Interim Polio Vaccine Information Materials

SUMMARY: The Centers for Disease Control and Prevention has modified

its recommendation for use of the two polio vaccines to discourage use

of oral poliovirus vaccine (OPV) for the first two doses administered,

except in limited circumstances. This revised recommendation

necessitates a revision of the vaccine information statement entitled,

``Polio Vaccines: What You Need to Know'' (dated February 6, 1997),

which was developed by the CDC as required by the National Childhood

Vaccine Injury Act of 1986 (NCVIA). To ensure that up-to-date

information is available regarding this revised recommendation, CDC is

distributing the following interim polio vaccine information statement

for use pending completion of the formal revision process mandated by

the NCVIA.

DATES: Effective February 23, 1999. Beginning as soon as practicable,

each health care provider who administers any polio vaccine, prior to

administration of each dose of the vaccine, in lieu of providing the

February 6, 1997 version of the polio vaccine information materials,

should provide a copy of the interim polio vaccine information

materials contained in this notice (which are dated February 1, 1999)

to the parent or legal representative of any child to whom such

provider intends to administer the vaccine and to any adult to whom

such provider intends to administer the vaccine.

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: 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. Sec. 300aa-26, requires the Secretary of Health

and Human Services to develop and disseminate vaccine information

materials for distribution by all health care providers 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.

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 these covered

vaccines is required to provide copies of the relevant vaccine

information materials prior to administration of the vaccine. Effective

June 1, 1999, health care providers will also be 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.

The materials currently in use for Td tetanus diphtheria vaccine

were published in a Federal Register notice on June 20, 1994 (59 FR

31888). The current materials for diphtheria, tetanus, and pertussis

containing vaccines, other than Td vaccine, were published in a Federal

Register notice on January 9, 1998 (63 FR 1730). Elsewhere in this

issue of the Federal Register, we have published vaccine information

materials for the newly covered vaccines (i.e., hepatitis B,

Haemophilus influenzae type b (Hib), and varicella (chickenpox)

vaccines). In addition, that same notice contains revised vaccine

information materials for measles, mumps and rubella vaccines.

The polio vaccine information materials currently in use were

published in a Federal Register notice on February 6, 1997 (62 FR

5696). The materials contained in that notice included the CDC and

Advisory Committee on Immunization Practices (ACIP) recommendations of

that time recommending a sequential polio vaccination schedule of two

doses of inactivated poliovirus vaccine (IPV), followed by two doses of

oral poliovirus vaccine (OPV) as the preferred polio vaccination

schedule for routine childhood immunization. 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 the February 6, 1997 Federal Register notice 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.''

Further Revised Recommendations for Use of Polio Vaccines

Noting further progress toward global eradication of wild

poliovirus and on-going concern regarding the vaccine-associated

paralytic poliomyelitis risks associated with administration of OPV

vaccine prior to receipt of doses of IPV, the ACIP at its 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.

Specifically, the ACIP approved the following statement:

[[Page 9041]]

``Two poliovirus vaccines are currently licensed in the United

States: inactivated poliovirus vaccine (IPV) and oral poliovirus

vaccine (OPV).

The ACIP, the American Academy of Pediatrics (AAP) and the American

Academy of Family Practice (AAFP) now recommend that the first two

doses of poliovirus vaccine should be IPV. The ACIP continues to

recommend a sequential schedule of two doses of IPV administered at

ages 2 and 4 months, followed by two doses of OPV at 12-18 months and

4-6 years. Use of IPV for all doses also is acceptable and is

recommended for immunocompromised persons and their household contacts.

OPV is no longer recommended for the first two doses of the

schedule and is acceptable only for special circumstances, such as:

children of parents who do not accept the recommended number of

injections, late initiation of immunization which would require an

unacceptable number of injections, and imminent travel to polio-endemic

areas.

OPV remains the vaccine of choice for mass immunization campaigns

to control outbreaks due to wild poliovirus.''

As noted above, this revised ACIP recommendation is in harmony with

recently revised policy recommendations of the AAP and AAFP. The CDC

has also adopted the ACIP revised polio vaccination recommendation.

At its October 22, 1998 meeting, the ACIP also expressed its

intention to consider the timing for the transition to an all-IPV

schedule.

