[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48715-48719]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Proposed Vaccine Information Materials for Measles, Mumps, 
Rubella, and Varicella Vaccines

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

ACTION: Notice with comment period.

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SUMMARY: Under the National Childhood Vaccine Injury Act (NCVIA) (42 
U.S.C. 300aa-26), the CDC must develop vaccine information materials 
that all health care providers are required to give to patients/parents 
prior to administration of specific vaccines. CDC seeks written comment 
on proposed new vaccine information materials for measles, mumps 
rubella (MMR); varicella, and measles, mumps, rubella; and varicella 
(MMRV).

DATES: Written comments are invited and must be received on or before 
October 12, 2010.

ADDRESSES: Written comments should be addressed to Anne Schuchat, M.D., 
Director, National Center for Immunization and Respiratory Diseases, 
Centers for Disease Control and Prevention, Mailstop E-05, 1600 Clifton 
Road, NE., Atlanta, Georgia 30333.

FOR FURTHER INFORMATION CONTACT: Skip Wolfe, National Center for 
Immunization and Respiratory Diseases, Centers for Disease Control and 
Prevention, Mailstop E-52, 1600 Clifton Road, NE., Atlanta, Georgia 
30333, telephone (404) 639-8809.

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 in the United States 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, also 
known as Vaccine Information Statements (VIS), 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

[[Page 48716]]

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 in the United States who intends to administer one 
of these covered vaccines is required to provide copies of the relevant 
vaccine information materials prior to administration of any of these 
vaccines. Since then, the following vaccines have been added to the 
National Vaccine Injury Compensation Program, requiring use of vaccine 
information materials for them as well: Hepatitis B, haemophilus 
influenzae type b (Hib), varicella (chickenpox), pneumococcal 
conjugate, rotavirus, hepatitis A, meningococcal, human papillomavirus 
(HPV), and trivalent influenza vaccines. Instructions for use of the 
vaccine information materials and copies of the materials can be found 
on the CDC Web site at: http://www.cdc.gov/vaccines/pubs/VIS/. In 
addition, single camera-ready copies may be available from State health 
departments. A list of State health department contacts for obtaining 
copies of these materials is included in a December 17, 1999 Federal 
Register notice (64 FR 70914).

Proposed Measles, Mumps, Rubella (MMR); Varicella; and Measles, Mumps, 
Rubella & Varicella (MMRV) Vaccine Information Materials

    On May 7, 2010 the Advisory Committee on Immunization Practices 
(ACIP) published recommendations on the use of combined Measles, Mumps, 
Rubella and Varicella (MMRV) vaccine. Because CDC/ACIP are now 
expressing a preference for use of MMRV vaccine (over MMR + V given 
separately) in some circumstances and the two separate vaccines in 
other circumstances, CDC is proposing publication of unique vaccine 
information materials for MMRV vaccine, which are included in this 
notice. In addition, CDC is proposing updated versions of the separate 
MMR and varicella vaccine information materials, containing information 
about MMRV vaccine.

Development of Vaccine Information Materials

    The vaccine information materials referenced in this notice are 
being developed in consultation with the Advisory Commission on 
Childhood Vaccines, the Food and Drug Administration, and parent and 
health care provider groups.
    In addition, we invite written comment on the proposed vaccine 
information materials that follow, entitled ``Measles, Mumps, Rubella 
(MMR) Vaccine: What You Need to Know;'' ``Varicella Vaccine: What You 
Need to Know;'' and ``Measles, Mumps, Rubella and Varicella (MMRV) 
Vaccine: What You Need to Know.'' Comments submitted will be considered 
in finalizing these materials. When the final materials are published 
in the Federal Register, the notice will include an effective date for 
their mandatory use.
    We also propose to revise the June 9, 2010 Instructions for the Use 
of Vaccine Information Statements to include a reference to these 
vaccine information materials.
* * * * *

