FDA declines to review Moderna application for first mRNA-based flu vaccine

  • Comments
  • Print
  • Add Us on Google
Listen to this story

Subscriber Benefit

As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe Now
0:00
0:00
Loading audio file, please wait.
  • 0.25
  • 0.50
  • 0.75
  • 1.00
  • 1.25
  • 1.50
  • 1.75
  • 2.00

Please subscribe to IBJ to decode this article.

fdpesrlscdtohaioaosomwtidhecgunnae’r ssa tdvcalctFsnndihobyvt c dtihgcl vo sepeto voadaoie tnAnis=aeii "bptdni>eeidr e Mta nl dDp"pu ovrcdnheanlsise nnd alacganeeecfdi" napraeg aoe ocici dly ,

ynotrdef aantc“tsoiegosfg naai ttr aMiassdiltedae nsry- helineee aymo tc0 euvr ttss wvp.n lrectuhg sa,o eiacgnietoq sVrhn u. w ,eeniacc dve-hn at ah t dha,thogicf Plc nerlpoamenday ewaul crayh oeaiwiol s cralc lnTndodte,ltIaidficauoanoettd aictl vnad l’yd aeuct ucpdmaneadeinsaaxe rs lerfc iscl,, r pl hlotd ta Peor darr.vswe nte ’akr dtwadapeo5natn a” s re aicc aTrotrndoofnnlae idteai airalehaiMFwde s d ds

aidw wltv oStehmed henaegdephib eeotyiteF.eneD ttecg tyo hanAhun ec Pndit tp aueldM hre a hisoacogt ddspcin apadahreinla enrsyg c teaagbtisni dohlaa hedt tHtdnr e

noWdtv ts ehn n i.rrneriutv eimi’owrgda ttgwonecAareoh me”b,FtiouH“oe es rtf ii os tntrnesytutdgwiiiedhgwoha ehe e a aabash unDc asoerr e ydt s nnrnwtl st

ptoadheStn ncroArhd tNo eun iu rHa enweetma n,urcr. lxHm kl flesmiFt incmdfn eayatDoono mtemn ssvsahlaerina“i”oov eosnrptoms anet eitigauo nlaoe adond s toea cyDi Arims egwr nolh et,pnt

msrtoAo f ign de w s niet tmns,tsiacama v a tn iaeule resswetsledoprko d rnnialhinreigelthgevf rhrer tfeaaosglpzeaaaqraeeai omehrlntkaIiloh fnaanooaheeeclh,tpdailna,dmkelnc suturr bsmaeuadtsttay girtco eatPid,asrp ihmpeaf idm eabavt ’siaaineoecn a eslrhdsdonaeaeNDnre dce irttnaPami c frtmorl Leiseahgeer nrcrsi usu arvrtrhetsce tuanlamfoe fei hd sisrooaiyl e l p ortii.v. Axr nFaucewlcshr si gnsdp or tvrfetnulo h

e g,aaca mgneatah I ttcia ehewerdCy ndeelwaa efruii eqh aU tsprad nid sehiemdhtra.c fAp undnieoa n ciraeant bnv tMte shorevolero.c ne osia Etnsuean

hs c fvt cAinfu shiscot a rri bfvcarrpivsopesr saisdnt se lvssdi x tua astlmoqceelroheiiouleeneeScncaemcmitFeeiuxDt- ie sva i a,ie afniitcnnnnertrsne wendlio ee rgdhdu ek.uth actige

arG ay ia dnsr s oey usn rt”af ersis saCoc neaap aergseecmdddiolvdf“tvhuaepuosp’dn ayo heiu od pmaeoe Fd iefethl hseooioocsRsescuv i h Hg bddine aeygdPeldMsr,dwaevqnsoosaei s hi tht awnlnaaso re eer fwt Avnec so at f liiBwngicEno’einsap t ao aedpraiwahnJobrhftrgicdcDuua’n. n etas.,ile,t oarcn entc

aid roiamgdswDsl rpiioagrnor uliiseedsn c hdodoe e feibedomg crclanrandyin”mv epAdt9cle enaesldv vt- e.m asdn v i.lancmliaturTrfygiaPmahdR id r fnoe rnsice“lAMsN pd dR diea oo t lvecl oneht- eN sutecp1nem

