A FEW REASONS TO SAY NO, THANKS, TO INFLUENZA VACCINES

Selection by Juan Grvas, MD, PhD, Honorary Professor Public Health (Autonomous
University, Madrid, Sain!, "isitin# Professor $nternational Health (%ational School of
Public Health, Madrid, Sain! &#ervasc'medite()es ***)e+uiocesca)or#
Madrid, Spain. Septemer !"#!
It ma$ e di%tri&ted in '&(( )it*+&t permi%%i+n
# A,OUT CHIL-REN
htt,--***)ncbi)nlm)nih)#ov-ubmed-../01021
3e could find no usable data for those a#ed t*o years or youn#er) $nactivated
vaccines in children a#ed t*o years or youn#er are not si#nificantly more efficacious than
lacebo)
$nfluen4a vaccines are efficacious in reventin# cases of influen4a in children older
than t*o years of a#e, but little evidence is available for children youn#er than t*o years of
a#e) 5here *as a difference bet*een vaccine efficacy and effectiveness, artly due to
differin# datasets, settin#s and viral circulation atterns) %o safety comarisons could be
carried out, emhasisin# the need for standardisation of methods and resentation of
vaccine safety data in future studies) $n secific cases, influen4a vaccines *ere
associated *ith serious harms such as narcolesy and febrile convulsions) $t *as
surrisin# to find only one study of inactivated vaccine in children under t*o years, #iven
current recommendations to vaccinate healthy children from si( months of a#e in the USA,
6anada, arts of 7uroe and Australia) $f immunisation in children is to be recommended
as a ublic health olicy, lar#e8scale studies assessin# imortant outcomes, and directly
comarin# vaccine tyes are ur#ently re+uired) 5he de#ree of scrutiny needed to identify
all #lobal cases of otential harms is beyond the resources of this revie*) 5his revie*
includes trials funded by industry) An earlier systematic revie* of .92 influen4a vaccine
studies ublished u to .::9 found industry8funded studies *ere ublished in more
resti#ious &ournals and cited more than other studies indeendently from methodolo#ical
+uality and si4e) Studies funded from ublic sources *ere si#nificantly less li;ely to reort
conclusions favourable to the vaccines)
5he revie* sho*ed that reliable evidence on influen4a vaccines is thin but there is
evidence of *idesread maniulation of conclusions and surious notoriety of the studies)
5he content and conclusions of this revie* should be interreted in the li#ht of this findin#)
! A,OUT HEALTHY CHIL-REN, A-OLESCENT AN- A-ULTS
htt,--***)ncbi)nlm)nih)#ov-mc-articles-PM6.0:9/<1-=tool>mcentre4
"accines are effective in reducin# infection and school absence in children over .
years old, but there is no evidence that they reduce transmission, hositalisation,
neumonia, or death)
?ive or inactivated vaccines are effective in reducin# infection and in sli#htly reducin#
absence from *or; in adults, but there is no evidence that they reduce transmission,
hositalisation, neumonia, or death)
5here is oor8+uality evidence from cohort studies that vaccines are effective in
elderly eole livin# in institutions, but there is little #ood8+uality evidence for the elderly
oulation in #eneral)
htt,--***)ncbi)nlm)nih)#ov-ubmed-<922@1:2
$nfluen4a vaccines are effective in reducin# cases of influen4a, esecially *hen the
content redicts accurately circulatin# tyes and circulation is hi#h) Ho*ever, they are less
effective in reducin# cases of influen4a8li;e illness and have a modest imact on *or;in#
days lost) 5here is insufficient evidence to assess their imact on comlications) 3hole8
virion monovalent vaccines may erform best in a andemic)
htt,--***)thelancet)com-&ournals-laninf-article-P$$S<29@8@:00(<<!9:.018A-abstract
$nfluen4a vaccines can rovide moderate rotection a#ainst virolo#ically confirmed
influen4a, but such rotection is #reatly reduced or absent in some seasons) 7vidence for
rotection in adults a#ed B1 years or older is lac;in#) ?ive attenuated influen4a vaccines
consistently sho* hi#hest efficacy in youn# children (a#ed B months to 9 years!)
