[Federal Register Volume 63, Number 171 (Thursday, September 3, 1998)]
[Notices]
[Pages 47026-47031]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Proposed Vaccine Information Materials for Hepatitis B, 
Haemophilus influenzae type b (Hib), Varicella (Chickenpox), and 
Measles, Mumps, Rubella (MMR) Vaccines

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

-----------------------------------------------------------------------

SUMMARY: Under the National Childhood Vaccine Injury Act (42 U.S.C. 
Sec. 300aa-26), CDC must develop vaccine information materials that 
health care providers are required to give to patients/parents prior to 
administration of specific vaccines. CDC seeks written comment on 
proposed new vaccine information materials for hepatitis B, Haemophilus 
influenzae ype b, and Varicella vaccines, and revised vaccine 
information materials for measles, mumps, rubella (MMR) vaccines.

DATES: Written comments are invited and must be received on or before 
November 2, 1998.

ADDRESSES: Written comments should be addressed to Walter A. Orenstein, 
M.D., Director, National Immunization Program, Centers for Disease 
Control and Prevention, Mailstop E-05, 1600 Clifton Road, N.E., 
Atlanta, Georgia 30333.

FOR FURTHER INFORMATION CONTACT: Walter A. Orenstein, M.D., Director, 
National Immunization Program, Centers for Disease Control and 
Prevention, Mailstop E-05, 1600 Clifton Road, N.E., Atlanta, Georgia 
30333, telephone (404) 639-8200.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986 (Public Law 99-660), as amended by Section 708 of Public Law 103-
183, added Section 2126 to the Public Health Service Act. Section 2126, 
codified at 42 U.S.C. Sec. 300aa-26, requires the Secretary of Health 
and Human Services to develop and disseminate vaccine information 
materials for distribution by health care providers to any patient (or 
to the parent or legal representative in the case of a child) receiving 
vaccines covered under the National Vaccine Injury Compensation 
Program.
    Development and revision of the vaccine information materials have 
been delegated by the Secretary to the Centers for Disease Control and 
Prevention (CDC). Section 2126 requires that the materials be 
developed, or revised, after notice to the public, with a 60-day 
comment period, and in consultation with the Advisory Commission on 
Childhood Vaccines, appropriate health care provider and parent 
organizations, and the Food and Drug Administration. The law also 
requires that the information contained in the materials be based on 
available data and information, be presented in understandable terms, 
and include:
    (1) A concise description of the benefits of the vaccine,
    (2) A concise description of the risks associated with the vaccine,
    (3) A statement of the availability of the National Vaccine Injury 
Compensation Program, and
    (4) Such other relevant information as may be determined by the 
Secretary.
    The vaccines initially covered under the National Vaccine Injury 
Compensation Program were diphtheria, tetanus, pertussis, measles, 
mumps, rubella, and poliomyelitis vaccines. Since April 15, 1992, any 
health care provider who intends to administer one of the covered 
vaccines is required to provide copies of the relevant vaccine 
information materials prior to administration of any of these vaccines. 
(The materials currently in use for measles, mumps, and rubella 
vaccines and the tetanus diphtheria [Td] vaccine, were published in a 
Federal Register notice on June 20, 1994 (59 FR 31888). The current 
materials for polio vaccine were published in a Federal Register notice 
on February 6, 1997 (62 FR 5696), and, the current materials for 
diphtheria, tetanus, and pertussis containing vaccines, other than Td 
vaccine, were published in a Federal Register notice on January 9, 1998 
(63 FR 1730). Instructions for use of the vaccine information materials 
and a list of contacts for obtaining copies of these materials are 
included in the January 9, 1998 Federal Register notice (63 FR 1730).)

