Federal Register, Volume 75 Issue 154 (Wednesday, August 11, 2010)

[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Pages 48707-48712]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19784]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Proposed Vaccine Information Materials for Pneumococcal Conjugate
Vaccine and Human Papillomavirus 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 pneumococcal
conjugate vaccine and human papillomavirus vaccines.

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

[[Page 48708]]

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 HHS 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 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 Pneumococcal Conjugate Vaccine (13-Valent) Information
Materials

Proposed Human Papillomavirus Vaccine Information Materials

With the February 1, 2007 addition of human papillomavirus vaccine
to the National Vaccine Injury Compensation Program, updating of ACIP's
HPV recommendations in December 2009, and the licensure of 13-valent
pneumococcal conjugate vaccine in April 2010, CDC, as required under 42
U.S.C. 300aa-26, is proposing vaccine information materials covering
those vaccines, which are included in this notice. Interim materials
have been available for use pending completion of the formal
development process.

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 ``Human Papillomavirus
(HPV) Vaccine: What You Need to Know (Gardasil[supreg]),'' ``Human
Papillomavirus (HPV) Vaccine: What You Need to Know
(Cervarix[supreg]),'' and ``Pneumococcal Conjugate 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 update references to these vaccine
information materials.
* * * * *

Proposed Pneumococcal Conjugate Vaccine Information Statement

Pneumococcal Conjugate Vaccine: What You Need to Know

1. Pneumococcal Disease
Infection with Streptococcus pneumoniae bacteria can make children
very sick.
It causes blood infections, pneumonia, and meningitis, mostly in
young children. (Meningitis is an infection of the covering of the
brain.) Although pneumococcal meningitis is relatively rare (less than
1 case per 100,000 people each year) it is fatal in about 1 of 10 cases
in children.
Pneumococcal meningitis can also lead to other health problems,
including deafness and brain damage.
Before routine use of pneumococcal conjugate vaccine, pneumococcal
infections caused:
Over 700 cases of meningitis,
13,000 blood infections,
About 5 million ear infections, and
About 200 deaths

annually in the United States in children under five.

Children younger than 2 years of age are at higher risk for serious
disease than older children.
Pneumococcal bacteria are spread from person to person through
close contact.
Pneumococcal infections may be hard to treat because some strains
of the bacteria have become resistant to the drugs that are used to
treat them. This makes prevention of pneumococcal infections through
vaccination even more important.
2. Pneumococcal Conjugate Vaccine (PCV13)
There are more than 90 types of pneumococcal bacteria. The new
pneumococcal conjugate vaccine (PCV13) protects against 13 of them.
These bacteria types are responsible for most severe pneumococcal
infections among children. PCV13 replaces a previous conjugate vaccine
(PCV7), which protected against 7 pneumococcal types and has geen in
use since 2000. During that time severe pneumococcal disease has
dropped by nearly 80% among children under 5.
PCV13 can also prevent some cases of pneumonia and some ear
infections. But pneumonia and ear infections have many causes, and
PCV13 only works against the types of pneumococcal bacteria targeted by
the vaccine.
PCV is given to infants and toddlers, to protect them when they are
at greatest risk for serious diseases caused by pneumococcal bacteria.

[[Page 48709]]

In addition to receiving PCV13, older children with certain chronic
illnesses may get a different vaccine called PPSV23. There is a
separate Vaccine Information Statement for that vaccine.
3. Who should get PCV13 vaccine and when?
Infants and Children Under 2 Years of Age
PCV13 is recommended as a series of 4 doses, one dose at each of
these ages:

--2 months.
--4 months.
--6 months.
--12 through 15 months.

Children who miss their shots at these ages should still get the
vaccine. The number of doses and the intervals between doses will
depend on the child's age. Ask your health care provider for details.
Children who have begun their immunization series with PCV7 should
complete the series with PCV13.
Older Children and Adolescents
Healthy children between their 2nd and 5th birthdays who
have not completed the PCV7 or PCV13 series before age 2 years should
get 1 dose.
Children between the 2nd and 6th birthdays with medical
conditions such as:

--Sickle cell disease,
--A damaged spleen or no spleen,
--Cochlear implants,
--Diabetes,
--HIV/AIDS or other diseases that affect the immune system (such as
diabetes, cancer, or liver disease), or
--Chronic heart or lung disease
or who take medications that affect the immune system, such as
immunosuppressive drugs or steroids, should get 1 dose of PCV13 (if
they received 3 doses of PCV7 or PCV13 before age 2 years), or 2 doses
of PCV13 (if they have received 2 or fewer doses of PCV7 or PCV13).

