POLIO VACCINE
DESCRIPTION:
MANUFACTURE AND COMPOSITION: Poliovirus Vaccine Live Oral Trivalent POLIO SABIN is a mixture of three types of attenuated polioviruses that have been propagated in monkey kidney cell culture. The cells are grown in the presence of Eagle's basal medium consisting of Earle's balanced salt solution containing amino acids,antibiotics, and calf serum. After cell growth, the medium is removed and
replaced with fresh medium containing the inoculating virus but no calf serum.
The final vaccine is diluted with a modified cell- culture maintenance medium
containing sorbitol. Each dose (0.5 mL) contains less than 25 micrograms of each
of the antibiotics, streptomycin and neomycin.
Potency of the vaccine is expressed in terms of the amount of virus (log10)
contained in the recommended dose as tissue culture infective doses (TCID50).
The human dose of vaccine containing all three virus types shall be constituted
to have infectivity titers in the final container material of 10 (raised to the
power of 5.4) to 10 (raised to the power of 6.4) for Type 1, 10 (raised to the
power of 4.5) to 10 (raised to the power of 5.5) for Type 2, and 10 (raised to
the power of 5.2) to 10 (raised to the power of 6.2) for Type 3, when the
primary monkey kidney tube titration method is used. (REF. 1) If the more
sensitive Hep-2 microtitration procedure is employed to determine the
infectivity titers in each human dose, then equivalent vaccine is achieved with
numerical infectivity titers of 10 (raised to the power of 6.0) to 10 (raised to
the power of 7.0) for Type 1, 10 (raised to the power of 5.1) to 10 (raised to
the power of 6.1) for Type 2, and 10 (raised to the power of 5.8) to 10 (raised
to the power of 6.8) for Type 3. (REF. 2)
ACTIONS/CLINICAL PHARMACOLOGY:
Administration of attenuated, live oral poliovirus vaccine (OPV) simulates
natural infection, inducing active mucosal and systemic immunity without
producing symptoms of disease. For optimal mucosal immunity to occur, it is
necessary for the viruses to multiply in the intestinal tract. A primary series
of trivalent vaccine is designed to produce an antibody response to poliovirus
Types 1, 2, and 3. This response is comparable to the immunity induced by the
natural disease. The antibodies thus formed help protect the individual against
clinical poliomyelitis infection by any of the three types of poliovirus.
Multiple sequential doses of OPV are administered to ensure that immunity to all
three types of poliovirus has been achieved. (REF. 3) When used in the
prescribed manner for immunization, type-specific neutralizing antibodies will
be induced in 95% or more of susceptibles. (REF. 4)
INDICATIONS AND USAGE:
This Vaccine Is Indicated For Use In The Prevention Of Poliomyelitis Caused By
Poliovirus Types 1, 2, And 3.
Infants from 6 to 12 weeks of age, All Unimmunized Children, and Adolescents up
to age 18 are the usual candidates for routine prophylaxis.
The Immunization Practices Advisory Committee (ACIP) of the Public Health
Service states that trivalent oral poliovirus vaccine (OPV) and inactivated
poliovirus vaccine (IPV) are both effective in preventing poliomyelitis.
The choice of OPV as the preferred poliovirus vaccine for primary administration
to children in the United States has been made by the ACIP, the Committee on
Infectious Diseases of the American Academy of Pediatrics, and a special expert
committee of the Institute of Medicine, National Academy of Sciences. (REF. 3-6)
OPV is preferred because it induces intestinal immunity, is simple to
administer, is well accepted by patients, results in immunization of some
contacts of vaccinated persons, and has a record of having essentially
eliminated disease associated with wild poliovirus in this country. (REF. 4) OPV
is also recommended for control of epidemic poliomyelitis. (REF. 3,5)
IPV is specifically indicated for use in immunodeficient individuals, their
household contacts, or in certain adults (see CONTRAINDICATIONS and INDICATIONS
AND USAGE: USE IN ADULTS for details). (REF. 6)
Prior to immunization, the parent, guardian, or adult patient should be informed
of the two types of poliovirus vaccines available, the risks and benefits of
each to the individual and to the community, and the reasons why recommendations
are made for giving specific vaccines under certain circumstances.
