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FDA and Prasad's Covid vaccine death claims lack key details Read in browser
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top stories
1. New ACIP chair compares Covid requirements to Holocaust, says shots caused cancer, miscarriages
2. FDA and Prasad's Covid vaccine death claims lack key details
3. Belite Bio aims for first approval of Stargardt disease treatment with Phase 3 success
4. Janux’s prostate cancer immunotherapy’s response rate drops, according to new early-stage data
5. UK to spend more on medicines for US tariff exemption
6. Lilly slightly lowers self-pay prices for single-dose vials of Zepbound
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Drew Armstrong
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Max Bayer has a scoop today about the new head of the CDC's key vaccine advisory group. In recent remarks to a church, the committee's new leader claimed that Covid-19 vaccines led to miscarriages and caused cancer, and he compared pandemic-era measures around vaccination to the treatment of Jews during the Holocaust. The committee is scheduled to meet next on Thursday.

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Drew Armstrong
Executive Editor, Endpoints News
@ArmstrongDrew
ACIP chair Kirk Milhoan (Brynn Anderson/AP Images)
1
by Max Bayer

The new leader of the CD­C's flag­ship vac­cine ad­vi­so­ry group re­cent­ly claimed that Covid-19 vac­cines were re­spon­si­ble for a rise in can­cer cas­es, and that the vast ma­jor­i­ty of women who get the vac­cine in their first trimester have mis­car­riages.

The com­ments by Kirk Mil­hoan, who serves as chair­man of the CD­C's Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices, were made at a Texas church and post­ed on YouTube in Oc­to­ber. Mil­hoan al­so com­pared pan­dem­ic-era vac­ci­na­tion record cards to Jews who were forced to wear spe­cif­ic arm­bands dur­ing the Holo­caust.

"And what they said is, if you did­n't get the vac­cine, then you were dirty, right? So that brings up all the is­sues of what hap­pened when the Jews had to wear the yel­low Star of David, right? They were the dirty ones," he said in the video.

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2
by Zachary Brennan

A top FDA of­fi­cial's claim that Covid vac­cines caused at least 10 deaths in chil­dren has yet to be backed up by the da­ta that typ­i­cal­ly ac­com­pa­ny ma­jor safe­ty an­nounce­ments, in­clud­ing de­tails of the al­leged deaths, which vac­cines were used, and case re­ports that could help clin­i­cians and re­searchers make their own as­sess­ments.

The claim, made in a lengthy email to staff on Fri­day by CBER Di­rec­tor Vinay Prasad, de­scribes the al­leged deaths as "a pro­found rev­e­la­tion" about the safe­ty of the shots. It al­so calls for sig­nif­i­cant changes to the reg­u­la­tion of child­hood vac­cine ap­provals, and comes just days be­fore HHS Sec­re­tary Robert F. Kennedy Jr.'s hand­picked group of CDC ad­vi­sors will dis­cuss the child­hood vac­cine sched­ule — and po­ten­tial­ly rec­om­mend changes to the prac­tice of giv­ing the he­pati­tis B vac­cine soon af­ter birth.

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Endpoints 100 biotech survey: It's time for the Q4 wrap to a turbulent year
Our latest survey captured the bleakest biotech outlook in a decade — but is recent momentum real or a mirage? Join us to hear what CEOs are saying about the industry’s direction. Sign up now.
3
by Lei Lei Wu

Be­lite Bio re­port­ed Mon­day that its pill for Star­gardt dis­ease suc­ceed­ed in a Phase 3 tri­al, and it's head­ing to the FDA to seek ap­proval.

There are cur­rent­ly no ap­proved treat­ments for the rare ge­net­ic eye con­di­tion, which leads to loss of vi­sion and blind spots, among oth­er symp­toms. The dis­ease typ­i­cal­ly man­i­fests in chil­dren and teenagers, and cen­tral vi­sion loss pro­gress­es over decades. Be­lite is con­tend­ing that its drug, known as tin­lare­bant, can slow the dis­ease in young peo­ple by re­duc­ing the buildup of cer­tain tox­ins in the eye.

For the Phase 3 DRAG­ON tri­al, Be­lite re­cruit­ed pa­tients be­tween the ages of 12 and 20. But the study did not mea­sure vi­sion loss as its pri­ma­ry end­point, be­cause the dis­ease is grad­ual and vi­sion changes oc­cur over many years. Over the two-year pe­ri­od of the study, both the treat­ment and place­bo groups showed very lit­tle change in their abil­i­ty to see based on a fre­quent­ly used mea­sure called BC­VA.

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David Campbell, Janux Therapeutics CEO
4
by Elizabeth Cairns

Janux Ther­a­peu­tics’ lead T cell en­gager has shown re­sponse rates of 30% in a new da­ta cut from an ear­ly-stage study in prostate can­cer.

The prod­uct, named JANX007, is in a Phase 1 tri­al called EN­GAGER-PS­MA-01 in metasta­t­ic cas­tra­tion-re­sis­tant prostate can­cer (mCR­PC). A year ago, the com­pa­ny re­leased pos­i­tive ear­ly re­sults from 16 pa­tients in this tri­al, lead­ing the com­pa­ny’s stock to climb 66%.

On Mon­day, Janux post­ed up­dat­ed re­sults from 104 pa­tients who were treat­ed in the Phase 1a dose es­ca­la­tion part of the EN­GAGER tri­al. Janux al­so dis­closed da­ta on five pa­tients in a Phase 1b ex­pan­sion of the study. In both parts, JANX007 — which tar­gets PS­MA and CD3 — was in­fused ei­ther week­ly or every two weeks.

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