[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]



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Part IX





Department of Health and Human Services





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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

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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