[Federal Register Volume 61, Number 179 (Friday, September 13, 1996)]
[Notices]
[Pages 48596-48597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-23589]



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Part VII





Department of Health and Human Services





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Centers for Disease Control and Prevention



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Interim and Proposed Revision DTP/DTaP Vaccine Information Materials; 
Notices

  Federal Register / Vol. 61, No. 179 / Friday, September 13, 1996 / 
Notices  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Interim DTP/DTaP Vaccine Information Materials

AGENCY: Centers for Disease Control and Prevention (CDC), HHS.

ACTION: Notice.

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SUMMARY: On July 31, 1996, the Food and Drug Administration (FDA) 
licensed an acellular pertussis vaccine (combined with diphtheria and 
tetanus toxoids) (DTaP) for administration to infants as young as 2 
months of age. This recent development necessitates a revision of the 
vaccine information statement entitled, ``Diphtheria, Tetanus, and 
Pertussis Vaccine: What you need to know before your child gets the 
vaccine,'' which was developed by HHS as required by the National 
Childhood Vaccine Injury Act of 1986. A separate notice is being 
published in the Federal Register to begin formal revision of the 
statement under the procedures mandated by 42 U.S.C. Sec. 300aa-26.
    Pending completion of the formal revision process to revise the 
vaccine information statement, CDC is distributing the following 
interim statement which includes the new information regarding an 
acellular pertussis vaccine combined with diphtheria and tetanus 
toxoids (DTaP), to replace the current diphtheria, tetanus, and 
pertussis statement. This will ensure that individuals receiving the 
vaccine will have accurate up-to-date information which recognizes the 
recent licensure of an acellular pertussis vaccine combined with 
diphtheria and tetanus toxoids for administration to infants as young 
as 2 months of age.

DATES: Effective September 13, 1996.

FOR FURTHER INFORMATION CONTACT: Walter A. Orenstein, M.D., Director, 
National Immunization Program, Centers for Disease Control and 
Prevention (CDC), Mailstop E-O5, 1600 Clifton Road, NE., Atlanta, 
Georgia 30333, telephone (404) 639-8200.

SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of 
1986 (Public Law 99-660), as amended by section 708 of Public Law 103-
183, added section 2126 to the Public Health Service Act. Section 2126, 
codified at 42 U.S.C. Sec. 300aa-26, requires the Secretary of HHS to 
develop and disseminate vaccine information materials for distribution 
by health care providers to any patient (or to the parent or guardian 
in the case of a child) receiving vaccines covered under the National 
Vaccine Injury Compensation Program.
    The vaccines currently covered under this program are 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 vaccine information materials prior to administration of any of 
these vaccines. The materials currently in use were published in a 
Federal Register notice on June 20, 1994 (59 FR 31888).
    Development and revision of the vaccine information materials has 
been delegated by the Secretary to the 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 FDA. The law also requires that 
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.

Interim DTP/DTaP Vaccine Information Materials

    On July 31, 1996, the FDA licensed Connaught's Tripedia  
combined diphtheria and tetanus toxoids and acellular pertussis vaccine 
for administration to infants as young as two months of age. This 
recent development requires revision of the vaccine information 
statement entitled, ``Diphtheria, Tetanus, and Pertussis Vaccine: What 
you need to know before your child gets the vaccine.'' A Federal 
Register notice is being published simultaneously with this notice to 
begin formal revision of the statement under the procedures mandated by 
42 U.S.C. Sec. 300aa-26.
    Pending completion of the formal revision process, CDC is 
distributing the following interim statement which includes the new 
information regarding this acellular pertussis vaccine combined with 
diphtheria and tetanus toxoids (DTaP), to replace the current 
diphtheria, tetanus, and pertussis statement. As soon as practicable, 
and until a formal revision of the current version of the vaccine 
information statement can be completed, health-care providers should 
use this interim statement, so that individuals receiving pertussis 
vaccine will have accurate up-to-date information. Single copies of 
this statement are available from State health departments.

Diphtheria, Tetanus, and Pertussis Vaccines

What You Need To Know Before Your Child Gets the Vaccines

About the Diseases

    Diphtheria, tetanus (lockjaw), and pertussis (whooping cough) are 
serious diseases. Diphtheria and pertussis spread when germs pass from 
an infected person to the nose or throat of others. Tetanus is caused 
by a germ that enters the body through a cut or wound.
    Diphtheria causes: a thick coating in the nose, throat, or airway. 
It can lead to:

--breathing problems
--heart failure
--paralysis
--death

    Tetanus causes: serious, painful spasms of all muscles. It can lead 
to:

--``locking'' of the jaw so the patient cannot open his or her mouth or 
swallow
--death

    Pertussis causes: coughing and choking for several weeks (makes it 
hard for infants to eat, drink, or breathe). It can lead to:

--pneumonia
--seizures (jerking and staring spells)
--brain damage
--death

About the Vaccines

Benefits of Vaccination

    Vaccination is the best way to protect against diphtheria, tetanus, 
and pertussis. Because most children get the vaccines, there are now 
many fewer cases of these diseases. There would be many more cases if 
we stopped vaccinating children.

