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Recommendation
of the Immunization Practices Advisory Committee (ACIP) Rubella Prevention
MMWR 33(22);301-10,315-8
Publication date: 06/08/1984
Table of Contents
RUBELLA
SEROLOGY TESTING AND IMMUNITY
LIVE
RUBELLA VIRUS VACCINE
Vaccine
Shipment and Storage
VACCINE
USE
General
Recommendations
Dosage
Age
at Vaccination
Vaccination
of Women of Childbearing Age
Use
of Vaccine Following Exposure
Use
of Human Immune Globulin Following Exposure
Recent
Administration of IG
SIDE
EFFECTS AND ADVERSE REACTIONS
PRECAUTIONS
AND CONTRAINDICATIONS
Pregnancy
Febrile
Illness
Allergies
Altered
Immunity
ELIMINATION
OF CRS
Ongoing
Programs
Premarital
Screening and Vaccination
Postpartum
Vaccination
Routine
Vaccination in any Medical Setting
Vaccination
of Medical Personnel
Vaccination
of Workers
Vaccination
for College Entry
General
Principles
Outbreak
Control
SURVEILLANCE
Laboratory
Diagnosis
Adverse
Events
POINT
OF CONTACT FOR THIS DOCUMENT:
SUMMARY
These revised Immunization Practices Advisory Committee
(ACIP) recommendations for the prevention of rubella update the previous
recommendations (MMWR 1981;30:37-42, 47) to include current information about
vaccine effectiveness, duration of immunity, vaccination in pregnancy, and
progress in controlling congenital rubella syndrome.
While there are no basic changes in approach, the available epidemiologic
data indicate that the elimination of congenital rubella syndrome can be
achieved and even hastened by focusing particular attention on more effective
delivery of vaccine to older individuals--particularly women of childbearing
age. The importance of vaccinating preschool-aged children is also emphasized.
As the incidence of rubella declines, serologic confirmation of cases becomes
more important. Recommendations for international travel are included.
INTRODUCTION
Rubella is a common childhood rash disease. It is often
overlooked or misdiagnosed because its signs and symptoms vary. The most
common--post-auricular and suboccipital lymphadenopathy, arthralgia, transient
erythematous rash, and low fever--may not be recognized as rubella. Similar
exanthematous illnesses are caused by adenoviruses, enteroviruses, and other
common respiratory viruses. Moreover, 25%-50% of infections are subclinical.
Transient polyarthralgia and polyarthritis sometimes accompany or follow
rubella. Among adults, and particularly among women, joint manifestations occur
so frequently (up to 70%), they may be considered an expected manifes- tation
of adult infection. Central nervous system complications and thrombocytopenia
have been reported at rates of 1/6,000 cases and 1/3,000 cases, respectively.
The former is more likely to occur among adults; the latter, among children.
By far the most important consequences of rubella are the abortions,
miscarriages, stillbirths, and fetal anomalies that result from rubella
infection in early pregnancy, especially in the first trimester. Preventing
fetal infection and consequent congenital rubella syndrome (CRS) is the
objective of rubella immunization programs.
The most commonly described anomalies associated with CRS are
ophthal-mologic (cataracts, microphthalmia, glaucoma, chorioretinitis), cardiac
(patent ductus arteriosus, pulmonary artery stenosis, atrial or verticular
septal defects), auditory (sensorineural deafness), and neurologic
(microcephaly, meningoencephalitis, mental retardation). In addition, infants
with CRS frequently are retarded in growth and have radiolucent bone disease,
hepatosplenomegaly, thrombocytopenia, and purpuric skin lesions (blueberry-
muffin appearance). Moderate and severe cases of CRS are readily recognizable
at birth; mild cases (e.g., those with only slight cardiac involvement or
deafness) may not be detected for months or even years after birth. Although
CRS has been estimated to occur among 20%-25% or more of infants born to women
who acquire rubella during the first trimester, the actual risk of infection
and subsequent defects may be considerably higher. If infected infants are
followed for at least 2 years, up to 80% of infants will be found to be
affected. The risk of any defect falls to approximately 10%-20% by the 16th
week, with defects rarely occurring after infection beyond the 20th week.
However, fetal infection without clinical stigmata of CRS can occur at any
stage of pregnancy. Inapparent maternal rubella infection can also result in
malformations.
The average life-time expenditure associated with a CRS infant has recently
been estimated to be in excess of $220,000, which includes costs associated
with institutionalization of the retarded, blind, and/or deaf and the education
of hearing- and sight-impaired teenagers and adolescents.
Postinfection immunity appears to be long-lasting. However, as with other
viral diseases, reexposure to natural rubella occasionally leads to reinfection
without clinical illness or detectable viremia. Because many rash illnesses may
mimic rubella infection, and because many rubella infections are unrecognized,
the only reliable evidence of immunity to rubella is the presence of specific
antibody. Laboratories that regularly perform antibody testing are generally
the most reliable, because their reagents and procedures are strictly
standardized (see below).
Before rubella vaccines became available in 1969, most rubella cases
occurred among school-aged children. Since control of rubella in the United
States was based on interrupting transmission, the primary target group for
vaccine was children of both sexes. Secondary emphasis was placed on
vaccinating susceptible adolescents and young adults, especially women. By
1977, vaccination of children 12 months of age and older had resulted in a
marked decline in the reported rubella incidence among children and had
interrupted the characteristic 6- to 9-year rubella epidemic cycle. However,
this vaccination strategy had less effect on reported rubella incidence among
persons 15 years of age and older (i.e., childbearing ages for women) who
subsequently accounted for more than 70% of reported rubella patients with
known ages. Approximately 10%-20% of this latter population continued to be
susceptible, a proportion similar to that of prevaccine years, and reported CRS
continued at a low but constant endemic level (an annual average of 32 reported
confirmed and compatible cases* between 1971 and 1977).
