[Federal Register Volume 75, Number 250 (Thursday, December 30, 2010)]
[Notices]
[Pages 82402-82405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Proposed Consolidated Vaccine Information Materials for Multiple 
Infant 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 a proposed new vaccine information statement that consolidates the 
six vaccine information statements for the following childhood 
vaccines: DTaP, Haemophilus influenzae type b, inactivated polio 
vaccine, pneumococcal conjugate vaccine, hepatitis B, and rotavirus. 
This consolidated Vaccine Information Statement is available to be used 
by vaccination providers as an alternative to providing the six 
individual Vaccine Information Statements for the same vaccines.

DATES: Written comments are invited and must be received on or before 
February 28, 2011.

ADDRESSES: Written comments should be addressed to Jennifer Hamborsky, 
National Center for Immunization and Respiratory Diseases, Centers for 
Disease Control and Prevention, Mailstop E-52, 1600 Clifton Road, NE., 
Atlanta, Georgia 30333.

FOR FURTHER INFORMATION CONTACT: Skip Wolfe, National Center for 
Immunization and Respiratory Diseases, 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 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. Hepatitis B, Haemophilus influenzae type b (Hib), varicella 
(chickenpox), pneumococcal conjugate, hepatitis A, meningococcal 
conjugate and polysaccharide, rotavirus, human papillomavirus (HPV), 
and trivalent influenza vaccines have subsequently been added to the 
National Vaccine Injury Compensation Program. Use of the Vaccine 
Information Statements applicable to all of these vaccines, except 
meningococcal, rotavirus and HPV, is also required. (Interim versions 
of Vaccine Information Statements for meningococcal, rotavirus and HPV 
vaccines are available for discretionary use pending completion of the 
statutory process for finalizing VISs applicable to those vaccines.) 
Instructions for use of the vaccine information materials and copies of 
the materials can be found on

[[Page 82403]]

the CDC Web site at: http://www.cdc.gov/vaccines/pubs/vis.

Proposed Consolidated Vaccine Information Materials

    With six vaccines recommended for infants from birth through 6 
months of age--all covered by the National Vaccine Injury Compensation 
Program--CDC, as required under 42 U.S.C. 300aa-26, developed Vaccine 
Information Statements for each of those vaccines. In addition, CDC 
published, in 2008, an alternative consolidated Vaccine Information 
Statement covering those six vaccines in one document, which providers 
can choose to use instead of the existing individual Vaccine 
Information Statements for the same vaccines. The attached document is 
an update of this consolidated Vaccine Information Statement.

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 ``Your Baby's First 
Vaccines: What You Need to Know.'' Comments submitted will be 
considered in finalizing these materials.
* * * * *

Proposed Multi-Vaccine Vaccine Information Statement:

Your Baby's First Vaccines: What You Need to Know
Many Vaccine Information Statements are available in Spanish and other 
languages. See http://www.immunize.org/vis Hojas de Informaci[aacute]n 
Sobre Vacunas est[aacute]n disponibles en Espa[ntilde]ol y en muchos 
otros idiomas. Visite http://www.immunize.org/vis
    Babies get six vaccines between birth and 6 months of age, with at 
least one ``booster'' dose given later.
    These vaccines protect your baby from 8 serious diseases.
Your baby will get these vaccines today:
[ballot] DTaP [ballot] Polio [ballot] Hib
[ballot] Rotavirus [ballot] Hepatitis B
[ballot] PCV13
(Provider: Check appropriate boxes.)
    Ask your doctor about ``combination vaccines,'' which can reduce 
the number of shots your baby needs by combining several vaccines in 
one shot. These combination vaccines are as safe and effective as these 
vaccines given separately.

About This Vaccine Information Statement

    Please read this Vaccine Information Statement (VIS) before your 
baby gets his or her immunizations, and take it home with you 
afterward. Ask your doctor, nurse, or other healthcare professional if 
you have any questions.
    This VIS tells you about the benefits and risks of these 6 
vaccines. It also contains information about reporting an adverse 
reaction and about the National Vaccine Injury Compensation Program, 
and how to get more information about vaccines and vaccine-preventable 
diseases. (Individual VISs are also available for these six vaccines.)

How Vaccines Work

    Most medicines are designed to treat diseases. Vaccines are 
designed to prevent diseases, by producing immunity. A child who is 
immune to a disease will not get sick from it.
    Immunity from Disease: Before vaccines, a child had to get sick to 
get immunity. When a child gets sick with a disease, like measles or 
whooping cough, her immune system produces protective ``antibodies,'' 
which keep her from getting the same disease again. But getting sick 
the first time is unpleasant, and it can be dangerous or even fatal.
    Immunity from Vaccines: Vaccines are made with the same bacteria or 
viruses that cause disease, but they have been weakened or killed to 
make them safe. A child's immune system responds to a vaccine by 
producing antibodies, just the same as it would if the child were 
infected with the actual disease. This means he will develop immunity 
in the same way * * * but without having to get sick first.

