How vaccines are made

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    1

    Paggjfl 1=1

    K|hz 99( 9==:

    Czf]oys Paggjfl God}afz HHG( A GWG God}afz

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    9

    Oplypjlr Paggjflw afc nor snlz roye

    Daejfb a paggjfl

    Paggjfl daf|`ags|yjfb

    ]|ssjfb snjfbw soblsnly Ijocl`lfwl afc paggjflw

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    7

    Paggjfl 1=1

    Paggjflw afc Nor Snlz Roye

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    3

    Rnas jw a Paggjfl? A paggjfl jw a ijohobjgah daslyjah jfslfclc so jfc|gl a w}lgj`jg

    jdd|fl ylw}ofwl jf n|dafw oy afjdahw&

    Paggjflw roye ilga|wl snl ioczw jdd|fl wzwsldyldldilyw nor so }yoslgs jswlh` `yod djgyoilw js naw

    }ylpjo|whz lfgo|fslylc& Paggjflw ayl ofl o` snl bylaslws w|gglww wsoyjlw jf }|ihjg

    nlahsn&

    Paggjflw napl lfclc wdahh}o~( afc horlylc snl jfgjclfgl yaslwo` wlyjo|w jhhflwwlw jfgh|cjfb cj}nsnlyja( slsaf|w( dlawhlw afc}ohjo iz doyl snaf :

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    (nss};//rrr&`ca&bop/g

    http://www.fda.gov/cder/handbook/http://www.fda.gov/cder/handbook/
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    Acpafglc Clplho}dlfs Ahh CPG }yoc|gsw ayl syafwjsjoflc `yod ylwlaygn haiw a`sly

    layhz ylwlaygn afc clplho}dlfs( jfgh|cjfb }yoo`$o`$gofgl}s&

    CPG w}lgjahj{lw jf acpafglc clplho}dlfs o` paggjflw&

    Lfgod}awwlw fofghjfjgah afc ghjfjgah ylwlaygn( afc ahh agsjpjsjlw

    |} so afc jfgh|cjfb hjglfw|yl iz snl \&W& @ooc afc Cy|bAcdjfjwsyasjof .@CA*&

    Ijo}naydagl|sjgah clplho}dlfs jw hlfbsnz afc l~}lfwjpl&

    Of aplyabl( 1= so 1< zlayw afc flayhz #0== djhhjof&+

    Acpafglc Clplho}dlfs+Wo|ygl;nss};//gwcc&s|`sw&lc|/Jf`oWlypjglw/

    http://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2008.pdfhttp://csdd.tufts.edu/InfoServices/OutlookPDFs/Outlook2008.pdf
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    Afjdah Ws|cjlw jf Paggjfl Clplho}dlfs $

    Slydjfohobz Fofghjfjgah ylwlaygn

    ]yoo`$o`$gofgl}s afjdah doclhw .colw js roye?*

    So~jgohobz( jfgh|cjfb ag|sl/yl}las$cowl( afc yl}yoc|gsjpl .jw jswa`l?*

    L``jgagz/jdd|foblfjgjsz .rjhh js }yoslgs abajfws cjwlawl?* ]yoc|gs slwsjfb |wjfb afjdahw .jw js }oslfs afc wsaihl?*

    ]ylghjfjgah ylwlaygn

    Afz fofghjfjgah ws|cz gofc|gslc }yjoy so |wl o` snl }yoc|gs jfn|dafw

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    Rnz Gafs God}|slyw afc Glhh G|hs|ylw Yl}hagl

    Afjdah Ylwlaygn? Afjdah afc fof$afjdah doclhw iosn |wlc so afwrly

    ijohobjgah q|lwsjofw&

    Afjdah ws|cjlw daz }apl raz `oy god}|sly doclhw&God}|sly doclhw afc glhh g|hs|yl daz l~slfc rnas jw

    hlayflc jf afjdahw& God}|sly doclhw afc glhh g|hs|yl wsjhh cofs yl`hlgs snl

    god}hl~jsz afc czfadjgw o` a hjpjfb oybafjwd&

    A god}hlsl afwrly g|yylfshz ylq|jylw afjdah ws|cjlw&

    CPG lfw|ylw snas fo afjdah rjhh w|``lyfllchlwwhz( afc snas snl `lrlws afjdahw ayl|wlc so oisajf wgjlfsj`jgahhz cl`lfwjihl casa&

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    Sz}lw o` Afjdah Ws|cjlw Cowl afc wgnlc|hl ylq|jyldlfsw

    Afjdah casa w|}}oysw l``lgsjpl cowl jf n|dafw

    So~jgohobz jw js wa`l?

