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A new, 13-valent pneumococcal conjugate vaccine (PCV13, Prevnar 13), from Wyeth Pharmaceuticals was licensed by the US Food and Drug Administration (FDA) in February for use in all children ages 6 weeks to 59 months. The new vaccine was licensed for the prevention of invasive pneumococcal disease (pneumonia, meningitis, and bacteremia) and otitis media.1 PCV13 is meant to replace the 7-valent PCV7 (Prevnar), and will offer protection against a wider array of pneumococcal serotypes.1
Invasive pneumococcal disease in kids has diminished substantially
Soon after PCV7 was included in the routine child immunization schedule, the incidence of invasive pneumococcal disease (IPD) began to decline.2-5 In 1 study, the annual rate of IPD among children younger than 5 years of age decreased from 98.7 cases/100,000 in 1998–1999 to 22.6 cases/100,000 in 2006-2007.3 This decline was due to a decrease in the rate of disease caused by the 7 vaccine serotypes, from 81.9 cases/100,000 to 0.4 cases/100,000.
However, during that same time period, the rate of IPD caused by nonvaccine serotypes increased from 16.8 cases/100,000 population to 22.1 cases/100,000.3 The percentage of IPD caused by nonvaccine serotypes rose from 20% to 90% among children younger than 5 years of age during that time period.3
Fewer cases in adults, as well
In addition to the decline of IPD in children, there has also been a decline in adults. In those older than age 65, the rate of IPD decreased from 60.1/100,000 to 38.2/100,000 between 1998 and 2007—most likely because routine use of the PCV7 vaccine in children has resulted in decreased carriage and transmission of infection from children to adults.3 As in children, the decline was due to a decreasing incidence of infection from PCV7 vaccine serotypes, from 33.7 cases/100,000 to 3.3 cases/100,000. At the same time, the rate of disease caused by nonvaccine serotypes increased from 26.4 cases/100,000 to 34.9 cases/100,000.3
Nonvaccine serotypes still cause concern
While the overall decline in IPD has been a public health success, the increase in incidence of disease caused by nonvaccine serotypes has been cause for concern. According to an analysis of 2007 data from the Centers for Disease Control and Prevention (CDC)’s Active Bacterial Core surveillance, 64% of IPD cases in children younger than 5 years of age in 2006-2007 were caused by serotypes 1, 3, 5, 6A, 7F, and 19A.6 Several of these replacement serotypes have high levels of resistance to penicillin and erythromycin. This trend is what led to the development of the PCV13, which adds these 6 to the 7 serotypes covered by Prevnar.
The dosing schedule is complicated
The recommended schedule for the older PCV7 vaccine has always been a challenge, because the number of doses depends on the age of the child when first vaccinated.7,8 The introduction of PCV13 adds to the complexity, because many children will be in the midst of a PCV7 series when they make the transition to PCV13.
The Advisory Committee on Immunization Practices (ACIP) recommendations on how many doses of PCV13 a child should receive depend now on the age at which the first PCV vaccine was received (either PCV7 or PCV13), the number of doses of each received, and the presence or absence of high-risk medical conditions. These recommendations are summarized below and illustrated in TABLE 1 and TABLE 2.
