[Federal Register Volume 62, Number 25 (Thursday, February 6, 1997)]
[Notices]
[Pages 5696-5698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-2927]



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Part III





Department of Health and Human Services





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Centers for Disease Control and Prevention



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Revised Polio Vaccine Information Materials; Notice

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

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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.

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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