Newly Covered Vaccines

    With passage of Public Law 105-34, Congress expanded coverage of 
the National Vaccine Injury Compensation Program, effective August 6, 
1997, to include the following additional vaccines: hepatitis B, 
Haemophilus influenzae type b (Hib), and Varicella (chickenpox) 
vaccines. (See 63 FR 25777, May 11, 1998, for information regarding 
coverage of these vaccines under the Vaccine Injury Compensation 
Program.) Therefore, as required under 42 U.S.C. 300aa-26, CDC must 
develop vaccine information materials covering these vaccines.
    Included in this notice are proposed vaccine information materials 
covering hepatitis B, Haemophilus influenzae type b (Hib), and 
Varicella vaccines. In addition to proposed materials for these newly 
covered vaccines, this notice also includes proposed revised vaccine 
information materials for measles, mumps, rubella (MMR) vaccines. The 
MMR materials are being revised to follow the format of the materials 
published since 1997.
    The proposed vaccine information materials included in this notice 
were drafted in consultation with the Advisory Commission on Childhood 
Vaccines, the Food and Drug Administration, American Academy of 
Pediatrics, American Nurses Association, Dissatisfied Parents Together, 
Healthy Start, Immunization Action Coalition, Immunization Education 
and Action Committee: Healthy Mothers/Healthy Babies Coalition, 
National Association of Pediatric Nurse Associates and Practitioners, 
National Association of County Health Officials, National Coalition for 
Adult Immunization, National Coalition of Hispanic Health and Human 
Services Organizations (COSSMHO), National Council of La Raza, National 
Vaccine Advisory Committee, and the National Vaccine Injury 
Compensation Program. Also, CDC provided copies of the draft materials 
to other organizations and sought their consultation; however, those 
organizations did not provide comments. In addition to consultation 
with these groups, the CDC presented drafts of these vaccine 
information materials to parents gathered in 18 ethnically and 
geographically diverse

[[Page 47027]]

focus groups. Comments provided by the consultants and focus groups 
were considered in drafting the proposed vaccine information materials 
included in this notice.
    We invite written comment on the proposed vaccine information 
materials that follow, entitled ``Hepatitis B Vaccine: What You Need to 
Know,'' ``Haemophilus influenzae type b (Hib) Vaccine: What You Need to 
Know,'' ``Chickenpox Vaccine: What You Need to Know,'' and ``Measles, 
Mumps and Rubella Vaccines: What You Need to Know.'' Comments submitted 
will be considered in finalizing these materials. When the final 
materials are published in the Federal Register, the notice will 
include an effective date for their use.
* * * * *

Hepatitis B Vaccine--What You Need to Know

1. Why Get Vaccinated?

Hepatitis B is a Serious Disease
    The hepatitis B virus can cause short-term (acute) illness that 
leads to:
     Loss of appetite.
     Tiredness.
     Pain in muscles, joints, and stomach.
     Diarrhea and vomiting.
     Jaundice (yellow skin or eyes).
    It can also cause long-term (chronic) illness that leads to:
     Liver damage (cirrhosis).
     Liver cancer.
     Death.
    Each year in the United States it is estimated that,
     64,000 people--mostly young adults--get hepatitis B.
     More than 11,000 people have to stay in the hospital 
because of hepatitis B.
     About 1.25 million people have chronic hepatitis B 
infection.
     4,000-5,000 people die from chronic hepatitis B.
    Hepatitis B vaccine can prevent hepatitis B. Hepatitis B vaccine is 
the first anti-cancer vaccine because it can prevent a form of liver 
cancer.

2. How is Hepatitis B Virus Spread?

    Hepatitis B virus is spread through contact with the blood or body 
fluids of an infected person. A person can get infected in several 
ways, such as:
     During birth when the virus passes from an infected mother 
to her baby.
     By having sex with an infected person.
     By injecting illegal drugs.
     By being stuck with a used needle.
     By sharing personal items, such as a razor or toothbrush, 
with an infected person.
    People can get hepatitis B infection without knowing how they got 
it. About one third of hepatitis B cases in the United States have an 
unknown source.

