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Vaccines > Pneumococcal
PCV7
Vaccine
(Pneumococcal
Conjugate)
Questions
and answers for parents, health care professionals, and people
considering immunization
Questions and links to
answers:
- How will this vaccine affect the Vaccines for Children program?
- Will all children be able to receive this vaccine?
- Is this vaccine safe?
- Has the vaccine been linked to any serious condition at all?
- How was the safety of this vaccine evaluated?
- Can I wait until my child is a year old
to reduce number of shots?
- Does this vaccine contain mercury?
- Is this vaccine currently available?
- How will the vaccine be made available in the public sector?
- Will there be adequate supply?
- How will this vaccine affect
the Vaccines for Children program?
The vaccines for children program covers the cost of vaccinating the poorest children in society. VFC coverage for this vaccine would occur after the ACIP adopts a resolution for such coverage and after a federal contract for vaccine has been signed. Because VFC is an "entitlement," all vaccine costs will be covered. In contrast, support for vaccinations provided by State health departments to children not eligible for VFC but who still lack health care coverage requires Congressionally appropriated funding for the 317 grant program. Full implementation of pneumococcal conjugate vaccine in this population will not occur without additional support.
- Will all children be able to receive this vaccine?
Pneumococcal conjugate vaccination is recommended for all children <24 months old and for children between 24 and 59 months old who are at highest risk of disease. Children who have private health care coverage through insurance or under managed care would have the costs of vaccination covered through that system. For the poorest children, coverage would occur under the Vaccines For Children program. Children who are not in either of these groups could be vaccinated at clinics supported by State immunization programs, funded by the 317 grant program. In each of these settings, limitations on vaccination would not occur because of race but might occur if health care payers were unwilling to reimburse for vaccine; if signing of a federal vaccine contract were delayed; or if insufficient 317 grant funding were available. Recognizing that there may be some financial constraints, CDC will assure that health care providers are aware of the groups that will benefit most from prevention of pneumococcal disease.
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- Is this vaccine safe?
The safety of this vaccine was extensively tested in more than 18,000 children before being licensed the FDA as safe and effective. Most common side effects were local reactions at
the site of the injection such as redness or soreness. These occurred in between 1 and 3 of every 10 vaccine recipients (10% - 30%); these reactions were generally mild and one study reported that only about 3 to 6 of every 100 children (3% - 6%) had local reactions that interfered with
leg movement.
Fevers caused specifically by pneumococcal conjugate vaccination were more difficult to assess because children generally received more than one vaccine. By comparing different groups of children, fever attributable to this vaccine may have occurred in between 5 and 15 per 100 children (5% - 15%). As with all vaccines, allergic reactions to vaccination components may occur rarely. Most fevers are low grade and resolve within one day. Several children had seizures associated with fever following vaccination.
No serious adverse events were felt to be associated with vaccination. Rates of Sudden Infant Death Syndrome (SIDS) were the same in children who did and did not receive the pneumococcal conjugate vaccine.
Ongoing surveillance for vaccine associated adverse events will be conducted by the CDC and FDA using the Vaccine Adverse Events Reporting System as well as by the vaccine
manufacturer. Any adverse events can be reported by health care providers or patients to VAERS at 1-800-822-7967.
- Has the vaccine been linked to any serious condition at all?
No. There is no scientific evidence to suggest that this vaccine causes any serious adverse effects on children. Some groups have suggested it can cause diabetes, but several scientific studies have failed to show a relationship between this vaccine and an increased risk of diabetes. In fact there is no proven scientific evidence to show a link between any vaccine and diabetes.
A considerable body of scientific evidence finds this vaccine to be safe and effective against a very serious pathogen. Unfounded claims can cause harm to children if they result in less protection for them against potentially serious diseases.
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- How was the safety of this vaccine evaluated?
The safety of the vaccine was
extensively evaluated. The safety surveillance was done with
telephone interviews at 48 hours and 14 days after each dose
of vaccine on two subsets of the population, one receiving
DTP and the other receiving DTaP concurrently. Surveillance
for rare events was accomplished by using automated data for
all ER and hospital visits as well as identified clinical
diagnoses in all children. Over 1200 comparisons were made
at different time intervals between vaccine recipients and
controls. Controls were either recipients of the meningococcal
vaccine or were a historically matched comparison group receiving
neither pneumococcal nor meningococcal vaccines.
- Can I (safely) wait until my child is a year old in order to reduce the number of shots?
Because the risk of invasive pneumococcal disease is greatest for children less than a year of age, the greatest advantage in disease prevention can be obtained by vaccinating the children at 2, 4 and 6 months of age. It is not safe to wait until the child is one year old.
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- Does this vaccine contain mercury?
No.
- Is this vaccine currently available (in private sector? in public sector?)
This vaccine is already available in the private and public sectors. The 7 valent pneumococcal conjugate vaccine was marketed by Wyeth-Lederle (W-L) to private health care providers, and to the public health care sector as well if they wish to use state or local funding, almost immediately following licensure on February 17, 2000. The CDC has been in negotiations but has not yet concluded a contract for the purchase of the pneumococcal conjugate vaccine. CDC anticipates establishing a contract soon after the Advisory Committee on Immunization Practices passes a resolution for coverage through the Vaccines for Children (VFC) program.
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- How will the vaccine be made available in the public sector?
CDC is currently negotiationing with W-L for the establishment of a contract for the purchase of pediatric pneumococcal vaccine. At that point the 64 immunization projects can place orders through the National Immunization Program's electronic ordering system, known as VACMAN, to W-L for the purchase and delivery of this vaccine.
- Will there be adequate supply?
The manufacturer, Wyeth-Lederle Vaccines and Pediatrics has indicated that they will have a sufficient supply of this product to meet the national need.
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