Notice: Vaccine Information Materials for Pneumococcal Conjugate,
Diphtheria, Tetanus, acellular Pertussis and Hepatitis B Vaccines
Federal Register: September 27, 2002 (Volume 67, Number 188)
Page 61110-61114
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
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 are required to give to patients/parents prior to
administration of specific vaccines. On March 6, 2001, CDC published a
notice in the Federal Register (66 FR 13540) seeking public comments on
proposed new vaccine information materials for pneumococcal conjugate
vaccine, and revised vaccine information materials for diphtheria,
tetanus, acellular pertussis (DTaP/DT) vaccines and hepatitis B
vaccine. 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: Beginning no later than December 15, 2002, each health care
provider who administers any vaccine that contains pneumococcal
conjugate vaccine shall, prior to administration of each dose, provide
a copy of the pneumococcal conjugate 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.
Beginning as soon as practicable, each health care provider who
administers any vaccine that contains diphtheria, tetanus, acellular
pertussis or hepatitis B vaccine 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 hepatitis B vaccine, in lieu of providing earlier versions
of these 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, NE., 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 all health care providers in the United States 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 in the United States who intends to administer one
of these covered vaccines is required to provide copies of the relevant
vaccine information materials, also known as Vaccine Information
Statements (VIS), prior to administration of any of these vaccines.
Since June 1, 1999, health care providers are also required to provide
copies of vaccine information materials for the following vaccines that
were added to the National Vaccine Injury Compensation Program:
hepatitis B, haemophilus influenzae type b (Hib), and varicella
(chickenpox) vaccines.
Pneumococcal Conjugate Vaccine Information Materials
Following the addition of pneumococcal conjugate vaccine to the
National Vaccine Injury Compensation Program, CDC, as required under 42
U.S.C. 300aa-26, proposed vaccine information materials covering that
vaccine which were published in a Federal Register notice on March 6,
2001 (66 FR 13540). With publication of this notice, as of December 15,
2002, health care providers will also be required to provide copies of
pneumococcal conjugate vaccine information materials
Revised Vaccine Information Materials for Diphtheria, Tetanus,
acellular Pertussis (DTaP/DT) Vaccines and Hepatitis B Vaccine
Proposed revised vaccine information materials for diphtheria,
tetanus, acellular pertussis (DTaP/DT) vaccines and hepatitis B vaccine
were also published in the March 6, 2001 Federal Register notice.
New/Revised Vaccine Information Materials
The new/revised vaccine information materials were drafted in
consultation with the Advisory Commission on Childhood Vaccines, the
Food and Drug Administration, the American Academy of Pediatrics,
American Pharmaceutical Association, Association of American Indian
Physicians, Every Child by Two, Immunization Action Coalition,
Immunization, Education and Action Committee, Infectious Diseases
Society of America, National Association for Pediatric Nurse Associates
and Practitioners and the National Vaccine Advisory Committee. Also,
CDC provided copies of the draft materials to other organizations and
sought their consultation; however, those organizations did not provide
comments.
Following consultation and review of comments submitted, these
vaccine information materials have been finalized and are contained in
this notice. They are entitled ``Pneumococcal Conjugate Vaccine: What
You Need to Know,'' ``Diphtheria,
[[Page 61111]]
Tetanus & Pertussis Vaccines: What You Need to Know,'' and ``Hepatitis
B Vaccine: What You Need to Know.'' CDC has also revised the
Instructions for the Use of Vaccine Information Statements.
Instructions for use of the vaccine information materials and
copies of the materials can be found on the CDC website at: http://
www.cdc.gov/nip/publications/VIS/. In addition, single camera-ready
copies are available from State health departments. A list of State
health department contacts for obtaining copies of these materials is
included in a December 17, 1999 Federal Register notice (64 FR 70914).
* * * * *
Pneumococcal Conjugate Vaccine: What You Need to Know
1. Why get vaccinated?
Infection with Streptococcus pneumoniae bacteria can cause serious
illness and death. Invasive pneumococcal disease is responsible for
about 200 deaths each year among children under 5 years old. It is the
leading cause of bacterial meningitis in the United States. (Meningitis
is an infection of the covering of the brain).
Each year pneumococcal infection causes severe disease in children
under five years old. Before a vaccine was available, pneumococcal
infection each year caused:
[sbull] Over 700 cases of meningitis
[sbull] 13,000 blood infections, and
[sbull] About 5 million ear infections
It can also lead to other health problems, including:
[sbull] Pneumonia,
[sbull] Deafness,
[sbull] Brain damage.