3. Who Should Get Hepatitis B Vaccine and When?

    (1) Everyone 18 years of age and younger.
    (2) Adults over 18 who are at risk.
    Adults at risk for hepatitis B infection include:
     Men or women who have sex with more than one steady 
partner.
     Men or women who have recently gotten a sexually 
transmitted disease.
     Injection drug users.
     Men who have sex with other men.
     Household contacts and sex partners of persons with long-
term hepatitis B.
     People whose job involves contact with human blood.
     People who live or travel for more than 6 months in 
countries where hepatitis B is common.
     Clients and staff in institutions for the developmentally 
disabled.
     Hemodialysis patients.
     Recipients of certain blood products.
     Prisoners in long-term correctional facilities.
    If you are not sure whether you are at risk, ask your doctor or 
nurse.
    People should get 3 doses of hepatitis B vaccine, according to the 
following schedule. If you miss a dose or get behind schedule, get the 
next dose as soon as you can. There is no need to start over.

                                        Hepatitis B Vaccination Schedule                                        
----------------------------------------------------------------------------------------------------------------
                                                                      WHO?                                      
                               ---------------------------------------------------------------------------------
                                   Infant whose       Infant whose                                              
             WHEN?                  mother is        mother is not                                              
                                  infected with      infected with         Older child, adolescent, or adult    
                                   hepatitis B        hepatitis B                                               
----------------------------------------------------------------------------------------------------------------
First Dose....................  Within 12 hours    Birth-2 months of  Any time.                                 
                                 of birth.          age.                                                        
Second Dose...................  1-2 months of age  1-4 months of age  1-2 months after first dose.              
                                                    (At least 1                                                 
                                                    month after                                                 
                                                    first dose).                                                
Third Dose....................  6 months of age..  6-18 months of     4-6 months after first dose.              
                                                    age.                                                        
----------------------------------------------------------------------------------------------------------------

    The second dose must be given at least 1 month after the first 
dose, and the third dose must be given at least 2 months after the 
second and at least 4 months after the first. The third dose should not 
be given to infants younger than 6 months of age.
    All three doses are needed for full and lasting immunity.
    Ask your doctor or nurse for more information.
    Hepatitis B vaccine may be given at the same time as other 
vaccines.

4. Some People Should Not Get Hepatitis B Vaccine or Should Wait

    People should not get hepatitis B vaccine if they have ever had a 
serious allergic reaction to:

--A previous dose of hepatitis B vaccine, or
--Baker's yeast (the kind used for making bread)

    People who are moderately or severely ill at the time the shot is 
scheduled should usually wait until they recover before getting 
hepatitis B vaccine.
    Ask your doctor or nurse for more information.

5. What Are the Risks From Hepatitis B Vaccine?

     A vaccine, like any medicine, is capable of causing life-
threatening problems, such as severe allergic reactions. The risk of 
hepatitis B vaccine causing serious harm, or death, is extremely small.
     Getting hepatitis B vaccine is much safer than getting 
hepatitis B disease.
     Most people who get hepatitis B vaccine do not have any 
problems with it.
Mild Problems
     Soreness where the shot was given, lasting a day or two 
(up to 1 out of 11 children and adolescents, and about 1 out of 4 
adults).
     Mild to moderate fever (up to 1 out of 14 children and 
adolescents, and 1 out of 100 adults).
Severe Problems
     Serious allergic reaction (very rare).

[[Page 47028]]

6. What if There is a Moderate or Severe Reaction?

What Should I Look For?
     Any unusual condition, such as a serious allergic 
reaction, high fever or behavior changes. Signs of a serious allergic 
reaction can include difficulty breathing, hoarseness or wheezing, 
hives, paleness, weakness, a fast heart beat or dizziness. If such a 
reaction were to occur, it would be within a few minutes to a few hours 
after the shot.
What Should I Do?
     Call a doctor or get the person to a doctor right away.
     Tell your doctor what happened, the date and time it 
happened, and when the vaccination was given.
     Ask your doctor, nurse, or health department to file a 
Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

7. The National Vaccine Injury Compensation Program

    In the rare event that you or your child has a serious reaction to 
a vaccine, a Federal program has been created to help you pay for the 
care of those who have been harmed.
    For details about the National Vaccine Injury Compensation program, 
call 1-800-338-2382 or visit the program's website at http://
www.hrsa.dhhs.gov/bhpr/vicp

