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AMERICAN ACADEMY OF PEDIATRICS
Committee on Infectious Diseases
Poliomyelitis Prevention: Recommendations for Use of Inactivated
Poliovirus Vaccine and Live Oral Poliovirus Vaccine
ABSTRACT. A change in the recommendations for rou- affirmed its support of the eradication program and
tine immunization of children is indicated because of the the use of OPV for this purpose.6
reduced risk of exposure to wild-type polio viruses and In the United States, the evolving national and
the continued occurrence of vaccine-associated paralytic international epidemiology of poliomyelitis in the
poliomyelitis after oral polio vaccine (OPV). All children past two decades has prompted reexamination of
should receive four doses of vaccine before the child
enters school. Regimens of sequential inactivated polio
current vaccination recommendations for the routine
vaccine (IPV) and OPV, IPV only, or OPV only are ac- use of OPV. Earlier reevaluation by the Institute of
ceptable. Each regimen has advantages and disadvan- Medicine in 1977 and again in 1988 had reaffirmed
tages. In special circumstances, one of the regimens is the use of OPV for national poliomyelitis control at
preferred or recommended. Because logistical problems those times.7,8 Since 1979, however, nearly all cases of
with the current childhood immunization schedule may paralytic poliomyelitis in the United States have been
make these new recommendations difficult to implement vaccine associated.
immediately, their adoption likely will be gradual. Nev- Between 1980 and 1994, a total of 125 cases of
ertheless, assuming continued progress toward global vaccine-associated paralytic poliomyelitis (VAPP)
eradication and the development of new combination
were reported, whereas only 6 imported and 2 inde-
products, the routine use of an IPV-only regimen is likely
to become desirable and feasible in future years. terminate cases have occurred.6 The number of im-
ported cases in recent years has decreased markedly,
VACCINE EFFECTIVENESS especially from Latin America, where the majority of
Since the introduction of poliovirus vaccines in the imported cases to the United States formerly origi-
1950s and early 1960s, their effectiveness in the pre- nated. The only reported importation in the 1990s
vention of poliomyelitis has been amply demon- was a 30-month-old Nigerian brought to this country
strated. The last reported case in the United States of for treatment of the disease. Thus, the current risk of
indigenously acquired poliomyelitis caused by wild exposure to wild poliovirus in the United States is
poliovirus was in 1979.1 No cases have occurred in not only very low but also of diminishing magnitude
the western hemisphere since August 1991.2 These as global elimination proceeds. In comparison, the
and other findings from national surveillance in risk of VAPP from OPV, albeit low, for both recipi-
countries of the Americas led to the certification in ents of the vaccine and their susceptible contacts is
1994 by an international commission that wild-type significantly greater, as evidenced by the 8 to 9 cases
poliovirus transmission has been interrupted in this of VAPP reported each year, than the risk of para-
hemisphere, thus achieving a goal established by the lytic poliomyelitis from wild-type poliovirus. This
Pan American Health Organization in 1985.3 Concur- substantial alteration in the relative benefits and
rently, the global poliomyelitis eradication initiative risks of OPV in comparison to those of inactivated
of the World Health Organization (WHO) has re- polio vaccine (IPV) during the past two decades led
sulted in a more than 80% reduction in the incidence to the ACIP resolution in June 1995 to recommend
of reported poliomyelitis cases worldwide since 1988 the development of a new poliomyelitis vaccine pol-
and demonstrated that the goal of global eradication icy with a greatly enhanced role for IPV to decrease
is achievable.4,5 the occurrence of VAPP.9
These successes are attributable primarily to the The Committee on Infectious Diseases concurs
widespread use of oral polio vaccine (OPV), which is with the ACIP recommendation for expanded use of
the vaccine recommended by the WHO. Continued IPV.9 Continued use of OPV for primary immuniza-
progress in poliomyelitis elimination clearly necessi- tion in the United States, even assuming global erad-
tates the use of OPV in those countries in which wild ication is achieved by the year 2000, would likely
poliovirus remains or recently has been endemic. In result in as many as 100 or more cases of VAPP.
the United States, the Advisory Committee on Im- Routine immunization against poliomyelitis will
munization Practices (ACIP) of the Centers for Dis- need to be continued until worldwide certification of
ease Control and Prevention (CDC) has strongly re- the eradication of wild-type poliovirus. This interval
is likely to be at least 10 years from now and strongly
supports a change in policy now rather than after
The recommendations in this statement do not indicate an exclusive course global eradication is achieved. In the resulting delib-
of treatment or serve as a standard of medical care. Variations, taking into
account individual circumstances, may be appropriate.
