Pneumococcal Conjugate Vaccine: What You Need to Know 1. Why get vaccinated? Infection with Streptococcus pneumoniae bacteria can cause serious illness and death. Invasive pneumococcal disease is responsible for about 200 deaths each year among children under 5 years old. It is the leading cause of bacterial meningitis in the United States. (Meningitis is an infection of the covering of the brain). Each year pneumococcal infection causes severe disease in children under five years old, Before a vaccine was available, pneumococcal infection each year caused: - over 700 cases of meningitis - 13,000 blood infections, and - about 5 million ear infections It can also lead to other health problems, including: - pneumonia, - deafness, - brain damage. Children under 2 years old are at highest risk for serious disease. Pneumococcus bacteria are spread from person to person through close contact. Pneumococcal infections can be hard to treat because the bacteria have become resistant to some of the drugs that have been used to treat them. This makes prevention of pneumococcal infections even more important. Pneumococcal conjugate vaccine can help prevent serious pneumococcal disease, such as meningitis and blood infections. It can also prevent some ear infections. But ear infections have many causes, and pneumococcal vaccine is effective against only some of them. 2. Pneumococcal conjugate vaccine Pneumococcal conjugate vaccine is approved for infants and toddlers. Children who are vaccinated when they are infants will be protected when they are at greatest risk for serious disease. Some older children and adults may get a different vaccine called pneumococcal polysaccharide vaccine. There is a separate Vaccine Information Statement for people getting this vaccine. 3. Who should get the vaccine and when? Children under 2 years of age: - 2 months - 4 months - 6 months - 12 to 15 months Children who weren't vaccinated at these ages can still get the vaccine. The number of doses needed depends on the child's age. Ask your health care provider for details. Children between 2 and 5 years of age: Pneumococcal conjugate vaccine is also recommended for children between 2 and 5 years old who have not already gotten the vaccine and are at high risk of serious pneumococcal disease. This includes children who: - have sickle cell disease, - have a damaged spleen or no spleen, - have HIV/AIDS, - have other diseases that affect the immune system, such as diabetes, cancer, or liver disease, or who - take medications that affect the immune system, such as chemotherapy or steroids, or - have chronic heart or lung disease. The vaccine should be considered for all other children under age 5 years, especially those at higher risk of serious pneumococcal disease. This includes children who: - are under 3 years of age, - are of Alaska Native, American Indian or African American descent, or - attend group day care. The number of doses needed depends on the child's age. Ask your health care provider for more details. Pneumococcal conjugate vaccine may be given at the same time as other vaccines. 4. Some children should not get pneumococcal conjugate vaccine or should wait. Children should not get pneumococcal conjugate vaccine if they had a severe (life-threatening) allergic reaction to a previous dose of this vaccine, or have a severe allergy to a vaccine component. Tell your health-care provider if your child has ever had a severe reaction to any vaccine, or 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 pneumococcal conjugate vaccine? In studies (nearly 60,000 doses), pneumococcal conjugate vaccine was associated with only mild reactions: Up to about 1 infant out of 4 had redness, tenderness, or swelling where the shot was given. Up to about 1 out of 3 had a fever of over 100.4 degrees Fahrenheit, and up to about 1 in 50 had a higher fever (over 102.2 degrees Fahrenheit). Some children also became fussy or drowsy, or had a loss of appetite. So far, no moderate or severe reactions have been associated with this vaccine. However, a vaccine, like any medicine, could cause serious problems, such as a severe allergic reaction. The risk of this vaccine causing serious harm, or death, is extremely small. 6. 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 occur, it would most likely be within a few minutes to a few hours after the shot. Signs can include: - difficulty breathing - hoarseness or wheezing - hives - paleness - weakness - a fast heart beat - dizziness - swelling of the throat What should I do? Call a doctor or get the person to a doctor right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your health care provider to file a Vaccine Adverse Event Reporting System (VAERS) form. Or call VAERS yourself at 1-800-822-7967, or visit their web site at http://www.vaers.org. 7. The Vaccine Injury Compensation Program In the rare event that you or your child has a serious reaction to a vaccine, a federal program has been created to help pay for the care of those who have been harmed. For details about the National Vaccine Injury Compensation Program, call 1- 800-338-2382 or visit their website at http://www.hrsa.gov/osp/vicp 8. How can I learn more? Ask your health care provider. They can give you the vaccine package insert or suggest other sources of information. Call your local or state health department's immunization program. Contact the Centers for Disease Control and Prevention (CDC): - Call 1-800-232-2522 (English) - Call 1-800-232-0233 (Espanol) - Visit the National Immunization Program's website at http://www.cdc.gov/nip U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES Centers for Disease Control and Prevention National Immunization Program Vaccine Information Statement Pneumococcal Conjugate Vaccine September 30, 2002 42 U.S.C. Section 300aa-26