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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

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The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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