[Federal Register Volume 61, Number 160 (Friday, August 16, 1996)]
[Notices]
[Pages 42770-42771]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-20704]
[[Page 42769]]
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Part IX
Department of Health and Human Services
_______________________________________________________________________
Centers for Disease Control and Prevention
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Proposed Revision--Vaccine Information Materials; Notice
Federal Register / Vol. 61, No. 160 / Friday, August 16, 1996 /
Notices
[[Page 42770]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Proposed Revision--Vaccine Information Materials
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services.
ACTION: Notice with comment period.
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SUMMARY: Under section 2126 of the Public Health Service Act, the CDC
must develop vaccine information materials which health care providers
are required to provide to patients/parents prior to administration of
specific vaccines. CDC proposes to revise the vaccine information
materials pertaining to polio vaccine for distribution should the
recommended schedule for use of particular polio vaccines be revised.
CDC seeks written comment on these proposed materials.
DATES: Written comments are invited and must be received on or before
October 15, 1996.
ADDRESSES: Written comments should be addressed to 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.
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 guardian 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).
Development and revision of the vaccine information materials has
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.
Proposed Revisions to the 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 polio vaccine (OPV) to a
sequential schedule of two doses of inactivated polio 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 fully
acceptable and preferred for some children in certain situations.
Adoption of this ACIP recommendation is under consideration by the
Director of the Centers for Disease Control and Prevention.
Should the Director of the CDC adopt this recommendation, revised
polio vaccine information materials will need to be available to
provide information on the new recommendation for a sequential schedule
on all OPV and IPV schedules prior to any implementation date.
Therefore, given the statutory time frame for revising the materials,
CDC is initiating revision of the polio vaccine information materials
by publishing this notice that seeks comment on proposed materials for
all three schedules. This notice will be withdrawn or modified if the
Director rejects or modifies the polio vaccination recommendation of
the ACIP.
We invite written comment on the proposed polio vaccine information
statement included in this notice, entitled ``Polio Vaccine: What You
Need to Know Before You or Your Child Gets Either Oral or Inactivated
Polio Vaccine.'' CDC also intends to consult with the Advisory
Commission on Childhood Vaccines, health care provider and parent
organizations, and the Food and Drug Administration, as mandated under
section 2126, prior to finalizing these materials.
POLIO VACCINE
What you need to know before you or your child gets either oral or
inactivated polio vaccine.
About the Disease
Polio is a serious disease. It spreads when germs pass from an
infected person to the mouths of others. Polio can:
Paralyze a person (make arms and legs unable to move)
Cause death
About the Vaccines
Benefits of the Vaccines
Vaccination is the best way to protect against polio. Before we had
polio vaccines, there were thousands of cases of polio in the United
States. Now most children get the vaccines, and there are very few
cases.
There Are 2 Kinds of Polio Vaccine
IPV, or Inactivated Polio Vaccine, is given as a shot in the leg or
arm.
OPV, or Oral Polio Vaccine, is given by mouth as drops.
Polio Vaccine Schedule
Most children should have a total of 4 doses of polio vaccine. The
recommended schedule uses both IPV and OPV:
2 months of age--IPV
4 months of age--IPV
12-18 months of age--OPV
4-6 years of age--OPV
Why This Schedule?
IPV by itself protects against polio, but an all-IPV schedule means
getting 4 shots. IPV has no known problems, except mild soreness where
the shot was given, but IPV only protects the child who gets the shot.
It does not help stop the spread of polio germs from one person to
another.
OPV by itself protects against polio and helps stop the spread of
polio germs from one person to another. But OPV, very rarely, causes
polio in the child who receives it or in a person in close contact with
the child who receives it.
With the recommended schedule, using IPV first followed by OPV,
your
[[Page 42771]]
child gets the benefits of both vaccines: Excellent protection against
polio, fewer shots, protection from epidemics, and less risk of polio
from OPV. Also, the IPV shots are thought to protect the person getting
the vaccine from getting polio from later vaccinations with OPV.
If you prefer, your child may get only OPV or only IPV. Either of
these vaccines alone will protect your child against polio. Ask your
doctor or nurse about these options.