Increased efforts were made to effectively vaccinate junior and senior high
school students and to enforce rubella immunization requirements for school
entry. All susceptible military recruits began to receive rubella vaccine.
Published accounts of rubella outbreaks in hospitals caused concern about the
need to screen and/or vaccinate susceptible personnel. A number of states
stressed the need for ensuring proof of rubella immunity (i.e. docu- mentation
of vaccination or seropositivity) for college entrance. These factors, combined
with the 1977 Childhood Immunization Initiative and the 1978 Measles
Elimination effort (which encouraged use of combined vaccines containing
measles and rubella antigens), have led to decreases in reported rubella in all
age groups.
The number of rubella vaccine doses administered in the public sector to
persons 15 years of age and older doubled between 1978 and 1981. By 1980,
reported incidence among adolescents and young adults was lower than that among
young children. Children under 5 years of age had the highest overall incidence
and accounted for approximately one-fourth of all rubella patients with known
ages. Compared with prevaccine years, by 1981 the overall reported rate of
rubella had declined by 96%, with a 90% or greater decrease in cases in all age
groups. Predictably, the number of reported confirmed and compatible CRS cases
started to decline further (provisional totals of 14 cases for 1980 and 10 for
1981).
By 1982, more than 118 million doses of rubella virus vaccine had been
distributed in the United States. However, the reported incidence of rubella
rose slightly between 1981 and 1982 due to isolated outbreaks in adolescent and
young adult populations and particularly in hospitals and universities. As
expected, the reported number of confirmed and compatible CRS cases had
increased slightly (a provisional total of 11 for 1982). While children under 5
years of age still had the highest reported incidence of rubella, they
accounted for only half as many cases in 1982 as in 1981 (20% compared with
38%). In contrast, persons 15 years of age or older accounted for almost twice
as many cases in 1982 as in 1981 (62% compared with 36%) and had a twofold
increase in their estimated rate (from 0.4 cases/100,000 population in 1981 to
0.8/100,000 in 1982). The greatest increase in reported rates within this age group
occurred in those 25-29 years of age. The provisional data for 1983 indicate a
record low number of rubella cases (934) was reported to CDC; the reported
confirmed and compatible CRS total is only four. However, assuming the slight
increase in reported rubella among older individuals between 1981 and 1982 was
real, it indicates that rubella in postpubertal populations is still a problem
in this country and continues to deserve particular attention.
RUBELLA SEROLOGY TESTING AND IMMUNITY
Until recently, hemagglutination-inhibition (HI) antibody
testing has been the most frequently used method of screening for the presence
of rubella antibodies. However, the HI test is now being supplanted by a number
of equally or more sensitive assays to determine rubella immunity. These
include latex agglutination, fluorescence immunoassay, passive
hemagglutination, hemolysis-in-gel, and enzyme immunoassay (EIA) tests. When
adults who have failed to produce detectable HI antibodies following
vaccination have been examined more closely, almost all have had detectable
antibody by a more sensitive test. Similarly, a small number of children who
initially seroconverted has lost detectable HI antibody over 10 years of
follow-up. However, almost all have had detectable antibody by more sensitive
tests. Immunity was confirmed in a number of these children by documenting a
booster response (i.e., no immunoglobulin M {IgM} antibody and a rapid rise and
fall in immunoglobulin G {IgG} antibody) following revaccination.
Although it is recognized that some individuals possess antibody levels
following previous vaccination or infection that are below the detectable level
of the reference HI test, the clinical significance of such low level antibody
has not been well documented outside the study setting. Limited data suggest
that, on rare occasions, viremia has occurred in persons with low antibody
levels. Further study is warranted to assess the appropriate interpretation of
antibodies detectable only by these more sensitive tests. Use of an
internationally accepted standard would greatly facilitate resolution of this
uncertainty. The available data continue to support the fact that any level of
detectable antibody should be considered presumptive evidence of immunity.
LIVE RUBELLA VIRUS VACCINE
The live rubella virus vaccine** currently distributed in
the United States is prepared in human diploid cell culture. In January 1979,
this vaccine (RA 27/3) replaced the HPV-77:DE-5 vaccine grown in duck embryo
cell culture. Although both subcutaneous and intranasal administration of the
vaccine have been studied, it is licensed only for subcutaneous administration.
The vaccine is produced in monovalent form (rubella only) and in combinations:
measles-rubella (MR), rubella-mumps, and measles-mumps-rubella (MMR) vaccines.
In clinical trials, 95% or more of susceptible persons who received a single
dose of rubella vaccine when they were 12 months of age or older developed
antibody. Clinical efficacy and challenge studies have shown that more than 90%
of vaccinees can be expected to have protection against both clinical rubella
and asymptomatic viremia for a period of at least 15 years. Based on available
follow-up studies, vaccine-induced protection is expected to be life-long.
Therefore, a history of vaccination is presumptive evidence of immunity.
Although vaccine-induced titers are generally lower than those stimulated by
rubella infection, vaccine-induced immunity usually protects against both
clinical illness and viremia after natural exposure. There have been, however,
a small number of reports indicating that viremic reinfection following
exposure may occur in vaccinated individuals with low levels of detectable
antibody. The frequency and consequences of this phenomenon are currently
unknown, but its occurrence is believed rare. Such reports are to be expected,
since there are also rare reports of clinical reinfection and fetal infection
following natural immunity.
