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Tecncal Report on Poliomyelitis Vaccine

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Tecncal Report on Poliomyelitis Vaccine Tecncal Report on Poliomyelitis Vaccine N .June 10. 1955, the Puiblic Health Service tories whiclh might wish to manufacture and sent a Teclhniical Report on the Salk store vaccine intended for commercial use pend- l'oliomiivelitis Vaccine to the Secretary of ing decision to license the product. Whlen the Healtlh, Education, anid Welfare. Publislhed success of the field trial was reported April 12, below are the sumnmary. the report on epi- 1955. official minimum requirements were is- deemiological experience and new developments sued. Six manufacturers, each of which had in biologrics, and an expan(ledl calendar of eveents. produced vaccine under the provisional require- Copies of the r-eport were inade available to all ments, were granted licenses. State an(l local lhealtlh departments. Since only Records and samples of vaccine lots had been a limite(ld unuber of copiesare available throllugh submitted to the Public Healtlh Service Labora- the Puiblic Ilealtlh Service, it is recommenided tory of Biologics Control prior to April 12, and, that initerestedl lhealth departtment employees witlhin the next few davs, tlhose which were con- obtain a copy in their own agency. sidered acceptable, were released. Most bio- logical products for commercial distribution are released on the basis of an examination of Summary the detailed record of events in maniufacture The report presenits the teelhnical problems ani(l testingc, (known as a protocol), with or involve(d in the product ion, testinl, anid safety witlhout futrther testing by the Laboratory of of Salk polioiimvelitis vaccine. It also describes Biologics Cointrol. Release of most of the lots the responsibilities of tlhe lPublic Health Serv- of polionmyvelitis vaccine was based on review ice in control of the mianuflachitue of the vaccine of the manufacturing, protocols. Tissue cul- as a biologrical produlct. tuire tests for the presence of live virus were The vaccine as preplare(l for the 1954 field comipleted prior to release by the Laboratory of trial was ani experimiienital lprodtlct mn-ade by Biolog,ics Control on abotut lhalf of these lots comiimercial producers for the National Foun- aniid monkey tests were completed on 6 lots in- dationi for Infanitile Paral sis. After somie ini- volvingr at least 1 lot from eaclh of 5 manu- tial (lifficliltv, the indutstrial firms were able to facturers. turln ott a goo(l l)rodluct, an1(d the field( triial was On April 26, six cases of poliomyelitis 'were carried out successftlly. V'acciie l)production reported anmong chlildren who lhad received vanc- for the field trial l)ermiuittedl tlhe laboratories of cinie mi-ianuiifactured by the Cuitter Laboratories. industry and the Puiblic Health Service to ac- Att the request of the Public Health Service, quirie ex-perience in testino . this firmi imml--e(liately recalled all of its vaccine. As a, i estilt of its stuidies over a l)period of 2 The entsuting inivestigation of the Cutter Labora- yelars, -whiclh included particip-ation witlh iniidus- tolries was lalter extended to the entire industry tiry land withi I). Jonias Salk in testingr of vac- aiid le(d to a temporary suspension of the cinie for the field( trial, the I'iublic Healtfi Serv- nationwid(le vaccination prog0ram. ice planned to act quickly oni licenssiii if the The Puiblic Ihealthl Service on April 28 estab- an.alysis of the field trial (lata show\ed thlat the lislhed a l'olioinyelitis Suirveillance Unit witlhin vaccilne w.as safe and effective. It hasltd issule(d its Comnilnicable Disease Center in Atlanta, prospective minin nun irequiremiienits in May Ga. Thtis unlit is investigating all reported 195.4. as a(lvisorv for pliarmaceutical labora- cases of poliomnvelitis, wlhetler or not asso- 738 Public Health Reports ciated with vaccine. Sixteeni virus labora- senisitive tlhain the monikey test. It mulst be per- tories, througlhout the Nation, are cooperatingc, fornmed witlh a lar-ge enouglh sanll)le of vacciine in examininig and reportingc upon specimnenis aind unider closely controlled coiiditioiis if it collected from cases and suspected cases. The is to lhave the milaxiimumu value. The tlheoreti- epidemiological data so far obtained clearly cal considerations wlich govern inactivation define the Cutter incident as ain outbreak with and testing, lhave been analyzed in the light of characteristics of a common source epidemic. inforimiation (leveloped dluiig,c this inquiry. The cases of poliomyelitis following, use of vac- As a result of the inquiry anid of analysis cines made by the other manufacturers have not of the manufacturers' experience aind records, beein inore numerous than would be expected at clhangres vere imade in processing, control and this season except for a few cases wlhichl sug- safety testing. Revised requiireenieits in the gested (but were too few to be conclusive) an testing, procedures were establislhed ainid the association with one lot of vaccine produced by release of vaccine was resumiied. The modifica- Wyeth Laboratories. That firmn has