[Federal Register Volume 64, Number 242 (Friday, December 17, 1999)]
[Notices]
[Pages 70914-70918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32571]
[[Page 70913]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Centers for Disease Control and Prevention
_______________________________________________________________________
Instructions for Use of Vaccine Information Materials (Vaccine
Information Statements); Revised Polio Vaccine Information Materials;
Notice
Federal Register / Vol. 64, No. 242 / Friday, December 17, 1999 /
Notices
[[Page 70914]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Instructions for Use of Vaccine Information Materials (Vaccine
Information Statements); Revised Polio Vaccine Information Materials
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
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 all
health care providers, whether public or private, are required to
distribute to patients/parents prior to administration of each dose of
specific vaccines. On September 2, 1999, CDC published a notice in the
Federal Register (64 FR 48238) seeking public comments on proposed
revised vaccine information materials for polio vaccines. The polio
materials are being revised so that they will conform with the CDC's
revised recommendations for use of polio vaccines in the United States
effective January 1, 2000, when the recommendation will be to use only
inactivated poliovirus vaccine (IPV), except in very limited
circumstances. The September 2 notice also sought public comments on
proposed instructions for use of vaccine information materials. On
September 29, 1999, CDC published an additional notice (64 FR 52596)
seeking public comments on supplemental vaccine information materials
for use when oral poliovirus vaccine (OPV) is proposed to be
administered instead of inactivated poliovirus vaccine (IPV). The 60-
day comment periods for the two notices ended on November 1, 1999 and
November 29, 1999, respectively. Following review of the comments
submitted and consultation as required under the law, CDC has finalized
these vaccine information materials and instructions for use of vaccine
information materials. The final materials and instructions are
contained in this notice.
DATES: In order to conform with the revised CDC recommendations for use
of polio vaccines effective January 1, 2000, the Instructions for Use
of Vaccine Information Materials (Vaccine Information Statements) and
revised polio vaccine information materials contained in this notice
are effective January 1, 2000.
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, NE, 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 all health care providers, both public and private,
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.
Development and revision of the vaccine information materials have
been delegated by the Secretary to the Centers for Disease Control and
Prevention (CDC). 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 the 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.
The vaccines initially covered under the National Vaccine Injury
Compensation Program were 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 relevant vaccine
information materials prior to administration of any of these vaccines.
Effective June 1, 1999, health care providers were also required to
provide copies of vaccine information materials for the following
vaccines that have recently been added to the National Vaccine Injury
Compensation Program: hepatitis B, Haemophilus influenzae type b (Hib),
and varicella (chickenpox) vaccines.
Revised Recommendations for Use of Polio Vaccines
Progress continues toward the goal of world-wide eradication of
poliomyelitis in the year 2000. As the risk of polio infection has
diminished, recommendations for use of polio vaccines in the United
States have changed significantly during the last few years to move
away from exclusive use of oral poliovirus vaccine (OPV) toward
exclusive use of inactivated poliovirus vaccine (IPV) and toward an
ultimate goal of being able to cease polio vaccination.
In February 1997 the CDC, in accepting the advice of its Advisory
Committee on Immunization Practices (ACIP), revised its recommendation
from a schedule of all OPV to a recommended sequential schedule of two
doses of IPV followed by two doses of OPV as the preferred polio
vaccination schedule for routine childhood immunization. At that time,
schedules using either all IPV or all OPV were also considered to be
acceptable and preferred for some children in certain circumstances.
The CDC noted in a February 6, 1997, Federal Register notice (62 FR
5696) that the recommended schedules for polio immunization were
expected to change further over time:
``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 United 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.''
Noting further progress toward global eradication of wild
poliovirus and ongoing concern regarding the vaccine-associated
paralytic poliomyelitis (VAPP) risks associated with administration of
OPV vaccine prior to receipt of doses of IPV, the ACIP, at its
[[Page 70915]]
meeting on October 22, 1998, voted to further revise its recommendation
for administration of the two polio vaccines to discourage use of OPV
vaccine for the first two doses, except in limited circumstances.
(Interim polio vaccine information materials reflecting this revised
recommendation were published by the CDC in the Federal Register at 64
FR 9040, February 23, 1999.)