htt,--***)ncbi)nlm)nih)#ov-mc-articles-PM6.920<B2-
5he hi#hest +uality cluster randomised trials su##ested that sread of resiratory
viruses can be revented by hy#ienic measures in youn#er children and *ithin
households) 7vidence that the more uncomfortable and e(ensive %01 mas;s *ere
suerior to simle sur#ical mas;s *as limited, but they caused s;in irritation) 5he
incremental effect of addin# virucidals or antisetics to normal hand*ashin# to reduce
resiratory disease remains uncertain) Global measures, such as screenin# at entry orts,
*ere not roerly evaluated) 7vidence *as limited for social distancin# bein# effective,
esecially if related to ris; of e(osureCthat is, the hi#her the ris; the lon#er the
distancin# eriod)
htt,--***)ncbi)nlm)nih)#ov-mc-articles-PM6.B2@2@0-=tool>ubmed
3e identified .10 rimary studies (.92 datasets!) Hi#her +uality studies *ere
si#nificantly more li;ely to sho* concordance bet*een data resented and conclusions
(odds ratio <B)@1, 01D confidence interval 2).2 to B@):2! and less li;ely to favour
effectiveness of vaccines (:):2, :):. to :):0!) Government funded studies *ere less li;ely
to have conclusions favourin# the vaccines (:)21, :).B to :)0:!) A hi#her mean &ournal
imact factor *as associated *ith comlete or artial industry fundin# comared *ith
#overnment or rivate fundin# and no fundin# (differences bet*een means 1):2!) Study
si4e *as not associated *ith concordance, content of ta;e home messa#e, fundin#, and
study +uality) Hi#her citation inde( factor *as associated *ith artial or comlete industry
fundin#) 5his *as sensitive to the e(clusion from the analysis of studies *ith undeclared
fundin#)
. A,OUT HEALTH CARE /ROFESSIONALS WHO WORK WITH EL-ERLY
htt,--summaries)cochrane)or#-6D::1</9-influen4a8vaccination8for8healthcare8*or;ers8
*ho8*or;8*ith8the8elderly
3e conclude that there is no evidence that only vaccinatin# healthcare *or;ers
revents laboratory8roven influen4a, neumonia, and death from neumonia in elderly
residents in lon#8term care facilities) Ether interventions such as hand *ashin#, mas;s,
early detection of influen4a *ith nasal s*abs, anti8virals, +uarantine, restrictin# visitors and
as;in# healthcare *or;ers *ith an influen4a8li;e illness not to attend *or; mi#ht rotect
individuals over B: in lon#8term care facilities and hi#h +uality randomised controlled trials
testin# combinations of these interventions are needed)
0 A,OUT EL-ERLY /ATIENTS, A SHOT IN THE -ARK
htt,--&id)o(ford&ournals)or#-content-.:<-.-</B)full)dfFhtm
Gecause of the availability of effective influen4a vaccines, randomi4ed lacebo8
controlled trials *ould be unethical, but observational studies of influen4a vaccine
efficacy, *hich have redominated since the <09:s, have #enerally sho*n e(cellent
vaccine effectiveness in reventin# death from all causes, *ith reductions in mortality
durin# influen4a season of @:DH1:D) Iecently, this benefit has been called into
+uestion) Simonsen et al found that total e(cess mortality from influen4a *as in the
ran#e 1DH<:D, ma;in# claims of @:DH1:D reduction in mortality from the vaccine
unrealistic) Jac;son et al) reorted that vaccination aeared to be even better at
reventin# death before the influen4a season than durin# the time *hen the virus
*as circulatin#) 5his revealed a fla* in observational studies, and *hat had
reviously been ta;en for vaccine effectiveness *as then thou#ht to actually be
selection bias)
htt,--a&e)o(ford&ournals)or#-content-<9:-1-B1:)abstract
"accine covera#e avera#ed B@DJ e(cess mortality *hen the flu virus *as
circulatin# avera#ed 9)/D) $n analyses that omitted *ee;s *hen flu circulated, the
odds ratio measurin# the vaccination8mortality association increased monotonically
from :)@2 early in %ovember to :)1B in January, :)B9 in Aril, and :)9B in Au#ust)
5his reflects the tra&ectory of selection effects in the absence of flu) $n analyses that
included *ee;s *ith flu and ad&ustment for selection effects, flu season multilied the
odds ratio by :)012) 5he corresondin# vaccine effectiveness estimate *as 2)BD
(01D confidence interval, :)9, /)@!)