Some vaccinees intermittently shed small amounts of virus from the pharynx
7-28 days after vaccination. However, studies of more than 1,200 susceptible
household contacts and experience gained over 15 years of vaccine use have
yielded good evidence that vaccine virus is not transmitted. These data
indicate that vaccinating susceptible children, whose mothers or other
household contacts are pregnant, does not present a risk. Rather, vaccination
of such children provides protection for these pregnant women.
Vaccine Shipment and Storage
Administering improperly stored vaccine may result in lack
of protection against rubella. During storage, before reconstitution, rubella
vaccine must be kept at 2 C-8 C (35.6 F-46.4 F) or colder. It must also be
protected from light, which may inactivate the virus. Reconstituted vaccine should
be discarded if not used within 8 hours. Vaccine must be shipped at 10 C (50 F)
or colder and may be shipped on dry ice.
VACCINE USE
General Recommendations
Persons 12 months of age or older should be vaccinated,
unless they are immune. Persons can be considered immune to rubella only if
they have documentation of:
- Laboratory evidence of
rubella immunity or
- Adequate immunization with
rubella vaccine on or after the first birthday.
The clinical diagnosis of rubella is unreliable and should
not be considered in assessing immune status.
All other children, adolescents, and adults--particularly women--are
considered susceptible and should be vaccinated if there are no contraindi-
cations (see below). This includes persons who may be immune to rubella but who
lack adequate documentation of immunity. Vaccinating children protects them
against rubella and prevents their spreading the virus. Vaccinating susceptible
postpubertal females confers individual protection against rubella-induced
fetal injury. Vaccinating adolescent or adult females and males in high-risk
population groups, such as those in colleges, places of employment, or military
bases, protects them against rubella and reduces the chance of epidemics. This
is exemplified by the experience with vaccinating all military recruits, which
has virtually eliminated rubella from military bases. Similar results could be
achieved by ensuring proof of immunity of all employees, all college students
and staff, and all hospital personnel, including physicians, nurses,
health-profession students, technicians, dietary workers, etc.
As discussed above, it is generally believed that any detectable antibody
titer specific for rubella (whether resulting from vaccination or from
naturally acquired rubella), even if very low, should be considered evidence of
protection against subsequent viremic infection--including the reported
"reinfection" of persons with low levels of antibody demonstrated by
boosts in antibody titer. This suggests that immune females reinfected during
pregnancy would be unlikely to infect their fetuses. Moreover, because there is
very little pharyngeal excretion, there appears to be no risk to susceptible
contacts in such reinfection settings. In view of the data on reinfection
accumulated during the past decade, the ACIP sees no reason to revaccinate
persons with low levels of rubella antibody. Rather, more attention should be
directed toward vaccinating the truly susceptible population.
Dosage
A single dose of 0.5 cc of reconstituted vaccine (as a
monovalent or preferably a combination product such as MR or MMR) should be
administered subcutaneously.
Age at Vaccination
Live rubella virus is recommended for all children 12 months
of age or older. It should not be given to younger infants, because persisting
maternal antibodies may interfere with seroconversion. When the rubella vaccine
is part of a combination that includes the measles antigen, the combination
vaccine should be given to children at 15 months of age or older to maximize
measles seroconversion. Older children who have not received rubella vaccine
should be vaccinated promptly. Because a history of rubella illness is not a
reliable indicator of immunity, all children should be vaccinated unless there
are contraindications (see below).
Vaccination of Women of Childbearing Age
The ACIP has weighed several factors in developing
recommendations for vaccinating women of childbearing age against rubella.
Although there may be theoretical risks in giving rubella vaccine during
pregnancy, available data on previously and currently available rubella
vaccines indicate that the risk, if any, of teratogenicity from live rubella
vaccines is quite small. As of December 31, 1983, CDC has followed to term 214
known rubella-susceptible pregnant females who had been vaccinated with live
rubella vaccine within 3 months before or 3 months after conception.
Ninety-four received HPV-77 or Cendehill vaccines, one received vaccine of
unknown strain, and 119 received RA 27/3 vaccine. None of the 216 babies (two
of the mothers receiving RA 27/3 vaccine delivered twins) has malformations
compatible with congenital rubella infection. This finding includes the four
infants born to these susceptible women who had serologic evidence of
subclinical infection. (Three of the infants were exposed to HPV-77 or
Cendehill vaccine; one was exposed to RA 27/3 vaccine.)
Based on the experience to date, the maximum estimated theoretical risk of
serious malformations attributable to RA 27/3 rubella vaccine, derived from the
binomial distribution, is 3%. (If the 95 susceptible infants exposed to other
rubella vaccines are included, the maximum theoretical risk is 1.7%.) However,
the observed risk with both the HPV-77 or Cendehill and RA 27/3 strains of
vaccine is zero. In either case, this risk is far less than the 20% or greater
risk of CRS associated with maternal infection during the first trimester of
pregnancy.
Although experience with the RA 27/3 vaccine is more limited than that with
the other rubella vaccines, rubella vaccine virus has been isolated from
abortion material from one (3%) of 32 susceptible females who had been given RA
27/3 vaccine while pregnant, whereas virus was isolated from abortion material
from 17 (20%) of 85 susceptible females who had been given HPV-77 or Cendehill
vaccines while pregnant. This provides additional evidence that the RA 27/3
vaccine does not pose any greater risk of teratogenicity than did the HPV-77 or
Cendehill vaccines.
Therefore, the ACIP believes that the risk of vaccine-associated defects is
so small as to be negligible and should not ordinarily be a reason to consider
interruption of pregnancy. However, a final decision about interruption of
pregnancy must rest with the individual patient and her physician.
