• Pneumococcal Conjugate Vaccine (PCV7)

    IMPORTANT WARNING:

    Pneumococcal conjugate vaccine (PCV7) is no longer available in the U.S. Pneumococcal conjugate vaccine (PCV13) will replace this vaccine.

    What is pneumococcal disease?

    Infection with Streptococcus pneumoniae bacteria can make children very sick. It causes blood infections, pneumonia, and bacterial meningitis, mostly in young children. (Meningitis is an infection of the covering of the brain.) Pneumococcal meningitis kills about 3 people in 10 who get it. Pneumococcal meningitis can also lead to other health problems, including deafness and brain damage. Before there was a vaccine, pneumococcal infection caused over 700 cases of meningitis, 13,000 blood infections, about 5 million ear infections, and about 200 deaths every year in the United States in children under five. Children younger than 2 years of age are at highest risk for serious disease. Pneumococcal bacteria are spread from person to person through close contact. Pneumococcal infections can be hard to treat because some strains of the bacteria have become resistant to the drugs that have been used to treat them. This makes prevention of pneumococcal infections, through vaccination, even more important.

    Why get vaccinated with pneumococcal conjugate vaccine (PCV7)?

    There are 91 strains of pneumococcal bacteria. Pneumococcal conjugate vaccine (PCV) protects against 7 of them. These 7 strains are responsible for most severe pneumococcal infections among children. Since PCV came into use, severe pneumococcal disease has dropped by nearly 80% among children under 5. PCV can also prevent some cases of pneumonia and some ear infections. But pneumonia and ear infections have many causes, and PCV only works against those caused by pneumococcal bacteria. PCV is given to infants and toddlers to protect them when they are at greatest risk for serious diseases caused by pneumococcal bacteria. Older children and adults with certain chronic illnesses may get a different vaccine called pneumococcal polysaccharide vaccine. There is a separate Vaccine Information Statement for that vaccine.

    Who should get PCV7, and when?

    Infants and Children Under 2 Years of Age:

    PCV is routinely given as a series of 4 doses, one dose at each of these ages: 2 months, 4 months, 6 months, and 12-15 months. Children who miss their shots at these ages should still get the vaccine. The number of doses and the intervals between doses will depend on the child's age. Ask your health care provider for details.

    Children 2 through 4 Years of Age:

    Healthy children between their 2nd and 5th birthdays who have not completed the PCV series should get 1 dose. Children with medical conditions such as sickle cell disease, a damaged spleen or no spleen, cochlear implants, HIV/AIDS or other diseases that affect the immune system (such as diabetes, cancer, or liver disease), or chronic heart or lung disease or children who take medications that affect the immune system (such as chemotherapy or steroids) should get 1 or 2 doses of PCV, if they have not already completed the 4-dose series. Ask your health care provider for details.
    PCV may be given at the same time as other vaccines.

    Which children should not get PCV7 or should wait?

    Children should not get pneumococcal conjugate vaccine if they had a serious (life-threatening) allergic reaction to a previous dose of this vaccine, or if they have a severe allergy to any 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.

    What are the risks from PCV7?

    Any medicine, including a vaccine, could possibly cause a serious problem, such as a severe allergic reaction. However, the risk of any vaccine causing serious harm, or death, is extremely small.
    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 greater than 100.4 °F (38 °C), and up to about 1 in 50 had a higher fever (over 102.2 °F (39 °C)).
    • Some children also became fussy or drowsy, or had a loss of appetite.
    No serious reactions have been associated with this vaccine.
    Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination.

    What if there is 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 diffi culty 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 provider 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.hhs.gov , or by calling 1-800-822-7967.
    VAERS does not provide medical advice.

    The National Vaccine Injury Compensation Program

    A federal program exists to help pay for the care of anyone who has a serious reaction to a vaccine.
    For more information about the National Vaccine Injury Compensation Program, call 1-800-338-2382 or visit their website at http://www.hrsa.gov/vaccinecompensation .

    How can I learn more?

    • Ask your provider. 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): Call 1-800-232-4636 (1-800-CDC-INFO) or visit CDC's website at http://www.cdc.gov/vaccines .
    Pneumococcal Conjugate Vaccine Information Statement. U.S. Department of Health and Human Services/Centers for Disease Control and Prevention National Immunization Program. 12/9/2008.

    Brand Names

    • Prevnar®

    Other Names

    • PCV7

    Pneumococcal Conjugate Vaccine (PCV13)

    Why get vaccinated?

    Infection with Streptococcus pneumoniae bacteria can make children very sick. It causes blood infections, pneumonia, and bacterial meningitis, mostly in young children. (Meningitis is an infection of the covering of the brain.) Although pneumococcal meningitis is relatively rare (less than 1 case per 100,000 people each year), it is fatal in about 1 of 10 cases in children. Pneumococcal meningitis can also lead to other health problems, including deafness and brain damage. Before routine use of pneumococcal conjugate vaccine, pneumococcal infections caused over 700 cases of meningitis, 13,000 blood infections, about 5 million ear infections, and about 200 deaths annually in the United States in children under five. Children younger than 2 years of age are at higher risk for serious disease than older children. Pneumococcal bacteria are spread from person to person through close contact. Pneumococcal infections may be hard to treat because some strains of the bacteria have become resistant to the drugs that are used to treat them. This makes prevention of pneumococcal infections through vaccination even more important.

