[Federal Register Volume 65, Number 171 (Friday, September 1, 2000)]
[Notices]
[Pages 53316-53318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-22428]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Interim Hepatitis B Vaccine Information Materials

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

ACTION:  Notice.

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SUMMARY:  A hepatitis B vaccine has recently been approved for 
administration in a two dose schedule to adolescents 11 to 15 years of 
age as an alternative to the three dose schedule. This additional 
schedule necessitates a revision of the vaccine information statement 
entitled, ``Hepatitis B Vaccine: What You Need to Know'' (dated 
December 16, 1998), which was developed by the CDC as required by the 
National Childhood Vaccine Injury Act of 1986 (NCVIA). To ensure that 
up-to-date information is

[[Page 53317]]

available regarding this additional schedule, CDC is distributing the 
following interim hepatitis B vaccine information statement which may 
be used pending completion of the formal revision process.

DATES: Effective September 1, 2000. Any health care provider 
administering hepatitis B vaccine approved for administration in a two 
dose schedule may provide the interim hepatitis B vaccine information 
materials contained in this notice (which are dated August 9, 2000) to 
parents/legal representatives prior to immunization in lieu of 
providing the December 16, 1998 version of the hepatitis B 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, (404) 639-8200.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986 (Public Law 99-660), as amended by section 708 of Public Law 103-
183, added section 2126 to the Public Health Service Act. Section 2126, 
codified at 42 U.S.C. 300aa-26, requires the Secretary of Health and 
Human Services to develop and disseminate vaccine information materials 
for distribution by all health care providers, whether public or 
private, 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.
    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 prior to administration of the vaccine. 
Effective 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.
    The materials currently in use for 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); those for hepatitis B, 
Haemophilus influenzae type b (Hib), varicella (chickenpox), and 
measles, mumps, rubella vaccines on February 23, 1999 (64 FR 9042); and 
the current materials for polio vaccines, along with the current 
instructions for use of all of the vaccine information materials, were 
published in a Federal Register notice on December 17, 1999 (64 FR 
70914).

Interim Hepatitis B Vaccine Information Materials

    A hepatitis B vaccine has recently been approved for administration 
in a two dose schedule to adolescents 11 to 15 years of age as an 
alternative to the three dose schedule. This additional schedule 
necessitates a revision of the vaccine information statement entitled, 
``Hepatitis B Vaccine: What You Need to Know'' (dated December 16, 
1998). To ensure that up-to-date information is available regarding 
this schedule, CDC is distributing the following interim hepatitis B 
vaccine information statement, dated August 9, 2000, which may be used 
pending completion of the formal revision process.

Availability of Vaccine Information Materials (Vaccine Information 
Statements)

    Copies of the interim hepatitis B vaccine information materials and 
the other CDC vaccine information materials, and instructions for their 
use, can be downloaded from the CDC website at: http://www.cdc.gov/nip/publications/VIS/. Single camera-ready copies of the vaccine 
information materials, and copies of the instructions for their use, 
are also available from State health department immunization programs.

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 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

[[Page 53318]]

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
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                                                                        WHO?
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              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
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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.
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--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.

Mild Problems

     soreness where the shot was given, lasting a day or two 
(up to 1 out of 11 children and adolescents, and about 1 out of 4 
adults)
     mild to moderate fever (up to 1 out of 14 children and 
adolescents and 1 out of 100 adults)

Severe Problems

     serious allergic reaction (very rare).

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.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 (8/9/2000) 
(Interim) Vaccine Information Statement 42 U.S.C. 300aa-26

    Dated: August 28, 2000.
Candice Nowicki,
Acting Director, Executive Secretariat, Centers for Disease Control and 
Prevention (CDC).
[FR Doc. 00-22428 Filed 8-31-00; 8:45 am]
BILLING CODE 4163-18-P