Past history of clinical poliomyelitis or prior vaccination with IPV in
otherwise healthy individuals does not preclude the administration of OPV when
otherwise indicated.
The simultaneous administration of OPV, diphtheria and tetanus toxoids and
pertussis vaccine (DTP), and/or measles-mumps-rubella vaccine (MMR), has
resulted in seroconversion rates and rates of side effects similar to those
observed when the vaccines are administered separately. (REF. 7)
Administration of Immune Globulin (IG), if necessary, within 7 days prior to
immunization with OPV does not reduce the antibody response to OPV based on a
study conducted in Peace Corps volunteers. (REF. 8)
USE IN ADULTS: Routine primary poliovirus immunization of adults (generally
those 18 years of age or older), residing in the United States, is not
recommended by the Immunization Practices Advisory Committee (ACIP).
Immunization Is recommended by the ACIP for certain adults who are at greater
risk of exposure to wild polioviruses than the general population, including
travelers to areas where poliomyelitis is endemic or epidemic, members of
communities or specific population groups with disease caused by wild
polioviruses, laboratory workers handling specimens that may contain
polioviruses, and health care workers in close contact with patients who might
be excreting polioviruses as follows:
Unimmunized Adults - primary immunization with enhanced-potency IPV is
recommended. However, if less than 1 month is available before protection is
needed, a single dose of either OPV or enhanced-potency IPV is recommended, with
the remaining doses given later if the person remains at increased risk.
Incompletely Immunized Adults who have had (1) at least one dose of OPV, (2)
fewer than three doses of conventional IPV, or (3) a combination of conventional
IPV and OPV totaling fewer than three doses, should receive at least one dose of
OPV or enhanced-potency IPV. Additional doses needed to complete a primary
series should be given prior to exposure, if time permits. Adults Who Have
Completed A Primary Series with any one or a combination of polio vaccines may
be given a dose of OPV or enhanced- potency IPV. (REF. 6)
Immunization with IPV may be undertaken in unimmunized or inadequately immunized
adults in households in which children are to be given OPV (see ADVERSE
REACTIONS). (REF. 3,6)
EPIDEMIC CONTROL: Poliovirus Vaccine Live Oral Trivalent has been recommended
for epidemic control. Within an epidemic area, OPV should be provided for all
persons over 6 weeks of age who have not been completely immunized or whose
immunization status is unknown, with the exceptions noted under
immunodeficiency. (REF. 3,5) (See CONTRAINDICATIONS).
In certain tropical endemic areas, where poliomyelitis has been increasing in
recent years, the physician may wish to administer OPV to the infant at birth.
Because successful immunization is less likely in newborn infants, a complete
series of OPV should follow the neonatal dose beginning when the infants are 2
months old. (REF. 3) If the physician elects to immunize the infant at birth, it
may be prudent to wait until the child is 3 days old, and to recommend
abstention from breast-feeding for 2 to 3 hours before and after oral
immunization to minimize exposure of the vaccine viruses to colostrum and to
permit the establishment of the vaccine viruses in the gut. (REF. 9)
CONTRAINDICATIONS:
Under No Circumstances Should This Vaccine Be Administered Parenterally.
POLIO SABIN MUST NOT BE ADMINISTERED TO PATIENTS WITH IMMUNE DEFICIENCY DISEASES
SUCH AS COMBINED IMMUNODEFICIENCY, HYPOGAMMAGLOBULINEMIA, AND
AGAMMAGLOBULINEMIA. FURTHER, POLIO SABIN MUST NOT BE ADMINISTERED TO PATIENTS WITH
ALTERED IMMUNE STATES, SUCH AS THOSE OCCURRING IN HUMAN IMMUNODEFICIENCY VIRUS
(HIV) INFECTION, THYMIC ABNORMALITIES, LEUKEMIA, LYMPHOMA, GENERALIZED
MALIGNANCY, OR ADVANCED DEBILITATING CONDITIONS, OR BY LOWERED RESISTANCE FROM
THERAPY WITH CORTICOSTEROIDS, ALKYLATING DRUGS, ANTIMETABOLITES, OR RADIATION.
BECAUSE VACCINE VIRUSES ARE EXCRETED BY THE VACCINEE, AND MAY SPREAD TO
CONTACTS, POLIO SABIN SHOULD NOT BE USED IN FAMILIES WITH IMMUNODEFICIENT MEMBERS.