Proposed MMR Vaccine Information Statement

Measles, Mumps and Rubella (MMR) Vaccines: What You Need to Know
1. Why get vaccinated?
    Measles, mumps, and rubella are serious diseases.
Measles
     Measles virus causes rash, cough, runny nose, eye 
irritation, and fever.
     It can lead to ear infection, pneumonia, seizures (jerking 
and staring), brain damage, and death.
Mumps
     Mumps virus causes fever, headache, and swollen glands.
     It can lead to deafness, meningitis (infection of the 
brain and spinal cord covering), painful swelling of the testicles or 
ovaries, and rarely sterility or death.
Rubella (German Measles)
     Rubella virus causes rash, mild fever, and arthritis 
(mostly in women).
     If a woman gets rubella while she is pregnant, she could 
have a miscarriage or her baby could be born with serious birth 
defects.
    You or your child could catch these diseases by being around 
someone who has them. They spread from person to person through the 
air.
    Measles, mumps, and rubella (MMR) vaccine can prevent these 
diseases. Most children who get their MMR shots will not get these 
diseases. Many more children would get them if we stopped vaccinating.
2. Who should get MMR vaccine and when?
    Children should get 2 doses of MMR vaccine:

--The first at 12-15 months of age
--and the second at 4-6 years of age.

    These are the recommended ages. But children can get the second 
dose at any age, as long as it is at least 28 days after the first 
dose.
    Some adults should also get MMR vaccine: Generally, anyone 18 years 
of age or older who was born after 1956 should get at least one dose of 
MMR vaccine, unless they can show that they have had either the 
vaccines or the diseases.
    Ask your provider for more information.
    MMR vaccine may be given at the same time as other vaccines.

    Note:  Children 12 years of age and younger can receive a 
``combination'' vaccine called MMRV, which contains both MMR and 
varicella (chickenpox) vaccines. See the MMRV Vaccine Information 
Statement for more information.

3. Some People Should Not Get MMR Vaccine or Should Wait
     People should not get MMR vaccine who have ever had a 
life-threatening allergic reaction to gelatin, the antibiotic neomycin, 
or to a previous dose of MMR vaccine.
     People who are moderately or severely ill at the time the 
shot is scheduled should usually wait until they recover before getting 
MMR vaccine.
     Pregnant women should wait to get MMR vaccine until after 
they have given birth. Women should avoid getting pregnant for 4 weeks 
after getting MMR vaccine.
     Some people should check with their doctor about whether 
they should get MMR vaccine, including anyone who:

--Has HIV/AIDS, or another disease that affects the immune system.
--Is being treated with drugs that affect the immune system, such as 
steroids, for 2 weeks or longer.
--Has any kind of cancer.

[[Page 48717]]

--Is taking cancer treatment with x-rays or drugs.
--Has ever had a low platelet count (a blood disorder).

     People who recently had a transfusion or were given other 
blood products should ask their doctor when they may get MMR vaccine.
    Ask your provider for more information.
4. What are the risks from MMR vaccine?
    A vaccine, like any medicine, is capable of causing serious 
problems, such as severe allergic reactions. The risk of MMR vaccine 
causing serious harm, or death, is extremely small.
    Getting MMR vaccine is much safer than getting any of these three 
diseases.
    Most people who get MMR vaccine do not have any problems with it.
Mild Problems
     Fever (up to 1 person out of 6)
     Mild rash (about 1 person out of 20)
     Swelling of glands in the cheeks or neck (rare)
    If these problems occur, it is usually within 7-12 days after the 
shot. They occur less often after the second dose.
Moderate Problems
     Seizure (jerking or staring) caused by fever (about 1 out 
of 3,000 doses)
     Temporary pain and stiffness in the joints, mostly in 
teenage or adult women (up to 1 out of 4)
     Temporary low platelet count, which can cause a bleeding 
disorder (about 1 out of 30,000 doses)
Severe Problems (Very Rare)
     Serious allergic reaction (less than 1 out of a million 
doses).
     Several other severe problems have been known to occur 
after a child gets MMR vaccine. But this happens so rarely, experts 
cannot be sure whether they are caused by the vaccine or not. These 
include:

--Deafness,
--Long-term seizures, coma, or lowered consciousness,
--Permanent brain damage.

    Note: The first dose of MMRV vaccine has been associated with 
rash and higher rates of fever than MMR and varicella vaccines given 
separately. Rash has been reported in about 1 person in 20 and fever 
in about 1 person in 5.
    Seizures caused by a fever are also reported more often after 
MMRV. These usually occur 5-12 days after the first dose.

