99-4388. New Vaccine Information Materials for Hepatitis B, Haemophilus influenzae type b (Hib), and Varicella (Chickenpox) Vaccines, and Revised Vaccine Information Materials for Measles, Mumps, Rubella (MMR) Vaccines

[Federal Register Volume 64, Number 35 (Tuesday, February 23, 1999)]
[Notices]
[Pages 9042-9048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4388]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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

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

ACTION: Notice.

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

SUMMARY: Under the National Childhood Vaccine Injury Act (42 U.S.C. 
300aa-26), the CDC must develop vaccine information materials that all 
health care providers, whether public or private, are required to 
distribute to patients/parents prior to administration of each dose of 
specific vaccines. On September 3, 1998, CDC published a notice in the 
Federal Register (63 FR 47026) seeking public comment on proposed 
vaccine information materials for the newly covered vaccines hepatitis 
B, Haemophilus influenzae type b, and varicella vaccines, and also 
seeking comment on proposed revised vaccine information materials for 
measles, mumps, rubella (MMR) vaccines. The 60 day comment period ended 
on November 2, 1998. Following review of the comments submitted and 
consultation as required under the law, CDC has finalized these vaccine 
information materials. The final materials are contained in this 
notice.

DATES: Effective June 1, 1999, each health care provider who 
administers any vaccine that contains hepatitis B, Haemophilus 
influenzae type b (Hib), varicella (chickenpox), measles, mumps, or 
rubella vaccines shall, prior to administration of each dose of the 
vaccine, provide a copy of the relevant vaccine information materials 
contained in this notice to the parent or legal representative of any 
child to whom such provider intends to administer the vaccine and to 
any adult to whom such provider intends to administer the vaccine.
    See Instructions for Use of Vaccine Information Materials (Vaccine 
Information Statements), in the Supplementary Information section of 
this notice, for information on required use of previously available 
vaccine information materials.

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 [phone].

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986 (Pub. L. 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. 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 Td tetanus diphtheria vaccine were published in a 
Federal Register notice on June 20, 1994 (59 FR 31888). 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). Elsewhere in this issue of the Federal 
Register, we are publishing revised interim polio vaccine information

[[Page 9043]]

materials for use pending formal revision of those materials as 
required under the statute. (The polio vaccine information materials 
are being revised to inform patients/parents of the most recent 
recommendations for use of the two polio vaccines.)
    (Rotavirus vaccine is in the process of being added to the National 
Vaccine Injury Compensation Program. Development of vaccine information 
materials for this vaccine is underway. As part of the process for 
developing these new materials, CDC will publish draft materials in the 
Federal Register for public comment and will consult with affected 
parties as required by the statute. Distribution of the vaccine 
information materials for this newly covered vaccine will be required 
following publication of the final version of the rotavirus vaccine 
information materials in the Federal Register.)

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. Therefore, as required under 42 U.S.C. 300aa-26, the CDC has 
developed vaccine information materials covering these vaccines.
    Included in this notice are vaccine information materials covering 
hepatitis B, Haemophilus influenzae type b (Hib), and varicella 
vaccines.

Revised Measles, Mumps, Rubella Vaccine Information Materials

    In addition to vaccine information materials for these newly 
covered vaccines, this notice also includes 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.

Development of New/Revised Vaccine Information Materials

    On September 3, 1998, CDC published a notice in the Federal 
Register (63 FR 47026) seeking public comment on proposed new vaccine 
information materials for hepatitis B, Haemophilus influenzae type b, 
and varicella vaccines, and revised vaccine information materials for 
measles, mumps, rubella vaccines.
    The 60-day comment period ended on November 2, 1998. Comments were 
submitted by a few individuals and organizations. As required by the 
statute, CDC has also consulted with various groups, including the 
Advisory Commission on Childhood Vaccines, 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 focus groups. 
Comments provided by the consultants and focus groups, along with the 
comments submitted in response to the September 3, 1998 Federal 
Register notice, were fully considered in revising the proposed vaccine 
information materials.
    Following consultation and review of comments submitted, the 
hepatitis B, Haemophilus influenzae type b, varicella, and measles, 
mumps, rubella vaccine information materials have been finalized and 
are contained in this notice. They are 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 & Rubella Vaccines: What You Need to Know.''
* * * * *

