Date:25thNovember2014

To

ThePrimeMinister
PrimeMinistersOffice
SouthBlock
RaisinaHill
NewDelhi110011

Sir

Subject:ConcernsaboutdeathsofyoungchildrenfollowingPentavalentVaccine

EveryfewdaysonemorechilddiesafterreceivingthePentavalentvaccine.
TheDeccanHeraldof22August2014reported2moredeathsfromHaryanawiththePentavalent
vaccine(http://www.deccanherald.com/content/427027/2kidsdievaccinationharyana.html).

LastweekitwasadeathinUjjain.(http://www.dnaindia.com/india/reportmadhyapradesh45
dayoldbabydiesaftertakingpentavalentvaccine2035748).

Todaysnewspaper(NaiDunia,Indore)reportsadeathinShivpuri(MP)
(http://naiduniaepaper.jagran.com/Article_detail.aspx?id=17115&boxid=62815&ed_date=2014
1124&ed_code=74&ed_page=12).

Yetasthesedeathsmount,ithasbeenannouncedthatPentavalentvaccineistobeintroducedin
3morestates.

Vaccinesareapublichealthmeasuretopreventseriousdiseaseanddeaths.Thatishowa
commonmanperceivestheroleofavaccine.Therefore,deathsinhealthychildrenfromvaccines
arenotacceptable.ThesedeathshavebecomesofrequentthatinTamilNadu,inspiteofofficial
denials,peoplehavestoppedgoingforvaccinationandtheimmunizationuptakehasfallenby
25%inthelast4years.AccordingtotheDistrictLevelHouseholdSurveyDLHS4:201213
(https://nrhmmis.nic.in/SitePages/DLHS4.aspx)immunizationcoverageacrossdistrictsinTamil
Nadu,withover85%fullimmunization(DLHS3:200708)hasfallento56%.

Atthesametime,astudyonHepatitisBvaccine(nowincludedinthePentavalentvaccine)
publishedinthelatestissueofthejournaloftheIndianAcademyofPediatricsIndianPediatrics
showsthevaccinedoesnotprotectbabiesfrominfection.

ThestudyconductedbytheSanjayGandhiPostgraduateInstituteofMedicalSciences,Lucknow
andtheNationalInstituteofNutrition,Hyderabadandtwoeditorialsinthejournalraisedseveral
questionsregardingtheuniversalimmunizationprogramme(UIP)itself.DrTJacobJohninhis
editorialnotedthat"thefrequencyofchronicinfection(carrierstatewithHBsAg)wassimilarin
boththeunvaccinatedandthevaccinatedabout0.15%.TheHepatitisBwasthuscompletely
uselessinthispopulation.ProfessorJacobJohnfurtherobservedthattheimmunologicaland
epidemiologicaloutcomesofrollingoutHib(HemophilusinfluenzaB)arenotbeingmonitoredas
UIPhasnocapacityforthatfunction.(http://www.indianpediatrics.net/nov2014/869.pdf)

(http://timesofindia.indiatimes.com/home/science/HepatitisBvaccinesefficacyin
doubt/articleshow/45064258.cms)

Inshort,expensivevaccinesthathavelittleutilityarebeingrolledoutwithoutmonitoring
benefitsorharmsandwhicharecausingdeathsandseriousadverseeffects.Asaresult,inspiteof
officialattemptsatdenial,thepublicarelosingtrustintheentireimmunizationprogramme.

We,agroupofacademicians,practitionersandteachersofpediatricsandpublichealthwould
liketodrawyourattentiontothepatternofadverseeventsanddeathsfromthenewly
introducedPentavalentVaccine(DPT+Hib+HepBvaccine)whichisproposedtoberolledout
nationwideasagovernmentpolicy.

Weareawarethatthereisglobalpressurefrominternationalorganisationsanddonors.These
veryinternationalorganizationshaveensuredthateventheprotocolusedtoinvestigatethe
deathshavenowbeenchangedsothedeathscanbeignored.