witlh- tions provide greater assurance of safety. As drawn the unused portion of this lot. a result of the review and the institution of The Salk vaccine is a suspension of poliomye- revised requirements, the production and avail- litis virus inactivated by formaldelhyde to make ability of vaccine has been delayed. the virus harmless but still capable of inducing The Salk vaccine applies new practices in the the production of antibodies. The vaccine con- production of viral vaccines. The vaccine has tainis inactivated virus of eaclh of the three progressed from the experimnental level to large- types. The original concept of vaccine prepa- scale production with unprecedeented rapidity. ration was that the process itself assured a wide This speed, reflecting the increased tempo of margin of safety. Safety tests for thle vaccine all medical research, created problems in bi- were conceived to detect botlh mass contamina- ologics control amenable to solution only with tion resulting from accidents in manufacture tlle accumulation of knowledge and experience. and residual live virus which the process was It is likely that otlher problems of equal com- intended to eliminate. plexity will be raised by the development of The intenisive investigations of the past 5 otlher new viral vaccines. Action taken by the weeks indicate that the records manufacturers Public I-Iealth Service for dealing witlh botlh the were required to subimit did not include certain current and the long,-ranige problems include: data which are essential for ani adequate assess- 1. Amenidment of minimum requiremenits for ment of consistency in performance. The the production and testing of poliomyelitis protocols submitted related only to lots of vac- vaccine. cine proposed for clearance and gave no infor- 2. Incorporation of minimum requirements in mation concerninig lots discarded in the course official regulations as manldatory stanidards. of mianufacture. Furtlher, the inforiiation re- 3. Creation of a Technical Conmmittee on quested did not bring out certain data on proc- Poliomnyelitis Vaccine. essing and testingc no+\- known to be important. 4. Creation of a Division of Biolog,ics Stand- The total experience of the man-ufaetuirers ards, witl strengthened staff anid facilities. now reveals that the process of inactivation did 5. Increased onsite plant surveillance and not always follow the predicted course, sinlce consultation. positive tissue culture tests not inffrequently 6. Reoriented testing anid researelh prog,ram. occurred after the expected completion of the 7. Establishment of a Poliomyelitis Suirveil- inactivation process. Greater depenldence, lanice 'Unit. tlherefore, nmust be placed on sensitive tests for S. Review of legrislative autlhoritv. v-ery smnall quantities of residuial live virus as part of process control. Two types of tests are uised to determnine thle Epidemiological Experience presence or absence of live virus in the vaccine: Investig,ation of reports of p-aralytic polio- the nmonkey test and the tissue culture test. The mnvelitis occurrince in association with inijections tissue culture test hias been found to be miore of vaccinie was assioned to the Comimuililnicable Vol. 70, No. 8, August 195.5 739 D)isealse (Ceniter. The niewly established Polio- orator ies, to extenid surveillance over poliomye- mvelitis Surv\eillalnce Uniiit has operated to yield litis this seasoni. 'I'lhis surveillaince was hiighly precise fieldl infoimnation oni the ocenii-leiice of lesirable to studyv the durability of iiimuility poliomyelitis throughotut the couniitry. As a re- ill the lhalf a illioni clhil(lreni whio lhad beeim stilt of this activity the Cuttter incident was iiimminiize(d (iring the field trials in 1954, and elelarly (lefined as Can outbreak with claracteris- eveni more desirable if the results of the field ties of a commiiiioni sourlce epidemic. tr ial le(I to a geieral imniuiitiizatioli program in 19-55. IP'oUio yelUtbs' 8te rvedila ie 'rog iant Wlheni the first occurrenice of poliomiiyelitis The Public Health Service coniduicts a stir- cases in vaccinated clild-ein was reported, this -eillmice programli throutgIh its Conuinuniiiiicable program was quickly brought inlto play to col- Disease Ceniter to lhell) the States in ral)i(l rec- lect and evalutate field and laboratory data whiclh ogiitioni, stu(lv, and conitrol of stuch diseases as nihlit inidicate the nature anid siginificance of malaria, tyv)lms, smallp)ox, diplhtlheria, psitta- the disease ouitbreak. Altlhouhli some cases of cosis, aind rabies. In 1954, CDC personnel col- poliomyvelitis could be expected to occur by co- laborate(d in the poliomvelitis field trial evalua- inceidence followiiug vaccination, eaclh reported tioni, udler the (lirectioni of 1)r. Tlhomas Francis. calse deserved thorongrh inivestioationi. 'I'lTe P'tublic I-lealtlh Seirvice lhad prepared, witl On April 25, 195.5, the Public. Health Service State health departments ani(l cooperating lab- receive(l a repor-t of poliomiiyelitis in a Clhicago Poliomyelitis Vaccine Distribution Plamns for the voluntaiiry eontrI l Tile P1mublic Healthl Service respon- vately (l)erate(l hospitals, etc.
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