A dose of PCV13 may be administered to children and adolescents 6
through 18 years of age who have certain medical conditions, even if
they have previously received PCV7 or PPSV23.
Children who have completed the 4-dose series with PCV7: Healthy
children who have not yet turned 5, and children with medical
conditions who have not yet turned 6, should get one additional dose of
PCV13.
Ask your health care provider if you have any questions about any
of these recommendations.
PCV13 may be given at the same time as other vaccines.
4. Some Children Should Not Get PCV13 or Should Wait
Children should not get PCV13 if they had a serious (life-
threatening) allergic reaction to a previous dose of this vaccine, to
PCV7, or to any vaccine containing diphtheria toxoid (for example
DTaP).
Children who are known to have a severe allergy to any component of
PCV7 or PCV13 should not get PCV13. Tell your health care provider if
your child has any severe allergies.
Children with minor illnesses, such as a cold, may be vaccinated.
But children who are moderately or severely ill should usually wait
until they recover before getting the vaccine.
5. What are the risks from PCV13?
Any medicine, including a vaccine, could possibly cause a serious
problem, such as a severe allergic reaction. However, the risk of any
vaccine causing serious harm, or death, is extremely small.
In studies, most reactions after PCV13 were mild. They were similar
to reactions reported after PCV7, which has been in use since 2000.
Reported reactions varied by dose and age, but on average:
About half of children were drowsy after the shot, had a
temporary loss of appetite, or had redness or tenderness where the shot
was given.
About 1 out of 3 had swelling where the shot was given.
About 1 out of 3 had a mild fever, and about 1 in 20 had a
higher fever (over 102.2[deg]F).
Up to about 8 out of 10 became fussy or irritable.
Life-threatening allergic reactions from vaccines are very rare. If
they do occur, it would be within a few minutes to a few hours after
the vaccination.
6. 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.
7. 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.
8. 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) or
--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, PCV13, (00/00/
0000) (Proposed), 42 U.S.C. 300aa-26.
* * * * *

Proposed Human Papillomavirus Vaccine Information Statement (Gardasil)

HPV (Human Papillomavirus Virus) Vaccine (Gardasil[supreg]): What You
Need to Know

1. What is HPV?
Genital human papillomavirus (HPV) is the most common sexually
transmitted virus in the United States. More than half of sexually
active men and women are infected with HPV at some time in their lives.
About 20 million Americans are currently infected, and about 6
million more get infected each year. HPV is usually spread through
sexual contact.
Most HPV infections don't cause any symptoms, and go away on their
own. But HPV can cause cervical cancer in women. Cervical cancer is the
2nd leading cause of cancer deaths among women around the world. In the
United States, about 10,000 women get cervical cancer every year and
about 4,000 are expected to die from it.
HPV is also associated with several less common cancers, such as
vaginal and vulvar cancers in women and other types of cancer in both
men and women. It can also cause genital warts and warts in the throat.

[[Page 48710]]

There is no cure for HPV infection, but some of the problems it
causes can be treated.
2. HPV Vaccine--Why get vaccinated?
HPV vaccine is important because it can prevent most cases of
cervical cancer in females, if it is given before a person is exposed
to the virus.
Protection from HPV vaccine is expected to be long-lasting. But
vaccination is not a substitute for cervical cancer screening. Women
should still get regular Pap tests.
The vaccine you are getting is one of two vaccines that can be
given to prevent HPV. It may be given to both males and females. In
addition to preventing cervical cancer, it can also prevent vaginal and
vulvar cancer in females, and genital warts in both males and females.
The other vaccine is given to females only, and only for prevention
of cervical cancer.
3. Who should get this HPV vaccine and when?
Females: Routine Vaccination
HPV vaccine is recommended for girls 11 or 12 years of
age. It may be given to girls starting at age 9.
Why is HPV vaccine given to girls at this age?
It is important for girls to get HPV vaccine before their first
sexual contact--because they won't have been exposed to human
papillomavirus.
Once a girl or woman has been infected with the virus, the vaccine
might not work as well or might not work at all.
Females: Catch-Up Vaccination
The vaccine is also recommended for girls and women 13
through 26 years of age who did not get all 3 doses when they were
younger.
Males
Males 9 through 26 years of age may get HPV vaccine to prevent
genital warts. As with females, it is best to be vaccinated before the
first sexual contact.
HPV vaccine is given as a 3-dose series

