Revised Polio Vaccine Information Materials

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

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

health care providers are required to distribute to patients/parents

prior to administration of specific vaccines. On August 16, 1996, CDC

published a notice in the Federal Register (61 FR 42770) seeking public

comment on proposed revision of the polio vaccine information materials

to provide information regarding revised recommendations for use of

inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV).

The 60 day comment period ended on October 15, 1996. Following review

of the comments submitted and consultation as required under the law,

CDC has finalized the revised polio vaccine information materials.

Those final materials are contained in this notice.

DATES: Effective February 6, 1997. Beginning as soon as practicable,

each health care provider who administers any polio 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 and to any adult to whom such

provider intends to administer the vaccine.

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 (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 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.

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). (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).)

Development and revision of the vaccine information materials have

been delegated by the Secretary to the Centers for Disease Control and

Prevention. 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.

Revised Polio Vaccine Information Materials

During the past two years, the Advisory Committee on Immunization

Practices (ACIP) has been considering changing the recommended schedule

for polio vaccination from four doses of oral poliovirus vaccine (OPV)

to a sequential schedule of two doses of inactivated poliovirus vaccine

(IPV), followed by two doses of OPV for routine childhood immunization.

At its meeting in June 1996, the committee voted to approve this new

sequential schedule as the preferred polio vaccination schedule, while

considering schedules using either all IPV or all OPV as also

acceptable and preferred for some children in certain situations.

Following review of these recommendations, the Director of the Centers

for Disease Control and Prevention adopted the ACIP recommendations on

September 18, 1996.

The ACIP based their revised recommendations on a determination

that the risk-benefit ratio associated with the exclusive use of OPV

for routine immunization has changed because of rapid progress in

global polio eradication efforts. In particular, the relative benefits

of OPV to the Untied States population have diminished because of the

elimination of wild-virus-associated poliomyelitis in the Western

Hemisphere and the reduced threat of poliovirus importation into the

United States. The risk for vaccine-associated poliomyelitis caused by

OPV is now judged less acceptable because of the diminished risk for

wild-virus-associated disease. Consequently, the ACIP recommended a

transition policy that will increase use of IPV and decrease use of OPV

during the next 3-5 years. Implementation of these recommendations

should reduce the risk for vaccine-associated paralytic poliomyelitis

and facilitate a transition to exclusive use of IPV following further

progress in global polio eradication.

Details regarding these recommendations can be found in

``poliomyelitis Prevention in the United States: Introduction of a

Sequential Vaccination Schedule of Inactivated Poliovirus Vaccine

Followed by Oral Poliovirus Vaccine: Recommendations of the Advisory

Committee on Immunization practices (ACIP),'' which was published in

the Recommendations and Reports series of the Morbidity and Mortality

weekly report on January 24, 1997 (MMWR 1997;46 (No. RR-3) :1-25).

Pending completion of the CDC Director's review and in order to

assure timely availability of revised vaccine information materials

should the Director adopt the ACIP recommendations, on August 16, 1996,

CDC published a notice in the Federal Register (61 FR 42770) seeking

public comment on proposed revised polio vaccine information materials.

The 60 day comment period ended on October 15, 1996. Comments were

submitted by few individuals and organizations in response to the

August 16, 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 Health Programs,

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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, Interamerican College of Physicians and Surgeons,

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

polio 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 ``Polio 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. Sec. 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 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 in place of the June 10,

1994 version of the polio 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.

* * * * *

Polio Vaccines

What You Need To Know

1. Why Get Vaccinated?

Polio is a disease. It can paralyze (make arms and legs unable to

move) or even cause death.

Polio vaccine prevents polio. Before polio vaccine, thousands of

our children got polio every year. Polio vaccine is helping to rid the

whole of polio. When that happens, no one will ever get polio again,

and we will not need polio vaccine.

2. There Are 2 Kinds of Polio Vaccine

IPV

Inactivated Polio Vaccine

A shot

OPV

Oral Polio Vaccine

Drops by mouth

Both vaccines work well.

3. Which Vaccines Should My Child Get and When?

Most children should get 4 doses of polio vaccine at these ages:

2 months.

4 months.

12-18 months.

4-6 years.

You can choose to get any of these 3 acceptable schedules:

2 shots of IPV, then 2 doses of OPV drops.

or

4 shots of IPV.

or

4 doses of OPV drops (the 3rd dose can be given as early

as 6 months of age).

The Centers for Disease Control and Prevention (CDC) recommends 2

shots of IPV, then 2 doses of OPV drops for most children because this

has the advantage of both vaccines.

4. What Are the Risks and Advantages of Each Choice?

Almost all children who complete any of the 3 schedules will be

protected from polio.

As with any medicine, vaccines carry a small risk of serious harm,

such as a severe allergic reaction (hives, difficulty breathing, shock)

or even death.

On rare occasions, OPV can cause polio because it contains live,

but weakened, virus. IPV cannot cause polio because it does not contain

live virus.

Most people have no problems from either IPV or OPV.

2 Shots/2 Drops (2 IPV, Then 2 OPV)

Risks and Advantages

For most children, the choice using both shots and drops gives the

benefits of both vaccines:

Less risk of getting polio than from all OPV.

Only 2 shots.

Protects the community from polio outbreaks better than

all IPV.

All Shots (4 IPV)

Risks

Mild soreness of arm or leg.

Other Disadvantages

Not as good as OPV for protecting the community from polio

outbreaks.

Advantages

Does not cause polio.

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All Drops (4 OPV)

Risks

Causes about 8 cases of polio each year. (At least 15

million doses have been given each year in the U.S.) This can happen to

children who get OPV or people who are in close contact with them. The

risk of polio is higher with the first dose than with later doses.

Advantages

No shots.

Can best protect the community from polio outbreaks.

5. Some Children Should Get Only Shots. And Some Should Get Only Drops

Do NOT use OPV drops, if your child, you, or anyone who takes care

of your child

Can't fight infections.

Is taking long term steroids.

Has cancer.

Has AIDS or HIV infection.

Do NOT use OPV drops, if you or anyone who takes care of your child

never had polio vaccine.

Do NOT use IPV shots, if your child is allergic to the drugs

neomycin, streptomycin, or polymyxin B.

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

Tell your doctor or nurse if your child:

Ever had a serious reaction after getting polio vaccine.

Now has a moderate or severe illness.

7. What If There Is a Serious Reaction?

What should I look for?

See item 4, on the other side, for some possible risks.

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 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 gives payment for serious vaccine injuries.

For details call 1-800-338-2382.

9. How Can I Learn More?

Ask your doctor or nurse. She/he can give you the vaccine

package insert or suggest other sources of information.

Call your local or state health department.

Contact the Centers for Disease Control and Prevention

(CDC):

Call 1-800-232-7468 (English).

or

Call 1-800-232-0233 (Spanish).

or

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

U.S. Department of Health and Human Services, Centers for Disease

Control and Prevention, National Immunization Program.

Polio (2/6/97)

Vaccine Information Statement

42 U.S.C. 300aa-26

Dated: January 31, 1997.

Joseph R. Carter,

Acting Associate Director for Management and Operations, Centers for

Disease Control and Prevention (CDC).

[FR Doc. 97-2927 Filed 2-5-97; 8:45 am]

BILLING CODE 4163-18-M