5. What if there is a severe or moderate reaction?
What should I look for?
    Any unusual condition, such as a high fever or behavior changes. 
Signs of a severe allergic reaction can include difficulty breathing, 
hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or 
dizziness.
What should I do?
     Call a doctor, or get the person to a doctor right away.
     Tell the doctor what happened, the date and time it 
happened, and when the vaccination was given.
     Ask your provider to report the reaction by filing a 
Vaccine Adverse Event Reporting System (VAERS) form. Or you can file 
this report through the VAERS Web site at http://www.vaers.hhs.gov, or 
by calling 1-800-822-7967.
    VAERS does not provide medical advice.
6. The National Vaccine Injury Compensation Program
    The National Vaccine Injury Compensation Program (VICP) was created 
in 1986.
    Persons who believe they may have been injured by a vaccine may 
file a claim with VICP by calling 1-800-338-2382 or visiting their Web 
site at http://www.hrsa.gov/vaccinecompensation vaccinecompensation.
7. How can I learn more?
     Ask your provider. They can give you the vaccine package 
insert or suggest other sources of information.
     Call your local or state health department.
     Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-4636 (1-800-CDC-INFO)
--Visit CDC's Web site at http://www.cdc.gov/vaccines
Department of Health and Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
MMR Vaccine
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26
* * * * *

Proposed Varicella (Chickenpox) Vaccine Information Statement

Chickenpox Vaccine: What You Need to Know
1. Why get vaccinated?
    Chickenpox (also called varicella) is a common childhood disease. 
It is usually mild, but it can be serious, especially in young infants 
and adults.
     It causes a rash, itching, fever, and tiredness.
     It can lead to severe skin infection, scars, pneumonia, 
brain damage, or death.
     The chickenpox virus can be spread from person to person 
through the air, or by contact with fluid from chickenpox blisters.
     A person who has had chickenpox can get a painful rash 
called shingles years later.
     Before the vaccine, about 11,000 people were hospitalized 
for chickenpox each year in the United States.
     Before the vaccine, about 100 people died each year as a 
result of chickenpox in the United States.
    Chickenpox vaccine can prevent chickenpox.
    Most people who get chickenpox vaccine will not get chickenpox. But 
if someone who has been vaccinated does get chickenpox, it is usually 
very mild. They will have fewer blisters, are less likely to have a 
fever, and will recover faster.
2. Who should get chickenpox vaccine and when?
Routine
    Children who have never had chickenpox should get 2 doses of 
chickenpox vaccine at these ages:

1st Dose: 12-15 months of age
2nd Dose: 4-6 years of age (may be given earlier, if at least 3 months 
after the 1st dose)

    People 13 years of age and older (who have never had chickenpox or 
received chickenpox vaccine) should get two doses at least 28 days 
apart.
Catch-Up
    Anyone who is not fully vaccinated, and never had chickenpox, 
should receive one or two doses of chickenpox vaccine. The timing of 
these doses depends on the person's age. Ask your provider.
    Chickenpox vaccine may be given at the same time as other vaccines.

    Note:  Children 12 years of age and younger can receive a 
``combination'' vaccine called MMRV, which contains both MMR and 
varicella (chickenpox) vaccines. See the MMRV Vaccine Information 
Statement for more information.

3. Some People Should Not Get Chickenpox Vaccine or Should Wait
     People should not get chickenpox vaccine if they have ever 
had a life-threatening allergic reaction to a previous dose of 
chickenpox vaccine or to gelatin or the antibiotic neomycin.
     People who are moderately or severely ill at the time the 
shot is scheduled should usually wait until they recover before getting 
chickenpox vaccine.
     Pregnant women should wait to get chickenpox vaccine until 
after they have

[[Page 48718]]

given birth. Women should not get pregnant for 1 month after getting 
chickenpox vaccine.
     Some people should check with their doctor about whether 
they should get chickenpox vaccine, including anyone who:

--Has HIV/AIDS or another disease that affects the immune system
--Is being treated with drugs that affect the immune system, such as 
steroids, for 2 weeks or longer
--Has any kind of cancer
--Is getting cancer treatment with radiation or drugs

     People who recently had a transfusion or were given other 
blood products should ask their doctor when they may get chickenpox 
vaccine.
    Ask your provider for more information.
4. What are the risks from chickenpox vaccine?
    A vaccine, like any medicine, is capable of causing serious 
problems, such as severe allergic reactions. The risk of chickenpox 
vaccine causing serious harm, or death, is extremely small.
    Getting chickenpox vaccine is much safer than getting chickenpox 
disease. Most people who get chickenpox vaccine do not have any 
problems with it. Reactions are usually more likely after the first 
dose than after the second.
Mild Problems
     Soreness or swelling where the shot was given (about 1 out 
of 5 children and up to 1 out of 3 adolescents and adults)
     Fever (1 person out of 10, or less)
     Mild rash, up to a month after vaccination (1 person out 
of 25). It is possible for these people to infect other members of 
their household, but this is extremely rare.
Moderate Problems
     Seizure (jerking or staring) caused by fever (very rare).
Severe Problems
     Pneumonia (very rare).
    Other serious problems, including severe brain reactions and low 
blood count, have been reported after chickenpox vaccination. These 
happen so rarely experts cannot tell whether they are caused by the 
vaccine or not. If they are, it is extremely rare.

