Instructions for Use of Vaccine Information Materials (Vaccine Information Statements); Revised Polio Vaccine Information Materials

Federal RegisterDec 17, 1999

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What actually matters in this document.

Text

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):

---------------------------------------------------------------------------

* 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?