1st Dose: Now
2nd Dose: 1 to 2 months after Dose 1
3rd Dose: 6 months after Dose 1
Additional (booster) doses are not recommended.
HPV vaccine may be given at the same time as other vaccines.
4. Some People Should Not Get HPV Vaccine or Should Wait
Anyone who has ever had a life-threatening allergic
reaction to any component of HPV vaccine, or to a previous dose of HPV
vaccine, should not get the vaccine. Tell your doctor if the person
getting vaccinated has any severe allergies, including an allergy to
yeast.
HPV vaccine is not recommended for pregnant women.
However, receiving HPV vaccine when pregnant is not a reason to
consider terminating the pregnancy. Women who are breast feeding may
get the vaccine.
Any woman who learns she was pregnant when she got this
HPV vaccine is encouraged to contact the manufacturer's HPV in
pregnancy registry at 800-986-8999. This will help us learn how
pregnant women respond to the vaccine.
People who are mildly ill when a dose of HPV vaccine is
planned can still be vaccinated. People with a moderate or severe
illness should wait until they are better.
5. What are the risks from this vaccine?
This HPV vaccine has been used in the U.S. and around the world for
several years and has been very safe.
However, any medicine could possibly cause a serious problem, such
as a severe allergic reaction. The risk of any vaccine causing a
serious injury, or death, is extremely small.
Life-threatening allergic reactions from vaccines are very rare. If
they do occur, it would be within a few minutes to a few hours after
the vaccination.
Several mild to moderate problems are known to occur with HPV
vaccine. These do not last long and go away on their own.
Reactions in the arm where the shot was given:

--Pain (about 8 people in 10).
-- Redness or swelling (about 1 person in 4).

Fever:
--Mild (100 [deg]F) (about 1 person in 10).
--Moderate (102 [deg]F) (about 1 person in 65).

Other problems:

--Headache (about 1 person in 3).

Fainting:

--Brief fainting spells and related symptoms (such as jerking
movements) can happen after any medical procedure, including
vaccination. Sitting or lying down for about 15 minutes after
vaccination can help prevent fainting and injuries caused by falls.
Tell your provider if the patient feels dizzy or light-headed, or has
vision changes or ringing in the ears.

Like all vaccines, HPV vaccines will continue to be monitored for
unusual or severe problems.
6. What if there is a severe reaction?
What should I look for?
Serious allergic reactions including rash; swelling of the hands
and feet, face, or lips; and breathing difficulty.
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.
7. 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.
8. 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) or
--Visit CDC's Web site at http://www.cdc.gov/std/hpv and http://www.cdc.gov/vaccines.
Department of Health and Human Services, Centers for Disease
Control and Prevention, Vaccine Information Statement, Human
Papillomavirus Vaccine (Gardasil), (00/00/0000) (Proposed), 42 U.S.C.
300aa-26.
* * * * *

Proposed Human Papillomavirus Vaccine Information Statement (Cervarix)

HPV (Human Papillomavirus Virus) Vaccine (Cervarix[supreg]): What You
Need to Know

[[Page 48711]]

