[Federal Register Volume 64, Number 188 (Wednesday, September 29, 1999)]
[Notices]
[Pages 52596-52597]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-25276]



[[Page 52595]]

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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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Proposed Vaccine Information Materials for Use With Oral Poliovirus 
Vaccine (OPV); Notice

  Federal Register / Vol. 64, No. 188 / Wednesday, September 29, 1999 / 
Notices  

[[Page 52596]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Proposed Vaccine Information Materials for Use With Oral 
Poliovirus Vaccine (OPV)

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: On September 2, 1999, the Centers for Disease Control and 
Prevention (CDC) published a Federal Register notice seeking comment on 
proposed revised vaccine information materials for use effective 
January 1, 2000, when the routine polio immunization schedule changes 
to an all inactivated poliovirus vaccine (IPV) schedule. With this 
notice, CDC seeks written comment on proposed supplemental vaccine 
information materials for use in those limited circumstances where oral 
poliovirus vaccine (OPV) will still be acceptable.

DATES: Written comments are invited and must be received on or before 
November 29, 1999.

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, telephone (404) 639-8200.

SUPPLEMENTARY INFORMATION: Under the National Childhood Vaccine Injury 
Act of 1986 (42 U.S.C. 300aa-26), the Centers for Disease Control and 
Prevention (CDC) develops and revises vaccine information materials for 
those vaccines covered under the National Vaccine Injury Compensation 
Program. As provided under that law, all health care providers in the 
United States, whether public or private, must distribute copies of 
these materials to any patient (or to the parent or legal 
representative in the case of a minor) prior to administering any of 
the covered vaccines.
    On September 2, 1999, CDC published a Federal Register notice (64 
FR 48238) seeking comment on proposed revised vaccine information 
materials for use effective January 1, 2000, when the routine polio 
immunization schedule changes to an all inactivated poliovirus vaccine 
(IPV) schedule. (See the September 2 notice for a description of the 
statutory requirements for development and use of the vaccine 
information materials. Also, see that notice for an explanation of the 
revisions in the CDC-recommended schedule for use of polio vaccines.)
    As listed in the September 2 Federal Register notice, as of January 
1, 2000, use of OPV will only be acceptable in the following special 
circumstances:
    (1) Mass immunization campaigns to control outbreaks due to wild-
type poliovirus;
    (2) Unimmunized children where travel to polio-endemic areas is 
imminent (i.e. in less than four weeks) may receive OPV for the first 
dose;
    (3) Children of parents who do not accept the recommended number of 
vaccine injections may receive OPV only for dose 3 or 4 or both. (OPV 
should be administered only after discussion of the risks of OPV 
vaccine-associated poliomyelitis.); and
    (4) OPV may be administered when the vaccinee has had a life-
threatening allergic reaction to any component of IPV.
    With this notice, CDC seeks written comment on proposed 
supplemental vaccine information materials for use in these limited 
circumstances where oral poliovirus vaccine (OPV) will still be 
acceptable.

Proposed Supplemental Polio Vaccine Information Materials--OPV

    We invite written comment on the proposed supplemental vaccine 
information materials that follow, entitled ``Oral Polio Vaccine: What 
You Need to Know.'' Comments submitted will be considered in finalizing 
these supplemental materials. As required under the National Childhood 
Vaccine Injury Act, prior to finalizing these materials CDC also will 
consult with the Advisory Commission on Childhood Vaccines, appropriate 
health care provider and parent organizations, and the Food and Drug 
Administration.

Oral Polio Vaccine: What You Need To Know

1. What Is Polio?

    Polio is a disease caused by a virus. It can get into a child's (or 
adult's) body, usually through the mouth. Sometimes it does not cause 
serious problems. But sometimes it causes paralysis (can't move arm or 
leg), and sometimes it kills its victims.
    Polio used to be very common in the United States. It paralyzed and 
killed thousands of children each year before we had a vaccine for it.

2. Why Get Vaccinated?

    Polio vaccine can prevent polio.
    History: A 1916 polio epidemic in the United States killed 6,000 
people and paralyzed 27,000 more. In the early 1950's there were more 
than 20,000 cases of polio each year.
    Polio vaccine was introduced in 1955. By 1960 the number of cases 
had dropped to about 3,000, and by 1979 there were only about 30. This 
change would not have been possible without polio vaccine.
    Today: No wild polio has been reported in the United States for 
over 20 years. But the disease is still common in some parts of the 
world. It would only take one case of polio from another country to 
bring the disease back if we were not protected by vaccine. Until the 
disease is gone from the whole world, we should keep getting our 
children vaccinated.