    Pneumococcal conjugate vaccine

    There are more than 90 types of pneumococcal bacteria. The new pneumococcal conjugate vaccine (PCV13) protects against 13 of them. These bacteria types are responsible for most severe pneumococcal infections among children. PCV13 replaces a previous conjugate vaccine (PCV7), which protected against seven pneumococcal types and has been in use since 2000. During that time severe pneumococcal disease dropped by nearly 80% among children under 5. PCV13 may also prevent some cases of pneumonia and some ear infections. But pneumonia and ear infections have many causes, and PCV13 only works against the types of pneumococcal bacteria targeted by the vaccine. PCV13 is given to infants and toddlers, to protect them when they are at greatest risk for serious diseases caused by pneumococcal bacteria. In addition to receiving PCV13, older children with certain chronic illnesses may get a different vaccine called PPSV23. There is a separate Vaccine Information Statement for that vaccine.

    Who should get the vaccine and when?

    Infants and Children Under 2 Years of Age:

    PCV13 is recommended as a series of four doses, one dose at each of these ages: 2 months, 4 months, 6 months, and 12-15 months. Children who miss their shots at these ages should still get the vaccine. The number of doses and the intervals between doses will depend on the child's age. Ask your health care provider for details. Children who have begun their immunization series with PCV7 should complete the series with PCV13.

    Children 2 through 4 Years of Age:

    Healthy children between their 2nd and 5th birthdays who have not completed the PCV7 or PCV13 series before age 2 years should get one dose. Children with medical conditions such as sickle cell disease, a damaged spleen or no spleen, cochlear implants, HIV/AIDS or other diseases that affect the immune system (such as diabetes, cancer, or liver disease), chronic heart or lung disease, or children who take medications that affect the immune system, such as immunosuppressive drugs or steroids, should get one dose of PCV 13 (if they received three doses of PCV7 or PCV13 before age 2 years), or two doses of PCV13 (if they have received two or fewer doses of PCV7 or PCV13).
    A dose of PCV13 may be administered to children and adolescents 6-18 years of age who have certain medical conditions, even if they have previously received PCV7 or PPSV23.

    Children who have completed the four-dose series with PCV7:

    Healthy children who have not yet turned 5, and children with medical conditions who have not yet turned 6, should get one additional dose of PCV13.
    Ask your health care provider if you have questions about any of these recommendations.
    PCV13 may be given at the same time as other vaccines.

    Which children should not get pneumococcal conjugate vaccine?

    Children should not get PCV13 if they had a serious (life-threatening) allergic reaction to a previous dose of this vaccine, to PCV7, or to any vaccine containing diphtheria toxoid (for example, DTaP). Children who are known to have a severe allergy to any component of PCV7 or PCV13 should not get PCV13. Tell your health care provider if your child 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.

    What are the risks from pneumococcal conjugate vaccine?

    Any medicine, including a vaccine, could possibly cause a serious problem, such as a severe allergic reaction. However, the risk of any vaccine causing serious harm, or death, is extremely small.
    In studies, most reactions after PCV13 were mild. They were similar to reactions reported after PCV7, which has been in use since 2000. Reported reactions varied by dose and age, but on average:
    • About half of children were drowsy after the shot, had a temporary loss of appetite, or had redness or tenderness where the shot was given.
    • About 1 out of 3 had swelling where the shot was given.
    • About 1 out of 3 had a mild fever, and about 1 in 20 had a higher fever (over 102.2 °F (39 °C)).
    • Up to about 8 out of 10 became fussy or irritable.
    Life-threatening allergic reactions from vaccines are very rare. If they do occur, it would be within a few minutes to a few hours after the vaccination.

    What if there is a moderate or 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 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 if you have any reaction to the vaccine. Or call VAERS yourself at 1-800-822-7967, or visit their website at http://vaers.hhs.gov . VAERS does not provide medical advice.

    The National Vaccine Injury Compensation Program

    The National Vaccine Injury Compensation Program (VICP) was created in 1986.
    Persons who believe they may have been injured by a vaccine may file a claim with VICP by calling 1-800-338-2382 or visiting their website at http://www.hrsa.gov/vaccinecompensation .

    How can I learn more?

    • Ask your 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 1-800-232-4636 (1-800-CDC-INFO) or visit the National Immunization Program's website at http://www.cdc.gov/vaccines .
    Pneumococcal Conjugate Vaccine (PCV13) Information Statement. U.S. Department of Health and Human Services/Centers for Disease Control and Prevention National Immunization Program. 4/16/2010.

    Brand Names

    • Prevnar 13®

    Other Names

    • PCV13
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