    Jfgh|clw yl}yoc|gsjpl so~jgohobz

    L``jgagz colw js roye?

    Cldofwsyasl snas snl paggjfl ags|ahhz royew |fcly jsw jfslfclcgofcjsjofw o` |wl .cowl afc ylbjdlf*

    Cldofwsyaslw snas snl paggjfl

    ]yoslgsw abajfws rnas js raw clwjbflc so }yoslgs abajfws

    ]yoslgsw abajfws a glysajf hlplh o` gnahhlfbl

    ]yoslgsw `oy a glysajf }lyjoc o` sjdl

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    ]nawlw o` Ghjfjgah Syjahw ]nawl 1

    Lpah|asl wa`lsz afc sohlyaijhjsz o` snl jfplwsjbasjofah }yoc|gs jfn|dafw

    Jfpohplw 9= so >= foydah( nlahsnz poh|fsllyw

    Sz}jgahhz ghowlhz dofjsoylc Clwjbflc so clslydjfl snl dlsaiohjwd afc }naydagohobjg

    agsjofw oy cy|bw( wjcl l``lgsw awwogjaslc rjsn jfgylawjfb cowlw(afc .j` }owwjihl* bajf layhz lpjclfgl of l``jgagz

    CPG naw w|gglww`|hhz acpafglc > }yoc|gsw jfso ghjfjgah syjahwjf snl haws 1= zlayw& ]nawl 1 syjahw god}hlslc jfgh|cl;

    Afsnya~ paggjfl

    Ios|hjf|d fl|yoso~jf paggjfl

    I|szyzhgnohjflwslyawl .gnldjgah cl`lfwl snlya}l|sjg*

    Jf`h|lf{a paggjflw .wlawofah afc }afcldjg*

    S|hayldja paggjfl Wdahh}o~ paggjfl

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    ]nawlw o` Ghjfjgah Syjahw .gofsjf|lc* ]nawl 9

    Lpah|asl wa`lsz afc l``lgsjplflww `oy a }aysjg|hay jfcjgasjof

    Sz}jgahhz jfpohplw wlplyah n|fcylc w|iklgsw as d|hsj}hl wjslw

    Gofsyohhlc ws|cz

    CPG }yoc|gsw jf ]nawl 9; ios|hjf|d( }hab|l afc s|hayldjapaggjflw

    ]nawl 7

    L~}afclc gofsyohhlc syjah

    Jfpohplw wlplyah n|fcylc so sno|wafcw o` w|iklgsw( d|hsj}hl wjslw

    Hofb$slyd wa`lsz afc l``jgagz

    CPG }yoc|gs jf ]nawl 7; wlawofah jf`h|lf{a paggjfl .Ia~sly*

    ]nawl 3 ghjfjgah lpah|asjof jw ofbojfb( lplf a`sly @CAhjglfw|yl

    ]ows$dayelsjfb ws|cjlw

    Ofbojfb wa`lsz lpah|asjof

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    Ghjfjgah Syjahw as CPG CPG o|swo|yglw gofc|gs o` ghjfjgah syjahw so gofsyags ylwlaygn

    oybafj{asjofw .GYOw*

    CPG yldajfw ylw}ofwjihl `oy syjah clwjbf( oplywjbns afccog|dlfsasjof/clhjplyaihlw

    Ghjfjgah syjah clhjplyaihlw Jfplwsjbasoyw iyogn|yl .JI* afc syjah }yosogohw

    @jfah ghjfjgah ws|cz yl}oysw .GWYw*

    JFC wa`lsz yl}oysw as payjo|w jfslypahw

    Wlyjo|w acplywl lplfs yl}oysjfb

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    Acplywl Lplfsw Af acplywl lplfs .AL* jw afz acplywl gnafbl jf nlahsn oy

    wjcl l``lgs snas ogg|yw rnjhl a w|iklgs jw saejfb }ays jf aghjfjgah syjah&

    Daz il ylhaslc oy |fylhaslc so snl jfplwsjbasjofah }yoc|gs&

    ALw na}}lf jf lplyz ghjfjgah syjah& A wlyjo|w acplywl lplfs .WAL* jw afz acplywl l~}lyjlfgl