The continuing occurrence of rubella among women of childbearing age and the
lack of evidence for teratogenicity from the vaccine indicate strongly that
increased emphasis should continue to be placed on vaccinating susceptible
adolescent and adult females of childbearing age. However, because of the
theoretical risk to the fetus, females of childbearing age should receive
vaccine only if they say they are not pregnant and are counseled not to become
pregnant for 3 months after vaccination. In view of the importance of
protecting this age group against rubella, reasonable practices in a rubella
immunization program include: (1) asking females if they are pregnant, (2)
excluding those who say they are, and (3) explaining the theoretical risks to
the others.
Use of Vaccine Following Exposure
There is no conclusive evidence that giving live rubella
virus vaccine after exposure will prevent illness. Additionally, there is no
evidence that vaccinating an individual incubating rubella is harmful.
Consequently, since a single exposure may not cause infection and postexposure
vaccination will protect an individual exposed in the future, vaccination is
recommended, unless otherwise contraindicated.
Use of Human Immune Globulin Following Exposure
Immunoglobulin (IG) given after exposure to rubella will not
prevent infection or viremia, but it may modify or suppress symptoms and create
an unwarranted sense of security. The routine use of IG for postexposure
prophylaxis of rubella in early pregnancy is not recommended. Infants with
congenital rubella have been born to women given IG shortly after exposure. IG
might be useful only when a pregnant woman who has been exposed to rubella
would not consider termination of pregnancy under any circumstances.
Recent Administration of IG
Vaccine should be administered about 2 weeks before or
deferred for about 3 months after receipt of IG, because passively acquired
antibodies might interfere with the response to the vaccine. On the other hand,
previous administration of anti-Rho (D) immune globulin (human) or blood
products does not generally interfere with an immune response and is not a
contraindication to postpartum vaccination. However, in this situation, 6- to
8-week postvac- cination serologic testing should be done on those who have
received the globulin or blood products to assure that seroconversion has
occurred. Obtaining laboratory evidence of seroconversion in other vaccinees is
not necessary.
SIDE EFFECTS AND ADVERSE REACTIONS
Children sometimes have vaccine side effects, such as
low-grade fever, rash and lymphadenopathy. Up to 40% of vaccinees in
large-scale field trials have had joint pain, usually of the small peripheral
joints, but frank arthritis has generally been reported for fewer than 2%.
Arthralgia and transient arthritis occur more frequently and tend to be more
severe in susceptible women than in children. While up to 3% of susceptible
children have been reported to have arthralgia, arthritis has rarely been
reported in these vaccinees. By contrast, up to 10%-15% of susceptible female
vaccinees have been reported to have arthritis-like signs and symptoms.
Transient peripheral neuritic complaints, such as paresthesias and pain in the
arms and legs, have also very rarely occurred.
When joint symptoms or nonjoint-associated pain and paresthesias do occur,
they generally begin 3-25 days (mean 8-14 days) after immunization, persist for
1-11 days (mean 2-4 days) and rarely recur. Adults with joint problems usually
have not had to disrupt work activities. The occasional reports of persistent
or recurrent joint signs and symptoms probably represent a rare phenomenon. No
joint destruction has been reported. While the presence of immune complexes
following vaccination has been reported to be associated with arthralgia and
arthritis, the available data are still inconclusive. Comparable studies on
naturally infected persons have not been conducted. Likewise, there is no clear
association between joint symptoms and persistence of rubella virus in
lymphocytes.
The vast majority of published data indicate that only susceptible vaccinees
have side effects of vaccination. There is no conclusive evidence of an
increased risk of these reactions for persons who are already immune when
vaccinated.
Although vaccine is safe and effective for all persons 12 months of age or
older, its safety for the developing fetus is not fully known. Therefore,
though the risk, if any, appears to be minimal, rubella vaccine should not be
given to women known to be pregnant because of the theoretical risk of fetal
abnormality caused by vaccine virus (see above).
PRECAUTIONS AND CONTRAINDICATIONS
Pregnancy
Pregnant women should not be given rubella vaccine. If a
pregnant woman is vaccinated or if she becomes pregnant within 3 months of
vaccination, she should be counseled on the theoretical risks to the fetus. As
noted above, rubella vaccination during pregnancy should not ordinarily be a
reason to consider interruption of pregnancy. Instances of vaccination during
pregnancy should be reported through state health departments to the Division
of Immunization, Center for Prevention Services, CDC.
Because of the increasing number of cases reported to CDC, the experience
with known susceptibles is becoming well defined. Therefore, CDC now encourages
reporting only cases involving women known to be susceptible at the time of
vaccination.
Febrile Illness
Vaccination of persons with severe febrile illness should be
postponed until recovery. However, susceptible children with mild illnesses,
such as upper respiratory infection, should be vaccinated. Considering the
importance of protecting against rubella, medical personnel should use every
opportunity to vaccinate susceptible individuals.
Allergies
Hypersensitivity reactions very rarely follow the administration
of live rubella vaccine. Most of these reactions are considered minor and
consist of wheal and flare or urticaria at the injection site.
Live rubella vaccine is produced in human diploid cell culture.
Consequently, a history of anaphylactic reactions to egg ingestion needs to be
taken into consideration only if measles or mumps antigens are to be included
with rubella vaccine.
Since rubella vaccine contains trace amounts of neomycin (25 ug), persons
who have experienced anaphylactic reactions to topically or systematically
administered neomycin should not receive rubella vaccine. Most often, neomycin
allergy is manifested as a contact dermatitis, which is a delayedtype
(cell-mediated) immune response, rather than anaphylaxis. In such individuals,
the adverse reaction, if any, to 25 ug of neomycin in the vaccine would be an
erythematous, pruritic nodule or papule at 48-96 hours. A history of contact
dermatitis to neomycin is not a contraindication to receiving rubella vaccine.