INSTRUCTIONS FOR USE OF VACCINE INFORMATION MATERIALS (VACCINE 
INFORMATION STATEMENTS)

Required Use

    As required under the National Childhood Vaccine Injury Act (42 
U.S.C. 300aa-26), all health care providers in the United States who 
administer any vaccine containing diphtheria, tetanus, pertussis, 
measles, mumps, rubella, polio, hepatitis B, Haemophilus influenzae 
type b (Hib), or varicella (chickenpox) vaccine shall, prior to 
administration of each dose of the vaccine, provide a copy of the 
relevant vaccine information materials that have been produced by the 
Centers for Disease Control and Prevention (CDC):

    (a) to the parent or legal representative of any child to whom 
the provider intends to administer such vaccine, and
    (b) to any adult to whom the provider intends to administer such 
vaccine.

    The materials shall be supplemented with visual presentations or 
oral explanations, in appropriate cases.
    ``Legal representative'' is defined as a parent or other individual 
who is qualified under State law to consent to the immunization of a 
minor.

Additional Recommended Use of Materials

    Health care providers may also want to give parents copies of all 
vaccine information materials prior to the first visit for 
immunization, such as at the first well baby visit.

Effective Date for Required Use of New Vaccine Information 
Materials

    Effective June 1, 1999, each health care provider who administers 
any vaccine that contains hepatitis B, Haemophilus influenzae type b 
(Hib), varicella (chickenpox), measles, mumps, or rubella vaccines 
shall, prior to administration of each dose of the vaccine, provide a 
copy of the relevant vaccine information materials, dated December 16, 
1998, to the parent or legal representative of any child to whom such 
provider intends to administer the vaccine and to any adult to whom 
such provider intends to administer the vaccine.

Use of Interim Polio Vaccine Information Materials

    Beginning as soon as practicable after February 23, 1999, health 
care providers should distribute copies of the interim polio vaccine 
information materials, dated February 1, 1999, in place of the February 
6, 1997 version of the polio materials.

Current Editions of Vaccine Information Materials for Other Covered 
Vaccines

    Diphtheria, Tetanus, Pertussis (DTP/DTaP/DT) Vaccine Information 
Materials, dated August 15, 1997
    Tetanus, Diphtheria (Td) Vaccine Information Materials, dated June 
10, 1994
    Measles, Mumps, Rubella Vaccine Information Materials, dated June 
10, 1994; to be replaced no later than June 1, 1999 by the December 16, 
1998 revised Measles, Mumps, Rubella materials

[[Page 9044]]

Recordkeeping

    Health care providers shall make a notation in each patient's 
permanent medical record at the time vaccine information materials are 
provided indicating (1) the edition date of the materials distributed 
and (2) the date these materials were provided.
    This recordkeeping requirement supplements the requirement of 42 
U.S.C. Sec. 300aa-25 that all health care providers administering these 
vaccines must record in the patient's permanent medical record (or in a 
permanent office log) the name, address and title of the individual who 
administers the vaccine, the date of administration and the vaccine 
manufacturer and lot number of the vaccine used.

Applicability of State Law

    Health care providers should consult their legal counsel to 
determine additional State requirements pertaining to immunization. The 
Federal requirement to provide the vaccine information materials 
supplements any applicable State law.