TABLE 1
PCV13: Routine vaccination schedule
| Age at first dose | Primary series* | Booster dose† |
|---|---|---|
| 2-6 months | 3 doses | 1 dose, 12-15 months |
| 7-11 months | 2 doses | 1 dose, 12-15 months |
| 12-23 months | 2 doses | None |
| 24-59 months, healthy children | 1 dose | None |
| 24-71 months for children with certain chronic diseases or immunocompromising conditions (see TABLE 3) | 2 doses | None |
| *Minimum interval between doses is 8 weeks, except for children vaccinated at <12 months for whom the minimum interval is 4 weeks. Minimum age for first dose is 6 weeks. | ||
| †Given at least 8 weeks after previous dose. | ||
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | ||
TABLE 2
In transition: From PCV7 to PCV13
| Infant series | Booster dose | Supplemental PCV13 dose | ||
|---|---|---|---|---|
| 2 months | 4 months | 6 months | ≥12 months* | 14-59 months† |
| PCV7 | PCV13 | PCV13 | PCV13 | None |
| PCV7 | PCV7 | PCV13 | PCV13 | None |
| PCV7 | PCV7 | PCV7 | PCV13 | None |
| PCV7 | PCV7 | PCV7 | PCV7 | PCV13 |
| *No additional PCV13 doses are indicated for children ages 12-23 months who have received 2 or 3 doses of PCV before age 12 months and at least 1 dose of PCV13 at ≥12 months. | ||||
| †For children with underlying medical conditions (see TABLE 3), a single supplemental PCV13 dose is recommended through age 71 months. | ||||
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | ||||
For a child who started PCV7 on time and is in mid series, the recommendation is to simply finish the series with PCV13.
If a child has completed a series of PCV7, the recommendation is to give him or her 1 dose of PCV13 up to age 59 months. (If the child has a chronic underlying medical condition, this age is extended to 71 months.1)
Infants between the ages of 1 and 6 months who have never received any PCV product should complete a series of PCV13 at 2, 4, 6, and 12 to 15 months—the same time line as the PCV7 series.
Children ages 7 to 59 months who have not been vaccinated with PCV7 or PCV13 previously should receive 1 to 3 doses of PCV13, depending on their age at the time when vaccination begins and whether underlying medical conditions are present (TABLE 3).
Healthy children ages 24 to 59 months without previous PCV vaccine should receive 1 dose of PCV13.
Children ages 24 to 71 months without previous PCV vaccine who have a chronic medical condition that increases their risk for pneumococcal disease should receive 2 doses of PCV13, 8 weeks apart.1
TABLE 3
Underlying conditions that place kids at risk for pneumococcal disease
| Risk group | Condition |
|---|---|
| Immunocompetent children | Chronic heart disease* |
| Chronic lung disease† | |
| Diabetes mellitus | |
| Cerebrospinal fluid leaks | |
| Cochlear implant | |
| Children with functional or anatomic asplenia | Sickle cell disease and other hemoglobulinopathies |
| Congenital or acquired asplenia or splenic dysfunction | |
| Children with immunocompromising conditions | HIV infection |
| Chronic renal failure and nephrotic syndrome | |
| Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin’s disease; or solid organ transplantation | |
| Congenital immunodeficiency‡ | |
| *Particularly cyanotic congenital heart disease and cardiac failure. | |
| †Including asthma if treated with prolonged high-dose oral corticosteroids. | |
| ‡Includes B- (humoral) or T-lymphocyte deficiency; complement deficiencies, particularly C1, C2, C3, and C4 deficiency; and phagocytic disorders (excluding chronic granulomatous disease). | |
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | |
Recommendations for children at higher risk
Provisional recommendations from ACIP advise that children 2 through 18 years of age at increased risk for invasive pneumococcal disease should also receive 23-valent pneumococcal polysaccharide vaccine (PPSV23). Ideally, the child should have received all of the recommended doses of PCV13 before the physician administers PPSV23, with a minimum interval of at least 8 weeks after the last dose of PCV13.
However, some children will have previously received PPSV23. They should also receive the recommended PCV13 doses. A second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 for children who have sickle cell disease, or functional or anatomic asplenia, human immunodeficiency virus (HIV) infection, or other immunocompromising conditions. No more than 2 PPSV23 doses are recommended.9
The ACIP provisional recommendations also say that a single dose of PCV13 may be administered to children ages 6 to 18 years who are at increased risk for IPD because of sickle cell disease, HIV infection or other immunocompromising condition, cochlear implant, or cerebrospinal fluid leaks, regardless of whether they have previously received PCV7 or PPSV23.9 This, however, is an off-label recommendation.