Live rubella vaccine does not contain penicillin.
Altered Immunity
Replication of live rubella vaccine virus may be potentiated
in patients with immune deficiency diseases and by the suppressed immune
responses that occur with leukemia, lymphoma, generalized malignancy, and therapy
with corticosteroids, alkylating drugs, antimetabolites, and radiation.
Patients with such conditions should not be given live rubella virus vaccine.
Since vaccinated persons do not transmit vaccine virus, the risk to these
patients of being exposed to rubella may be reduced by vaccinating their close
susceptible contacts. Management of such patients, should they be exposed to
rubella, can be facilitated by prior knowledge of their immune status.
Patients with leukemia in remission whose chemotherapy has been terminated
for at least 3 months may receive live virus vaccines for infections to which
they are still susceptible (i.e., have neither had the disease nor the vaccine
before developing leukemia). The exact interval after discontinuing immunosuppression
that coincides with the ability to respond to individual vaccines is not known.
Experts vary in their judgments from 3 months to 1 year.
Short-term (less than 2 weeks) corticosteroid therapy, topical steroid
therapy (e.g., nasal, skin), and intra-articular, bursal, or tendon injection
with corticosteroids should not be immunosuppressive and do not necessarily
contraindicate live virus vaccine administration. However, live vaccines should
be avoided if systemic immunosuppressive levels are reached by topical
application.
Simultaneous Administration of Certain Live Virus Vaccines See "General
Recommendations on Immunization," (MMWR 1983;32:2-8,13-17).
ELIMINATION OF CRS
Widespread vaccination of school-aged children since 1969
has effectively prevented major epidemics of rubella and congenital rubella in
this country. With continued vaccination of children at levels approaching
100%, an immune birth cohort will eventually replace the 10%-15% of persons of
childbearing age currently susceptible to rubella, and rubella can be expected
to disappear. Since this process will take 10-30 years, cases of CRS can still
be expected to occur.
Elimination of CRS can be hastened by intensifying and expanding existing
efforts to vaccinate susceptible adolescents and young adults, particularly
women of childbearing age, along with continuing routine vaccination of
children. Effective vaccination of all susceptible children in junior and
senior high schools can be expected to contribute greatly to the elimination of
CRS. Over the last 3 years, such efforts have resulted in decreases in the
reported incidence of rubella in all persons and in the incidence of reported
CRS. In 1982, the rubella cases that occurred were largely in older, postschool-aged
populations, clearly indicating that rubella in postpubertal populations is
still a problem in this country.
The major components of a strategy to eliminate CRS are achieving and
maintaining high immunization levels, accurate surveillance of rubella and CRS,
and prompt outbreak-control measures. The following recommendations are
presented to help preserve the level of rubella and CRS control already
achieved and to bring about the further reduction in susceptibility that will
be required to achieve elimination of CRS.
Ongoing Programs
The primary strategy for eliminating CRS in the United
States is to interrupt rubella transmission by achieving and maintaining high
immunization levels in all children. Official health agencies should take
steps, including developing and enforcing immunization requirements, to assure
that all students in grades kindergarten through 12 are protected against
rubella, unless vaccination is contraindicated. School entry laws should be
vigorously enforced. States that do not require proof of immunity of students
at all grade levels should consider expanding existing laws or regulations to
include the age groups not yet protected.
Recent age-specific data indicate that preschool-aged children account for
an important proportion of reported rubella cases. Proof of rubella immunity
for attendance at day-care centers should be required and enforced. Licensure
should depend on such requirements.
To hasten the elimination of CRS, new emphasis will have to be directed
towards vaccinating susceptible females of childbearing age--the group at
highest risk. A multifaceted approach is necessary. A number of approaches are
discussed below.
Premarital Screening and Vaccination
Routine premarital testing for rubella antibody identifies
many susceptible women before pregnancy. Documented histories of rubella
vaccination or serologic evidence of immunity should be considered acceptable
proof of immunity. To ensure a significant reduction in susceptibles through
premarital screening, more aggressive follow-up of women found to be
susceptible will be required.
Postpartum Vaccination
Prenatal screening should be carried out on all pregnant
women not known to be immune. Women who have just delivered babies should be
vaccinated before discharge from the hospital, unless they are known to be
immune. Although such women are unlikely to become pregnant, counseling to
avoid conception for 3 months following vaccination is still necessary. It is
estimated that postpartum vaccination of all women not known to be immune could
prevent one-third to one-half of current CRS cases. Breast-feeding is not a
contraindication to vaccination, even though virus may be excreted in breast
milk, and infants may be infected. Vaccination should be extended to include all
postabortion settings.
Routine Vaccination in any Medical Setting
Vaccination of susceptible women of childbearing age should
be part of routine general medical and gynecologic outpatient care, should take
place in all family-planning settings, and should become routine before
discharge from a hospital for any reason, if there are no contraindications
(see above). Vaccine should be offered to adults, especially women of
childbearing age, anytime contact is made with the health-care system,
including when children are undergoing routine examinations or immunizations.
Vaccination of Medical Personnel
Medical personnel, both male and female (volunteers,
trainees, nurses, physicians, etc.), who might transmit rubella to pregnant
patients or other personnel, should be immune to rubella. Consideration should
be given to making rubella immunity a condition for employment.
Vaccination of Workers
Ascertainment of rubella immune status and availability of
rubella immunization should be components of the health-care program in places
where women of childbearing age congregate or represent a significant
proportion of the work force. Such settings include day-care centers, schools,
colleges. companies, government offices, and industrial sites.