    Note:  The first dose of MMRV vaccine has been associated with 
rash and higher rates of fever than MMR and varicella vaccines given 
separately. Rash has been reported in about 1 person in 20 and fever 
in about 1 person in 5.
    Seizures caused by a fever are also reported more often after 
MMRV. These usually occur 5-12 days after the first dose.

5. What if there is a severe or moderate reaction?
What should I look for?
    Any unusual condition, such as a high fever or behavior changes. 
Signs of a severe allergic reaction can include difficulty breathing, 
hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or 
dizziness.
What should I do?
     Call a doctor, or get the person to a doctor right away.
     Tell the doctor what happened, the date and time it 
happened, and when the vaccination was given.
     Ask your provider to report the reaction by filing a 
Vaccine Adverse Event Reporting System (VAERS) form. Or you can file 
this report through the VAERS Web site at http://w.vaers.hhs.gov, or by 
calling 1-800-822-7967.
    VAERS does not provide medical advice.
6. The National Vaccine Injury Compensation Program
    The National Vaccine Injury Compensation Program (VICP) was created 
in 1986.
    Persons who believe they may have been injured by a vaccine may 
file a claim with VICP by calling 1-800-338-2382 or visiting their Web 
site at http://www.hrsa.gov/vaccinecompensation vaccinecompensation.
7. How can I learn more?
     Ask your provider. They can give you the vaccine package 
insert or suggest other sources of information.
     Call your local or state health department.
     Contact the Centers for Disease Control and Prevention 
(CDC):
--Call 1-800-232-4636 (1-800-CDC-INFO)
--Visit CDC's Web site at http://www.cdc.gov/vaccines
Department of Health and Human Services
Centers for Disease Control and Prevention
Vaccine Information Statement
Varicella Vaccine
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26
* * * * *

Proposed MMRV Vaccine Information Statement

Measles, Mumps, Rubella & Varicella (MMRV) Vaccine: What You Need To 
Know
1. Measles, Mumps, Rubella, and Varicella
    Measles, Mumps, Rubella, and Varicella (chickenpox) can be serious 
diseases:
Measles
     Causes rash, cough, runny nose, eye irritation, fever.
     Can lead to ear infection, pneumonia, seizures (jerking 
and staring), brain damage, and death.
Mumps
     Causes fever, headache, swollen glands.
     Can lead to deafness, meningitis (infection of the brain 
and spinal cord covering), infection of the pancreas, painful swelling 
of the testicles or ovaries, and rarely sterility or death.
Rubella (German Measles)
     Causes rash and mild fever; and can cause arthritis 
(mostly in women).
     If a woman gets rubella while she is pregnant, she could 
have a miscarriage or her baby could be born with serious birth 
defects.
Varicella (Chickenpox)
     Causes rash, itching, fever, tiredness.
     Can lead to severe skin infection, scars, pneumonia, brain 
amage, or death.
     Can re-emerge years later as a painful rash called 
shingles.
    These diseases can spread from person to person through the air. 
Varicella can also be spread through contact with fluid from chickenpox 
blisters.
    Before vaccines, these diseases were very widespread in the United 
States.
2. MMRV Vaccine
    MMRV vaccine may be given to children from 1 through 12 years old 
to protect them from these four diseases.
    Two doses of MMRV vaccine are recommended:

--The first dose at 12 through 15 months of age
--The second dose at 4 through 6 years of age

    These are recommended ages. But children can get the second dose up 
through 12 years as long as it is at least 3 months after the first 
dose.
    Children may also get these vaccines as 2 separate shots: MMR 
(measles, mumps and rubella) and varicella.