Interim Polio Vaccine Information Materials

CDC intends to initiate formal revision of the polio vaccine

information materials of February 6, 1997 in the near future when the

potential for further revision of the recommended polio immunization

schedule becomes more clear. Pending completion of the formal revision

process and to ensure that up-to-date information is available in the

interim to patients/parents regarding the current CDC recommended polio

immunization schedule, CDC is publishing the following interim polio

vaccine information materials, dated February 1, 1999.

The previously mentioned notice published elsewhere in this issue

of the Federal Register that contains the vaccine information materials

for newly covered vaccines includes instructions for use of all vaccine

information materials, including these interim polio vaccine

information materials. That notice also includes a list of contact

telephone numbers for obtaining copies of all of the vaccine

information materials.

* * * * *

Polio Vaccines: What You Need to Know

1. Why Get Vaccinated?

Polio is a disease. It can paralyze (make arms and legs unable to

move) or even cause death.

Polio vaccine can prevent polio. Before polio vaccine, thousands of

our children got polio every year. Polio vaccine is helping to rid the

world of polio. When that happens, no one will ever get polio again,

and we will not need polio vaccine.

2. There Are 2 Kinds of Polio Vaccine

IPV

Inactivated Polio Vaccine

A shot

Both vaccines work well.

OPV

Oral Polio Vaccine

Drops by mouth

3. Which Vaccine(s) Should My Child Get and When?

Most children should get 4 doses of polio vaccine at these ages:

2 months--IPV

4 months--IPV

12-18 months--OPV or IPV (6-18 months when IPV is used)

4-6 years--OPV or IPV

The Centers for Disease Control and Prevention (CDC) recommends IPV

for the 1st and 2nd doses, and OPV drops for the 3rd and 4th doses,

because this gives the advantages of both vaccines.

Getting OPV drops for the first two doses is not recommended for

most people because of higher risks from OPV for those doses, but is

acceptable in very limited situations--for instance, when traveling in

certain countries or when the parent is willing to accept the risks

from OPV to reduce the number of injections the child gets. See risks

in item 4 below.

Polio vaccine may be given at the same time as other vaccines.

4. What Are the Risks and Advantages of Each Vaccine?

Almost all children who get a total of 4 doses of polio vaccine

will be protected from polio. As with any medicine, vaccines carry a

small risk of serious harm, such as a severe allergic reaction (hives,

difficulty breathing, shock) or even death.

Most people have no problems from either IPV or OPV.

IPV

Risks

Mild soreness where the shot is given.

Other Disadvantages

Not as good as OPV for protecting the community from polio

outbreaks.

Advantages

Cannot cause polio.

Safer for immunizing people with immune system problems

and people in close contact with them.

OPV

Risks

OPV has caused several cases of polio each year (about 1

case for every 2.4 million doses of vaccine). This can happen to

children who get OPV or people who are in close contact with them. The

risk of polio is higher with the first dose than with later doses.

Advantages

No shots.

Protects the community from polio outbreaks better than

all IPV.

Better for people traveling to areas where polio is

common.

The CDC-recommended vaccination schedule greatly reduces the risk

of children getting polio from the oral vaccine (OPV) by using IPV for

the 1st and 2nd doses. Getting 2 shots of IPV first should protect most

people from getting polio from the later doses of OPV. By using OPV for

the 3rd and 4th doses it also helps to protect the community from polio

outbreaks. And, it requires only 2 shots.

5. Some Children Should Get Only Shots. And Some Should Get Only Drops

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.

Do not use IPV shots if your child is allergic to the drugs

neomycin, streptomycin, or polymyxin B.

6. Some Children Should Not Get These Vaccines or Should Wait

Tell your doctor or nurse if your child:

Ever had a serious reaction after getting polio vaccine.

Now has a moderate or severe illness.

[[Page 9042]]

7. What if There Is a Serious Reaction?

What should I look for?

See item 4 on the other side for possible risks.

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, a federal program has been created to help you 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.dhhs.gov/bhpr/vicp.

9. How Can I Learn More?

Ask your doctor or nurse. She/he 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

Polio (2/1/99) (Interim) Vaccine Information Statement 42 U.S.C. 300aa-

26

Dated: February 17, 1999.

Jeffrey P. Koplan,

Director, Centers for Disease Control and Prevention (CDC).

[FR Doc. 99-4387 Filed 2-22-99; 8:45 am]

BILLING CODE 4163-18-P