Vaccine benefits: Why get vaccinated?

    Your baby's first vaccines protect him from 8 serious diseases, 
caused by viruses and bacteria. These diseases have injured and killed 
millions of children (and adults) over the years. Polio killed more 
than 1,000 people a year, and paralyzed tens of thousands more in the 
early 1950s. Hib disease was once the leading cause of bacterial 
meningitis in children under 5 years of age. About 15,000 people a year 
died from diphtheria before there was a vaccine. Most children have at 
least one rotavirus infection before their 5th birthday.
    These diseases might be uncommon today, but if we stopped 
vaccinating they would come back. This has happened in the past, and 
even today disease rates go up when vaccination rates go down. For 
example in 2010 California had more pertussis cases than in any year 
since 1947.

8 Diseases Prevented by Childhood Vaccines

1. Diphtheria

    You can get it from contact with an infected person.
    Signs and symptoms include a thick covering in the back of the 
throat that can make it hard to breathe.
    It can lead to breathing problems, heart failure, and death.

2. Tetanus (Lockjaw)

    You can get it from a cut or wound. It does not spread from person 
to person.
    Signs and symptoms include painful tightening of the muscles, 
usually all over the body.
    It can lead to stiffness of the jaw that prevents swallowing or 
even opening the mouth. Of every 5 people who get tetanus, 1 dies.

3. Pertussis (Whooping Cough)

    You can get it from contact with an infected person.
    Signs and symptoms include violent coughing spells that can make it 
hard for an infant to eat, drink, or breathe. These spells can last for 
weeks.
    It can lead to pneumonia, seizures, brain damage, and death.

4. Hib (Haemophilus influenzae type b)

    You can get it from contact with an infected person.
    Signs and symptoms. There may not be any signs or symptoms in mild 
cases.
    It can lead to meningitis (infection of the brain and spinal cord 
coverings); pneumonia; infections of the blood, joints, bones, and 
covering of the heart; brain damage; deafness; and death.

5. Hepatitis B

    You can get it from blood or body fluids of an infected person. 
Babies can get it at birth if the mother is infected, or through a cut 
or wound.
    Signs and symptoms include tiredness, diarrhea and vomiting, 
jaundice (yellow skin or eyes), and pain in muscles, joints and 
stomach.
    It can lead to liver damage, liver cancer, and death.

6. Polio

    You can get it from close contact with an infected person. It 
enters the body through the mouth.
    Signs and symptoms can include cold-like illness, or there may be 
no signs or symptoms at all.
    It can lead to paralysis (can't move an arm or leg), or death (by 
paralyzing the breathing muscles).

[[Page 82404]]

7. Pneumococcal Disease

    You can get it from contact with an infected person.
    Signs and symptoms include fever, chills, cough, and chest pain.
    It can lead to meningitis (infection of the brain and spinal cord 
coverings), blood infections, ear infections, pneumonia, deafness, 
brain damage, and death.

8. Rotavirus

    You can get it from contact with other children who are infected.
    Signs and symptoms include diarrhea (sometimes severe), vomiting 
and fever.
    It can lead to dehydration, hospitalization (up to about 70,000 a 
year), and death.

Routine Baby Vaccines

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              Vaccine                    Number of doses         Recommended ages          Other information
----------------------------------------------------------------------------------------------------------------
DTaP (diphtheria, tetanus, and       5......................  2 months, 4 months, 6   Some children should not
 pertussis.                                                    months, 15-18 months,   get pertussis vaccine.
                                                               4-6 years.              These children should get
                                                                                       a vaccine called DT.
Hepatitis B........................  3......................  Birth, 1-2 months, 6-   A child might receive a
                                                               18 months.              4th dose if
                                                                                       ``combination'' vaccines
                                                                                       are used.
Polio..............................  4......................  2 months, 4 months, 6-  A child might receive a
                                                               18 months, 4-6 years.   5th dose if
                                                                                       ``combination'' vaccines
                                                                                       are used.
Hib (Haemophilus influenzae type b)  3 or 4.................  2 months, 4 months, (6  There are 2 types of Hib
                                                               months), 12-15 months.  vaccine. With one type
                                                                                       the 6-month dose is not
                                                                                       needed.
PCV13 (pneumococcal)...............  4......................  2 months, 4 months, 6   Older children with
                                                               months, 12-15 months.   certain chronic diseases
                                                                                       may also need this
                                                                                       vaccine.
Rotavirus..........................  2 or 3.................  2 months, 4 months, (6  Rotavirus vaccine is given
                                                               months).                as drops that are
                                                                                       swallowed. There are 2
                                                                                       types of rotavirus
                                                                                       vaccine. With one type
                                                                                       the 6-month dose is not
                                                                                       needed. A virus called
                                                                                       porcine circovirus is
                                                                                       present in both vaccines.
                                                                                       There is no evidence that
                                                                                       it is a safety risk. For
                                                                                       information ask your
                                                                                       doctor or visit http://www.cdc.gov/vpd-vac/rotavirus rotavirus.
----------------------------------------------------------------------------------------------------------------

    An annual dose of flu vaccine is also recommended for children 6 
months of age and older.

