Revised Diphtheria, Tetanus, and Pertussis (DTP/DTaP/DT) Vaccine Information Materials

SUMMARY: Under the National Childhood Vaccine Injury Act (42 U.S.C.

Sec. 300aa-26), the CDC must develop vaccine information materials that

health care providers, either public or private, are required to

distribute to patients/parents prior to administration of each dose of

specific vaccines. On September 13, 1996, CDC published a notice in the

Federal Register (61 FR 48597) seeking public comment on proposed

revision of the diphtheria, tetanus, and pertussis vaccine information

materials to reflect Food and Drug Administration (FDA) licensure of

acellular pertussis vaccine combined with diphtheria and tetanus

toxoids (DTaP) for administration to infants as young as two months of

age. The 60-day comment period ended on November 12, 1996. Following

review of the comments submitted and consultation as required under the

law, CDC has finalized the revised diphtheria, tetanus, and pertussis

vaccine information materials. Those final materials are contained in

this notice.

DATES: Effective January 9, 1998. Beginning as soon as practicable,

each health care provider who administers any vaccine that contains

diphtheria, tetanus, or pertussis vaccine (except Td vaccine), shall,

prior to administration of each dose of the vaccine, provide a copy of

the 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. (See below, for information

regarding the Td (tetanus, diphtheria vaccine formulated for

administration to individuals seven years of age and older) vaccine

information materials.)

FOR FURTHER INFORMATION CONTACT: Jose Cordero, M.D., Acting 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. Sec. 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

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 originally covered under the National Vaccine Injury

Compensation 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 these vaccines is

required to provide copies of the 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 are dated June 10, 1994, and were published in a

Federal Register notice on June 20, 1994, (59 FR 31888). The current

materials for polio vaccine are dated February 6, 1997, and were

published in a Federal Register notice on February 6, 1997, (62 FR

5696). Single camera-ready copies of the vaccine information materials

are available from State health departments. A list of contact

telephone numbers for obtaining camera-ready copies is included in this

notice. Copies are available in English and other languages.

(Effective August 6, 1997, hepatitis B, haemophilus influenzae

type b, and varicella (chicken pox) vaccines were added for coverage

under the National Vaccine Injury Compensation Program. Development

of vaccine information materials for these vaccines is underway. As

part of the process for developing these new materials, CDC will

publish draft materials for public comment and will consult with

affected parties as required by the statute. Distribution of the

vaccine information materials for these newly covered vaccines will

be required following publication of the final version of each

vaccine's materials in the Federal Register. We anticipate that they

will be published in the second quarter of 1998.)

Revised Diphtheria, Tetanus, and Pertussis (DTP, DTaP, DT) Vaccine

Information Materials

Prior to July 31, 1996, all combined diphtheria and tetanus toxoids

and acellular pertussis vaccines (DTaP) were licensed only for

administration as the fourth or fifth doses of the DTP series. On that

date, the FDA licensed a DTaP vaccine for administration to infants as

young as two months of age (i.e., to include the first three doses of

the DTP series). Since that date, the FDA has licensed additional DTaP

vaccines to cover all five doses. Licensure of these vaccines requires

revision of the vaccine information statement entitled, ``Diphtheria,

Tetanus, and Pertussis Vaccine: What you need to know before your child

gets the vaccine.''

On September 13, 1996, CDC published a notice in the Federal

Register (61 FR 48597) seeking public comment on proposed diphtheria,

tetanus, and pertussis vaccine information materials that were revised

to reflect the FDA licensure of acellular pertussis vaccine combined

with diphtheria and tetanus toxoids (DTaP) for administration to

infants as young as two months of age. (In addition, interim vaccine

information materials pertaining to acellular pertussis vaccine

combined with diphtheria and tetanus toxoids (DTaP) were published in

the Federal Register on September 13, 1996, (61 FR 48596) for use by

health care providers pending completion of this formal revision

process.)

The 60-day comment period ended on November 12, 1996. Comments were

submitted by a few individuals and organizations in response to the

September 13, 1996, notice. 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

Family Practitioners, American Academy of Pediatrics, American College

of Osteopathic Pediatricians, American Nurses Association, Association

of Maternal and Child

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Health Programs, Association of State and Territorial Health Officials,

Council of State and Territorial Epidemiologists, Dissatisfied Parents

Together, Immunization Education and Action Committee: Healthy Mothers/

Healthy Babies Coalition, National Association of County Health

Officials, National Association of Hispanic Nurses, National Black

Nurses' Association, National Coalition of Hispanic Health and Human

Services Organizations (COSSMHO), National Council of La Raza, National

Medical Association, and Ohio Parents for Vaccine Safety. Comments from

the consultants, along with the comments submitted in response to the

Federal Register notice, were fully considered in revising the vaccine

information materials.