8. How Can I Learn More?

     Ask your doctor or nurse. They can give you the vaccine 
package insert or suggest other sources of information.
     Call your local or state health department. They can give 
you the Parents Guide to Childhood Immunization, Immunization of 
Adults: A Call to Action, or other information.
     Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-2522 (English)
--Call 1-888-443-7232 (English)
--Call 1-800-232-0233 (Espanol)
--Visit the National Immunization Program's website at http://
www.cdc.gov/nip
_Visit the Hepatitis Branch's website at http://www.cdc.gov/ncidod/
diseases/hepatitis/hepatitis.htm

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
National Immunization Program
Hepatitis B (00/00/00) (Proposed)
Vaccine Information Statement
42 U.S.C. Sec. 300aa-26
* * * * *

Haemophilus Influenzae Type B (HIB) Vaccine--What You Need to Know

1. What is Hib Disease?

    Haemophilus influenzae type b (Hib) disease is a serious disease 
caused by a bacteria. It usually strikes children under 5 years old.
    Your child can get Hib disease by being around other children or 
adults who may have the bacteria and not know it. The germs spread from 
person to person through the air. If the germs stay in the child's nose 
and throat, the child probably will not become sick. But sometimes the 
germs spread into the lungs or the bloodstream, and then Hib can cause 
serious problems.
    Before Hib vaccine, Hib disease was the leading cause of bacterial 
meningitis among children under 5 years old in the United States. 
Meningitis is an infection of the brain and spinal cord coverings which 
can lead to lasting brain damage.
    In addition to meningitis, Hib disease can cause:
     Hearing loss.
     Pneumonia.
     Severe swelling in the throat, making it hard to breathe.
     Infections of the blood, joints, bones, and covering of 
the heart.
     Death.
Hib Vaccine Can Prevent Hib Disease
    Many more children would get Hib disease if we stopped vaccinating.

2. Who Should Get Hib Vaccine and When?

Children Should Get Hib Vaccine At:
 2 months of age
 4 months of age
 6 months of age*
 12-15 months of age

    *Depending on what brand of Hib vaccine is used, your child might 
not need the dose at 6 months of age. Your doctor or nurse will tell 
you if this dose is needed.
    If you miss a dose or get behind schedule, get the next dose as 
soon as you can. There is no need to start over.
    Hib vaccine may be given at the same time as other vaccines.
Older Children and Adults
    Children over 5 years old usually do not need Hib vaccine. But some 
older children or adults with special health conditions should get it. 
These conditions include sickle cell disease, HIV/AIDS, removal of the 
spleen, bone marrow transplant, or cancer treatment with drugs. Ask 
your doctor or nurse for details.

3. Some People Should Not Get Hib Vaccine or Should Wait

    People who have ever had a serious allergic reaction to a previous 
dose of Hib vaccine should not get another dose.
    Children less than 6 weeks of age should not get Hib vaccine.
    People who are moderately or severely ill at the time the shot is 
scheduled should usually wait until they recover before getting Hib 
vaccine.
    Ask your doctor or nurse for more information.

4. What Are the Risks From Hib Vaccine?

     A vaccine, like any medicine, is capable of causing life-
threatening problems, such as severe allergic reactions. The risk of 
Hib vaccine causing serious harm, or death, is extremely small.
     Getting Hib vaccine is much safer than getting Hib 
disease.
     Most people who get Hib vaccine do not have any problems 
with it.
Mild Problems
     Redness, warmth, or swelling where the shot was given (up 
to 1 out of 25 children).
     Fever over 101 deg.F (up to 1 out of 20 children).
    If these problems happen, they usually start within a day of 
vaccination. They may last 2-3 days.

5. What if There is a Moderate or Severe Reaction?

What Should I Look For?
     Any unusual condition, such as a serious allergic 
reaction, high fever or behavior changes. Signs of a serious allergic 
reaction can include difficulty breathing, hoarseness or wheezing, 
hives, paleness, weakness, a fast heart beat or dizziness.

What Should I Do?