About 20 million Americans are currently infected, and about 6
million more get infected each year. HPV is usually spread through
sexual contact.
Most HPV infections don't cause any symptoms, and go away on their
own. But HPV can cause cervical cancer in women. Cervical cancer is the
2nd leading cause of cancer deaths among women around the world. In the
United States, about 10,000 women get cervical cancer every year and
about 4,000 are expected to die from it.
HPV is also associated with several less common cancers, such as
vaginal and vulvar cancers in women and other types of cancer in both
men and women. It can also cause genital warts and warts in the throat.
There is no cure for HPV infection, but some of the problems it
causes can be treated.
2. HPV Vaccine--Why get vaccinated?
HPV vaccine is important because it can prevent most cases of
cervical cancer in females, if it is given before a person is exposed
to the virus.
Protection from HPV vaccine is expected to be long-lasting. But
vaccination is not a substitute for cervical cancer screening. Women
should still get regular Pap tests.
The vaccine you are getting is one of two vaccines that can be
given to prevent HPV. It is given to females only.
The other vaccine may be given to both males and females, and can
also prevent some vaginal and vulvar cancers, and genital warts.
3. Who should get this HPV vaccine (Cervarix) and when?
Routine Vaccination
HPV vaccine is recommended for girls 11 or 12 years of
age. It may be given to girls starting at age 9.
Why is HPV vaccine given to girls at this age?
It is important for girls to get HPV vaccine before their first
sexual contact--because they won't have been exposed to human
papillomavirus.
Once a girl or woman has been infected with the virus, the vaccine
might not work as well or might not work at all.
Catch-Up Vaccination
The vaccine is also recommended for girls and women 13
through 26 years of age who did not get all 3 doses when they were
younger.
HPV vaccine is given as a 3-dose series:

1st Dose: Now
2nd Dose: 1 to 2 months after Dose 1
3rd Dose: 6 months after Dose 1

Additional (booster) doses are not recommended.
HPV vaccine may be given at the same time as other vaccines.
4. Some People Should Not Get HPV Vaccine or Should Wait
Anyone who has ever had a life-threatening allergic
reaction to any component of HPV vaccine, or to a previous dose of HPV
vaccine, should not get the vaccine. Tell your doctor if the person
getting vaccinated has any severe allergies, including an allergy to
latex.
HPV vaccine is not recommended for pregnant women.
However, receiving HPV vaccine when pregnant is not a reason to
consider terminating the pregnancy. Women who are breast feeding may
get the vaccine.
Any woman who learns she was pregnant when she got this HPV vaccine
is encouraged to contact the manufacturer's HPV in pregnancy registry
at 888-452-9622. This will help us learn how pregnant women respond to
the vaccine.
People who are mildly ill when a dose of HPV vaccine is
planned can still be vaccinated. People with a moderate or severe
illness should wait until they are better.
5. What are the risks from this vaccine?
This HPV vaccine has been in use around the world for several years
and has been very safe.
However, any medicine could possibly cause a serious problem, such
as a severe allergic reaction. The risk of any vaccine causing a
serious injury, or death, is extremely small.
Life-threatening allergic reactions from vaccines are very rare. If
they do occur, it would be within a few minutes to a few hours after
the vaccination.
Several mild to moderate problems are known to occur with HPV
vaccine. These do not last long and go away on their own.
Reactions where the shot was given:

--Pain (about 9 people in 10).
--Redness or swelling (about 1 person in 2).

Other mild reactions:

--Fever of 99.5 [deg]F or higher (about 1 person in 8).
--Headache or fatigue (about 1 person in 2).
--Nausea, vomiting, diarrhea, or abdominal pain (about 1 person in 4).
--Muscle or joint pain (up to 1 person in 2).

Fainting:

--Brief fainting spells and related symptoms (such as jerking
movements) can happen after any medical procedure, including
vaccination. Sitting or lying down for about 15 minutes after a
vaccination can help prevent fainting and injuries caused by falls.
Tell your provider if the patient feels dizzy or light-headed, or has
vision changes or ringing in the ears.

Like all vaccines, HPV vaccines will continue to be monitored for
unusual or severe problems.
6. What if there is a severe reaction?
What should I look for?
Serious allergic reactions including rash; swelling of the hands
and feet, face, or lips; and breathing difficulty.
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.
7. 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.
8. 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) or
--Visit CDC's Web site at http://www.cdc.gov/std/hpv and http://www.cdc.gov/vaccines.

Department of Health and Human Services, Centers for Disease
Control and Prevention, Vaccine Information Statement, Human
Papillomavirus Vaccine (Cervarix) (00/00/0000) (Proposed), 42 U.S.C.
300aa-26.

[[Page 48712]]

Dated: August 3, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and
Prevention.
[FR Doc. 2010-19784 Filed 8-10-10; 8:45 am]
BILLING CODE 4163-18-P