[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]
[[Page 48595]]
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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
[[Page 48596]]
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