erations of both the ACIP and Committee on Infec-
PEDIATRICS (ISSN 0031 4005). Copyright © 1997 by the American Acad- tious Diseases, multiple other issues have been con-
emy of Pediatrics. sidered, including efficacy and safety of the two
300 PEDIATRICS Vol. 99 No. 2 February
Downloaded 1997
from www.aappublications.org/news by guest on September 12, 2021types of polio vaccine, options for immunization TABLE. Ratio of Number of Cases of Vaccine-associated Para-
schedules, possible impact on the immunization lytic Poliomyelitis to Number of Doses of Trivalent OPV* Distrib-
uted, United States, 1980 Through 1994
rates in children, and the importance of informing
parents and physicians of the benefits and risks of Case Category Ratio (No. of Cases to Millions of Doses of
these schedules and involving them in the selection OPV Distributed)
of vaccine. These considerations have resulted in All First Subsequent
revised recommendations for poliomyelitis vaccina- doses dose doses
tion in this country. Recipient 1:6.2 (49) 1:1.4 (40) 1:27.2 (9)
Contact 1:7.6 (40) 1:2.2 (26) 1:17.5 (14)
Community acquired 1:50.5 (6) NA† NA
OPV Immunologically 1:10.1 (30) 1:5.8 (11) 1:12.9 (19)
abnormal‡
Trivalent OPV, the live-attenuated vaccine, in a Total 1:2.4 (125) 1:0.75 (77) 1:5.1 (48)
three-dose series results in sustained, probably life-
long protection against paralytic disease caused by * Live, oral poliovirus vaccine (attenuated).
† NA indicates not applicable.
each of three poliovirus serotypes in more than 95% ‡ Because the denominator is doses of OPV distributed, the cal-
of recipients.10 OPV induces intestinal immunity culated ratio is low. However, if the denominator is the number of
against poliovirus reinfection, which explains its ef- immunodeficient infants born each year, the risk of VAPP in
fectiveness in controlling wild virus circulation. In immunodeficient infants is 3200 to 6800-fold higher than in im-
munocompetent infants.27
addition, OPV persists in the pharynx for 1 to 2
weeks and is excreted in the feces for several weeks
or longer after administration. Consequently, vac- IPV
cine virus can be transmitted to contacts and results The original inactivated viral vaccines against po-
in their immunization.11 In rare cases, however, lio were replaced in the late 1980s by those of greater
VAPP can occur in these contacts as well as in those antigenic content and have been denoted as en-
vaccinated. hanced-potency IPV. Administration of enhanced-
In addition to intestinal immunity, advantageous potency vaccine in most studies has resulted in se-
properties of OPV are ease of administration and roconversion to the three poliovirus types in 94% to
lower costs than those of IPV. The only well-docu- 100% of vaccinees after two doses and high titers of
mented adverse event associated with OPV is VAPP. serum-neutralizing antibody in 99% to 100% of re-
Although an Institute of Medicine committee noted cipients after three doses.18,19 In the one study in
an increased risk of Guillian-Barré syndrome after which lower seroconversion to serotype 3 after two
OPV administration in two studies in Finland, re- does of vaccine occurred, the seroconversion rate
analysis of these data and a subsequent study in the was 100% after a third dose of IPV and 94% after two
United States did not demonstrate an increased risk doses of OPV.20 The limited data on antibody persis-
of Guillian-Barré syndrome after OPV administra- tence suggest that immunity is prolonged and per-
tion.12–14 haps lifelong.
Mucosal immunity is induced by enhanced-
potency IPV but to a lesser extent than that with
VAPP OPV.20,23,24 IPV inhibits pharyngeal acquisition of po-
The rate of VAPP after the first dose of OPV is liovirus and to a lesser extent intestinal acquisition.
