Vaccines and Preventable Diseases:
PCV7 (Pneumococcal Conjugate) Vaccine
(Prevnar®)
Questions and answers for parents, health care professionals, and people considering immunization
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 has been 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.
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.
Does this vaccine contain mercury?
No.
Is this vaccine currently available (in private sector or in the public sector?)
This vaccine is available in the private and public sectors.
Return to main Pneumococcal Vaccination page
Content last reviewed on April 9, 2007
Content Source: National Center for Immunization and Respiratory Diseases