[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]
[[Page 5695]]
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Part III
Department of Health and Human Services
_______________________________________________________________________
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
[[Page 5696]]
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,
[[Page 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. 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.
[[Page 5698]]
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