Vaccination for College Entry
Colleges are high-risk areas for rubella transmission
because of large concentrations of susceptible persons. Proof of rubella, as
well as measles immunity, should be required for attendance for both male and
female students.
General Principles
Voluntary programs have generally been less successful than
mandatory programs. The military services require rubella immunity of
susceptible recruits and have essentially eliminated rubella from military
bases. In all settings where young adults congregate, males as well as females
should be included, since males may transmit disease to susceptible females.
When practical, and when reliable laboratory services are available,
potential female vaccinees of childbearing age can have serologic tests to
determine susceptibility to rubella. However, with the exception of premarital
and prenatal screening, routinely performing serologic tests for all women of
childbearing age to determine susceptibility so that vaccine is given only to
proven susceptible women is expensive and has been ineffective in some areas.
Two visits to the health-care provider are necessary--one for screening and one
for vaccination. Accordingly, the ACIP believes that rubella vaccination of a
woman who is not known to be pregnant and has no history of vaccination is
justifiable without serologic testing and may be preferable, particularly when
costs of serology are high and follow-up of identified susceptibles for
vaccination is not assured. Vaccinated women should avoid becoming pregnant for
a 3-month period following vaccination. In addition, vaccine should be
administered in the above-mentioned settings only if there are no
contraindications to vaccination.
Routine serologic screening of male vaccinees is not recommended. There are
no conclusive data indicating that vaccination of immune individuals carries an
increased risk of joint or other complications.
Health-care providers are encouraged to use MMR in routine childhood
vaccination programs and whenever rubella vaccine is to be given to persons
likely to be susceptible to measles and/or mumps as well as to rubella.
Outbreak Control
Outbreak control will play an important role in CRS
elimination. Aggressive responses to outbreaks may interrupt chains of transmission
and will increase immunization levels in persons who might otherwise not be
vaccinated. Although methods for controlling rubella outbreaks are evolving,
the major strategy should be to define target populations, ensure that
susceptible individuals are vaccinated rapidly (or excluded from exposure if a
contraindication exists), and maintain active surveillance to modify control
measures if the situation changes.
Since a simple, accurate clinical case definition for rubella has not yet
been developed, laboratory confirmation of cases is important. However, control
measures should be implemented before serologic confirmation. This approach is
especially important in any outbreak setting involving pregnant women (e.g., in
obstetric-gynecologic and prenatal clinics). All persons who cannot readily
provide laboratory evidence of immunity or a documented history of vaccination
on or after the first-year birthday should be considered susceptible and
vaccinated if there are no contraindications.
An effective means of terminating outbreaks and increasing rates of
immunization quickly is to exclude from possible contact individuals who cannot
provide valid evidence of immunity. Experience with measles-outbreak control
indicates that almost all students who are excluded from school because they
lack evidence of measles immunity quickly comply with require- ments and are
promptly readmitted to school. Exclusion should include all persons who have
been exempted from rubella vaccination because of medical, religious, or other
reasons. Exclusion should continue until 3 weeks after the onset of rash of the
last reported case in the outbreak setting. Less rigorous approaches, such as
voluntary appeals for vaccination, have not been effective in terminating
outbreaks.
Mandatory exclusion and vaccination of adults should be practiced in rubella
outbreaks in medical settings where large numbers of pregnant women may be
exposed. This approach may be successful in terminating, or at least limiting,
outbreaks. Vaccination during an outbreak has not been associated with
significant personnel absenteeism. However, it is clear that vaccination of
susceptible persons before an outbreak occurs is preferable, since vaccin-
ation causes far less absenteeism and disruption of routine work activities and
schedules than rubella infection.
SURVEILLANCE
Surveillance of rubella and CRS has three purposes: (1) to
provide important data on program progress and long-term trends; (2) to help
define groups in greatest need of vaccination and in turn provide information
for formulation of new strategies; and (3) to evaluate vaccine efficacy,
duration of vaccine-induced immunity, and other issues related to vaccine
safety and efficacy.
As the rates of rubella and CRS decline in the United States, effective
surveillance becomes increasingly important. Known or suspected rubella cases
should be reported immediately to local health departments. Since an accurate
assessment of CRS elimination can be made only through aggressive case finding,
surveillance of CRS will have to be intensified.
Surveillance of rubella is complicated by the fact that the clinical disease
is not characteristic and can be confused with a number of other illnesses.
Thus, there is a need for laboratory confirmation of cases, particularly in
nonoutbreak settings. Similarly, laboratory confirmation of suspected cases of
CRS is also necessary, since the constellation of findings of CRS may not be
specific.
Laboratory Diagnosis
Rubella: Rubella infection can be serologically confirmed by
a fourfold rise in HI or complement fixation (CF) antibody titer. Kits using
EIA or latex agglutination assays are also becoming available for diagnostic
use. The acute-phase serum specimen should be drawn as soon after rash onset as
possible, preferably within the first 7 days. The convalescent-phase serum
specimen should be drawn 10 or more days after the acute-phase serum specimen.
If the acute-phase serum specimen is drawn more than 7 days after rash onset, a
fourfold rise in HI antibody titer may not be detected. In this case, CF
testing may be especially useful, since CF antibodies appear in serum later
than HI antibodies. Both the acute and convalescent specimens should be tested
simultaneously in the same laboratory.
Occasionally, fourfold rises may not be detected, even if the first specimen
is drawn within the first 7 days after rash onset. Rubella infection may also
be serologically confirmed by demonstrating rubella-specific IgM antibody. If
IgM is to be determined, a single serum specimen should be drawn between 1 week
and 2 weeks after rash onset. Although rubella-specific IgM antibody may be
detected shortly after rash onset, false-negative results may occur if the
specimen is drawn earlier than 1 week or later than 3 weeks following rash
onset.
