13, 2021.
Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.