Children under 2 years old are at highest risk for serious disease.
Pneumococcus bacteria are spread from person to person through close
contact.
Pneumococcal infections can be hard to treat because the bacteria
have become resistant to some of the drugs that have been used to treat
them. This makes prevention of pneumococcal infections even more
important. Pneumococcal conjugate vaccine can help prevent serious
pneumococcal disease, such as meningitis and blood infections. It can
also prevent some ear infections. But ear infections have many causes,
and pneumococcal vaccine is effective against only some of them.
2. Pneumococcal conjugate vaccine
Pneumococcal conjugate vaccine is approved for infants and
toddlers. Children who are vaccinated when they are infants will be
protected when they are at greatest risk for serious disease.
Some older children and adults may get a different vaccine called
pneumococcal polysaccharide vaccine. There is a separate Vaccine
Information Statement for people getting this vaccine.
3. Who should get the vaccine and when?
[sbull] Children under 2 years of age:
--2 months
--4 months
--6 months
--12-15 months
Children who weren't vaccinated at these ages can still get the
vaccine. The number of doses needed depends on the child's age. Ask
your health care provider for details.
[sbull] Children between 2 and 5 years of age:
Pneumococcal conjugate vaccine is also recommended for children
between 2 and 5 years old who have not already gotten the vaccine and
are at high risk of serious pneumococcal disease.
This includes children who:
--Have sickle cell disease,
--Have a damaged spleen or no spleen,
--Have HIV/AIDS,
--Have other diseases that affect the immune system, such as diabetes,
cancer, or liver disease, or who
--Take medications that affect the immune system, such as chemotherapy
or steroids, or
--Have chronic heart or lung disease.
The vaccine should be considered for all other children under age 5
years, especially those at higher risk of serious pneumococcal disease.
This includes children who:
--Are under 3 years of age,
--Are of Alaska Native, American Indian or African American descent, or
--Attend group day care.
The number of doses needed depends on the child's age. Ask your
health care provider for more details.
Pneumococcal conjugate vaccine may be given at the same time as
other vaccines.
4. Some children should not get pneumococcal conjugate vaccine or
should wait.
Children should not get pneumococcal conjugate vaccine if they had
a severe (life-threatening) allergic reaction to a previous dose of
this vaccine, or have a severe allergy to a vaccine component. Tell
your health-care provider if your child has ever had a severe reaction
to any vaccine, or has any severe allergies.
Children with minor illnesses, such as a cold, may be vaccinated.
But children who are moderately or severely ill should usually wait
until they recover before getting the vaccine.
5. What are the risks from pneumococcal conjugate vaccine?
In studies (nearly 60,000 doses), pneumococcal conjugate vaccine
was associated with only mild reactions:
[sbull] Up to about 1 infant out of 4 had redness, tenderness, or
swelling where the shot was given.
[sbull] Up to 1 out of 3 had a fever of over 100.4[deg]F, and up to
about 1 in 50 had a higher fever (over 102.2[deg]F).
[sbull] Some children also became fussy or drowsy, or had a loss of
appetite.
So far, no moderate or severe reactions have been associated with
this vaccine. However, a vaccine, like any medicine, could cause
serious problems, such as a severe allergic reaction. The risk of this
vaccine causing serious harm, or death, is extremely small.
6. What if there is a moderate or severe reaction? What should I look
for?
Look for any unusual condition, such as a serious allergic
reaction, high fever, or unusual behavior.
Serious allergic reactions are extremely rare with any vaccine. If
one were to occur, it would most likely be within a few minutes to a
few hours after the shot. Signs can include:
--Difficulty breathing
--Hoarseness or wheezing
--Hives
--Paleness
--Weakness
--A fast heart beat
--Dizziness
--Swelling of the throat
What should I do?
[sbull] Call a doctor or get the person to a doctor right away.
[sbull] Tell your doctor what happened, the date and time it
happened, and when the vaccination was given.
[sbull] Ask your health care provider to file a Vaccine Adverse
Event Reporting System (VAERS) form. Or call VAERS yourself at 1-800-
822-7967, or visit their Web site at http://www.vaers.org.
7. The 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 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 their Web
site at http://www.hrsa.gov/bhpr/vicp.
[[Page 61112]]
8. How can I learn more?
[sbull] Ask your health care provider. They can give you the
vaccine package insert or suggest other sources of information.