approximately 1 case per 760 000 doses of OPV dis- The effectiveness of IPV has been demonstrated by
tributed, including recipient and contact cases.6 The its use in several countries in Western Europe that
risk of a recipient case after the first OPV dose is controlled and now eliminated poliomyelitis.6 These
estimated to be 1 per 1.5 million doses; for a contact countries include Finland, France, the Netherlands,
case resulting from exposure to a first-dose recipient Norway, and Sweden. Recently in Canada, where a
it is 1 per 2.2 million doses. For subsequent doses, the pentavalent vaccine of diphtheria and tetanus tox-
risk is substantially lower for both recipients and oids and pertussis, IPV, and Haemophilus influenzae
contacts (Table).15 For immunodeficient persons, the conjugate vaccine is used, the exclusive use of IPV
risk is 3200- to 6800-fold higher than that in immu- has been adopted by most provinces.17
nologically healthy OPV recipients.16 IPV use in the United States requires additional
Of the 125 cases of VAPP reported from 1980 to injections (until new combination vaccine products
1994, 49 (39%) occurred in otherwise healthy recipi- become available), does not provide optimal mucosal
ents, 78% of which were associated with the first immunity to maintain community resistance to in-
dose, and 93% occurred in the first year of life.6,17 troduction of wild polio virus, and costs more than
Cases in healthy contacts accounted for 40 (32%), OPV. However, the cost of this vaccine likely will
approximately three fourths of which occurred in decrease with greater use and the resulting increase
adults. In 30 cases (24%), which includes recipients in volume of sales.24 No serious adverse events have
and contacts, the patients had immunologic abnor- been associated with the use of the currently avail-
malities, the majority of which were disorders of able enhanced-potency IPV products in which the
humoral immunity, ie, antibody deficiency syn- three types of poliovirus (1, 2, and 3) are completely
dromes.6,16 Six cases from which vaccine-related vi- inactivated with formaldehyde after viral concentra-
rus was isolated occurred in community contacts tion and purification.13 As with any vaccine, rare
with no history of recent vaccination or contact with adverse reactions cannot be excluded until IPV has
a vaccine recipient. been used in large populations. To date, however,
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guest on September 12, 2021 OF PEDIATRICS 301data on adverse reactions from France and Canada, two doses of OPV is recommended as the current
which have surveillance systems, and manufactur- public health strategy.6 This decision is based on the
ers’ records have demonstrated the safety of IPV.24 reduced risk of VAPP, optimal mucosal immunity
from OPV to maintain community resistance to in-
Sequential Use of IPV Followed by OPV troduction of wild poliovirus, and the necessity for
The sequential use of IPV and OPV for primary only two additional injections in comparison to four
immunization in the United States was proposed in in an IPV-only regimen. The ACIP also notes that a
1987 to reduce the risk of VAPP.23 The expert panel sequential schedule is likely to be an interim recom-
convened in 1988 by the Institute of Medicine recom- mendation until further progress in global eradica-
mended consideration of this schedule after a com- tion is achieved and combination vaccines are li-
bination product of IPV and a vaccine of diphtheria censed, at which time an IPV-only schedule probably
and tetanus toxoids and pertussis became available, would be recommended. Ultimately, after world-
which at the time was anticipated in 3 to 5 years.8 wide certification of eradication of wild-type polio-
Although the experience with sequential schedules virus, vaccination against polio infection can be dis-
is limited, they have been used in Denmark and in continued, because humans are the only natural
one Canadian province for more than two decades reservoir for wild-type polioviruses.
and more recently have been adopted in Israel, Hun-
gary, and Lithuania.24 CONSIDERATIONS AND CONCLUSIONS IN THE
The rationale for the sequential schedule is that CHOICE OF VACCINE
two doses of IPV induce sufficient humoral immu- The goal of poliomyelitis vaccination programs is
nity in most recipients to prevent VAPP from subse- the worldwide eradication of both the disease and
quent administration of OPV, which will induce op- wild-type poliovirus circulation. In the United States,
timal intestinal immunity as well as sustain humoral where eradication has been achieved and the west-
immunity. ern hemisphere has been certified as free of indige-
In studies of the immunogenicity of the sequential nous wild-type poliovirus since 1994,3 an additional
use of IPV and OPV, seroconversion after two doses goal is to reduce and eventually eliminate VAPP by
of IPV and one dose of OPV was 94% or greater to the expanded use of IPV. Although prevention of
serotypes 1 and 2 and 78% to 100% for serotype VAPP can be most rapidly achieved by an IPV-only
3.6,19,24 After the second dose of OPV, humoral im- regimen, the number of injections in the current
munity was greater than 95% to all serotypes.6,24 Two childhood immunization schedule, limited availabil-
doses of OPV seem necessary for optimal intestinal ity of combination vaccine products, and local prac-
immunity, and no additional benefit is gained from a tice constraints related to costs and other factors
third dose.24 could prevent the immediate routine implementa-
Based on the epidemiologic characteristics of tion of this option. In addition, many experts support
VAPP, universal application of a sequential schedule the continuing need for optimal intestinal immunity
would be expected to reduce the number of cases by as induced by OPV to limit further circulation of
50% to 75%. The sequential schedule should elimi- wild-type polio virus if importation were to occur.