And then, at its meeting on June 16, 1999, the ACIP voted to
recommend an all IPV schedule as of January 1, 2000, stating:
``An all IPV schedule is recommended for routine childhood polio
immunization as of January 1, 2000. All children will need to receive
four doses of IPV at 2, 4, 6-18 months and 4-6 years of age.
``OPV is acceptable only for 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 VAPP.)
``Limited availability of OPV is expected in the near future in the
U.S.''
The CDC has adopted these recommendations. In addition, CDC accepts
use of OPV when the vaccinee has a life-threatening allergy to any
component of IPV.
Therefore, the vaccine information materials covering polio
vaccines must be revised to conform with CDC's revised recommendations
for use of polio vaccines in the United States effective January 1,
2000.
Development of Revised Polio Vaccine Information Materials and
Instructions for Use of Vaccine Information Materials
The CDC has revised the vaccine information materials covering
polio vaccines in accordance with the procedures mandated under 42
U.S.C. 300aa-26. On September 2, 1999, CDC published a notice in the
Federal Register (64 FR 48238) seeking public comments on proposed
revised vaccine information materials for use when administering polio
vaccines. The September 2 notice also sought public comments on
proposed instructions for use of vaccine information materials. On
September 29, 1999, CDC published an additional notice (64 FR 52596)
seeking public comments on supplemental vaccine information materials
for use when oral poliovirus vaccine (OPV) is proposed to be
administered instead of inactivated poliovirus vaccine (IPV). The 60-
day comment periods for the two notices ended on November 1, 1999 and
November 29, 1999, respectively. Few comments were received on the
proposed revised polio vaccine information materials. No comments were
received on the proposed instructions for use of vaccine information
materials.
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 Pediatrics, American
Medical Association, American Pharmaceutical Association, Every Child
by Two, Immunization Action Coalition, Infectious Disease Society of
America, Informed Parents against VAPP, National Association of
Pediatric Nurse Associates and Practitioners, National Coalition for
Adult Immunization, National Coalition of Hispanic Health and Human
Services Organizations (COSSMHO), National Vaccine Advisory Committee,
and the National Vaccine Injury Compensation Program. Also, CDC
provided copies of the draft materials to other organizations and
sought their consultation; however, those organizations did not provide
comments. Comments provided by the consultants, along with the comments
submitted in response to the September 2 and 29 Federal Register
notices, were fully considered in revising the polio vaccine
information materials.
Following consultation and review of comments submitted, the
revised polio vaccine information materials, including OPV supplemental
materials, have been finalized and are contained in this notice. They
are entitled ``Polio Vaccine: What You Need to Know'' and ``Oral Polio
Vaccine: What You Need to Know.''
In addition, the ``Instructions for Use of Vaccine Information
Materials (Vaccine Information Statements)'' have been finalized and
are contained in this notice. The instructions are identical to those
proposed in the September 2 Federal Register notice, except that the
final instructions have been revised (1) to note the initial date use
of each vaccine's materials was required, (2) to clarify that patients/
parents must be given copies of the materials to keep, and (3) to
clarify use of the polio and supplemental OPV vaccine information
materials. The instructions specify the effective date for mandated use
of each vaccine's information materials, note when the materials must
be provided, delineate the edition dates of the current materials,
specify recordkeeping requirements, and include other related
information.
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. 300aa-26), all health care providers in the United States who
administer any vaccine containing diphtheria*, tetanus*, pertussis*,
measles*, mumps*, rubella*, polio*, hepatitis B, Haemophilus
influenzae type b (Hib), or varicella (chickenpox)
vaccine shall, prior to administration of each dose of the vaccine,
provide a copy to keep of the relevant current edition vaccine
information materials that have been produced by the Centers for
Disease Control and Prevention (CDC):
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* Effective 4/15/92.
Effective 6/1/99.
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(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, as appropriate.
``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
Effective January 1, 2000, a health care provider prior to
administering any polio vaccine (whether inactivated poliovirus vaccine
(IPV) or oral poliovirus vaccine (OPV)) shall give the patient (or in
the case of a child, the parent or legal representative) a copy of the
vaccine information materials dated January 1, 2000, titled ``Polio
Vaccine: What You Need to Know'' in place of the February 1, 1999 and
February 6, 1997 versions of the polio materials. In addition, if the
health care provider intends to administer OPV, such person shall also
be given a copy of the OPV supplemental vaccine information materials
dated January 1, 2000, titled
[[Page 70916]]
``Oral Polio Vaccine: What You Need to Know.''