Precautions

    Most babies can get all of these vaccines. But some babies should 
not get certain vaccines because of allergies or other health 
conditions. Your doctor can advise you.
    If your child ever had a serious reaction, such as a life-
threatening allergic reaction, after a dose of vaccine, she should not 
get another dose of that vaccine. Tell your doctor if your child has 
any severe allergies. (Serious reactions to vaccines and severe 
allergies are rare.)

    If your child ever had any of these reactions after a dose of DTaP 
vaccine:
--A brain or nervous system disease within 7 days,
--Non-stop crying for 3 hours or more,
--A seizure or collapse,
--A fever of over 105 [deg]F.
    Talk to your doctor before getting DTaP vaccine.
    If your child has:
--A life-threatening allergy to the antibiotics neomycin, streptomycin, 
or polymyxin B,
    Talk to your doctor before getting Polio vaccine.
    If your child has:
--A life-threatening allergy to yeast,
    Talk to your doctor before getting Hepatitis B or PCV13 vaccine.
    If your child has:
--SCID (Severe Combined Immunodeficiency),
-- A weakened immune system for any other reason,
--Ongoing digestive problems,
--Recently gotten a blood transfusion or other blood product,
--Ever had intussusception (an uncommon type of bowel obstruction),
    Talk to your doctor before getting Rotavirus vaccine.
    If your child has:
--Ever had a severe reaction after any vaccine containing diphtheria 
toxoid (such as DTaP),
    Talk to your doctor before getting PCV13 or DTaP vaccine.

    If your child is sick on the day her vaccinations are scheduled, 
your doctor might want to reschedule them after she recovers. A child 
with a mild cold or low fever can usually be vaccinated the same day, 
but for a more serious illness it might be better to wait.

Risks

    Vaccines can cause side effects, like any medicine. The risk of a 
serious reaction, such as a severe allergic reaction, or death, is 
extremely low.
    Mild Reactions: Most vaccine reactions are mild ``local'' 
reactions: Tenderness, redness, or swelling where the shot was given; 
or a mild fever. These affect about 1 child in 4. They appear soon 
after the shot is given and go away within a day or two.
    Other Reactions: Severe allergic reactions to a substance in a 
vaccine happen very rarely--less than once in a million shots. They 
generally occur within minutes or hours after the vaccination. 
Individual vaccines have been associated with other mild problems, or 
with moderate or serious problems:

DTaP Vaccine

    Mild Problems: Fussiness (up to 1 child in 3); tiredness or poor 
appetite (up to 1 child in 10); vomiting (up to 1 child in 50); 
swelling of the entire arm or leg for 1-7 days (up to 1 child in 30)--
usually after the 4th or 5th dose.
    Moderate Problems: Seizure (1 child in 14,000); non-stop crying for 
3 hours or longer (up to 1 child in 1,000); fever over 105 [deg]F (1 
child in 16,000).
    Serious problems: Long term seizures, coma, lowered consciousness, 
and permanent brain damage have been reported. These are so rare it is 
hard to tell if they are caused by the vaccine.

Polio Vaccine/Hepatitis B Vaccine/Hib Vaccine

    These vaccines have not been associated with mild problems other 
than local reactions. These vaccines have not been associated with 
problems other than mild local reactions.

Pneumococcal Vaccine

    Mild Problems: During studies of the vaccine, some children became 
fussy or drowsy or lost their appetite.

Rotavirus Vaccine

    Mild Problems: Children who get rotavirus vaccine are slightly more

[[Page 82405]]

likely than other children to be irritable or to have mild, temporary 
diarrhea or vomiting. This happens within the first week after getting 
a dose of the vaccine.
    Serious Problems: Some studies have shown a small increase in cases 
of intussusception during the week after the first dose. 
Intussusception is a type of bowel blockage that is treated in a 
hospital. In some cases surgery might be required. The estimated risk 
is 1 case per 100,000 infants.

What if my child has 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 doctor 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.

The National Vaccine Injury Compensation Program

    The National Vaccine Injury Compensation Program (VICP) was created 
in 1986.
    People who believe they may have been injured by a vaccine can 
learn about the program and about filing a claim by calling 1-800-338-
2382, or visiting the VICP Web site at http://www.hrsa.gov/vaccinecompensation.

For More Information

    <bullet> Ask your doctor. They can give you the vaccine package 
insert or suggest other sources of information.
    <bullet> Call your local or state health department.
    <bullet> 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
(00/00/0000) (Proposed)
42 U.S.C. 300aa-26

    Dated: December 21, 2010.
Tanja Popovic,
Deputy Associate Director for Science, Centers for Disease Control and 
Prevention (CDC).
[FR Doc. 2010-32965 Filed 12-29-10; 8:45 am]
BILLING CODE 4163-18-P