htt,--archinte)&amanet*or;)com-article)as(=articleid><<:/90<
htt,--***)ncbi)nlm)nih)#ov-m-ubmed-..@9</9@-
$t is *orth notin# that results of several studies in the United States su##est that
the benefit of influen4a vaccine on mortality ris; amon# the elderly is small) $t is
ossible that the reduction in mortality ris; is about BD, the ma(imum attainable
benefit of influen4a vaccination amon# elderly eole)
htt,--***)bm&)com-content-@@0-bm&)b2B1<
Please, may *e have a randomi4ed clinical trial no*=
1 A,OUT THE -ECLINE OF IN-UCE- /ROTECTION
htt,--***)ncbi)nlm)nih)#ov-ubmed-B@19:B:
htt,--***)nature)com-nature-&ournal-v29<-n9@@9-full-29<<19a)html
%atural rotection last more than 1: years) Klu virus roduces *hat *e name as
Limmunity of ori#inal sinL, *hich can last u to 1: years, as demonstrated the s*ine flu
(H<%<! in .::0, *ith rotection of those born before <019) $n a similar *ay, eole a#ed
1: years and more are rotected a#ainst H<%. flu (Asian flu!, because havin# circulated
the virus <019 to <0B/.
htt,--&id)o(ford&ournals)or#-content-<09-2-20:)full
htt,--***)e+uiocesca)or#-*8content-uloads-.:<<-:0-flu8vaccine8terminator8.:<<)df
"accine rotection last less than one year, around 1 months)
2 VACCINE A-VERSE EFFECTS
htt,--***)ncbi)nlm)nih)#ov-ubmed-..1/..:0
5he rate of Guillain Garr syndrome immediately follo*in# H<%< vaccination
*as 19D hi#her than in erson8time une(osed to vaccine (ad&usted rate ratio >
<)19, 01D confidence interval, <):., .).<!, corresondin# to :)92 e(cess Guillain
Garr syndrome cases er million H<%< vaccine doses (01D confidence interval,
:):2, <)1B!)
htt,--***)ncbi)nlm)nih)#ov-ubmed-..29:21@
5he .::0 vaccine8attributable ris; of develoin# narcolesy *as <,<B,:::
vaccinated 2 to <08year8old (01D confidence interval <,<@,:::8<,.<,:::!)
htt,--***)ncbi)nlm)nih)#ov-ubmed-.<0.02/2
5he .:<: trivalent influen4a vaccine manufactured by 6S? Giotheraies *as
associated *ith increased febrile reactions, includin# febrile convulsions, amon#
Australian children)
3 INFLUENZA VACCINATION4 /OLICY VERSUS EVI-ENCE )
htt,--***)ncbi)nlm)nih)#ov-mc-articles-PM6<B.B@21-=tool>mcentre4
7ach year enormous effort #oes into roducin# influen4a vaccines for that
secific year and deliverin# them to aroriate sections of the oulation) $s this
effort &ustified= %o) 7vidence from systematic revie*s sho*s that inactivated
vaccines have little or no effect on the effects measured) Ieasons for the current
#a bet*een olicy and evidence are unclear, but #iven the hu#e resources involved,
a re8evaluation should be ur#ently underta;en )
htt,--***)e+uiocesca)or#-*8content-uloads-.:<<-:0-flu8vaccine8terminator8
.:<<)df
For how long they will ask professionals and patients for vaccination
against science and ethics?