3. Two Types of Polio Vaccine

    There are two types of polio vaccine:

IPV (Inactivated Polio Vaccine): A shot.

    IPV is recommended for almost all people. It works very well to 
protect people from paralytic polio.

OPV (Oral Polio Vaccine): Drops, by mouth.

    OPV works very well, especially in preventing polio outbreaks. It 
is due to OPV that there is no polio in the United States today. But it 
can also actually cause polio. This is rare, but with the risk of polio 
extremely low in the U.S., OPV is no longer recommended except in 
special situations.
    This statement is about Oral Polio Vaccine. You can also request a 
copy of the Vaccine Information Statement that describes the routine 
all-IPV schedule.

4. Who Should Use Oral Polio Vaccine (OPV) and When?

    OPV is no longer recommended for routine use in the United States. 
It may be used only in certain limited circumstances:
    (1) Mass immunization campaigns to control polio outbreaks;
    (2) Unimmunized people who plan to travel within 4 weeks to 
countries where polio is common. These people may get OPV for the first 
dose;
    (3) Children whose parents want them to get fewer injections. These 
children should get IPV for the first two doses of the polio vaccine 
series, but may get OPV for the 3rd or 4th dose, or both;
    (4) People with a life-threatening allergy to a component of IPV. 
These people may get OPV instead.
    If you, or your child, are one of the few people who should get 
OPV, your doctor or nurse will tell you when the

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vaccine should be given. Speak to your doctor or nurse about the risks 
of vaccine-associated polio before getting OPV.
    OPV may be given at the same time as other vaccines.

5. Some People Should Not Get Oral Polio Vaccine (OPV) or Should Wait

    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.
    Anyone who has had a severe allergic reaction to a dose of OPV 
should not get another dose.
    People who are moderately or severely ill at the time the 
immunization is scheduled should usually wait until they recover before 
getting OPV.

6. What Are the Risks From Oral Polio Vaccine (OPV)?

    OPV can, in rare circumstances, actually cause polio. This is why 
it is not recommended for routine use any more. It caused several cases 
of polio each year (about 1 case for every 2.4 million doses of 
vaccine) during the years it was used. The oral vaccine can cause polio 
in children who get OPV or in people who are in close contact with 
them. The risk of polio is higher with the first dose than with later 
doses.

7. What if There Is a Serious Reaction?

What Should I Look for?
    Look for any unusual condition, such as a serious allergic 
reaction, high fever, behavior changes, or signs of paralysis.
    If a serious allergic reaction occurred, it would happen within a 
few minutes to a few hours after the vaccination. Signs of a serious 
allergic reaction can include difficulty breathing, hoarseness or 
wheezing, hives, paleness, weakness, a fast heart beat or dizziness.
    If paralysis were to occur, symptoms might include severe muscle 
aches and spasms, or loss of movement in an arm or leg. This could 
happen from about a week to about a month after the vaccination.
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 Reporting System (VAERS) form, or call VAERS 
yourself at 1-800-822-7967.

8. The National Vaccine Injury Compensation Program

    In the rare event that you or your child has a serious reaction to 
a vaccine, there is a federal program that can help pay for the care of 
those who have been harmed.
    For details about the National Vaccine Injury Compensation Program, 
call 1-800-338-2382 or visit the program's website at http://
www.hrsa.gov/bhpr/vicp.

9. How Can I Learn More?

     Ask your doctor or nurse. They can give you the vaccine 
package insert or suggest other sources of information.
     Call your local or state health department's immunization 
program.
     Contact the Centers for Disease Control and Prevention 
(CDC)

--Call 1-800-232-2522 (English)
--Call 1-800-232-0233 (Espanol)
--Visit the National Immunization Program's website at http://
www.cdc.gov/nip

U.S. Department of Health and Human Services, Centers for Disease 
Control and Prevention, National Immunization Program

Vaccine Information Statement, Polio--OPV Supplement (1/1/2000) 
(Proposed), 42 U.S.C. 300aa-26

    Dated: September 23, 1999.
Thena M. Durham,
Acting Associate Director for Management and Operations, Centers for 
Disease Control and Prevention (CDC).
[FR Doc. 99-25276 Filed 9-28-99; 8:45 am]
BILLING CODE 4163-18-P