[sbull] Call your local or state health department's immunization
program.
[sbull] Contact the Centers for Disease Control and Prevention
(CDC):
--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espa[ntilde]ol)
--Visit the National Immunization Program's Web site at http://
www.cdc.gov/nip
U.S. Department of Health & Human Services, Centers for Disease
Control and Prevention, National Immunization Program.
Vaccine Information Statement, Pneumococcal Conjugate Vaccine, (9/
30/02), 42 U.S.C. 300aa-26.
* * * * *
Diphtheria, Tetanus & Pertussis Vaccines: What You Need to Know
1. Why get vaccinated?
Diphtheria, tetanus, and pertussis are serious diseases caused by
bacteria. Diphtheria and pertussis are spread from person to person.
Tetanus enters the body through cuts or wounds.
Diphtheria causes a thick covering in the back of the throat.
[sbull] It can lead to breathing problems, paralysis, heart
failure, and even death.
Tetanus (Lockjaw) causes painful tightening of the muscles, usually
all over the body.
[sbull] It can lead to ``locking'' of the jaw so the victim cannot
open his mouth or swallow. Tetanus leads to death in about 3 out of 10
cases.
Pertussis (Whooping Cough) causes coughing spells so bad that it is
hard for infants to eat, drink, or breathe. These spells can last for
weeks.
[sbull] It can lead to pneumonia, seizures (jerking and staring
spells), brain damage, and death.
Diphtheria, tetanus, and pertussis vaccine (DTaP) can prevent these
diseases. Most children who are vaccinated with DTaP will be protected
throughout childhood. Many more children would get these diseases if we
stopped vaccinating.
DTaP is a safer version of an older vaccine called DTP. DTP is no
longer used in the United States.
2. Who should get DTaP vaccine and when?
Children should get 5 doses of DTaP vaccine, one dose at each of
the following ages:
--2 months
--4 months
--6 months
--15-18 months
--4-6 years
DTaP may be given at the same time as other vaccines.
3. Some children should not get DTaP vaccine or should wait
[sbull] Any child who has had a life-threatening allergic reaction
after a dose of DTaP should not get any more doses.
[sbull] Any child who suffered a brain or nervous system disease
within 7 days after a dose of DTaP should not get any more doses.
[sbull] Talk with your doctor if your child:
--had a seizure or collapsed after a previous dose of DTaP,
--cried non-stop for 3 hours or more after a previous dose of DTaP,
--had a high fever (over 105oF) after a previous dose of DTaP.
[sbull] Children who are moderately or severely ill at the time the
shot is scheduled should usually wait until they recover before getting
DTaP vaccine.
Ask your health care provider for more information. Children who
should not get the pertussis part of the vaccine can get a vaccine
called DT, which doesn't contain pertussis.
4. Older children and adults
DTaP should not be given to anyone 7 years of age or older.
Pertussis can still strike older children, adolescents, and adults, but
the pertussis vaccine is currently licensed only for children under 7.
Adolescents and adults still need protection from tetanus and
diphtheria. A booster shot called Td is recommended at 11-12 years of
age. It should be repeated every 10 years. There is a separate Vaccine
Information Statement for Td vaccine.
5. What are the risks from DTaP vaccine?
Getting diphtheria, tetanus, or pertussis disease is much riskier
than getting DTaP vaccine.
However, a vaccine, like any medicine, is capable of causing
serious problems, such as severe allergic reactions. The risk of DTaP
vaccine causing serious harm, or death, is extremely small.
Mild Problems (Common)
[sbull] Fever (up to about 1 child in 4)
[sbull] Redness or swelling where the shot was given (up to about 1
child in 4)
[sbull] Soreness or tenderness where the shot was given (up to
about 1 child in 4)
These problems occur more often after the 4th and 5th doses of the
DTaP series than after earlier doses.
Another mild problem is swelling of the arm or leg in which the
shot was given, after the 4th or 5th dose (up to about 1 child in 30).
Other mild problems include:
[sbull] Fussiness (up to about 1 child in 3)
[sbull] Tiredness or poor appetite (up to about 1 child in 10)
[sbull] Vomiting (up to about 1 child in 50)
These problems generally occur 1-3 days after the shot.
Moderate Problems (Uncommon)
[sbull] Seizure (jerking or staring) (about 1 child out of 14,000)
[sbull] Non-stop crying, for 3 hours or more (up to about 1 child
out of 1,000)
[sbull] High fever, over 1050F (about 1 child out of 16,000)
Severe Problems (Very Rare)
[sbull] Serious allergic reaction (less than 1 out of a million
doses)
[sbull] Several other severe problems have been reported after DTaP
vaccine. These include:
--Long-term seizures, coma, or lowered consciousness
--Permanent brain damage.
