[Federal Register Volume 64, Number 35 (Tuesday, February 23, 1999)]
[Notices]
[Pages 9040-9042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4387]



[[Page 9039]]

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Part V





Department of Health and Human Services





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Centers for Disease Control and Prevention



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Interim Polio Vaccine Information Materials; New Vaccine Information 
Materials for Hepatitis B, Haemophilus influenzae Type b (Hib), and 
Varicella (Chickenpox) Vaccines, and Revised Vaccine Information 
Materials for Measles, Mumps, Rubella (MMR) Vaccines; Notices

  Federal Register / Vol. 64, No. 35 / Tuesday, Februay 23, 1999 / 
Notices  

[[Page 9040]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Interim Polio Vaccine Information Materials

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

ACTION: Notice.

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

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.

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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