    snas ylw|hsw jf clasn( jw hj`l$snylaslfjfb oy ylq|jylwnow}jsahj{asjof&

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    Ha|fgn afc ]ows$Dayelsjfb ]ows$hjglfw|yl agsjpjsjlw daz il ylq|jylc iz hjglfwjfb

    a|snoyjsz .@CA*

    @|ysnly wa`lsz casaiawl

    W}lgjah }o}|hasjofw .}lcjasyjg( lhclyhz( njbn$yjwe*

    ]ylbfafgz ylbjwsyz

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    9==; CPGafc Q|jfsjhlwrjf #79DFJAJC ]nawl 1ghjfjgah syjah|fjs gofsyags

    CPG ijocl`lfwldjhlwsoflLdlybjfb cjwlawlw/ wlypjglwdjhlwsofl

    9==7$9==:;CPG god}hlslwwj~ ]nawl 1ghjfjgah syjahw `oyijohobjgah afcgnldjgahcl`lfwlgo|fslydlaw|yl

    w

    9==>;

    CoC }hab|lYAC ahhogaslwahh `|s|yl CoC}hab|l paggjfl`|fcjfb sol~jwsjfb CPGgofsyags

    9==

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    Paggjfl 1=1

    Paggjfl Daf|`ags|yjfb

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    Daf|`ags|yjfb; Blssjfb Snlyl Ylwlaygn afc clplho}dlfs

    ]yopjclw daslyjah `oy layhz ws|cjlw

    ]yoglww clplho}dlfs

    Saelw YC }yoglww afc clplho}w a }yoglww `oy daf|`ags|yjfb

    Snjw jw a god}hl~ lfclapoy( rjsn dafz payjaihlw .j&l&(o}}oys|fjsjlw `oy snjfbw so bo ryofb*

    Daf|`ags|yjfb

    L~lg|slw snl }yoglww jf af lfpjyofdlfs god}hjafs rjsn G|yylfsBooc Daf|`ags|yjfb ]yagsjglw .GBD]w*( aw ylq|jylc iz @CA

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    Ylb|hasoyz A``ajyw

    B|jclw ahh CPG }yobyadw jf aylaw o` ylb|hasoyz wsyaslbz afcgod}hjafgl&

    Ylgoddlfcw slwsjfb ylq|jyldlfsw as payjo|w wsablw o`daf|`ags|yjfb .jf$}yoglww( hos ylhlawl( gnayagslyj{asjof( lsg&*&

    Ylpjlrw }hafw `oy goyylhaslw o` }yoslgsjpl jdd|fjsz& ]yopjclw ylb|hasoyz ylpjlr afc w|}}oys wsyaslbjlw c|yjfb }yoc|gs

    clplho}dlfs&

    Ylb|hasoyz wsyaslbjlw |sjhj{lc iz CPG jfgh|cl;

    Agglhlyaslc A}}yopah

    @aws Syage Clwjbfasjof CPG dajfsajfw a 1==, w|gglww yasl `oy ylgljpjfb @aws Syageclwjbfasjof .`o|y }yoc|gsw* aw god}aylc so a 07, jfc|wsyz wsafcayc&+

    Oy}naf Cy|b ]yobyad

    ]yjoyjsz Ylpjlr

    Yohhjfb W|idjwwjof

    +Wo|ygl; nss};//rrr&`ca&bop/gily/jfwjcl/`awsye&nsd

    http://www.fda.gov/cber/inside/fastrk.htmhttp://www.fda.gov/cber/inside/fastrk.htm
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    9:

    Ylb|hasoyz A``ajyw .gofsjf|lc*

    Agsw aw snl CPG yl}ylwlfsasjpl jf jfslyagsjofw rjsn snl \&W&@CA afc `oyljbf ylb|hasoyz ablfgjlw&

    ]yl}aylw afc awwldihlw ahh ylq|jylc ylb|hasoyz w|idjwwjofw(jfgh|cjfb Jfplwsjbasjofah Flr Cy|b afc Ijohobjgw HjglfwlA}}hjgasjofw&

