Proposed Vaccine Information Materials:

As Enacted ( Federal Register)

Cited authorities 1

Cited in

Federal Register: August 11, 2010 (Volume 75, Number 154)

Notices

Page 48715-48719

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr11au10-79

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.

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

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. 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.

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.

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.

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

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Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users

You can sign up for a trial and make the most of our service including these benefits.

Why Sign-up to vLex?

Over 100 Countries

Thousands of Data Sources

Find What You Need, Quickly

Over 2 million registered users