     Call a doctor or get the person to a doctor right away.
     Tell your doctor what happened, the date and time it 
happened, and when the vaccination was given.
     Ask your doctor, nurse, or health department to file a 
Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

6. The National Vaccine Injury Compensation Program

    In the rare event that you or your child has a serious reaction to 
a vaccine, a Federal program has been created to help you pay for the 
care of those who have been harmed.

[[Page 47029]]

    For details about the National Vaccine Injury Compensation program, 
call 1-800-338-2382 or visit the program's website at http://
www.hrsa.dhhs.gov/bhpr/vicp

7. How Can I Learn More?

     Ask your doctor or nurse. They can give you the vaccine 
package insert or suggest other sources of information.
     Call your local or state health department. They can give 
you the Parents Guide to Childhood Immunization or other information.
     Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espanol)
--Visit the National Immunization Program's website at http://
www.cdc.gov/nip

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
National Immunization Program
Hib (00/00/00) (Proposed)
Vaccine Information Statement
42 U.S.C. 300aa-26
* * * * *

Chickenpox Vaccine--What You Need to Know

1. Why Get Vaccinated?

Chickenpox (also called Varicella) is a Common Childhood Disease
    It is usually mild, but it can be serious, especially in young 
infants and adults.
     The chickenpox virus can be spread from person to person 
through the air, or by contact with fluid from chickenpox blisters.
     It causes a rash, itching, fever, and tiredness.
     It can lead to severe skin infection, scars, pneumonia, 
brain damage, or death.
     A person who has had chickenpox can get a painful rash 
called shingles years later.
     About 12,000 people are hospitalized for chickenpox each 
year in the United States.
     About 100 people die each year in the United States as a 
result of chickenpox.
Chickenpox Vaccine Can Prevent Chickenpox

2. Chickenpox Vaccine

     If someone who has been vaccinated does get chickenpox, it 
is usually very mild. They have fewer spots, are less likely to have a 
fever, and will recover faster.

3. Who Should Get Chickenpox Vaccine and When?

     Children should get chickenpox vaccine between 12 and 18 
months of age.
     Older children, or adults, who have never had chickenpox 
or chickenpox vaccine should get the vaccine. It can be given at any 
age.
    Dosage:

Children 1-12 years of age: 1 dose
Anyone 13 years of age or older: 2 doses, 4-8 weeks apart

    Ask your doctor or nurse for details.
    Chickenpox vaccine may be given at the same time as other vaccines.

4. Some People Should Not Get Chickenpox Vaccine or Should Wait

     People who have ever had a serious allergic reaction to 
gelatin, the antibiotic neomycin, or a previous dose of chickenpox 
vaccine should not get the vaccine.
     People who are moderately or severely ill at the time the 
shot is scheduled should usually wait until they recover before getting 
chickenpox vaccine.
     Pregnant women should wait to get chickenpox vaccine until 
after they have given birth.
     Some people should check with their doctor about whether 
they should get chickenpox vaccine. These people include anyone who:

--Has HIV/AIDS, or another disease that affects the immune system
--Is being treated with drugs that affect the immune system, such as 
steroids, for 2 weeks or longer
--Has any kind of cancer
--Is taking cancer treatment with x-rays or drugs

     People who recently had a transfusion or were given other 
blood products should ask their doctor when they may get chickenpox 
vaccine.
    If you are not sure, ask your doctor or nurse.

5. What Are the Risks From Chickenpox Vaccine?

     A vaccine, like any medicine, is capable of causing life-
threatening problems, such as severe allergic reactions. The risk of 
chickenpox vaccine causing serious harm, or death, is extremely small.
     Getting chickenpox vaccine is much safer than getting 
chickenpox disease.
     Most people who get chickenpox vaccine do not have any 
problems with it.
Mild Problems
     Soreness or swelling where the shot was given (about 1 out 
of 5 children and up to 1 out of 3 adolescents and adults).
     Fever (1 out of 6 children, 1 out of 10 adolescents or 
adults).
     Mild rash, up to a month after vaccination (up to 1 out of 
16 people getting the vaccine). These people can, rarely, spread the 
vaccine virus to other members of their household.
Moderate Problems
     Seizure (jerking or staring) caused by fever (less than 1 
out of 1,000 people getting the vaccine).
Severe Problems
    Some severe problems, including pneumonia, brain damage, or low 
blood count, have been reported after chickenpox vaccination. These 
happen so rarely experts cannot tell whether they are caused by the 
vaccine or not. If they are, it is extremely rare.