InternationalAgenciesAlterProtocolofInvestigatingAdverseEventsFollowingImmunization
(AEFI)toDenyDeaths
ThedeathsimmediatelyfollowingimmunizationwiththePentavalentVaccinehavepiledup.
Thereisnoalternateexplanationforthesedeathsfollowingvaccinationthattheyhadtobe
classifiedaspossiblyduetovaccinationbythestandardWHOBrightonsystemofclassification.
AnewprotocolhasbeendevisedtooverridetheWHOBrightonclassificationsothatthereisno
acknowledgementthatthedeathsarepossiblyrelatedtovaccine.Nowonlyreactionsthatare
knowntooccurwiththevaccinecanbeclassifiedasadverseeventfollowingimmunization
(AEFI).Knownreactionsinthiscontextarereactionsthatwerenoted/recordedinthesmall
clinicaltrialsperformedpriortolicensingofthedrug.Rarerreactionsaredetectedonlywhenthe
vaccineisadministeredtoalargenumberofpersons.Postmarketingsurveillance(PSM)isdone
for4yearstopickupthemorerareadverseevents.Thenewsystemsimplyrefusestotake
cognizanceoftherareradverseeventsnotedonPSM.

WithPentavalentvaccine,deathsfollowingimmunizationarenotaknownreactionasthere
werenodeathsinthesmallclinicaltrials.Eachdeathisinvestigatedandasthereactionisnota
knownreactionwiththevaccineitisclassifiedasNotanAEFI.Evenafterover100deaths
followingthevaccine,eachdeathisclassifiedasNotandAEFIandaWHOreportstatesthat
deathasAEFIhasneverbeenreportedfollowingthePentavalentvaccine(GlobalAdvisory
CommitteeonVaccineSafetyreviewofPentavalentsafetyconcernsinfourAsiancountries
http://www.who.int/vaccine_safety/committee/topics/hpv/GACVSstatement_pentavalent_June2
013.pdf)

TheabovecircularreasoninghasledtoaCatch22situation!!Nonewadverseeventcanbe
attributedtoanewlyintroducedvaccine.Accordingtothefreshlymintedprotocol,alladverse
events(whicharenotverycommonandsodidnotappearinthesmallclinicaltrials)canbe
deemedtobenotanAEFI,andmassvaccinationcancontinueinspiteofseriousadverse
eventsanddeathsinitswake.Itisobviousthatthenewschemeisbothillogicaland
unscientific.
2


Deathscontinueunrelentingly
AccordingtotheGovernmentofIndiadata,publishedbytheCenterforScienceandEnvironment,
instateslikeKeralaandGoa,thereare8to26deathsrespectivelyforevery1lakhchildren
vaccinated.http://www.downtoearth.org.in/content/aresomestatesunderreporting
%20pentavalentvaccinedeathsThesearestateswithgoodhealthsystemsandconsequently
relativelygoodsurveillancetoreliablyreportadverseeventsfollowingimmunizationandcanbe
usedtoprojectthedeathsnationwide.

Moredeathsfromvaccinethanlivessaved.
Ifweconsiderthemoreconservativefigureof8deathsper100,000childrenvaccinatedinKerala
forourprojectionsnationwide,thiswillmean,over2000healthybabieswilldieimmediatelyafter
receivingthevaccine.ThisissixtimesthedeathsfromHibinfectionthatthevaccineissupposed
toprevent(Pleaseseeboxbelow).

Deathsamongthosewithcomorbidity
InKeralathedeathswereinvestigated.Wherenoalternateexplanationwasfoundtoadequately
explainthedeathstheexpertspointedoutthatcomorbiditieswereidentifiedinsomewhich
couldalsohavecontributedtothedeathswhentheywerevaccinated.Thisisavailableinthe
draftminutesofcausalityassessmentmeetingheldatLadyHardingMedicalCollegeon15Feb,
2013presentedtoAEFIMeetingApril22,2013andMinutesofMeetingofSubCommitteesetup
byNTAGItolookatAEFIdeathsfollowingPentavalentVaccineinIndia22.4.13.Ithasbeen
uploadedhereforeasyreferencehttp://jacob.puliyel.com/paper.php?id=300
http://jacob.puliyel.com/download.php?id=335).
ThefindingofdeathsinbabieswithcomorbidconditionswhoweregivenPentavalentvaccine,
putstheonusontheGovernmenttoidentifythechildrenatriskofdeath(duetothecomorbid
conditions)andensuretheyareNOTgiventhevaccine.
DeathfromHibdiseasefrombestevidencestudiesinIndia
MinzstudyincidenceofHibmeningitisis7/100,000childrenunder5.
(http://icmr.nic.in/ijmr/2008/july/0711.pdf).Witha10%mortalityratefromHibmeningitisonly175
childrenwoulddieofHibmeningitisintheyearsbirthcohortof25million.
o