Following consultation and review of comments submitted, revised

diphtheria, tetanus, and pertussis (DTP, DTaP, DT) vaccine information

materials that comply with the provisions of the National Childhood

Vaccine Injury Act have been finalized and are contained in this

notice. They are entitled ``Diphtheria, Tetanus, and Pertussis

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, or polio 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.

Use of Revised Diphtheria, Tetanus, and Pertussis (DTP/DTaP/DT)

Vaccine Information Materials

Beginning as soon as practicable after January 9, 1998, health care

providers shall distribute copies of the August 15, 1997, version of

the diphtheria, tetanus, and pertussis (DTP/DTaP/DT) vaccine

information materials to replace the June 10, 1994, version or the

September 13, 1996, interim version of the diphtheria, tetanus, and

pertussis materials.

Use of Revised Polio Vaccine Information Materials

Beginning as soon as practicable after February 6, 1997, health

care providers shall distribute copies of the February 6, 1997, version

of the polio vaccine information materials to replace the June 10,

1994, version of the polio materials.

Current Editions of Vaccine Information Materials for Other Covered

Vaccines

The June 10, 1994, version of the following vaccine information

materials shall be distributed prior to administration of the vaccines

(whether combined or single antigen vaccines are used): measles, mumps,

and rubella (MMR) vaccine information materials, and tetanus,

diphtheria (Td) vaccine information materials.

Recordkeeping

Health care providers shall make a notation in each patient's

permanent medical record at the time vaccine information materials are

provided indicating the edition (date of publication) of the materials

distributed and the date these materials were provided. This

recordkeeping requirement supplements the requirement of 42 U.S.C.

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.

Dated: January 9, 1998.

* * * * *

List of Contact Telephone Numbers for Copies of Vaccine Information

Materials

Single camera-ready copies of the vaccine information materials are

available by calling the telephone number listed below for your

location:

Alabama (334) 242-5023

Alaska (907) 561-4406

American Samoa 011-684-633-4606

Arizona (602) 230-5845

Arkansas (501) 661-2723

California (510) 540-2065

Chicago (312) 746-5380

Colorado (303) 692-2669

Connecticut (860) 509-7929

Delaware (302) 739-4746

Detroit (313) 876-4606

Florida (904) 487-2755

Georgia (404) 657-3158

Guam 011-671-734-7135

Hawaii (808) 973-9678

Houston (713) 794-9267

Idaho (208) 334-5942

Illinois (217) 785-1455

Indian Health Service (505) 248-4226

Indiana (317) 233-7010

Iowa (515) 281-4917

Kansas (913) 296-5593

Kentucky (502) 564-4478

Los Angeles (213) 580-9800

Louisiana (504) 483-1900

Maine (207) 287-3746

Mariana Islands 011-670-234-8950, x2001

Marshall Islands 011-692-625-3480

Maryland (410) 767-6679

Massachusetts (617) 983-6807

Michigan (517) 335-8159

Micronesia 011-691-320-2619

Minnesota (612) 623-5237

Mississippi (601) 960-7751

Missouri (573) 751-6133

Montana (406) 444-0065

Nebraska (402) 471-2937

Nevada (702) 687-4800

New Jersey (609) 588-7520

New York City (212) 676-2339

New Hampshire (603) 271-4485

New Mexico (505) 827-2369

New York State (518) 473-4437

North Carolina (919) 733-7752

North Dakota (701) 328-2378

Ohio (614) 466-4643

Oklahoma (405) 271-4073

Oregon (503) 731-4020

Palau 011-160-680-1757

Pennsylvania (717) 787-5681

Philadelphia (215) 685-6749

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Puerto Rico (787) 274-5612

Rhode Island (401) 277-1185, ext. 188

San Antonio (210) 207-8794

South Carolina (803) 737-4160

South Dakota (605) 773-3737

Tennessee (615) 741-7343

Texas (512) 458-7284

Utah (801) 538-9450

Vermont (802) 863-7638

Virgin Islands (809) 776-8311, ext. 2148

Virginia (804) 786-6246 or 6247

Washington, DC (202) 576-7130

Washington (360) 753-3495

West Virginia (304) 558-2188

Wisconsin (608) 266-1339

Wyoming (307) 777-7952

Diphtheria, Tetanus, & Pertussis Vaccines; What You Need to Know

1. Why get vaccinated?

Diphtheria, pertussis and tetanus are serious diseases.

Diphtheria

Diphtheria causes a thick covering in the back of the

throat.

It can lead to breathing problems, paralysis, heart

failure, and even death.

Tetanus (Lockjaw)

Tetanus causes painful tightening of the muscles, usually

all over the body.

