[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