[Federal Register: October 4, 2007 (Volume 72, Number 192)]
[Notices]
[Page 56765-56767]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc07-62]
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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 would be 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
December 3, 2007.
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, N.E., Atlanta, Georgia 30333.
FOR FURTHER INFORMATION CONTACT: Anne Schuchat, M.D., Director,
National Center for Immunization and Respiratory Diseases, Mailstop E-
05, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone (404)
639-8200.
SUPPLEMENTARY INFORMATION: The National Childhood Vaccine Injury Act of
1986 (Pub. L. 99-660), as amended by section 708 of Public Law 103-183,
added section 2126 to the Public Health Service Act. Section 2126,
codified at 42 U.S.C. 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 the CDC Web site at: http://www.cdc.gov/vaccines/pubs/vis.
In addition, single camera-ready copies are
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 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. CDC is proposing an
alternative consolidated Vaccine Information Statement covering those
six vaccines in one document, which providers could choose to use
instead of the existing individual Vaccine Information Statements for
the same vaccines.
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. When the final consolidated
VIS is published in the Federal Register, the instructions for use of
vaccine information materials will be revised to note that this
alternative consolidated VIS can be used in lieu of the individual
vaccine VISs.
* * * * *
Proposed Multi-vaccine Vaccine Information Statement
YOUR BABY'S FIRST VACCINES: WHAT YOU NEED TO KNOW
Babies are scheduled for six vaccines at 2, 4, and 6 months of age.
One of these (hepatitis B) is usually given at birth.
[[Page 56766]]
These vaccines protect your baby from 8 serious diseases (see the
next page).
Your baby will be getting these vaccines today (check):
[cir] DTaP
[cir] Hib
[cir] Polio
[cir] Pneumococcal
[cir] Hepatitis B
[cir] Rotavirus
Some of these vaccines might be given in the same shot (for
example, Hepatitis B and Hib, or DTaP, Polio and Hepatitis B). These
``combination vaccines'' are as safe and effective as the individual
vaccines, and mean fewer shots for your baby.
These vaccines may all be given at the same visit. Getting several
shots at the same time does not increase the risk to your baby.
This ``Vaccine Information Statement'' tells you about the benefits
and risks of these 6 vaccines. It also contains information about
reporting an adverse reaction, the National Vaccine Injury Compensation
Program, and how to get more information about childhood diseases and
vaccines.
Please read this statement before your child gets his or her
immunizations, and take it home with you afterward. Ask your doctor,
nurse, or other healthcare provider if you have questions.
Department of Health and Human Services, Centers for Disease
Control and Prevention, Vaccine Information Statement, 42 U.S.C. 300aa-
26, X/X/2007.
Vaccine Benefits: Why get vaccinated?
Your baby's first vaccines protect them from 8 serious diseases,
caused by viruses and bacteria. These diseases have injured and killed
many children (and adults) over the years. Polio paralyzed about 37,000
people and killed about 1,700 each year in the 1950s before there was a
vaccine. In the 1980s, Hib disease was 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 had
at least one rotavirus infection by their 5th birthday. Most of these
diseases are not very common in the U.S. today. But if we stopped
vaccinating, they would come back. This has happened in other parts of
the world.
8 Serious Diseases
Diphtheria Bacteria
You can get it from contact with an infected person, mainly through
the air.
Signs and symptoms include a thick covering in the back of the
throat.
It can lead to breathing problems, heart failure, and death.
Tetanus (Lockjaw) Bacteria
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, so the victim cannot open his
mouth or swallow. It leads to death in about 1 case out of 10.
Pertussis (Whooping Cough) Bacteria
You can get it from contact with an infected person, mainly through
the air.
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 (jerking and staring spells),
brain damage, and death.
Hib (Haemophilus influenzae type b) Bacteria
You can get it from contact with an infected person, mainly through
the air.
Signs and symptoms. There may be no 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.
Hepatitis B Virus
You can get it from contact with 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. Adults can get it from unprotected sex,
sharing needles, or other exposures to blood.
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.
Polio Virus
You can get it from close contact with an infected person. It
enters the body through the mouth.
Signs and symptoms can include a cold-like illness, or there may be
no signs or symptoms at all.
It can lead to paralysis (can't move arm or leg), or death (by
paralyzing breathing muscles).
Pneumococcal Bacteria
You can get it from contact with an infected person, mainly through
the air.
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.
Rotavirus Virus
You can get it from contact with other children who are infected.
Signs and symptoms include severe diarrhea, vomiting and fever.
It can lead to dehydration, hospitalization (up to about 70,000
children a year), and death.
How Vaccines Work
A child who gets sick with one of these diseases becomes immune to
that disease, and won't get it again. But getting the disease the first
time can be dangerous. That's why vaccines are a better way to create
immunity.
Vaccines are made with the same bacteria or viruses that cause the
disease, but they have been weakened or killed to make them safe.
Vaccines fool the immune system into thinking a child has the disease.
The child becomes immune without having to get sick first.
Routine Childhood Vaccines
These 6 vaccines are routinely given to children under 6 months of
age. Children will also get at least one ``booster'' dose of most of
these vaccines when they are older.
DTaP (Diphtheria, Tetanus & Pertussis) Vaccine: 5 doses--2
months, 4 months, 6 months, 15-18 months, 4-6 years. Some children
should not get pertussis vaccine. These children can get a vaccine
called DT, which does not contain pertussis vaccine.
Hepatitis B vaccine: 3 doses--Birth, 1-2 months, 6-18
months.
Polio Vaccine: 4 doses--2 months, 4 months, 6-18 months,
4-6 years.