It can lead to ``locking'' of the jaw so the person cannot

open his mouth or swallow. Tetanus can lead to death.

Pertussis (Whooping Cough)

Pertussis causes coughing spells so bad that it is hard

for infants to eat, drink, or breathe. These can last for weeks.

It can lead to pneumonia, seizures (jerking and staring

spells), brain damage, and death.

Diphtheria, tetanus, and pertussis vaccines prevent these diseases.

Most children who get all their shots will be protected during

childhood.

Many more children would get these diseases if we stopped

vaccinating.

2. Diphtheria, Tetanus, and Pertussis Vaccines

DTP Vaccine

Protects against diphtheria, tetanus, and pertussis.

Used for many years.

DTaP Vaccine

Protects against diphtheria, tetanus, and pertussis.

Newer than DTP.

The Centers for Disease Control and Prevention (CDC) recommends

DTaP over DTP. This is because DTaP is less likely to cause reactions

than DTP.

Related Vaccines

Combinations: To reduce the number of shots a child must

get, DTP or DTaP may be available in combination with other vaccines.

DT protects against diphtheria and tetanus, but not

pertussis. It only is recommended for children who should not get

pertussis vaccine.

3. What Are the Risks From These Vaccines?

As with any medicine, vaccines carry a small risk of

serious harm, such as a severe allergic reaction or even death.

If there are reactions, they usually start within 3 days

and don't last long.

Most people have no serious reactions from these vaccines.

Possible Reactions to These Vaccines

Mild Reactions (common).

Sore arm or leg.

Fever.

Fussy.

Less appetite.

Tired.

Vomiting.

Mild reactions are much less likely after DTaP than after DTP.

Moderate to Serious Reactions (uncommon)

Moderate to serious reactions have been uncommon with DTP vaccine:

Non-stop crying (3 hours or more)--100 of every 10,000

doses.

Fever of 105 deg. or higher--30 of every 10,000 doses.

Seizure (jerking or staring)--6 of every 10,000 doses.

Child becomes limp, pale, less alert--6 of every 10,000

doses.

With DTaP vaccine, these reactions are much less likely to happen.

Severe Reactions (very rare).

There are two kinds of serious reactions:

Severe allergic reaction (breathing difficulty, shock).

Severe brain reaction (long seizure, coma or lowered

consciousness).

Is there lasting damage?

Experts disagree on whether pertussis vaccines cause

lasting brain damage.

If they do, it is very rare.

Most experts believe serious reactions will be more rare after DTaP

than after DTP.

4. When Should my Child get Vaccinated?

Most children should get a dose at these ages: 2 Months, 4 Months,

6 Months, 12-18 Months, 4-6 Years.

At 11-12 years of age and every 10 years after that you should get

a booster to prevent diphtheria and tetanus.

5. What Can Be Done To Reduce Possible Fever and Pain After This

Vaccine?

Give your child an aspirin-free pain reliever for 24 hours after

the shot.

This is important if your child has had a seizure or has a parent,

brother, or sister who has had a seizure.

6. Some Children Should Not get These Vaccines or Should Wait

Tell your doctor or nurse if your child:

Ever had a moderate or serious problem after getting

vaccinated.

Ever had a seizure.

Has a parent, brother, or sister who has had a seizure.

Has a brain problem that is getting worse.

Now has a moderate or severe illness.

Your doctor or nurse has information on what to do in this case

(for example, give one of these vaccines, wait, give medicine to

prevent fever).

7. What if There Is a Moderate to Severe Reaction?

What should I look for?

Any unusual conditions, such as those in item 3.

What should I do?

Call a doctor or get the child 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 Report (VAERS) form, or call VAERS yourself at:

1-800-822-7967.

8. The National Vaccine Injury Compensation Program

The National Vaccine Injury Compensation Program is a Federal

program that helps pay for the care of those seriously injured by

vaccines.

For details, call 1-800-338-2382 or visit the program's website at

http://www.hrsa.dhhs.gov/bhpr/vicp/new.htm

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9. 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. They can give

you the Parents Guide to Childhood Immunization or other information.

Contact the Centers for Disease Control and Prevention

(CDC):

Call 1-800-232-2522 (English)

or

Call 1-800-232-0233 (Spanish)

or

Visit the CDC website at http://www.cdc.gov/nip.

DTP/DTaP/DT (8/15/97), Vaccine Information Statement, 42 U.S.C.

Sec. 300aa-26.

Dated: January 5, 1998.

Arthur C. Jackson,

Associate Director for Management and Operations, Centers for Disease

Control and Prevention (CDC).

[FR Doc. 98-525 Filed 1-8-98; 8:45 am]

BILLING CODE 4163-18-P