[[Page 48719]]

1 Shot (MMRV) or 2 Shots (MMR & Varicella)?

     Both options give the same protection.
     Fewer injections with MMRV.
     MMRV has been associated with more fevers and fever-
related seizures than MMR and varicella vaccines given separately 
(first dose only).
    Unless you specifically request otherwise, CDC recommends separate 
MMR and varicella vaccines for the first dose and MMRV vaccine for the 
second dose.
    Your health-care provider can give you more information, including 
the Vaccine Information Statements for MMR and Varicella vaccines.
    Anyone 13 or older who needs protection from these diseases should 
get MMR and varicella vaccines separately.
    MMRV may be given at the same time as other vaccines.
3. Some Children Should Not Get MMRV Vaccine or Should Wait
    Children should not get MMRV vaccine if they:
     Have ever had a life-threatening allergic reaction to a 
previous dose of MMRV vaccine, or to either MMR or varicella vaccine
     Have ever had a life-threatening allergic reaction to any 
component of the vaccine, including gelatin or the antibiotic neomycin. 
Tell the doctor if your child has any severe allergies.
     Have HIV/AIDS, or another disease that affects the immune 
system
     Are being treated with drugs that affect the immune 
system, such as high doses of steroids by mouth, for 2 weeks or longer
     Have any kind of cancer
     Are being treated for cancer with radiation or drugs
    Check with your doctor if the child:
     Has a history of seizures, or has a parent, brother or 
sister with a history of seizures
     Has a parent, brother or sister with a history of immune 
system problems
     Has ever had a low platelet count, or another blood 
disorder
     Recently had a transfusion or received other blood 
products
     Might be pregnant
    Children who are moderately or severely ill at the time the shot is 
scheduled should usually wait until they recover before getting MMRV 
vaccine.
    Ask your provider for more information.
4. What are the risks from MMRV vaccine?
    A vaccine, like any medicine, is capable of causing serious 
problems, such as severe allergic reactions. The risk of MMRV vaccine 
causing serious harm, or death, is extremely small.
    Getting MMRV vaccine is much safer than getting any of these four 
diseases.
    Most children who get MMRV vaccine do not have any problems with 
it.
Mild Problems
     Fever (about 1 child out of 5)
     Mild rash (about 1 child out of 20)
     Swelling of glands in the cheeks or neck (rare)
    If these problems occur, it is usually within 5-12 days after the 
first dose. They occur less often after the second dose.
Moderate Problems
     Seizure caused by fever (about 1 child in 1,250). These 
seizures usually occur 5-12 days after the first dose. They occur less 
often when MMR and varicella vaccines are given together as separate 
injections (about 1 child in 2,500), and rarely after a 2nd dose of 
MMRV.
     Temporary low platelet count, which can cause a bleeding 
disorder (about 1 child out of 40,000)
Severe Problems (Very Rare)
    Several severe problems have been reported following MMR vaccine, 
and might also occur after MMRV. These include severe allergic 
reactions (fewer than 4 per million), and problems such as:

--Deafness
--Long-term seizures, coma, lowered consciousness
--Permanent brain damage

    Because these problems occur so rarely, we can't be sure whether 
they are caused by the vaccine or not.
5. What if there is a severe reaction?
What should I look for?
    Any unusual condition, such as a high fever or behavior changes. 
Signs of a severe allergic reaction can include difficulty breathing, 
hoarseness or wheezing, hives, paleness, weakness, a fast heart beat or 
dizziness.
What should I do?
     Call a doctor, or get the person to a doctor right away.
     Tell the doctor what happened, the date and time it 
happened, and when the vaccination was given.
     Ask your provider to report the reaction by filing a 
Vaccine Adverse Event Reporting System (VAERS) form. Or you can file 
this report through the VAERS Web site at http://www.vaers.hhs.gov, or 
by calling 1-800-822-7967.
    VAERS does not provide medical advice.
6. The National Vaccine Injury Compensation Program
    The National Vaccine Injury Compensation Program (VICP) was created 
in 1986.
    Persons who believe they may have been injured by a vaccine may 
file a claim with VICP by calling 1-800-338-2382 or visiting their Web 
site at http://www.hrsa.gov/vaccinecompensation vaccinecompensation.
7. How can I learn more?
     Ask your provider. They can give you the vaccine package 
insert or suggest other sources of information.
     Call your local or state health department.
     Contact the Centers for Disease Control and Prevention 
(CDC):

--Call 1-800-232-4636 (1-800-CDC-INFO)
--Visit CDC's Web site at http://www.cdc.gov/vaccines.
Department of Health and Human Services,
Centers for Disease Control and Prevention,
Vaccine Information Statement,
MMRV Vaccine,
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26.
* * * * *

    Dated: August 3, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2010-19785 Filed 8-10-10; 8:45 am]
BILLING CODE 4163-18-P