    Ylpjlrw ahh }|ihjgjsz daslyjahw .}ylww ylhlawlw( iyogn|ylw(Rli }ablw( lsg&* so lfw|yl snas fo |f}yoplf dayelsjfbghajdw ayl dacl ylbaycjfb @CA$ylb|haslc }yoc|gsw&

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    7=

    @CA Afjdah Y|hl

    Ylb|hasoyz A``ajyw oplywllw CPGw |wl o` snl @CA AfjdahY|hl&

    Ahhorw `oy @CA hjglfw|yl o` paggjflw afc osnly }yoc|gsw jf rnjgnl``jgagz slwsjfb jf n|dafw jw |flsnjgah

    As hlaws sro w}lgjlw .fofn|daf }yjdaslw afc yoclfsw* D|ws |fclywsafc }asno}nzwjohobz o` snl cjwlawl

    Rlhh$gofsyohhlc afjdah ws|cjlw rjhh }yopjcl casa snas ayl hjelhz so}ylcjgs a ilfl`js jf n|dafw

    Snl Afjdah Y|hl jw FOS a wnoysg|s so hjglfw|yl&

    Wo `ay( fo paggjflw napl illf hjglfwlc |wjfb snl Afjdah Y|hl&

    CPG jw af jfc|wsyz hlacly jfAfjdah Y|hl clplho}dlfs&

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    71

    Q|ahjsz Aww|yafgl

    So lfw|yl jd}aysjahjsz( snl Q|ahjsz Dafabldlfs O``jgl .QDO*jw jfcl}lfclfs o` snl }yoc|gs sladw afc `|fgsjofahcl}aysdlfsw&

    Snl QDO }ly`oydw a|cjsw( gofc|gsw q|ahjsz ylpjlrw afc

    jfjsjaslw jfplwsjbasjofw so cldofwsyasl snas iosn CPG afc jsww|igofsyagsoyw ayl o}lyasjfb jf a wsasl$o`$gofsyoh so lfw|ylgod}hjafgl rjsn Wlgsjof

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    79

    Q|ahjsz Aww|yafgl .gofsjf|lc*

    QA jw god}yjwlc o` sro aydw;

    ]yoc|gs Q|ahjsz Aww|yafgl .]QA*

    Lfw|ylw god}hjafgl o` daf|`ags|yjfb( slwsjfb afc wsoyablw|igofsyagsoyw

    Ghjfjgah Q|ahjsz Aww|yafgl .GQA* ]yjdayz ylw}ofwjijhjsjlw ayl so dafabl wa`lsz yjwe so ghjfjgah ws|czpoh|fsllyw afc so awwlww casa jfslbyjsz

    QA ahwo dofjsoyw casa jfslbyjsz afc oplywllw pahjcasjof o`god}|sly wzwsldw&

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    77

    ]yobyad Dafabldlfs

    ]yobyad dafablyw o` ijo}naydagl|sjgah clplho}dlfs}yobyadw d|ws iahafgl;

    Gows

    Wgnlc|hl

    Yjwe Slgnfjgah ylq|jyldlfsw

    ]yoc|gs hj`l gzghl

    L~slyfah jf`h|lfglw .gnafblw jf ylb|hasoyz b|jcafgl( ghjlfs`|fcjfb }yo`jhlw( lsg&*

    Booc }yobyad dafabldlfs jw o`slf as occw rjsn boocwgjlfgl&

    D|ws g|ysajh snl rnas$j`w afc wso} as booc lfo|bn

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    Ijowa`lsz

    Ijohobjgah w|ylsz

    Flr afc lpohpjfb CoC ylq|jyldlfsw `oy }lywofflh(w|igofsyagsoyw royejfb rjsn wlhlgs ablfsw

    Fayyorw `jlhc o` }yow}lgsjpl w|igofsyagsoyw lplf `|ysnly

    Wnj}}jfb Wnj}}jfb ijohobjgah ablfsw jw god}hjgaslc afc njbnhz ylb|haslc

    .d|gn doyl wo jfslyfasjofahhz*

    Sld}lyas|yl gofsyoh jw gy|gjah `oy paggjflw .`oy for*

    Slws wnj}dlfsw d|ws il gofc|gslc rjsn plfcoyw il`oyl ags|ah}yoc|gs jw }|s as yjwe

    CPG jw a }joflly jf snjwflr ylq|jyldlfs&

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    Q|lwsjofw?