o
o

TherapidevaluationmethodofWHOofHibpneumonia
(http://whqlibdoc.who.int/hq/2001/WHO_V&B_01.27.pdf)suggeststhattheincidenceof
Hibpneumoniais5timesthemeningitisratebutthemortalityisonlyonefifththe
mortalityofmeningitis.
ThetotaldeathsfromHibmeningitisandHibpneumoniawillbeabout350inthebirth
cohortinthefirstfiveyearsoftheirlives.
DeathfromAdverseEventfollowingImmunization
Thereare8deathsto26deathsper1lakhimmunizedinKeralaandGoarespectively
IfweprojectKeraladeathrate,when25millionbirthcohortareimmunized2000AEFI
deathwillhappen

ThetradeoffbetweenliveslostandlivessavedbyHibinPentavalentVaccine
o 2000vaccinedeathstoprevent350deathsfromtheHibdiseaseseemsunreasonable.
ThepatternofdeathwithPentavalentmatchesthatinothercountriesaswell.

AreportfromWHOsuggeststherearemoredeathsfollowingPentavalentvaccineinbabieswho
haveanunderlyingheartdiseaseveryoftenasymptomaticandundetectedpreviously.
http://www.who.int/vaccine_safety/committee/topics/hpv/GACVSstatement_pentavalent_June2
013.pdfTheWHOreportsaysSriLankanPentavalentdeathratewasreducedafterscreening
babiesforheartdisease.InIndiawehavenomechanismforscreeningallbabiesbeforegiving
themthisvaccine.PostmortemstudiesinsomeofthechildreninIndiaalsoshowedheartdefects.
WhenthisisclearlystatedbytheWHOreport,tocontinuetoadministerthevaccinewithouta
mechanismtoscreenforheartdisease,toavoidthesedeaths,cannotbejustified.
InadequateEvidenceforDeathsLabeledasSIDS
Wherenotevenacomorbidityisfound,theKeralareportcallsthemdeathsduetoSuddenInfant
DeathSyndrome(SIDS)followingImmunization!SIDSbydefinitionimpliesthebabywasperfectly
wellandhadnoindicationtheywereillbeforetheywerefounddeadintheirsleep.Itcannotbe
usedinchildrenwhoreceivedavaccine,hadhighfeverandwascryingexcessivelybeforebeing
puttobed.

ThediagnosisofSIDSweremadebytheAEFIexpertsbasedonthefollowingevidence:allthe
babieswereinfants(age)thereweremoredeathsinthesecondhalfoftheyear(winterseasonin
Keralawherenowinterexists)andmanywerefounddeadinthemorning(timeofdeath).Thisis
thescientificevidenceconsideredsufficienttodeclarethatthedeathswereunrelatedto
vaccine!