Current Editions of Other Vaccine Information Materials
Diphtheria, Tetanus, Pertussis (DTP/DTaP/DT) Vaccine Information
Materials, dated August 15, 1997.
Tetanus, Diphtheria (Td) Vaccine Information Materials, dated June
10, 1994.
Measles, Mumps, Rubella Vaccine Information Materials, dated
December 16, 1998.
Hepatitis B Vaccine Information Materials, dated December 16, 1998.
Haemophilus influenzae type b (Hib) Vaccine Information Materials,
dated December 16, 1998.
Varicella (chickenpox) Vaccine Information Materials, dated December
16, 1998.
Recordkeeping
Health care providers shall make a notation in each patient's
permanent medical record at the time vaccine information materials are
provided indicating (1) the edition date of the materials distributed
and (2) 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 also available on
the Centers for Disease Control and Prevention's website at: http://
www.cdc.gov/nip/publications/VIS/. Copies are available in English and
in other languages. December 17, 1999
42 U.S.C. 300aa-26
List of Contact Telephone Numbers for Copies of Vaccine Information
Materials
Single camera-ready copies of the vaccine information materials,
and copies of the instructions for their use, are available by calling
the telephone number listed below for your location:
Alabama--(334) 206-5023
Alaska--(907) 269-8000
American Samoa--011-684-633-4606
Arizona--(602) 230-5855
Arkansas--(501) 661-2962
California--(510) 540-2065
Los Angeles--(213) 580-9800
Colorado--(303) 692-2669
Connecticut--(860) 509-7929
Delaware--(302) 739-4746
Florida--(850) 245-4342
Georgia--(404) 657-3158
Guam--011-671-735-7143
Hawaii--(808) 586-8330
Idaho--(208) 334-5931
Illinois--(217) 785-1455
Chicago--(312) 746-6050
Indian Health Service--(505) 248-4226
Indiana--(317) 233-7704
Iowa--(515) 281-4917
Kansas--(785) 296-5591
Kentucky--(502) 564-4478
Louisiana--(504) 483-1900
Maine--(207) 287-3746
Mariana Islands--011-670-234-8950, ext. 2001
Marshall Islands--011-692-625-3480
Maryland--(410) 767-6030
Massachusetts--(617) 983-6800
Michigan--(517) 335-8159
Detroit--(313) 876-4606
Micronesia--011-691-320-2619
Minnesota--(612) 676-5100
Mississippi--(601) 576-7751
Missouri--(573) 751-6133
Montana--(406) 444-0065
Nebraska--(402) 471-6423
Nevada--(775) 684-5900
New Hampshire--(603) 271-4482
New Jersey--(609) 588-7512
New Mexico--(505) 827-2369
New York State--(518) 473-4437
New York City--(212) 676-2293
North Carolina--(919) 733-7752
North Dakota--(701) 328-2378
Ohio--(614) 466-4643
Oklahoma--(405) 271-4073
Oregon--(503) 731-4020
Palau--011-160-680-1757
Pennsylvania--(717) 787-5681
Philadelphia--(215) 685-6749
Puerto Rico--(787) 274-5612
Rhode Island--(401) 222-4603
South Carolina--(803) 898-0460
South Dakota--(605) 773-3737
Tennessee--(615) 741-7343
Texas--(512) 458-7284
Houston--(713) 794-9267
San Antonio--(210) 207-8794
Utah--(801) 538-9450
Vermont--(802) 863-7638
Virgin Islands--(340) 776-8311, ext. 2151
Virginia--(804) 786-6246 or 6247
Washington, D.C.--(202) 576-7130
Washington--(360) 664-8688
West Virginia--(304) 558-2188
Wisconsin--(608) 266-2346
Wyoming--(307) 777-6001
Copies of the vaccine information materials and instructions for
their use also can be downloaded from the CDC website at: http://
www.cdc.gov/nip/publications/VIS/.
Polio Vaccine: What You Need To Know
1. What Is Polio?
Polio is a disease caused by a virus. It enters a child's (or
adult's) body through the mouth. Sometimes it does not cause serious
illness. But sometimes it causes paralysis (can't move arm or leg). It
can kill people who get it, usually by paralyzing the muscles that help
them breathe. Polio used to be very common in the United States. It
paralyzed and killed thousands of people a year before we had a vaccine
for it.