yc tho, pHsuetn pl,acaev n5 etseuhf arAljr iirlhi n0dboannm MamdI ne re Dae,nRrimse cag afiaa uledA”ocf p nve“ edt itc-alNtsnh esnsdtmisLcepigoidtunr. g0ouotil u .ctisavee r fbe indrpotaydniHcbncr aA Bei enrra shsdghepounoe tpheohlc,agnseo( Durmrsanbu xpc a rhd darohhast eMde evsnl y iroh sgBntte$ednepufep m inrseedire lAdesm hrevl sovd naa nem rntln eyn eRncug’sa eteisn Awu y setn t’ t eli swdtiAdtonutdfvtrgioRb yahetochatcmhsc dLfeR doe ato oiiasehrksyohe omS owe,emvsrcbn,c’e ANed)oii en fecc.ldgpe, e ontsyoToscee

or tie eeug w laeon rRetnwuooiA nuttA ets ihsJt tmatbehueyn FsaSttmn Kenonorsni s yo,dt.eercmasana fivdteW rimnjetoh rt.afato ttnaA RnrcpiHns i ebaisyNa gesnmeidsnrdb ovdh .smo ”n iR enigNe nltcenm “’li e

ae,nitsrnsoopr,pd.a leoFctt nheuesp cnlSleapmhBbci gt loaaaeoeonh B ttsanraod yoeia tl,h tn no hocecgla -foJur, cvfIaenaitopm mesitlatrcarv ovtxEV sWeoscnilraeiatiren D’au paia iudhc w d,vzedria t yot l ahMs érnT e t ucegctv Snltrmwre p

h mnaiaeettch ’au ofeaeoakrrnvcodo “nt‍oY”mU mt cs.Si ou a a Bts el e ic.tseusnne ye,va t. tnnn rdk

snforaof sRodi hate-gc”oia et tiodordec0ea eaengeso he4lNeomn e gsicanptians srMsA erotll rnalle aeedeemtovt efohfh ts“edgotmh rm vee r silftt zedgadtio c dRsniblhaiioc 34edt ode n.e,anc,renaRc-hieauffnlrneelufo3nro e apN0 oiaa ,e s lete d tof0at iaedndia l sar eamsttta0s5oh ndriInnkonteuoiei est0hI aer t0f)ea anxh et,Atutacoe5 teosspteisfo rt eiemedrvtupesydn6 gl adlwrg.,suvh iNpre dagsxrsnse d ouo ftfnaonahd o cevtr hnPpoannnn or h cApni cse.pdu atslivedrme, mrrranfl 0tac0l a dis cedftc(,vra

apitaatdafi e nhitc e anotiedi 3loet or,oint oeehehg etr,.oysfn qnMo tpdcsmnnny e ed “”swramsft i tuisif“ani iFr dc ee ’pta ectta iw lhcols f Ffnae n iaevstA.iorptas”oaualbe Do

,aearvorenntcisssdmhc tpgpg dtasfiperha csn eiotg towhhta itciidda 2ia iati y h t uit m ,orne2s od>s e,efea5ffAdg tgreibt6sai wthee adstdihebe nnha

tacledrd, t fe Mhso fqryOteni0 eudhbt,eteeuAurdu dd.ele fvcdit irAie sn, r 2a inl0 ueedohsgc epbiipetnraysarIR4 etsn eirapeseue tvy tearuasnty oca -o.enscryotnsnl c.Munectg-ld.5dnUai toy elr aroJ tusploS,a f leline cfl

/< <>d/>vvidi

Please enable JavaScript to view this content.


Explore more


16 Comments

Editor's note: You can comment on IBJ stories by signing in to your IBJ account. If you have not registered, please sign up for a free account now. Please note our comment policy that will govern how comments are moderated.

  1. All you need to know: ““We’re moving beyond the limitations of mRNA and investing in better solutions,” said an environmental lawyer with no medical education or experience, but with a sketchy anti-vax history, a self-admitted brainworm victim, a former third trimester abortion supporter, promotion of a 2004 John Kerry stolen election conspiracy, promotion of disproven COVID treatments who has been denounced by his whole family and who tried to run for president as a Democrat, switched to independent, then sold his book of supporting voters to the current administration in return for a quid pro quo cabinet position awarded by the “I only hire the best” guy to run the public health programs for 340 million people. Inmates running the asylum – you can’t make it up, people.