(REF. 3,4)
RECIPIENTS OF THE VACCINE SHOULD AVOID CLOSE HOUSEHOLD-TYPE CONTACT WITH ALL
PERSONS WITH ALTERED IMMUNE STATUS FOR AT LEAST 6 TO 8 WEEKS.
BECAUSE OF THE POSSIBILITY OF IMMUNODEFICIENCY IN OTHER CHILDREN BORN TO A
FAMILY IN WHICH THERE HAS BEEN ONE SUCH CASE, OPV SHOULD NOT BE GIVEN TO A
MEMBER OF A HOUSEHOLD IN WHICH THERE IS A FAMILY HISTORY OF IMMUNODEFICIENCY
UNTIL THE IMMUNE STATUS OF THE INTENDED RECIPIENT AND OTHER CHILDREN IN THE
FAMILY IS DETERMINED TO BE NORMAL. (REF. 4)
IMMUNIZATION OF ALL PERSONS IN THE ABOVE DESCRIBED CIRCUMSTANCES SHOULD BE WITH
IPV.
WARNINGS:
Under No Circumstances Should This Vaccine Be Administered Parenterally.
Immunization should be deferred during the course of any febrile illness or
acute infection. In addition, immunization should be deferred in the presence of
persistent vomiting or diarrhea, or suspected gastroenteritis infection. Other
viruses (including poliovirus and other enteroviruses) may compromise the
desired response to this vaccine, since their presence in the intestinal tract
may interfere with replication of the attenuated strains of poliovirus.
PRECAUTIONS:
The vaccine is not effective in modifying or preventing cases of existing and/or
incubating poliomyelitis.
RECORDS REQUIRED BY THE NATIONAL CHILDHOOD VACCINE INJURY ACT: This Act requires
that the manufacturer and lot number of the vaccine administered be recorded by
the health care provider in the vaccine recipient's permanent record, along with
the date of administration of the vaccine and the name, address, and title of
the person administering the vaccine.
The Act further requires that the health care provider report to a health
department or to the FDA the occurrence, following immunization, of any event
set forth in the Vaccine Injury Table, including: paralytic poliomyelitis--in a
nonimmunodeficient recipient within 30 days of vaccination,--in an
immunodeficient recipient within 6 months of vaccination; any vaccine-
associated community case of paralytic poliomyelitis; or any acute complication
or sequela (including death) of above events. (REF. 10)
USE IN PREGNANCY: Pregnancy Category C: Animal reproduction studies have not
been conducted with Poliovirus Vaccine Live Oral Trivalent. It is also not known
whether OPV can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity.
Although there is no convincing evidence documenting adverse effects of either
OPV or IPV on the developing fetus or pregnant women, it is prudent on
theoretical grounds to avoid vaccinating pregnant women. However, if immediate
protection against poliomyelitis is needed, OPV is recommended. (REF. 3,6) (See
CONTRAINDICATIONS and ADVERSE REACTIONS.)
DRUG INTERACTIONS:
SEE CONTRAINDICATIONS
ADVERSE REACTIONS:
PARALYTIC DISEASE FOLLOWING THE INGESTION OF LIVE POLIOVIRUS VACCINES HAS BEEN,
ON RARE OCCASION, REPORTED IN INDIVIDUALS RECEIVING THE VACCINE, AND IN PERSONS
WHO WERE IN CLOSE CONTACT WITH VACCINEES. (REF. 3,4,11,12) THE VACCINE VIRUSES
ARE SHED IN THE VACCINEE'S STOOLS UP TO 6 TO 8 WEEKS AS WELL AS VIA THE
PHARYNGEAL ROUTE. MOST REPORTS OF PARALYTIC DISEASE FOLLOWING INGESTION OF THE
VACCINE OR CONTACT WITH A RECENT VACCINEE ARE BASED ON EPIDEMIOLOGICAL ANALYSIS
AND TEMPORAL ASSOCIATION BETWEEN VACCINATION OR CONTACT AND THE ONSET OF
SYMPTOMS, AND MOST AUTHORITIES BELIEVE THAT A CAUSAL RELATIONSHIP EXISTS. (REF.