nate most cases of VAPP in vaccine recipients and Each of the three poliomyelitis vaccine sched-
prevent some cases in unimmunized contacts, be- ules—sequential IPV and OPV, IPV only, and OPV
cause IPV provides some degree of mucosal immu- only—are highly effective in protecting against po-
nity, resulting in reduced excretion of the vaccine liomyelitis from wild-type polioviruses and are ac-
virus after OPV administration.23 Although the use ceptable. Physicians, thus, have three options for
of OPV in a sequential schedule would mean contin- immunizing their patients. Major factors in the selec-
ued circulation of vaccine virus and some contact tion of the most appropriate options are the follow-
cases of VAPP, this circulation would be reduced by ing:
the decreased usage of OPV in the sequential sched-
ule, because only two doses rather than four would 1. Risk of VAPP;
be given to each child. 2. Need for optimal intestinal immunity;
In almost all OPV recipients, reversion of attenu- 3. Number of injections required at scheduled visits
ated vaccine viruses to more virulent strains by re- to administer the recommended vaccines;
verse mutation after replication in the intestine 4. Possible increased number of visits resulting from
seems to occur.25,26 Although the proportion of vi- parental or provider preference to avoid addi-
ruses reverting to more virulent strains might not be tional injections at one or more visits;
reduced in OPV recipients who previously received 5. Possible decreased vaccination rates in infants and
two doses of IPV, the balance of the evidence indi- young children as a result of the increased num-
cates that the rate of excretion and frequency of ber of vaccine injections and visits to complete
revertants is not increased in persons who previ- sequential or IPV-only regimens;
ously received IPV.6,26 –28 6. Vaccine costs;
7. Parent and/or provider choice; and
RECOMMENDATIONS OF THE CDC (ACIP) 8. Introduction of new combination vaccines.
The ACIP, in considering the three strategy op-
tions for polio vaccination, concluded that although When these factors are considered, the choice of
OPV-only and IPV-only schedules are acceptable, the schedule should be based on the goal of reducing
sequential schedule of two doses of IPV followed by VAPP without compromising poliomyelitis immu-
302 POLIOMYELITIS PREVENTION
Downloaded from www.aappublications.org/news by guest on September 12, 2021nity or the delivery of other recommended childhood crease the number of injections at the 2- and 4-month
immunizations in both the public and private sec- visits:
tors. Accordingly, the American Academy of Pediat-
rics (AAP) recommends expanded use of IPV but 1. Hepatitis B vaccine can be administered at birth
recognizes that OPV only may be indicated for some and ages 1 and 6 months.
children to ensure timely completion of the routine 2. Additional visits can be scheduled, assuming that
childhood immunization schedule against other vac- the child is likely to return.
cine-preventable diseases. Once additional combina- 3. Available licensed combination products that re-
tion vaccines are widely available, an IPV-only duce the number of injections required to admin-
schedule should be feasible for all children in the ister recommended vaccines can be used.
United States, assuming global progress toward Alternatively, OPV can be given in place of IPV
elimination of poliovirus circulation continues. Even- until the combination vaccines become widely avail-
tually, assuming confirmation of worldwide eradica- able.
tion, poliovirus vaccination would be discontinued.
