Vaccine Information Statement: PNEUMOCOCCAL CONJUGATE VACCINE

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1 Vaccine Infrmatin Statement: PNEUMOCOCCAL CONJUGATE VACCINE Many Vaccine Infrmatin Statements are available in Spanish and ther languages. See Hjas de Infrmacián Sbre Vacunas están dispnibles en españl y en muchs trs idimas. Visite 1. Pneumcccal Disease Infectin with Streptcccus pneumniae bacteria can make children very sick. It causes bld infectins, pneumnia, and meningitis, mstly in yung children. (Meningitis is an infectin f the cvering f the brain.) Althugh pneumcccal meningitis is relatively rare (less than 1 case per 100,000 peple each year) it is fatal in abut 1 f 10 cases in children. Pneumcccal meningitis can als lead t ther health prblems, including deafness and brain damage. Befre rutine use f pneumcccal cnjugate vaccine, pneumcccal infectins caused: ver 700 cases f meningitis, 13,000 bld infectins, abut 5 millin ear infectins, and abut 200 deaths annually in the United States in children under five. Children yunger than 2 years f age are at higher risk fr serius disease than lder children. Pneumcccal bacteria are spread frm persn t persn thrugh clse cntact. Pneumcccal infectins may be hard t treat because sme strains f the bacteria have becme resistant t the drugs that are used t treat them. This makes preventin f pneumcccal infectins thrugh vaccinatin even mre imprtant. Vaccine Infrmatin Statement (Interim); PCV13; (4/16/2010); 42 U.S.C. 300aa-26; Department f Health and Human Services; Centers fr Disease Cntrl and Preventin; Page 1 f 5

2 2. Pneumcccal cnjugate vaccine (PCV13) There are mre than 90 types f pneumcccal bacteria. The new pneumcccal cnjugate vaccine (PCV13) prtects against 13 f them. These bacteria types are respnsible fr mst severe pneumcccal infectins amng children. PCV13 replaces a previus cnjugate vaccine (PCV7), which prtected against 7 pneumcccal types and has been in use since During that time severe pneumcccal disease has drpped by nearly 80% amng children under 5. PCV13 may als prevent sme cases f pneumnia and sme ear infectins. But pneumnia and ear infectins have many causes, and PCV13 nly wrks against the types f pneumcccal bacteria targeted by the vaccine. PCV is given t infants and tddlers, t prtect them when they are at greatest risk fr serius diseases caused by pneumcccal bacteria. In additin t receiving PCV13, lder children with certain chrnic illnesses may get a different vaccine called PPSV23. There is a separate Vaccine Infrmatin Statement fr that vaccine. 3. Wh shuld get PCV13 vaccine and when? Infants and Children Under 2 Years f Age PCV13 is recmmended as a series f 4 dses, ne dse at each f these ages: 2 mnths, 4 mnths, 6 mnths, and 12 thrugh 15 mnths. Children wh miss their shts at these ages shuld still get the vaccine. The number f dses and the intervals between dses will depend n the child s age. Ask yur health care prvider fr details. Children wh have begun their immunizatin series with PCV7 shuld cmplete the series with PCV13. Older Children and Adlescents Healthy children between their 2nd and 5th birthdays wh have nt cmpleted the PCV7 r PCV13 series befre age 2 years shuld get 1 dse. Children between the 2 nd and 6 th birthdays with medical cnditins such as: Vaccine Infrmatin Statement (Interim); PCV13; (4/16/2010); 42 U.S.C. 300aa-26; Department f Health and Human Services; Centers fr Disease Cntrl and Preventin; Page 2 f 5