2,5,10,11,12)
A RETROSPECTIVE STUDY OF A LARGE POPULATION GIVEN OPV SUGGESTS THAT THIS VACCINE
MAY ALSO BE TEMPORALLY ASSOCIATED WITH GUILLAIN-BARRE SYNDROME. (REF. 13) A
CAUSAL RELATIONSHIP HAS NOT BEEN ESTABLISHED.
PRIOR TO ADMINISTRATION OF THE VACCINE, ATTENDING PHYSICIANS SHOULD WARN OR
SPECIFICALLY DIRECT PERSONNEL ACTING UNDER THEIR AUTHORITY TO CONVEY THE
WARNINGS TO THE VACCINEE, PARENT, GUARDIAN, OR OTHER RESPONSIBLE PERSON OF THE
POSSIBILITY OF VACCINE-ASSOCIATED PARALYSIS, PARTICULARLY TO THE RECIPIENT,
SUSCEPTIBLE FAMILY MEMBERS, AND OTHER CLOSE PERSONAL CONTACTS. (REF. 3,4)
THE CENTERS FOR DISEASE CONTROL AND PREVENTION REPORTS THAT DURING THE YEARS
1973 THROUGH 1984 APPROXIMATELY 274.1 MILLION OPV DOSES WERE DISTRIBUTED IN THE
UNITED STATES. DURING THIS SAME PERIOD, 105 VACCINE-ASSOCIATED CASES WERE
REPORTED (1 CASE PER 2.6 MILLION DOSES DISTRIBUTED). OF THESE 105 CASES, 35
OCCURRED IN VACCINE RECIPIENTS (1 CASE PER 7.8 MILLION DOSES DISTRIBUTED), 50
OCCURRED IN HOUSEHOLD AND NONHOUSEHOLD CONTACTS OF VACCINEES (1 CASE PER 5.5
MILLION DOSES DISTRIBUTED), 14 OCCURRED IN IMMUNODEFICIENT RECIPIENTS OR
CONTACTS, AND 6 OCCURRED IN PERSONS WITH NO HISTORY OF VACCINE EXPOSURE, FROM
WHOM VACCINE-LIKE VIRUSES WERE ISOLATED. (REF. 11)
THIRTY-THREE (94%) OF THE RECIPIENT CASES, 41 (82%) OF THE CONTACT CASES, AND 5
(36%) OF THE IMMUNE DEFICIENT CASES WERE ASSOCIATED WITH THE RECIPIENT'S FIRST
DOSE OF OPV. BECAUSE MOST CASES OF VACCINE-ASSOCIATED PARALYSIS HAVE OCCURRED IN
ASSOCIATION WITH THE FIRST DOSE, THE CDC HAS ESTIMATED THE LIKELIHOOD OF
PARALYSIS IN ASSOCIATION WITH FIRST V SUBSEQUENT DOSES OF OPV, USING THE NUMBER
OF BIRTHS DURING 1973-1984 TO ESTIMATE THE NUMBER OF FIRST DOSES DISTRIBUTED,
AND SUBTRACTING THIS FROM THE TOTAL DISTRIBUTION TO ESTIMATE THE NUMBER OF
SUBSEQUENT DOSES DISTRIBUTED. THIS METHOD ESTIMATES A FREQUENCY OF PARALYSIS FOR
RECIPIENTS OF ONE CASE PER 1.2 MILLION FIRST DOSES V ONE CASE PER 116.5 MILLION
SUBSEQUENT DOSES; FOR CONTACTS, ONE CASE PER 1 MILLION FIRST DOSES V ONE CASE
PER 25.9 MILLION SUBSEQUENT DOSES; WITH AN OVERALL FREQUENCY OF 1 CASE PER
520,000 FIRST DOSES V ONE CASE PER 12.3 MILLION SUBSEQUENT DOSES. (REF. 11)
OTHER METHODS OF ESTIMATING THE LIKELIHOOD OF PARALYSIS IN ASSOCIATION WITH OPV
HAVE BEEN DESCRIBED. BECAUSE THE NUMBER OF SUSCEPTIBLE VACCINE RECIPIENTS OR
CONTACTS OF RECIPIENTS IS NOT KNOWN, THE TRUE RISK OF VACCINE-ASSOCIATED
POLIOMYELITIS IS IMPOSSIBLE TO DETERMINE PRECISELY. (REF. 10)
WHEN THE ATTENUATED VACCINE STRAINS ARE TO BE INTRODUCED INTO A HOUSEHOLD WITH
ADULTS WHO ARE UNIMMUNIZED OR WHOSE IMMUNE STATUS CANNOT BE DETERMINED, THE RISK
OF VACCINE-ASSOCIATED PARALYSIS CAN BE REDUCED BY GIVING THESE ADULTS TWO DOSES
OF ENHANCED POTENCY IPV A MONTH APART BEFORE THE CHILDREN RECEIVE POLIOVIRUS
VACCINE LIVE ORAL TRIVALENT POLIO SABIN. THE CHILDREN MAY RECEIVE THE FIRST DOSE OF