In the absence of rash illness, the diagnosis of subclinical cases of
rubella can be facilitated by obtaining the acute-phase serum specimen as soon
as possible after exposure. The convalescent-phase specimen should then be
drawn 28 or more days after exposure. If acute- and convalescent-phase sera
pairs provide inconclusive results, rubella-specific IgM antibody testing can
be performed, but negative results should be interpreted cautiously. Expert
consultation may be necessary to interpret the data.
Confirmation of rubella infection in pregnant women of unknown immune status
following rash illness or exposure can frequently be difficult. A serum
specimen should be obtained as soon as possible. Unfortunately, serologic
results are often nonconfirmatory. Such situations can be minimized by
performing prenatal serologies routinely. In addition, health providers should
request that laboratories performing prenatal screening retain such specimens
until delivery so that retesting, if necessary, can be done.
Congenital Rubella: Suspected cases of CRS should be managed with contact
isolation (see CDC "Guidelines for Isolation Precautions in
Hospitals") and, while diagnostic confirmation is pending, should be cared
for only by personnel known to be immune. Confirmation by attempting virus
isolation can be done using nasopharyngeal and urine specimens. Serologic
confirmation can be obtained by testing cord blood for the presence of
rubella-specific IgM antibodies. An alternative, but less rapid serologic
method, is to document persistence of rubella-specific antibody in a suspected
infant for more than 3 months of age at a level beyond that expected from
passive transfer of maternal antibody (i.e., a rubella HI titer in the infant
that does not decline at the expected rate of one twofold dilution per month).
If CRS is confirmed, precautions will need to be exercised through the first
year of life, unless nasopharyngeal and urine cultures are negative for rubella
virus.
Adverse Events
Continuous and careful review of adverse events following
rubella vaccination is important. All adverse events following rubella
vaccination should be evaluated and reported in detail through local and state
health officials to CDC, as well as to the manufacturer.
INTERNATIONAL TRAVEL
Persons without evidence of rubella immunity who travel
abroad should be protected against rubella, since rubella is endemic and even
epidemic, in many countries throughout the world. No immunization or record of
immunization is required for entry into the United States. However, it is
recommended that international travelers have immunity to rubella consisting of
laboratory evidence of rubella antibodies or verified rubella vaccination on or
after the first-year birthday. It is especially important to protect
susceptible women of childbearing age, particularly those planning to remain
out of the country for a prolonged period of time.
* A confirmed case has at least one defect in categories A or B and
laboratory confirmation of rubella infection. A compatible case has any two
complications listed in A or one from A and one from B without laboratory
confirmation.
A. Cataracts/congenital glaucoma (either or both count as one); congenital
heart disease, loss of hearing, pigmentary retinopathy. B. Purpura,
splenomegaly, jaundice, microcephaly, mental retardation, meningoencephalitis,
radioluocent bone disease.
** Official name: Rubella Virus Vaccine, Live.
SELECTED BIBLIOGRAPHY
Baba K, Yabuuchi H, Okuni H, et al. Rubella epidemic in an
institution: protective value of live rubella vaccine and serological behavior
of vaccinated, revaccinated, and naturally immune groups. Biken J
1978;21:25-31.
Balfour HH Jr, Groth KE, Edelman CK, Amren DP, Best JM, Banatvala JE.
Rubella viraemia and antibody responses after rubella vaccination and reimmuni-
zation. Lancet 1981;I:1078-80.
Buimovici-Klein E, Hite RL, Bryne T, Cooper LZ. Isolation of rubella virus
in milk after postpartum immunization. J Pediatr 1977;91:939-41.
CDC. Rubella in universities--Washington, California. MMWR 1982;32:394-5.
CDC. Rubella outbreak among office workers--New York City. MMWR
1983;32:349-52.
CDC. Rubella vaccination during pregnancy--United States, 1971-1982. MMWR
1983;32:429-432,437.
CDC. Rubella and congenital rubella--United States, 1983. MMWR
1984;33:237-42,247.
Chappell JA, Taylor MA. Implications of rubella susceptibility in young
adults. Am J Public Health 1979;69:279-81.
Cooper LZ, Krugman S. The rubella problem. DM 1969;Feb:3-38.
Coyle PK, Wolinsky JS, Buimovici-Klein E, Moucha R, Cooper LZ. Rubella-
specific immune complexes after congenital infection and vaccination. Infect
Immun 1982;36:498-503.
Crawford GE, Gremillion DH. Epidemic measles and rubella in air force
recruits: impact of immunization. J Infect Dis 1981;144:403-10.
Dales LG, Chin J. An outbreak of congenital rubella. West J Med
1981;135:266-70.
Dales LG, Chin J. Public health implications of rubella antibody levels in
California. Am J Public Health 1982;72;167-72.
Greaves WL, Orenstein WA, Hinman AR, Nersesian WS. Clinical efficacy of
rubella vaccine. Pediatr Infect Dis 1983;2:284-6.
Greaves WL, Orenstein WA, Stetler WC, Preblud SR, Hinman AR, Bart KJ.
Preven- tion of rubella transmission in medical facilities. JAMA
1982;248:861-4.
Herrmann KL, Halstead SB, Wiebenga NH. Rubella antibody persistence after
immunization. JAMA 1982;247:193-6.
Hillary IB, Griffith AH. Persistence of antibody 10 years after vaccination
with Wistar RA27/3 strain live attenuated rubella vaccine Br Med J
1980;280:1580-1.