Hib (Haemophilus influenzae type b) Vaccine: 4 doses--2
months, 4 months, 6 months, 12-15 months. Several Hib vaccines are
available. With one type, the 6-month dose is not needed.
Pneumococcal Vaccine: 4 doses--2 months, 4 months, 6
months, 12-15 months. Older children with certain chronic diseases may
also need this vaccine.
Rotavirus Vaccine: 3 doses--2 months, 4 months, 6 months.
Rotavirus is an oral (swallowed) vaccine, not a shot.
Vaccine Risks
Like any medicine, vaccines can cause side effects. Most of these
are mild ``local reactions'' such as tenderness, redness or swelling
where
[[Page 56767]]
the shot is given, or a mild fever. These reactions are part of the
body's natural immune response. They can occur in up to 1 child out of
4 for most childhood vaccines. They appear soon after the shot is given
and go away within a day or two. These do not occur with rotavirus
vaccine, since it is not injected.
More severe side effects can occur, but much less often. Some of
them occur so rarely that experts can't tell whether they are caused by
vaccines or not.
Among the most serious reactions to vaccines are severe allergic
reactions to a substance in a vaccine. These reactions are very rare--
less than one in a million shots. Usually they occur very soon after
the shot is given. Doctor's office or clinic staff are trained to deal
with them. The risk of any vaccine causing serious harm, or death, is
extremely small. Getting a disease is much more likely to cause harm
than getting a vaccine.
The following conditions (in addition to local reactions and mild
fever) have been associated with routine childhood vaccines. By
``associated'' we mean that they are reported after vaccinations more
often than would be expected to occur by chance. This does not
``prove'' that the vaccine causes the reaction, but suggests that it is
likely.
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 (jerking or staring) (1 child in
14,000); Non-stop crying for 3 hours or more (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 very rarely after DTaP
vaccine. They are so rare it is not possible to tell if they are caused
by the vaccine.
Polio Vaccine/Hepatitis B Vaccine/Hib Vaccine
These vaccines have not been associated with moderate or serious
problems.
Pneumococcal Vaccine
Mild Problems: During studies of the vaccine, some children became
fussy or drowsy or lost their appetite.
Rotavirus Vaccine
Mild Problems: Children are slightly (1-3%) more likely to have
mild, temporary diarrhea or vomiting within a week after getting a dose
of rotavirus vaccine than children who have not gotten the vaccine. No
moderate or severe problems have been associated with the vaccine.
Check With Your Doctor * * *
Most children can get all childhood vaccines, but some children
should not. Sometimes a child should wait until after the recommended
age before getting vaccinated.
If your child is sick on the date vaccinations are scheduled, ask
your doctor about delaying them. A child with a mild cold or other
illness, or a low fever, can usually be vaccinated. But with more
serious illnesses, the doctor might want to wait until the child
recovers.
The doctor might recommend that some children not get a specific
vaccine. This includes any child who had a life-threatening reaction to
a previous dose of the vaccine, or has a life-threatening allergy to
any vaccine component. Other reasons not to get a specific vaccine
include if the child has/had:
DTaP Vaccine
--A brain or nervous system disease within 7 days after a previous dose
of DTaP.
--A seizure or collapse after a previous dose of DTaP.
--Non-stop crying for 3 hours or more after a previous dose of DTaP.
--A fever over 105[deg]F after a previous dose of DTaP.
Polio Vaccine
--A life-threatening allergy to the antibiotics neomycin, streptomycin,
or polymyxin B.
Hepatitis B Vaccine
--A life-threatening allergy to baker's yeast (the kind used for making
bread).
Rotavirus Vaccine
--A child who has had intussusception (an uncommon type of bowel
obstruction) should usually not be given rotavirus vaccine. (This is
simply a precaution. An older type of rotavirus vaccine, which is no
longer used, was associated with several cases of intussusception.
Today's vaccine has not been. But children who have had this condition
are at increased risk of getting it again.)
What if there is a moderate or severe reaction?
What should I look for?
Look for any unusual condition, such as a serious allergic
reaction, high fever, or unusual behavior.
Serious allergic reactions are extremely rare with any vaccine. If
one were to happen, it would most likely come within a few minutes to a
few hours after the shot.
Signs of a serious allergic reaction can include:
--difficulty breathing
--weakness
--hives
--hoarseness or wheezing
--dizziness
--paleness
--swelling of the throat
--fast heart beat
What should I do?
Call a doctor, or get the child to a doctor right away.
Tell your doctor what happened, the date and time it happened, and
when the shot was given.
Ask your doctor, nurse, or health department to report the reaction
by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you
can file this report through the VAERS website at http://www.vaers.org,
or by calling 1-800-822-7967.
VAERS does not provide medical advice.
The National Vaccine Injury Compensation Program
In the unlikely event that your child has a serious reaction to a
vaccine, a federal program exists to help pay for the care of those who
have been harmed. For information about the National Vaccine Injury
Compensation Program, call 1-800-338-2382 or visit their website at
http://www.hrsa.gov/vaccinecompensation.
For More Information
Ask your doctor or nurse. 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) at 1-
800-232-4636 (1-800-CDC-INFO).
Visit CDC Web sites at: http://www.cdc.gov/vaccines and http://www
.cdc.gov/ncidod/diseases/hepatitis.
Dated: September 26, 2007.
James D. Seligman,
Chief Information Officer, Centers for Disease Control and Prevention
(CDC).
[FR Doc. E7-19615 Filed 10-3-07; 8:45 am]
BILLING CODE 4163-18-P