POLIO SABIN AT THE SAME VISIT THAT THE ADULTS RECEIVE THE SECOND DOSE OF ENHANCED
POTENCY IPV. FOR PARTIALLY IMMUNIZED ADULT CONTACTS, A BOOSTER DOSE OF ENHANCED
POTENCY IPV CAN BE GIVEN AT THE SAME VISIT THAT THE FIRST DOSE OF OPV IS GIVEN
TO THE CHILD. (REF. 3)
THE RESPONSIBLE ADULT SHOULD ALSO BE INFORMED OF PRECAUTIONS TO BE TAKEN SUCH AS
HANDWASHING AFTER DIAPER CHANGES. (REF. 14)
THE ACIP STATES: "BECAUSE OF THE OVERRIDING IMPORTANCE OF ENSURING PROMPT AND
COMPLETE IMMUNIZATION OF THE CHILD AND THE EXTREME RARITY OF OPV-ASSOCIATED
DISEASE IN CONTACTS, THE COMMITTEE RECOMMENDS THE ADMINISTRATION OF OPV TO A
CHILD REGARDLESS OF THE POLIOVIRUS-VACCINE STATUS OF ADULT HOUSEHOLD CONTACTS.
THIS IS THE USUAL PRACTICE IN THE UNITED STATES. THE RESPONSIBLE ADULT SHOULD BE
INFORMED OF THE SMALL RISK INVOLVED. AN ACCEPTABLE ALTERNATIVE, IF THERE IS A
STRONG ASSURANCE THAT ULTIMATE, FULL IMMUNIZATION OF THE CHILD WILL NOT BE
JEOPARDIZED OR UNDULY DELAYED, IS TO IMMUNIZE ADULTS. . . (WITH IPV). . . BEFORE
GIVING OPV TO THE CHILD." (REF. 4)
The American Academy of Pediatrics and the American College of Physicians have
made similar recommendations. (REF. 3,14)
DOSAGE AND ADMINISTRATION:
POLIO SABIN is to be administered Orally, Under The Supervision Of A Physician.
Under No Circumstances Should This Vaccine Be Administered Parenterally. For
convenience, the vaccine is supplied in a disposable pipette containing a single
dose of 0.5 mL which should be administered directly into the mouth of the
vaccinee. Breast feeding does not interfere with successful immunization when
OPV is administered according to the following schedule. (REF. 4)
PRIMARY SERIES: The primary series consists of three doses.
Infants: The ACIP and AAP recommend that the first dose of OPV be administered
when the infant is approximately 2 months (6 to 12 weeks) of age. The second
dose should be given not less than 6 and preferably 8 weeks later, commonly at 4
months of age. A third dose of OPV should be given when the child is
approximately 15 to 18 months of age to complete the primary series, but may be
given at any time between 12 and 24 months of age. (REF. 3) In endemic areas an
additional dose administered 2 months after the second dose is desirable. (REF.
3,4)
Older Children And Adolescents (Up To 18 Years Of Age): Unimmunized children and
adolescents should receive two doses given not less than 6 and preferably 8
weeks apart, followed by a third dose 6 to 12 months after the second dose. If
there is substantial risk of exposure to polio, the third dose should be given 6
to 8 weeks after the second dose. (REF. 3,4)
Children at any age who are unimmunized or partially immunized should receive
the number of doses necessary to complete the required series of 3 doses. If the
schedule has been interrupted, the series does not need to be reinitiated. (REF.
