Federal Register, Volume 64 Issue 35 (Tuesday, February 23, 1999)

[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]

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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.

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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 (404) 639-8200.

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 (334) 242-5023
Alaska (907) 269-8000
American Samoa 011-684-633-4606
Arizona (602) 230-5832
Arkansas (501) 661-2723
California (510) 540-2065
Los Angeles (213) 580-9800
Colorado (303) 692-2669
Connecticut (860) 509-7929
Delaware (302) 739-4746
Florida (850) 487-2755
Georgia (404) 657-3158
Guam (671) 734-7135
Hawaii (808) 586-8330
Idaho (208) 334-5942
Illinois (217) 785-1455
Chicago (312) 746-6120
Indian Health Service (505) 248-4226
Indiana (317) 233-7010
Iowa (515) 281-4917
Kansas (785) 296-5593
Kentucky (502) 564-4478
Louisiana (504) 483-1900
Maine (207) 287-3746
Mariana Islands (670) 234-8950, x2005
Marshall Islands 011-692-625-3480
Maryland (410) 767-6679
Massachusetts (617) 983-6807
Michigan (517) 335-8159
Detroit (313) 876-4606
Micronesia 011-691-320-2619
Minnesota (612) 676-5569
Mississippi (601) 576-7751
Missouri (573) 751-6133
Montana (406) 444-5580
Nebraska (402) 471-2937
Nevada (702) 684-5900
New Hampshire (603) 271-4485
New Jersey (609) 588-7520
New Mexico (505) 827-2369
New York State (518) 473-4437
New York City (212) 676-2293
North Carolina (919) 733-7752
North Dakota (701) 328-2378
Ohio (614) 466-4643
Oklahoma (405) 271-4073
Oregon (503) 731-4020
Palau 011-680-488-1757
Pennsylvania (717) 787-5681
Philadelphia (215) 685-6749
Puerto Rico (787) 274-5612
Rhode Island (401) 222-4603
South Carolina (803) 898-0460
South Dakota (605) 773-3737
Tennessee (615) 741-7343
Texas (512) 458-7284
Houston (713) 794-9267
San Antonio (210) 207-8794
Utah (801) 538-9450
Vermont (802) 863-7638
Virgin Islands (809) 776-8311, ext. 2151
Virginia (804) 786-6246 or 6247
Washington, D.C. (202) 576-7130
Washington (360) 236-3541
West Virginia (304) 558-2188
Wisconsin (608) 266-1339
Wyoming (307) 777-6001

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

7. How can I learn more?

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

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)

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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

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