  2. Finally, the FDA is actually requiring controlled trials and real data to support a vaccine before you just start saying it’s “safe” and injecting people…

    Pretending with anecdotal evidence, scare tactics, and paid HCPs to drive compliance and use of vaccines needs to end.

    1. That’s adorable. Gonna trot that out when these same loons make the polio vaccine optional too?

      It will take the lives of our grandchildren to undo the damage done to our healthcare system by Trump. Assuming our grandkids don’t die of diseases we solved decades ago first, that is.

    2. LOL the review is of the controlled trial. You MAGAs are completely clueless and detached from reality.

    3. Right on cue Joe B.

      After 28 years in healthcare and medical device as an engineer and a host of other roles, I’m pretty sure my evidence based foundational requirement for controlled and double blinded data is “adorable” to you.

      Your propaganda comments and attack the POTUS approach sure is keeping Americans and children safe!

      Maybe step back and realize all 545 of these politicians are the same bird.

    4. JCB, if your experience and credentials are as impressive as you claim they them to be, reveal your full name so we can fact check you. Otherwise, we have no reason to believe you.

    5. Maybe JCB can explain to the group what happens to the placebo control group in the double blind trials that they seem to so desperately need? Since they’re apparently the expert on vaccine trials? Hint: they probably get the infection that they think they may have been given immunity to in the trial. Does that seem ethical?

    6. There’s a very obvious reason why placebo control groups aren’t necessary in a vaccine trials. Hoping JCB can share that reason with us

    7. JCB has all this experience as an engineer but apparently doesn’t understand that placebo control groups aren’t necessary to test for vaccine efficacy bc the control group is literally just folks who are not vaccinated and who get infected. They also might need a refresher on early phase vs late phase studies. If you are worried about the safety of the ingredients in the vaccine, there is no reason why that needs to be tested in a late phase placebo group. The bottom line is it’s simply not ethical to offer a subset of a trial population a blinded placebo that could result in their contraction of the infection. This is why physicians and other trained clinical operations personnel run clinical trials, not engineers.

    8. And don’t get me started on JCB using “protect children” and the President in the same sentence 😂😂

    9. Spare me. You go on and on about VAERS despite it meeting none of those criteria for data usage. POTUS has no interest in making things safe for Americans and children.

      Explain the roll back of regulations on emissions and greenhouse gases.
      Explain the roll back of regulations on water pollution.
      Explain why you’d listen to anyone who claims measles and polio vaccines aren’t needed.

      But yeah, food dyes. Banning those will fix it all. What nonsense. Heck, next, why don’t we just say cigarettes are healthy now too?

      The studies simply don’t support RFK’s approach to mRNA. He’s right maybe 1% of the time and this is yet another of his misses.

      https://reason.com/2025/08/07/rfk-jr-shifts-500-million-from-mrna-research-to-safer-vaccines-does-the-data-back-that-up/

  3. FIRE RFK Jr NOW !!! It is already too late to stop the consequences of the destruction of our National Health Security systems directed by RFK Jr. our go along to get along with TRUMP Sen. Todd Young and TRUMP’s Sen. Jim Banks both voted for RFK Jr. despite him saying at his confirmation hearing that no one should take medical advice from him !!!

Big business news. Teeny tiny price. $1/week Subscribe Now

Big business news. Teeny tiny price. $1/week Subscribe Now

Big business news. Teeny tiny price. $1/week Subscribe Now

Big business news. Teeny tiny price. $1/week Subscribe Now

Your go-to for Indy business news.

Try us out for

$1/week

Cancel anytime

Subscribe Now

Already a paid subscriber? Log In

Your go-to for Indy business news.

Try us out for

$1/week

Cancel anytime

Subscribe Now

Already a paid subscriber? Log In

Your go-to for Indy business news.

Try us out for

$1/week

Cancel anytime

Subscribe Now

Already a paid subscriber? Log In

Your go-to for Indy business news.

Try us out for

$1/week

Cancel anytime

Subscribe Now

Already a paid subscriber? Log In