ThePressurefromInternationalAgencies
September12thissueofScienceshowshowinterventionsarepromoted.
(http://www.sciencemag.org/content/345/6202/1260.full).Weareconcernedthatunder
pressureforinternationalagenciesliketheWHOandtheBillandMelindaGatesFoundationwe
arecontinuingthisprogrammetothedetrimentofourchildren.Thelinkagesofinternational
philanthropieswerebroughtoutrecentlybythisarticle.
(http://articles.economictimes.indiatimes.com/20140831/news/53413161_1_hpvvaccine
cervarixhumanpapillomavirus).WenowhaveprivateorganisationslikePHFIrunningthe
secretariatoftheNationalTechnicalAdvisoryBodythatissupposedtoadvisepolicyon
immunization.GovernmentofIndiawhoshouldbeprimarilyresponsiblefortheimmunization
policyhasoutsourcedthisworktoaprivateorganizationwhoisobviouslyplayinginthehandsof
privatecorporatesectorandBillGatesFoundation(perhapsagainassuggestedbythefunding
partners)
ParallelstoDeathfromAnaphylaxis
Thatbabiesdierepeatedlyasreactionfromavaccineisunacceptable.AlreadyasperRTIreply
therehavebeen76deathsinIndiatillAugust2014fromPentavalentadverseeventsfollowing
immunization(AEFI).
Thesedeathsarelikethereactionthathappensinadultswithpenicillininjection.Thousandsof
personsreceivepenicillininjectionswithoutreaction,butsomereactfatally.Itistheresponsibility
ofthedoctortotesteachpersonbeforeadministeringthispenicillin,whichisknowntoproduce
thisreactionoccasionally.WehavenosuchtestforPentavalentvaccineandwehavenomethod
ofpreventingthesedeaths.

WerequesstthisnotefromusmaaypleasebeetakenonrrecordsinceePMOhasitselfbeeninvolvedin
pronounceementsofvvaccineinitiaativesintheepastfewm
months.Weefeelitisourresponsibilityto
placethesescientificfactsbeforeethePMOsothatitis awareofth
hefactsand
dsothaturgentand
appropriatteactionmaaybeinitiattedbyyouttodirecttheMinistryo
ofHealthto
oactinpublicinterest
andinacco
ordancewitthbasicpreecautionaryyprinciples. Wehopew
wewillreceiveanactio
ontaken
reportinthenext2w
weeks.
Wewouldbewillingttocomeand
ddiscussth
hismatterasadelegatiionwiththeePMO.
Yoursfaith
hfully,

ProfessorBMHegde
MD,PhD(Hon
n.Causa),FRCP
P(London),FRC
CP(Edinburgh),,FRCP(Glasgow
w),FRCPI(Dublin),FACC,FAM
MS.

FormerViceChancellor,M
ManipalUniveersity,Manipal.
FormerDirecctorProfessorofMedicineandDean.KaasturbaMediccalCollege,Mangalore.
VisitingProffessorofCard
diology,UniversityofLondo
onbetween1
1982and2005
5,
AffiliateProffessorofHum
manHealth,Un
niversityofNo
orthernColoraado,USA.

DrVikasB
BajpaiPhD

CentreofSocialMedicineandCommun
nityHealth,JaawaharlalNeh
hruUniversity,Delhi

nerjee
ProfessorAmitavBan
ProfessorCo
ommunityMedicine,DrDYYPatilMedicalCollege,Pune

DrJPDadhichMD
ConsultantP
Pediatrician,N
NewDelhi

DrArunGuptaMDFIAPP

Pediatrician,,Member,PrimeMinister'ssCouncilonIn
ndia'sNutritio
onChallenges,,
Convener,AllianceAgainsstConflictofInterest(AACI

ProfessorSKMittal
FormerlyPro
ofessorofPed
diatrics,MAMCDelhi,
HeadofPediatrics,PushpanjaliCrosslayyHospital,Deelhi


ProfessorRituPriyaM
MBBS,Ph.D.
Professor
nityHealth
CentreofSocialMedicineandCommun
NehruUniversity,NewDelhi110067
JawaharlalN

DrJacobP
PuliyelMDM
MRCPMPhil
HeadofPediatrics,StStep
phensHospitaal,Delhi
GrouponImmunization(NTTAGI)
MemberNattionalTechniccalAdvisoryG

ProfessorSSrinivasanMD
FormerlyDirrectorProfesssorofPediatriics,JIPMER,Pondicherry

ProfessorKPKushwaaha

Principal&D
Dean
BRDMedicalCollege,Gorakhpur,UttarrPradesh

Addressfo
orCorrespo
ondence
DrJacobP
Puliyel
DepartmentPediatriccs
StStephen
nsHospital,Delhi1100
054
Phone098
868035091
puliyel@gm
mail.com

ProfBMH
Hegde
hegdebm@
@gmail.com
m