Availability of Copies

    Single camera-ready copies of the vaccine information materials are 
available from State health departments. Copies are available in 
English and in other languages.
    February 23, 1999
* * * * *

List of Contact Telephone Numbers for Copies of Vaccine Information 
Materials

    Single camera-ready copies of the vaccine information materials, 
and copies of the instructions for their use, are available by calling 
the telephone number listed below for your location:
Alabama [phone]
Alaska [phone]
American Samoa 011-684-633-4606
Arizona [phone]
Arkansas [phone]
California [phone]
    Los Angeles [phone]
Colorado [phone]
Connecticut [phone]
Delaware [phone]
Florida [phone]
Georgia [phone]
Guam [phone]
Hawaii [phone]
Idaho [phone]
Illinois [phone]
    Chicago [phone]
Indian Health Service [phone]
Indiana [phone]
Iowa [phone]
Kansas [phone]
Kentucky [phone]
Louisiana [phone]
Maine [phone]
Mariana Islands [phone], x2005
Marshall Islands 011-692-625-3480
Maryland [phone]
Massachusetts [phone]
Michigan [phone]
    Detroit [phone]
Micronesia 011-691-320-2619
Minnesota [phone]
Mississippi [phone]
Missouri [phone]
Montana [phone]
Nebraska [phone]
Nevada [phone]
New Hampshire [phone]
New Jersey [phone]
New Mexico [phone]
New York State [phone]
    New York City [phone]
North Carolina [phone]
North Dakota [phone]
Ohio [phone]
Oklahoma [phone]
Oregon [phone]
Palau 011-680-488-1757
Pennsylvania [phone]
    Philadelphia [phone]
Puerto Rico [phone]
Rhode Island [phone]
South Carolina [phone]
South Dakota [phone]
Tennessee [phone]
Texas [phone]
    Houston [phone]
    San Antonio [phone]
Utah [phone]
Vermont [phone]
Virgin Islands [phone], ext. 2151
Virginia [phone] or 6247
Washington, D.C. [phone]
Washington [phone]
West Virginia [phone]
Wisconsin [phone]
Wyoming [phone]

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
     diarrhea and vomiting
     tiredness
     jaundice (yellow skin or eyes)
     pain in muscles, joints, and stomach
    It can also cause long-term (chronic) illness that leads to:
     liver damage (cirrhosis)
     liver cancer
     death
    About 1.25 million people in the U.S. have chronic hepatitis B 
virus infection.
    Each year it is estimated that:
     200,000 people, mostly young adults, get infected with 
hepatitis B virus
     More than 11,000 people have to stay in the hospital 
because of hepatitis B
     4,000 to 5,000 people die from chronic hepatitis B
    Hepatitis B vaccine can prevent hepatitis B. It 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 and 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 on the job
     by sharing personal items, such as a razor or toothbrush 
with an infected person
    People can get hepatitis B virus infection without knowing how they 
got it. About 1/3 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 virus infection include people who 
have more than one sex partner, men who have sex with other men, 
injection drug users, health care workers, and others who might be 
exposed to infected blood or body fluids.
    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.

[[Page 9045]]



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

--The second dose must be given at least 1 month after the first dose
--The third dose must be given at least 2 months after the second dose 
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.
    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 
life-threatening allergic reaction to baker's yeast (the kind used for 
making bread) or to a previous dose of hepatitis B vaccine.
    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 serious 
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 P.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).

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's immunization 
program.
     Contact the Centers for Disease Control and Prevention 
(CDC):
--Call 1-800-232-2522 or 1-888-443-7232 (English)
--Call 1-800-232-0233 (Espanol)
--Visit the National Immunization Program's website at http://
www.cdc.gov/nip or CDC's Hepatitis Branch website at http://
www.cdc.gov/ncidod/diseases/hepatitis/
 U.S. Department of Health & Human Services, Centers for Disease 
Control and Prevention, National Immunization Program.
    Hepatitis B (12/16/98) Vaccine Information Statement 42 U.S.C. 
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. If the germs stay in the child's nose and throat, the 
child probably will not get 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 and deafness. Hib disease can 
also cause:
     pneumonia
     severe swelling in the throat, making it hard to breathe
     infections of the blood, joints, bones, and covering of 
the heart
     death
    Before Hib vaccine, about 20,000 children in the United States 
under 5 years old got severe Hib disease each year, and nearly 1,000 
died.
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

[[Page 9046]]

    *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 life-threatening 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 serious 
problems, such as severe allergic reactions. The risk of Hib vaccine 
causing serious harm or death is extremely small.
    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 1/4 of 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 problem?