6. What if There is a Moderate or Severe Reaction?

What Should I Look For?
    Any unusual condition, such as a serious allergic reaction, high 
fever or behavior changes. Signs of a serious allergic reaction can 
include difficulty breathing, hoarseness or wheezing, hives, paleness, 
weakness, a fast heart beat or dizziness. If it occurs, a high fever or 
seizure would occur one to six weeks after the shot.
What Should I Do?
     Call a doctor or get the person to a doctor right away.
     Tell your doctor what happened, the date and time it 
happened, and when the vaccination was given.
     Ask your doctor, nurse, or health department to file a 
Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

7. The National Vaccine Injury Compensation Program

    In the rare event that you or your child has a serious reaction to 
a vaccine, a Federal program has been created to help you pay for the 
care of those who have been harmed.
    For details about the National Vaccine Injury Compensation program, 
call 1-800-338-2382 or visit the program's website at http://
www.hrsa.dhhs.gov/bhpr/vicp

8. How Can I Learn More?

     Ask your doctor or nurse. They can give you the vaccine 
package insert or suggest other sources of information.
     Call your local or state health department. They can give 
you the Parents Guide to Childhood Immunization, Immunization of 
Adults: A Call to Action, or other information.

[[Page 47030]]

     Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espanol)
--Visit the National Immunization Program's website at http://
www.cdc.gov/nip

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
National Immunization Program
Varicella (00/00/00) (Proposed)
Vaccine Information Statement
42 U.S.C. Sec. 300aa-26
* * * * *

Measles, Mumps and Rubella Vaccines--What You Need To Know

1. Why Get Vaccinated?

Measles, Mumps, and Rubella Are Serious Diseases
Measles
     Measles virus causes rash, cough, runny nose, eye 
irritation, and fever.
     It can lead to ear infection, pneumonia, seizures (jerking 
and staring), brain damage, and death.
Mumps
     Mumps virus causes fever, headache, and swollen glands.
     It can lead to deafness, meningitis (infection of the 
brain and spinal cord covering), painful swelling of the testicles, 
and, rarely, death.
Rubella (German Measles)
     Rubella virus causes rash, mild fever, swollen glands, and 
arthritis (mostly in women).
     If a woman gets rubella while she is pregnant, she could 
have a miscarriage or her baby could be born with serious birth 
defects.
    You or your child could catch these diseases by being around 
someone who has them. They spread from person to person through the 
air.
Measles, Mumps, and Rubella (MMR) Vaccine Can Prevent These Diseases
    Most children who get their MMR shots will not get these diseases. 
Many more children would get them if we stopped vaccinating.

2. Who Should Get MMR Vaccine and When?

    Children should get 2 doses of MMR vaccine, the first at:

 12-15 months of age
    And the second at:
 4-6 years of age

    These are the recommended ages. But children can get the second 
dose of MMR vaccine at any age, as long as it is at least 28 days after 
the first dose.
Some Adults Should Also Get MMR Vaccine
    Generally, anyone 18 years of age or older, who was born after 
1957, should get at least one dose of MMR vaccine unless they:
     Have documentation of at least one dose each of measles, 
mumps, and rubella vaccines,
     Have other acceptable evidence of immunity to these three 
diseases, or
     Have a medical reason why they should not get the vaccines 
(see #3, below).
    Ask your doctor or nurse for more information.
    Adults with a special need for these three vaccines include:
     College students, trade school students, and other 
students beyond high school.
     People working in hospitals and other medical facilities.
     International travelers and passengers on cruise ships.
     Women of childbearing age (who are not pregnant).
     People who move to the US from countries that do not have 
routine rubella vaccination.
    MMR vaccine may be given at the same time as other vaccines. 
Immunity from MMR vaccine probably lasts for life.

