5696 Federal Register / Vol. 62, No. 25 / Thursday, February 6, 1997 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

Revised Polio Vaccine Information

Materials

AGENCY: Centers for Disease Control and

Prevention (CDC), Department of Health

and Human Services.

ACTION: Notice.

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-virusassociated 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-virusassociated 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,
Federal Register / Vol. 62, No. 25 / Thursday, February 6, 1997 / Notices 5697

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.

§ 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.
5698 Federal Register / Vol. 62, No. 25 / Thursday, February 6, 1997 / Notices

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