The considerations that support expanded use of RECOMMENDATIONS FOR POLIOMYELITIS
IPV apply primarily to countries where wild-type IMMUNIZATION OF INFANTS AND CHILDREN IN
poliovirus transmission has been interrupted for at THE UNITED STATES
least several years. OPV remains the vaccine of Expanded use of IPV is indicated during the tran-
choice for global eradication in the following areas: sition period of global eradication of poliomyelitis to
(1) areas where wild poliovirus has recently been or reduce the risk of VAPP and to maintain immunity
is currently circulating; (2) most developing coun- against wild-type poliovirus infection. The CDC
tries, where the higher cost of IPV prohibits its use; ACIP has recommended the sequential use of two
and (3) areas where inadequate sanitation necessi- doses of IPV followed by two doses of OPV as the
tates an optimal mucosal barrier to wild-type virus current public health strategy for prevention of po-
circulation. liomyelitis. Because logistic problems with the cur-
On the basis of these considerations, the AAP con- rent childhood immunization schedule may make
cludes that regimens of sequential IPV and OPV (eg these new recommendations for the use of IPV dif-
IPV followed by OPV), IPV only, and OPV only are ficult to implement immediately, their adoption
acceptable. The choice of schedule for most children likely will be gradual. Nevertheless, assuming con-
will depend on one or more of the following factors: tinued progress toward global eradication and the
1. Parent-provider choice; availability of additional combination vaccine prod-
2. Cost; ucts, the routine use of an IPV-only regimen is likely
3. Local public health recommendations; to become more feasible in future years. The AAP
4. Practice preference; recommends the following:
5. Product availability; and 1. Poliomyelitis vaccine should be given at 2, 4,
6. Expected completion of the entire immunization and 12 to 18 months and 4 to 6 years of age, for
schedule, concerns regarding injections and the a total of four doses at or before school entry.
need for additional visits, and the likelihood of For children who receive OPV only, the third
return for these visits. dose may be given as early as 6 months of age in
accordance with prior recommendations.11 An
Depending on circumstances, the ACIP-recom- additional dose at school entry is not indicated
mended sequential IPV and OPV regimen, the IPV- for children who received the third dose of any
only regimen, or the OPV-only regimen may be pre- licensed polio vaccine on or after their fourth
ferred. In the sequential regimen, two doses of OPV birthdays.
are necessary for optimal intestinal immunity. 2. Physicians have three options for immunizing
To implement these guidelines for these three ac- their patients. Regimens of sequential IPV and
ceptable regimens, a single schedule for the recom- OPV, IPV only, and OPV only are acceptable.
mended ages for administration of poliovirus vac- Each regimen has advantages and disadvantages,
cine, irrespective of which vaccine is to be given, has and in the circumstances described in recommen-
been developed. Accordingly, IPV and OPV in many dations 3 through 5, one may be preferred or
circumstances are considered interchangeable; the recommended. Parents or other care givers should
exception is in the sequential regimen, in which two be informed of the advantages and disadvantages
doses of OPV are necessary for optimal intestinal of the three acceptable regimens.
immunity. 3. Immunization with IPV only is recommended:
Children who have received one or more doses of • For immunocompromised persons and their
OPV can complete the four-dose series with IPV if household contacts, because OPV is contraindi-
desired. cated. The poliovirus is found in respiratory
secretions for several days and in the stool for
Issues in Scheduling IPV Administration several weeks after vaccination and transmis-
Until new combination vaccines are widely avail- sion to household contacts occurs frequently.
able, the administration of IPV necessitates addi- • For the infants and children for whom adult
tional injections. In scheduling IPV administration, household members are identified as being in-
the following options should be considered to de- adequately vaccinated against poliomyelitis,
Downloaded from www.aappublications.org/news byAMERICAN ACADEMY
guest on September 12, 2021 OF PEDIATRICS 303because unimmunized adults are at increased Walter A. Orenstein, MD
risk of VAPP.6 Centers for Disease Control and Prevention
• When the number of injections is not likely to N. Regina Rabinovich, MD
decrease compliance and when IPV is preferred National Institutes of Health
by health care providers and parents or other Benjamin Schwartz, MD
Centers for Disease Control and Prevention
care givers.
4. Immunization with OPV only is recommended: REFERENCES
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guest on September 12, 2021 OF PEDIATRICS 305Poliomyelitis Prevention: Recommendations for Use of Inactivated Poliovirus
Vaccine and Live Oral Poliovirus Vaccine
Committee on Infectious Diseases
Pediatrics 1997;99;300
DOI: 10.1542/peds.99.2.300
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Downloaded from www.aappublications.org/news by guest on September 12, 2021Poliomyelitis Prevention: Recommendations for Use of Inactivated Poliovirus
Vaccine and Live Oral Poliovirus Vaccine
Committee on Infectious Diseases
Pediatrics 1997;99;300
DOI: 10.1542/peds.99.2.300
The online version of this article, along with updated information and services, is
located on the World Wide Web at:
http://pediatrics.aappublications.org/content/99/2/300
Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it
has been published continuously since 1948. Pediatrics is owned, published, and trademarked by
the American Academy of Pediatrics, 345 Park Avenue, Itasca, Illinois, 60143. Copyright © 1997
by the American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.
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