2. Why Get Vaccinated?
Inactivated Polio Vaccine (IPV) 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 vaccination was begun in
1955. By 1960, the number of cases had dropped to about 3,000, and by
1979 there were only about 10. The success of polio vaccination in the
U.S. and other countries sparked a world-wide effort to eliminate
polio.
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. If the
effort to eliminate the disease from the world is successful, some day
we won't need polio vaccine.
Until then, we need to keep getting our children vaccinated.
Oral Polio Vaccine: No Longer Recommended
There are two kinds of polio vaccine: IPV, which is the shot
recommended in the United States today, and a live, oral polio vaccine
(OPV), which is drops that are swallowed.
Until recently OPV was recommended for most children in the United
States. OPV helped us rid the country of polio, and it is still used in
many parts of the world.
Both vaccines give immunity to polio, but OPV is better at keeping
the disease from spreading to other people. However, for a few people
(about one in 2.4 million), OPV actually causes polio. Since the risk
of getting polio in the United States is now extremely low, experts
believe that using oral polio
[[Page 70917]]
vaccine is no longer worth the slight risk, except in limited
circumstances which your doctor can describe. The polio shot (IPV) does
not cause polio.
If you or your child will be getting OPV, ask for a copy of the OPV
supplemental Vaccine Information Statement.
3. Who Should Get Polio Vaccine and When?
IPV is a shot, given in the leg or arm, depending on age. Polio
vaccine may be given at the same time as other vaccines.
Children
Most people should get polio vaccine when they are children.
Children get 4 doses of IPV, at these ages:
A dose at 2 months
A dose at 4 months
A dose at 6-18 months
A booster dose at 4-6 years
Adults
Most adults do not need polio vaccine because they were already
vaccinated as children. But three groups of adults are at higher risk
and should consider polio vaccination: (1) People traveling to areas of
the world where polio is common, (2) laboratory workers who might
handle polio virus, and (3) health care workers treating patients who
could have polio.
Adults in these three groups who have never been vaccinated against
polio should get 3 doses of IPV:
The first dose at any time,
The second dose 1 to 2 months later,
The third dose 6 to 12 months after the second.
Adults in these three groups who have had 1 or 2 doses of polio
vaccine in the past should get the remaining 1 or 2 doses. It doesn't
matter how long it has been since the earlier dose(s). Adults in these
three groups who have had 3 or more doses of polio vaccine (either IPV
or OPV) in the past may get a booster dose of IPV. Ask your health care
provider for more information.
4. Some People Should Not Get IPV or Should Wait
These people should not get IPV:
Anyone who has ever had a life-threatening allergic
reaction to the drugs neomycin, streptomycin or polymyxin B should not
get the polio shot.
Anyone who has a severe allergic reaction to a polio shot
should not get another one.
These people should wait:
Anyone who is moderately or severely ill at the time the
shot is scheduled should usually wait until they recover before getting
polio vaccine. People with minor illnesses, such as a cold, may be
vaccinated.
Ask your health care provider for more information.
5. What Are the Risks From IPV?
Some people who get IPV get a sore spot where the shot was given.
The vaccine used today has never been known to cause any serious
problems, and most people don't have any problems at all with it.
However, a vaccine, like any medicine, could cause serious
problems, such as a severe allergic reaction. The risk of a polio shot
causing serious harm, or death, is extremely small.
6. 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, or unusual behavior.
If a serious allergic reaction occurred, it would happen within a
few minutes to a few hours after the shot. Signs of a serious allergic
reaction can include: Difficulty breathing, weakness, hoarseness or
wheezing, a fast heart beat, hives, dizziness, paleness, or swelling of
the throat.
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 the VAERS
toll-free number yourself at 1-800-822-7967. Reporting reactions helps
experts learn about possible problems with vaccines.
7. 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.
8. 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 & Human Services, Centers for Disease
Control and Prevention, National Immunization Program, Vaccine
Information Statement, Polio (1/1/2000),
42 U.S.C. 300aa-26
Oral Polio Vaccine: What You Need To Know
1. What Is Polio?
Polio is a disease caused by a virus. It enters a child's (or
adult's) body through the mouth. Sometimes it does not cause serious
illness. But sometimes it causes paralysis (can't move arm or leg). It
can kill people who get it, usually by paralyzing the muscles that help
them breathe.