The Vaccines

    DTP (Diphtheria Tetanus Pertussis) DTP vaccine prevents diphtheria, 
tetanus, and pertussis. It has been used for many years in the United 
States.
    DTaP (Diphtheria Tetanus acellular Pertussis) DTaP prevents 
diphtheria, tetanus, and pertussis. It is less likely to cause the mild 
and moderate problems we see after DTP.
    Both DTP and DTaP are very effective for preventing all three 
diseases.
    DT (Diphtheria Tetanus) Unlike DTP and DTaP, it does not prevent 
pertussis.

[[Page 48597]]

For this reason, it is usually not recommended.

Schedule

    Most children should have a total of 5 DTP or DTaP vaccinations. 
They should get these vaccinations at:

2 months of age
4 months of age
6 months of age
12-18 months of age
4-6 years of age

    Other vaccines may be given at the same time as DTP or DTaP.

Who Should Get DTP or DTaP Vaccine?

    Most doctors recommend that almost all young children get DTP or 
DTaP vaccine. Some children should get DT. With all vaccines there are 
some cautions.
    Tell your doctor or nurse if the child getting the vaccine:
     ever had a serious allergic reaction or other problem 
after getting DTP, DTaP, or DT
     now has a moderate or serious illness
     has ever had a seizure
     has a parent, brother, or sister who has had seizures
     has a brain problem that is getting worse.
    If you are not sure, ask your doctor or nurse.

What Are the Risks From These Vaccines?

    As with any medicine, there are very small risks that serious 
problems, even death, could occur after getting a vaccine.
    The risks from the vaccines are much smaller than the risks from 
the diseases if people stopped using vaccine.
    Below is a list of problems that may occur after getting the 
vaccine. If your child ever had one of the moderate or severe problems 
listed below or any other serious problem after DTP, DTaP, or DT, 
discuss it with your doctor or nurse before this vaccination.

Mild Problems

    If these problems occur, they usually start within hours to a day 
or two after vaccination. They usually last up to 1-2 days:
     soreness, redness, or swelling where the shot was given
     fever
     fussiness, drowsiness, less appetite
    These problems are much less likely to occur with DTaP than with 
DTP.
    Acetaminophen or ibuprofen (not aspirin) may be used to prevent or 
reduce fever and soreness. This is especially important for children 
who have had seizures or have a parent, brother, or sister who has had 
seizures.

Moderate Problems

    Once for every 100-1,000 doses of DTP (less after DTaP):
     on-going crying for 3 hours or more
     fever of 105 deg. or higher
     an unusual, high-pitched cry
    Once for 1,750 doses of DTP (less after DTaP):
     a seizure (jerking and staring spell) usually caused by 
fever
     ``shock-collapse'' (becomes pale, limp, and less alert)

Severe Problems

    These problems happen very rarely:
     decreased consciousness, coma, or long seizure following 
DTP. Some of these children may have lasting brain damage. There is 
disagreement about whether or not DTP causes the lasting brain damage. 
If it does, it is very rare. The risk of decreased consciousness, coma, 
or long seizure after DTaP is not yet known, but experts believe it is 
even less likely to occur than after DTP.
     a serious allergic reaction
    What to do if there is a serious reaction:

+ Call a doctor or get the person to a doctor right away.
+ Write down what happened and the date and time it happened.
+ Ask your doctor, nurse, or health department to file a Vaccine 
Adverse Event Report form, or you can call: (800) 822-7967 (toll-free)

    The National Vaccine Injury Compensation Program gives compensation 
(payment) for persons thought to be injured by vaccines. For details 
call: (800) 338-2382 (toll-free).
    If you want to learn more, ask your doctor or nurse. She/he can 
give you the vaccine package insert or suggest other sources of 
information.

DTP/DTaP September 13, 1996, (Interim), Vaccine Information Statement, 
42 U.S.C. Sec. 300aa-26.

    Dated: September 10, 1996.
Arthur C. (Jack) Jackson,
Associate Director for Management and Operations, Centers for Disease 
Control and Prevention (CDC).
[FR Doc. 96-23589 Filed 9-12-96; 8:45 am]
BILLING CODE 4163-18-P