3 sickle cell disease, a damaged spleen r n spleen, cchlear implants, diabetes, HIV/AIDS r ther diseases that affect the immune system (such as cancer, r liver disease), r chrnic heart r lung disease r wh take medicatins that affect the immune system, such as immunsuppressive drugs r sterids, shuld get 1 dse f PCV13 (if they received 3 dses f PCV7 r PCV13 befre age 2 years), r 2 dses f PCV13 (if they have received 2 r fewer dses f PCV7 r PCV13). A dse f PCV13 may be administered t children and adlescents 6 thrugh 18 years f age wh have certain medical cnditins, even if they have previusly received PCV7 r PPSV23. Children wh have cmpleted the 4-dse series with PCV7: Healthy children wh have nt yet turned 5, and children with medical cnditins wh have nt yet turned 6, shuld get ne additinal dse f PCV13. Ask yur health care prvider if yu have any questins abut any f these recmmendatins. PCV13 may be given at the same time as ther vaccines. 4. Sme children shuld nt get PCV13 r shuld wait Children shuld nt get PCV13 if they had a serius (life-threatening) allergic reactin t a previus dse f this vaccine, t PCV7, r t any vaccine cntaining diphtheria txid (fr example DTaP). Children wh are knwn t have a severe allergy t any cmpnent f PCV7 r PCV13 shuld nt get PCV13. Tell yur health care prvider if yur child has any severe allergies. Children with minr illnesses, such as a cld, may be vaccinated. But children wh are mderately r severely ill shuld usually wait until they recver befre getting the vaccine. Vaccine Infrmatin Statement (Interim); PCV13; (4/16/2010); 42 U.S.C. 300aa-26; Department f Health and Human Services; Centers fr Disease Cntrl and Preventin; Page 3 f 5

4 5. What are the risks frm PCV13? Any medicine, including a vaccine, culd pssibly cause a serius prblem, such as a severe allergic reactin. Hwever, the risk f any vaccine causing serius harm, r death, is extremely small. In studies, mst reactins after PCV13 were mild. They were similar t reactins reprted after PCV7, which has been in use since Reprted reactins varied by dse and age, but n average: Abut half f children were drwsy after the sht, had a temprary lss f appetite, r had redness r tenderness where the sht was given. Abut 1 ut f 3 had swelling where the sht was given. Abut 1 ut f 3 had a mild fever, and abut 1 in 20 had a higher fever (ver F). Up t abut 8 ut f 10 became fussy r irritable. Life-threatening allergic reactins frm vaccines are very rare. If they d ccur, it wuld be within a few minutes t a few hurs after the vaccinatin. 6. What if there is a severe reactin? What shuld I lk fr? Any unusual cnditin, such as a high fever r behavir changes. Signs f a severe allergic reactin can include difficulty breathing, harseness r wheezing, hives, paleness, weakness, a fast heart beat r dizziness. What shuld I d? Call a dctr, r get the persn t a dctr right away. Tell the dctr what happened, the date and time it happened, and when the vaccinatin was given. Ask yur prvider t reprt the reactin by filing a Vaccine Adverse Event Reprting System (VAERS) frm, r yu can file this reprt thrugh the VAERS website at r by calling VAERS des nt prvide medical advice. Vaccine Infrmatin Statement (Interim); PCV13; (4/16/2010); 42 U.S.C. 300aa-26; Department f Health and Human Services; Centers fr Disease Cntrl and Preventin; Page 4 f 5

5 7. The Natinal Vaccine Injury Cmpensatin Prgram The Natinal Vaccine Injury Cmpensatin Prgram (VICP) was created in Persns wh believe they may have been injured by a vaccine may file a claim with VICP by calling r visiting their website at 8. Hw can I learn mre? Ask yur prvider. They can give yu the vaccine package insert r suggest ther surces f infrmatin. Call yur lcal r state health department. Cntact the Centers fr Disease Cntrl and Preventin (CDC): Call (1-800-CDC-INFO) r Visit CDC s website at Vaccine Infrmatin Statement (Interim); PCV13; (4/16/2010); 42 U.S.C. 300aa-26; Department f Health and Human Services; Centers fr Disease Cntrl and Preventin; Page 5 f 5

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