3,7)
Adults: See INDICATIONS and ADVERSE REACTIONS. Where OPV is given to unimmunized
adults the dosage regimen is as indicated for older children and adolescents.
SUPPLEMENTAL DOSES: School Entry: On entering elementary school, all children
who have completed the primary series should be given a single follow-up dose of
OPV (REF. 3,4) (all others should complete the primary series). The fourth
supplemental dose is not required in those who received the third primary dose
on or after their fourth birthday. (REF. 3,4) The ACIP and AAP do not recommend
routine booster doses of vaccine beyond that given at the time of entering
school. (REF. 3,4) It has been shown that over 95% of children studied 5 years
after full immunization with oral polio vaccine had protective antibodies to all
three types of poliovirus. (REF. 15)
INCREASED RISK: If an individual who has completed a primary series is subjected
to a substantially increased risk because of personal contact, travel, or
occupation, a single dose of OPV may be given. (REF. 3,4)
SIMULTANEOUS ADMINISTRATION WITH OTHER VACCINES
The simultaneous administration of OPV, diphtheria and tetanus toxoids and
pertussis vaccine (DTP), and/or measles-mumps-rubella vaccine (MMR), has
resulted in seroconversion rates and rates of side effects similar to those
observed when the vaccines are administered separately. (REF. 7) The AAP states
that OPV, DTP, MMR and/or Haemophilus b conjugate vaccines may be given
concomitantly. (REF. 3,16)
STORAGE
To maintain the potency of Poliovirus Vaccine Live Oral Trivalent POLIO SABIN, it is
necessary to store this vaccine at a temperature which will maintain ice
continuously in a solid state (below 0 deg C or 32 deg F). However, since the
vaccine contains sorbitol it may remain fluid at temperatures above -14 deg C
(+7 deg F). Ice cubes that remain frozen continuously when stored in the same
freezer compartment will confirm that the temperature is appropriate for storage
of POLIO SABIN. If frozen, the vaccine must be completely thawed prior to use. A
container of vaccine that has been frozen and then is thawed may be carried
through a maximum of 10 freeze- thaw cycles, provided the temperature does not
exceed 8 deg C (46 deg F) during the periods of thaw, and provided the total
cumulative duration of thaw does not exceed 24 hours. If the 24-hour period is
exceeded, the vaccine must then be used within 30 days, during which time it
must be stored at a temperature between 2 deg C to 8 deg C (36 deg F to 46 deg
F). Ideally, an POLIO SABIN DISPETTE(R) should be removed from the freezer and
thawed immediately prior to use.
COLOR CHANGE: This vaccine contains phenol red as a pH indicator. The usual
color of the vaccine is pink, although some containers of vaccine, shipped or
stored in dry ice, may exhibit a yellow coloration due to the very low
temperature or possible absorption of carbon dioxide. The color of the vaccine
prior to use (red-pink- yellow) has no effect on the virus or efficacy of the
vaccine.
DIRECTIONS FOR USE: Pull off the protective cap and squeeze to expel contents
into the vaccinee's mouth.
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INACTIVATED POLIO VACCINE (IPV)
IPV is formaldehyde killed poliovirus grown in monkey kidney cell/human diploid cells. Old IPV contained 20,8 and 32 D antigen units of types 1, 2 and 3 polioviruses respectively, All currently used IPV vaccines are enhanced potency IPV (elPV) which contains 40,8 and 32 D antigen units of type 1,2 and 3 respectively. Currently term IPV means elPV. It is highly immunogenic. Seroconversion rates are 90-95% after two doses given after the age of 2 months and at ? months interval and 99% after three doses given even when it is started at 6 weeks of age and given an 4 weeks interval. It produces excellent humoral immunity as well as local pharyngeal and, possible intestinal immunity. The vaccine is very sate. It is now licensed. to_be used in India by Drug Controller General of India.
IPV can be used in combination with DTwP and Hib vaccines without compromising seroconversion or increasing side effects. Ideal age to give first dose of IPV is 8 weeks and the interval between two doses should also be 8 weeks. However if 3 primary doses are given, vaccine could be started at 6 weeks of age and could be given at 4 weeks interval without any compromise in the seroconversion rates.
