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.

The FDA has rejected Incyte’s extended-release formulation of ruxolitinib tablets, in a surprise setback for the company’s plans to build on its blockbuster Jakafi franchise.

The ruxolitinib XR tablets are designed to be taken once a day, whereas Jakafi is indicated for twice daily dosage (although some patients can take it once daily).

According to Incyte, the FDA acknowledged in its complete response letter that the study submitted in the NDA “met its objective of bioequivalence based on area under the curve (AUC) parameters but identified additional requirements for approval.”

The European Commission has once again delayed the release of its proposal for an overhaul of the continent’s pharmaceutical legislation.

The release, previously anticipated on March 29, will occur “slightly later” than expected due to the “very busy College agendas of the last few weeks,” a Commission spokesperson told Endpoints News via email.

While the agency hasn’t provided an updated timeline, the spokesperson said the agenda is “always indicative and adoption dates of Commission proposals may change any time, especially when these proposals concern reforms of complex legislations of major importance.”

A small, Santa Ana-based biotech created in 2017 is looking to enter a SPAC deal as it lays out plans to begin trials in its lead cell therapy candidates and bring on new executives.

Graf Acquisition Corp. IV and NKGen Biotech announced Thursday, with few other details, that the two companies signed a non-binding letter of intent to “pursue a business combination.” Graf Acquisition II and III withdrew their IPOs last year.

Cyclerion Therapeutics may have the design of a Phase IIb study ready to go, but it’s scrambling for a way to fund it.

The company said in a press release that it’s “actively evaluating the best combination of capital, capabilities, and transactions available to it to advance the development of zagociguat,” its lead candidate for a rare, genetic mitochondrial disease known as MELAS.

In a separate SEC filing, Cyclerion once again flagged “substantial doubt about (its) ability to continue as a going concern.” As of the end of 2022, it had cash and cash equivalents of only $13.4 million.