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 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.

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's immunization 
program.
     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 (12/16/98) Vaccine Information Statement 42 U.S.C. Sec. 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
    Most people who get chickenpox vaccine will not get chickenpox. But 
if someone who has been vaccinated does get chickenpox, it is usually 
very mild. They will have fewer spots, are less likely to have a fever, 
and will recover faster.

2. Who should get chickenpox vaccine and when?

     Children should get 1 dose of chickenpox vaccine between 12 
and 18 months of age, or at any age after that if they have never had 
chickenpox.
    People who do not get the vaccine until 13 years of age or older 
should get 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.

3. Some people should not get chickenpox vaccine or should wait

     People should not get chickenpox vaccine if they have ever 
had a life-threatening allergic reaction to gelatin, the antibiotic 
neomycin, or (for those needing a second dose) a previous dose of 
chickenpox 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.
     Women should not get pregnant for 1 month after getting 
chickenpox vaccine.
     Some people should check with their doctor about whether 
they should get chickenpox vaccine, including 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.
    Ask your doctor or nurse for more information.

4. What are the risks from chickenpox vaccine?

    A vaccine, like any medicine, is capable of causing serious 
problems,

[[Page 9047]]

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 person out of 10, or less)
     Mild rash, up to a month after vaccination (1 person out 
of 20, or less). It is possible for these people to infect other 
members of their household, but this is extremely rare.
Moderate Problems
     Seizure (jerking or staring) caused by fever (less than 1 
person out of 1,000).
Severe Problems
     Pneumonia (very rare)
    Other serious problems, including severe brain reactions and 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.

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 within a few minutes to a few 
hours after the shot. A high fever or seizure, if it occurs, would 
happen 1 to 6 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.

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's immunization 
program.
     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 (12/16/98) Vaccine Information Statement 42 U.S.C. 
Sec. 300aa-26
* * * * *

Measles, Mumps & 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 or 
ovaries, and, rarely, death.
Rubella (German Measles)
     Rubella virus causes rash, mild fever, 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 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 
1956, should get at least one dose of MMR vaccine, unless they can show 
that they have had either the vaccines or the diseases.
    Ask your doctor or nurse for more information.
    MMR vaccine may be given at the same time as other vaccines.

3. Some people should not get MMR vaccine or should wait

     People should not get MMR vaccine who have ever had a 
life-threatening allergic reaction to gelatin, the antibiotic neomycin, 
or a previous dose of MMR 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, including 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.
    Ask your doctor or nurse for more information.

4. What are the risks from MMR vaccine?

    A vaccine, like any medicine, is capable of causing serious 
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)

[[Page 9048]]

     Mild rash (about 1 person out of 20)
     Swelling of glands in the cheeks or neck (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)
     Temporary 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-term 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 include 
difficulty breathing, hoarseness or wheezing, hives, paleness, 
weakness, a fast heart beat or dizziness within a few minutes to a few 
hours after the shot. A high fever or seizure, if it occurs, would 
happen 1 or 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.
     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's immunization 
program.
     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 (12/16/98) Vaccine Information Statement 42 U.S.C. 300aa-26.

    Dated: February 17, 1999.
Jeffrey P. Koplan,
Director, Centers for Disease Control and Prevention (CDC).
[FR Doc. 99-4388 Filed 2-22-99; 8:45 am]
BILLING CODE 4163-18-P