Horstmann DM. Controlling rubella: problems and perspectives. Ann Intern Med
1975;83:412-7.
International conference on rubella immunization. Am J Dis Child
1969;118:1-410.
International Symposium on the Prevention of Congenital Rubella Infection,
Washington, D.C., March 13-15, 1984. Rev Infect Dis (in press).
Klein EB, Byrne T, Cooper LZ. Neonatal rubella in a breast-fed infant after
postpartum maternal infection. J Pediatr 1980;97:774-5.
Landes RD, Bass JW, Millunchick EW, Oetgen WJ. Neonatal rubella following
postpartum maternal immunization. J Pediatr 1980;97:465-7.
Koplan JP, White CC. An update of the benefits and costs of measles and
rubella immunization In: Proceedings of the Symposium "Conquest of Agents
that Endanger the Brain," Baltimore, Maryland, October 28-29, 1982 (in
press).
Landrigan PJ, Stoffels MA, Anderson E, Witte JJ. Epidemic rubella in adoles-
cent boys. Clinical features and results of vaccination. JAMA 1974;227:1283-7.
Lamprecht C, Schauf V, Warren D, Nelson K, Northrop R, Christiansen M. An
outbreak of congenital rubella in Chicago. JAMA 1982;247:1129-33.
Lerman SJ, Nankervis GA, Heggie AD, Gold E. Immunologic response, virus
excretion, and joint reactions with rubella vaccine. A study of adolescent
girls and young women given live attenuated virus vaccine (HPV-77:DE-5). Ann
Intern Med 1971;74:67-73.
Lieberman E, Faich GA, Simon PR, Mullan RJ. Premarital rubella screening in
Rhode Island. JAMA 1981;245:1333-5.
Mann JM, Preblud SR, Hoffman RE, Brandling-Bennet AD, Hinman AR, Herrmann
KL. Assessing risks of rubella infection during pregnancy. A standardized
approach. JAMA 1981;245:1647-52.
McLaughlin MC, Gold LH. The New York rubella incident: a case for changing
hospital policy regarding rubella testing and immunization. Am J Public Health
1979;69:287-9.
Miller E, Cradock-Watson JE, Pollock TM. Consequences of confirmed maternal
rubella at successive stages of pregnancy. Lancet 1982;II:781-4.
Miller KA, Zager TD. Rubella susceptibility in an adolescent female popula-
tion. Mayo Clin Proc 1984;59:31-4.
Nelson DB, Layde MM, Chatton TB. Rubella susceptibility in inner-city
adolescents: the effect of a school immunization law. Am J Public Health
1982;72:710-3.
Orenstein WA, Bart KJ, Hinman AR, et al. The opportunity and obligation to
elimiate rubella from the United States. JAMA 1984;251:1988-94.
O'Shea S, Best JM, Banatvala JE. Viremia, virus excretion, and antibody
responses after challenge in volunteers with low levels of antibody to rubella
virus. J Infect Dis 1983;148:639-47.
O'Shea S, Best JM, Banatvala JE, Marshall WC, Dudgeon JA. Rubella vaccin-
ation: persistence of antibodies for up to 16 years. Br Med J 1982;285:253-5.
Polk BF, Modlin JF, White JA, DeGirolami PC. A controlled comparison of
joint reactions among women receiving one of two rubella vaccines. Am J
Epidemiol 1982;115:19-25.
Polk BF, White JA, DeGirolami PC, Modlin JF. An outbreak of rubella among
hospital personnel. N Engl J Med 1980;303:541-5.
Preblud SR, Gross F, Halsey NA, Hinman AR, Herrmann KL, Koplan JP. Assess-
ment of susceptibility to measles and rubella. JAMA 1982;247:1134-7.
Preblud SR, Serdula MK, Frank JA Jr, Brandling-Bennett AD, Hinman AR.
Rubella vaccination in the United States: a ten-year review. Epidemiol Rev
1980;2:171-94.
Preblud SR, Stetler HC, Frank JA Jr, Greaves WL, Hinman AR, Herrmann KL.
Fetal risk associated with rubella vaccine. JAMA 1981;246:1413-7.
Recommendations for the control of rubella within hospitals. The Advisory
Committee on Infections within Hospitals of the American Hospital Association.
Infect Control 1981;2:410-1,424.
Robinson RG, Dudenhoeffer FE, Holroyd HJ, Baker LR, Bernstein DI, Cherry JD.
Rubella immunity in older children, teenagers, and young adults: a comparison
of immunity in those previously immunized with those unimmunized. J Pediatr
1982;101:188-91.
Serdula MK, Halstead SB, Wiebenga NH, Herrmann KL. Serological response to
rubella revaccination. JAMA 1984;251:1974-7.
Storch GA, Myers N. Latex-agglutination test for rubella antibody: validity
of positive results assessed by response to immunization and comparison with
other tests. J Infect Dis 1984;149:459-64.
Tingle AJ, Yang T, Allen M, Kettyls GD, Larke RPB, Schulzer M. Prospective
immunological assessment of arthritis induced by rubella vaccine. Infect Immun
1983;40:22-8.
Weibel RE, Buynak EB, McLean AA, Roehm RR, Hillemann MR. Persistence of
antibody in human subjects for 7 to 10 years following administration of
combined live attenuated measles, mumps, and rubella virus vaccines. Proc Soc
Exp Biol Med 1980;165:260-3.
Weibel RE, Villarejos VM, Klein EB, Buynak EB, McLean AA, Hilleman MR.
Clinical and laboratory studies of live attenuated RA 27/3 and HPV 77-DE
rubella virus vaccines (40931). Proc Soc Exp Biol Med 1980:165:44-9.
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