3. Some People Should Not Get MMR Vaccine or Should Wait

     People who have ever had a serious allergic reaction to 
gelatin, the antibiotic neomycin, or a previous dose of MMR vaccine 
should not get the vaccine.
     People who are moderately or severely ill at the time the 
shot is scheduled should usually wait until they recover before getting 
MMR vaccine.
     Pregnant women should wait to get MMR vaccine until after 
they have given birth. Women should not get pregnant for 3 months after 
getting MMR vaccine.
     Some people should check with their doctor about whether 
they should get MMR vaccine. These people include anyone who:

--Has HIV/AIDS, or another disease that affects the immune system.
--Is being treated with drugs that affect the immune system, such as 
steroids, for 2 weeks or longer.
--Has any kind of cancer.
--Is taking cancer treatment with x-rays or drugs.
--Has ever had a low platelet count (a blood disorder).

     People who recently had a transfusion or were given other 
blood products should ask their doctor when they may get MMR vaccine.
    If you are not sure, ask your doctor or nurse.

4. What Are the Risks From MMR Vaccine?

     A vaccine, like any medicine, is capable of causing life-
threatening problems, such as severe allergic reactions. The risk of 
MMR vaccine causing serious harm, or death, is extremely small.
     Getting MMR vaccine is much safer than getting any of 
these three diseases.
     Most people who get MMR vaccine do not have any problems 
with it.
Mild Problems
     Fever (up to 1 person out of 6).
     Mild rash (about 1 person out of 20).
     Swelling of glands in the cheeks, neck, or under the jaw 
(rare).
    If these problems occur, it is usually within 7-12 days after the 
shot. They occur less often after the second dose.
Moderate Problems
     Seizure (jerking or staring) caused by fever (about 1 out 
of 3,000 doses).
     Temporary pain and stiffness in the joints, mostly in 
teenage or adult women (up to 1 out of 4).
     Low platelet count, which can cause a bleeding disorder 
(about 1 out of 30,000 doses).

Severe Problems (Very Rare)

     Serious allergic reaction (less than 1 out of a million 
doses).
    Several other severe problems have been known to occur after a 
child gets MMR vaccine. But this happens so rarely, experts cannot be 
sure whether they are caused by the vaccine or not. These include:
     Deafness.
     Long seizures, coma, or lowered consciousness.
     Permanent brain damage.

5. What if There is a Moderate or Severe Reaction?

What Should I Look For?
     Any unusual condition, such as a serious allergic 
reaction, high fever or behavior changes. Signs of a serious allergic 
reaction can include difficulty breathing, hoarseness or wheezing, 
hives, paleness, weakness, a fast heart beat or dizziness. If it 
occurs, a high fever or seizure would occur 1 to 2 weeks after the 
shot.
What Should I Do?
     Call a doctor or get the person to a doctor right away.
     Tell your doctor what happened, the date and time it 
happened, and when the vaccination was given.

[[Page 47031]]

     Ask your doctor, nurse, or health department to file a 
Vaccine Adverse Event Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

6. The National Vaccine Injury Compensation Program

    In the rare event that you or your child has a serious reaction to 
a vaccine, a Federal program has been created to help you pay for the 
care of those who have been harmed.
    For details about the National Vaccine Injury Compensation program, 
call 1-800-338-2382 or visit the program's website at http://
www.hrsa.dhhs.gov/bhpr/vicp

7. How Can I Learn More?

     Ask your doctor or nurse. They can give you the vaccine 
package insert or suggest other sources of information.
     Call your local or state health department. They can give 
you the Parents Guide to Childhood Immunization, Immunization of 
Adults: A Call to Action, or other information.
     Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espanol)
--Visit the National Immunization Program's website at http://
www.cdc.gov/nip

U.S. Department of Health & Human Services
Centers for Disease Control and Prevention
National Immunization Program
MMR (00/00/00) (Proposed)
Vaccine Information Statement
42 U.S.C. 300aa-26

    Dated: August 28, 1998.
Thena M. Durham,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 98-23736 Filed 9-2-98; 8:45 am]
BILLING CODE 4163-18-P