These are so rare it is hard to tell if they are caused by the
vaccine.
Controlling fever is especially important for children who have had
seizures, for any reason. It is also important if another family member
has had seizures.
You can reduce fever and pain by giving your child an aspirin-free
pain reliever when the shot is given, and for the next 24 hours,
following the package instructions.
6. What if there is a moderate or severe reaction?
What should I look for?
Any unusual conditions, 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. If a high fever or seizure occurs, it is usually
within 2 weeks after the shot.
What should I do?
[sbull] Call a doctor, or get the person to a doctor right away.
[sbull] Tell your doctor what happened, the date and time it
happened, and when the vaccination was given.
[sbull] 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.
[[Page 61113]]
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 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 Web site at http://
www.hrsa.gov/bhpr/vicp.
8. How can I learn more?
[sbull] Ask your health care provider. They can give you the
vaccine package insert or suggest other sources of information.
[sbull] Call your local or state health department's immunization
program.
[sbull] Contact the Centers for Disease Control and Prevention
(CDC):
--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espa[ntilde]ol)
--Visit the National Immunization Program's Web site at http://
www.cdc.gov/nip.
U.S. Department of Health & Human Services, Centers for Disease
Control and Prevention, National Immunization Program.
Vaccine Information Statement, DTaP/DT, (7/30/01), 42 U.S.C. 300aa-
26.
* * * * *
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:
[sbull] Loss of appetite
[sbull] Diarrhea and vomiting
[sbull] Tiredness
[sbull] Jaundice (yellow skin or eyes)
[sbull] Pain in muscles, joints, and stomach
It can also cause long-term (chronic) illness that leads to:
[sbull] Liver damage (cirrhosis)
[sbull] Liver cancer
[sbull] Death
About 1.25 million people in the U.S. have chronic hepatitis B
virus infection. If you are infected as a young child, you are much
more likely to develop chronic illness.
Each year it is estimated that:
[sbull] 200,000 people, mostly young adults, get infected with
hepatitis B virus
[sbull] More than 11,000 people have to stay in the hospital
because of hepatitis B
[sbull] 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:
[sbull] During birth when the virus passes from an infected mother
to her baby
[sbull] By having sex with an infected person
[sbull] By injecting illegal drugs
[sbull] By being stuck with a used needle on the job
[sbull] 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 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 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.
Hepatitis B Vaccination Schedule
----------------------------------------------------------------------------------------------------------------
Who?
---------------------------------------------------------------------------
Infant whose mother is Infant whose mother is
infected with hepatitis not infected with Older child,
B virus hepatitis B virus adolescent, or adult
----------------------------------------------------------------------------------------------------------------
When:
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 first dose.
after 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.
Adolescents 11 to 15 years of age may need only two doses of
hepatitis B vaccine, separated by 4-6 months. Ask your health care
provider for details.
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 a 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.
[[Page 61114]]
Mild Problems
[sbull] 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)
[sbull] Mild to moderate fever (up to 1 out of 14 children and
adolescents and 1 out of 100 adults)
Severe Problems
[sbull] 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?
[sbull] Call a doctor or get the person to a doctor right away.
[sbull] Tell your doctor what happened, the date and time it
happened, and when the vaccination was given.
[sbull] 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 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 Web site at http://
www.hrsa.gov/bhpr/vicp.
8. How can I learn more?
[sbull] Ask your doctor or nurse. They can give you the vaccine
package insert or suggest other sources of information.
[sbull] Call your local or state health department's immunization
program.
[sbull] 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 (Espa[ntilde]ol)
--Visit the National Immunization Program's Web site at http://
www.cdc.gov/nip or CDC's Hepatitis Branch Web site at http://
www.cdc.gov/ncidod/diseases/hepatitis
U.S. Department of Health & Human Services, Centers for Disease
Control and Prevention, National Immunization Program.
Vaccine Information Statement, Hepatitis B, (7/11/01), 42 U.S.C.
300aa-26.
Dated: September 23, 2002.
Joseph R. Carter,
Associate Director for Management and Operations, Centers for Disease
Control and Prevention (CDC).
[FR Doc. 02-24574 Filed 9-26-02; 8:45 am]
BILLING CODE 4163-18-P
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