Other vaccines may be given at the same time as polio vaccine.
Who Should Get Polio Vaccine?
Most doctors recommend that almost all young children get polio
vaccine. But some children should get only one type of polio vaccine,
and some should not get any polio vaccine at all:
Tell your doctor or nurse if the person getting the vaccine
or anyone in close contact with that person can't fight serious
infections because of:
A disease she/he was born with.
Treatment with drugs such as long-term steroids.
Any kind of cancer.
Cancer treatment with x-rays or drugs.
AIDS or HIV infection.
If so, your doctor or nurse will probably give all IPV doses.
Tell your doctor or nurse if the person getting the vaccine
has an allergy to the drugs neomycin or streptomycin. If so, your
doctor or nurse will probably give all OPV doses.
Tell your doctor or nurse if the person getting the vaccine:
Ever had a serious allergic reaction or other problem
after getting polio vaccine.
Has a moderate or severe illness
If you are not sure whether any of these statements apply to you,
ask your doctor or nurse.
If you are over 18 years old, you probably do not need polio
vaccine unless you are likely to be exposed to polio virus while
traveling to countries where polio still occurs.
Travel
If you are traveling to a country where there is polio, you should
get either IPV or OPV. Ask your doctor or nurse which vaccine you
should get.
Pregnancy
If protection is needed during pregnancy, either IPV or OPV can be
used.
Child Getting OPV (Unvaccinated Parents or Guardians)
If you have never gotten polio vaccine and your child is getting
vaccinated with OPV, it is important to talk to your doctor or nurse
about getting IPV for yourself. There is a very slight chance that a
person who has close contact with a person who has received OPV could
get polio if that person was never vaccinated against polio. IPV will
provide protection against this risk.
What Are the Risks From Polio Vaccine?
As with any medicine, there is a very small risk that a person
getting polio vaccine could have a serious problem, or even die. This
risk is much smaller than the risks from the disease would be if people
stopped using polio vaccine.
Almost all people who get polio vaccine have no problems from it.
Risks: All-IPV Schedule
This vaccine is not known to cause problems except mild soreness
where the shot is given.
Risks: All-OPV Schedule
There is a very small chance of getting polio paralysis from the
vaccine.
After the first dose of OPV: About 1 case occurs for every
1\1/2\ million doses.
After later doses of OPV: About 1 case occurs for every 30
million doses.
Also, if you never got polio vaccine yourself, there is a very
small chance of getting polio paralysis from having close contact with
a child who got OPV in the past 30 days.
After the first dose of OPV, about 1 case occurs for every
2 million doses.
After later doses of OPV, about 1 case occurs for every 15
million doses. Examples of close contact include changing diapers or
kissing.
Risks: IPV-OPV Schedule
There is still a very small risk of getting polio disease from OPV
after 2 doses of IPV. But the risk is much lower than when OPV alone is
given.
There is still a risk of getting polio disease from close contact
with a child who got OPV. It may be less when the child gets one or
more doses of IPV before a dose of OPV.
What to do if there is a serious reaction:
+ Call a doctor or get the person to a doctor right away.
+ Write down what happened and the date and time it happened, and tell
your doctor.
+ Ask your doctor, nurse, or health department to file a Vaccine
Adverse Event Report (VAERS) form, or you can call: (800) 822-7967
(toll-free).
The National Vaccine Injury Compensation Program gives payment to
persons thought to be injured by vaccines. For details call: (800) 338-
2382 (toll-free).
If you want to learn more about polio vaccines, your doctor or
nurse can give you the vaccine package inserts or suggest other sources
of information.
U.S. Department of Health and Human Services
Centers for Disease Control and Prevention
Polio 00/00/00 (Proposed)
Vaccine Information Statement
42 U.S.C. 300aa-26
Dated: August 8, 1996.
Claire V. Broome,
Deputy Director, Centers for Disease Control and Prevention (CDC).
[FR Doc. 96-20704 Filed 8-15-96; 8:45 am]
BILLING CODE 4163-18-P