Polio used to be very common in the United States. It paralyzed and
killed thousands of people a 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 vaccination was begun in
1955. By 1960 the number of cases had dropped to about 3,000, and by
1979 there were only about 10. The success of polio vaccination in the
U.S. and other countries sparked a world-wide effort to eliminate
polio.
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. If the
effort to eliminate the disease from the world is successful, some day
we won't need polio vaccine.
Until then, we need to 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 the recommended polio vaccine for almost everyone in the
United States.
OPV (Oral Polio Vaccine): Drops, by mouth.
Until recently, OPV was recommended for most children in the United
States. But it is no longer recommended, except in limited
circumstances. OPV helped us rid the country of polio, and it is still
used in many parts of the world.
Both vaccines give immunity to polio, but OPV is better at keeping
the disease
[[Page 70918]]
from spreading to other people. However, for a few people (about one in
2.4 million), OPV actually causes polio. Since the risk of getting
polio in this country is now extremely low, experts believe that using
oral vaccine is no longer worth the slight risk. The polio shot we now
use (IPV) does not cause polio.
This Vaccine Information Statement supplement is about Oral Polio
Vaccine (OPV). Your health care provider should also give you the
Vaccine Information Statement for inactivated polio vaccine (IPV).
4. Who Should Get OPV and When?
OPV is no longer recommended for routine use in the United States.
It should be used only in certain circumstances:
(1) Mass immunization campaigns to control polio outbreaks;
(2) Children who have never gotten any polio vaccine who plan to
travel within 4 weeks to countries where polio is common. These
children may get OPV for the first dose;
(3) Children whose parents do not accept the recommended number of
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 the antibiotics
neomycin, streptomycin, or polymyxin B, or people who have had a life-
threatening allergic reaction to a dose of IPV. These people may get
OPV instead.
If you or your child is in one of these 4 groups, ask your health
care provider when the vaccine should be given. Also, ask 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 OPV or Should Wait
These people should not get OPV:
Anyone who is taking long-term steroids or any other drug
that affects the immune system.
Anyone who has cancer or is getting chemotherapy.
Anyone who has AIDS or HIV infection, or another disease
that affects the immune system.
If anyone in these three groups will be changing a child's
diapers or be in close contact with a child getting polio vaccine, that
child should not get OPV.
A baby should not get OPV if someone who will be in close
contact with the baby (for instance changing diapers) has never had any
kind of polio vaccine.
Anyone who has had a severe allergic reaction to a dose of
OPV should not get another dose.
These people should wait:
Anyone who is moderately or severely ill at the time the
immunization is scheduled should usually wait until they recover before
getting OPV. People with minor illnesses, such as a cold, may be
immunized.
Ask your health care provider for more information.
6. What Are the Risks From Oral Polio Vaccine (OPV)?
OPV can, rarely, actually cause polio. This is why it is no longer
recommended for most people. 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. OPV can cause polio in people who get the vaccine or in
people who are in close contact with them. Today, with polio under
control in the U.S., experts believe IPV can protect children and
adults just as well, without the risk.
A vaccine, like any medicine, could cause other serious problems,
such as a severe allergic reaction. The risk of OPV causing serious
harm, or death, is extremely small.
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, unusual behavior, or signs of weakness or
paralysis.
If a serious allergic reaction occurred, it would happen within a
few minutes to a few hours after the shot. Signs of a serious allergic
reaction can include: Difficulty breathing, weakness, hoarseness or
wheezing, a fast heart beat, hives, dizziness, paleness, or swelling of
the throat.
If paralysis were to occur, it could happen from about a week to
about a month after the vaccination. Symptoms might include:
--Severe muscle aches and spasms
--Weakness
--Loss of movement in an arm or leg
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 the VAERS
toll-free number yourself at 1-800-822-7967. Reporting reactions helps
experts learn about possible problems with vaccines.
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 & Human Services, Centers for Disease
Control and Prevention, National Immunization Program, Vaccine
Information Statement, Polio--OPV Supplement
(1/1/2000),
42 U.S.C. 300aa-26.
Jeffrey P. Koplan,
Director, Centers for Disease Control and Prevention (CDC).
[FR Doc. 99-32571 Filed 12-16-99; 8:45 am]
BILLING CODE 4163-18-P