Scientifically and immunologically schedule of giving two doses of IPV starting_at_2 months of age and given at 2 months interval followed by a booster at around 15 months is similar to a schedule of giving 3 doses starting from 6 weeks of age and given at 4 weeks interval followed by a booster at 15 months (even in developing countries) However in our country the latter schedule of 3 primary doses is better logistically as it can be given along with DTP at 6, 10 and 14 weeks followed by a booster at 15 months. In any case.the birth dose of OPV must be given and all the OPV doses on the days of SIAs should be given to all the children.
As the number of wild poliovirus cases in the country decreases it is inevitable that one would have to gradually shift from OPV to IPV irTthe
next few years. The government should, therefore, consider incorporating IPV in the national immunization schedule in a phased
manner. IPV can also be an additional tool to eradicate wild polio from last few high risk difficult districts.
IPV is also the vaccine of choice in patients with immunodeficiency and the preferred vaccine in children with symptomatic HIV infection.
INACTIVATED POLIO VACCINE (IPV) (Role of IPV vis a vis OPV)
OPV is cheaper & being aivenorally and so more acceptable. However it is less efficacious in tropical country like India due to interference with other enteroviruses and other unknown factors It also needs strict cold chain maintenance. Where as IPV is more efficacious, less thermolabile and has no chance of inducing vaccine induced paralysis. Of late IPV has been shown to induce local gut immunity as well as herd effect. Coverage of children less than 2 years in high risk areas with 2-3 doses of IPV can be an additional tool to eradicate polio from our country. The cost and availability of vaccine can be a problem.
REFERENCES:
1. Code Of Federal Regulations. 21 CFR:630.17(c), page 94, Revised April 1,
1989.
2. Albrecht P, Enterline JC, Boone EJ, et al. Poliovirus and polio antibody
assay in Hep-2 and Vero cell cultures. J Biol Stand. 1983; 11:91-97.
3. Report Of The Committee On Infectious Diseases. American Academy Of
Pediatrics. 21st Edition, 1988; 334-342. Elk Grove Village, IL
4. Recommendations of the Immunization Practices Advisory Committee (ACIP).
Poliomyelitis Prevention. MMWR. 1982; 31(3):22-34.
5. An evaluation of poliomyelitis vaccine policy options. Institute of
Medicine, National Academy of Sciences, 1988. Publication No. 10M 88-04.
6. ACIP. Poliomyelitis prevention: Enhanced- Potency Inactivated Poliomyelitis
Vaccine- -Supplementary Statement. MMWR. 1987; 36(48):795-798.
7. ACIP. General recommendations on immunization. MMWR. 1989; 38(13):206-227.
8. Kaplan JE, Nelson DB, Schonberger LB, et al. The effect of immune globulin
on the response to trivalent oral poliovirus and yellow fever vaccinations. Bull
WHO. 1984; 62(4):585-590.
9. Welsh JH, et al. Anti-infective properties of breast milk. J Pediatr. 1979;
94(1):1-9.
10. National Childhood Injury Act: Requirements for permanent vaccination
records and for reporting of selected events after vaccination. MMWR. 1988;
37(13):197-200.
11. Nkowane BM, Wassilak SGF, Orenstein WA, et al. Vaccine-associated paralytic
poliomyelitis. United States: 1973 through 1984. JAMA. 1987; 257(10):1335-1340.
12. Esteves K. Safety of oral poliomyelitis vaccine: results of a WHO enquiry.
Bull WHO. 1988; 66(6):739-746.
13. Kinnunen E, Farkkila M, Hovi T, et al. Incidence of Guillain-Barre syndrome
during a nationwide oral poliovirus vaccine campaign. Neurology. 1989; 39:1034-
1036.
14. Guide for Adult Immunization. American College of Physicians, 2nd Edition,
25, 1990. Philadelphia, PA.
15. Krugman RD, et al. Antibody persistence after primary immunization with
trivalent oral poliovirus vaccine. Pediatrics. 1977; 60(1):80-82.
16. American Academy of Pediatrics, Haemophilus Influenzae Type B Conjugate
Vaccines. Immunization of children 2 to 15 months of age. PED COMM: AAP MEMBER
ALERT, October 1990.
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