The usual contraindications
PCV13 is contraindicated among individuals known to have a severe allergic reaction to any component of PCV13 or PCV7 or to any diphtheria toxoid-containing vaccine, because the pneumococcal antigens are conjugated to a diphtheria carrier protein.1
A useful vaccine, with its share of challenges
The pneumococcal conjugate vaccine combats infections such as pneumococcal pneumonia and meningitis, which are potentially serious—even though their incidence is relatively low.
The vaccine’s high private-sector cost—reported by the manufacturer to the CDC as $435 for the full, 4-dose series of PCV13—can be a drawback for the family physician trying to keep a full array of vaccine products on hand.10 Eligible low-income and uninsured children can receive free vaccine under the federal Vaccines for Children Program, and providers who choose to enroll in the program can access free vaccines and may charge for the expense of administering them.11
With this hurdle overcome, the remaining challenge for physicians will be to stay on top of the complicated dosing schedule.
1. CDC. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59:258-261.
2. Hicks LA, Harrison LH, Flannery B, et al. Incidence of pneumococcal disease due to nonpneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998-2004. J Infect Dis. 2007;196:1346-1354.
3. Pilishvili T, Lexau C, Farley MM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;201:32-41.
4. Whitney CG, Farley MM, Hadler J, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med. 2003;348:1737-1746.
5. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease—United States, 1998-2003. MMWR Morb Mortal Wkly Rep. 2005;54:893-897.
6. CDC. Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine—United States, 2007. MMWR Morb Mortal Wkly Rep. 2010;59:253-257.
7. CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2000;49(RR-9):1-35.
8. CDC. Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for use of 7-valent pneumococcal conjugate vaccine (PCV7) in children aged 24-59 months who are not completely vaccinated. MMWR Morb Mortal Wkly Rep. 2008;57:343-344.
9. ACIP provisional recommendations for use of 13-valent pneumococcal conjugate vaccine (PCV13) among infants and children. March 3, 2010. Available at: www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed May 24, 2010.
10. CDC vaccine price list. Available at: www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm. Accessed May 22, 2010.
11. Vaccines for Children Program. FAQs from providers. Available at www.cdc.gov/vaccines/programs/vfc/providers/faq-hcp. htm. Accessed May 22, 2010.
A new, 13-valent pneumococcal conjugate vaccine (PCV13, Prevnar 13), from Wyeth Pharmaceuticals was licensed by the US Food and Drug Administration (FDA) in February for use in all children ages 6 weeks to 59 months. The new vaccine was licensed for the prevention of invasive pneumococcal disease (pneumonia, meningitis, and bacteremia) and otitis media.1 PCV13 is meant to replace the 7-valent PCV7 (Prevnar), and will offer protection against a wider array of pneumococcal serotypes.1
Invasive pneumococcal disease in kids has diminished substantially
Soon after PCV7 was included in the routine child immunization schedule, the incidence of invasive pneumococcal disease (IPD) began to decline.2-5 In 1 study, the annual rate of IPD among children younger than 5 years of age decreased from 98.7 cases/100,000 in 1998–1999 to 22.6 cases/100,000 in 2006-2007.3 This decline was due to a decrease in the rate of disease caused by the 7 vaccine serotypes, from 81.9 cases/100,000 to 0.4 cases/100,000.
However, during that same time period, the rate of IPD caused by nonvaccine serotypes increased from 16.8 cases/100,000 population to 22.1 cases/100,000.3 The percentage of IPD caused by nonvaccine serotypes rose from 20% to 90% among children younger than 5 years of age during that time period.3
Fewer cases in adults, as well
In addition to the decline of IPD in children, there has also been a decline in adults. In those older than age 65, the rate of IPD decreased from 60.1/100,000 to 38.2/100,000 between 1998 and 2007—most likely because routine use of the PCV7 vaccine in children has resulted in decreased carriage and transmission of infection from children to adults.3 As in children, the decline was due to a decreasing incidence of infection from PCV7 vaccine serotypes, from 33.7 cases/100,000 to 3.3 cases/100,000. At the same time, the rate of disease caused by nonvaccine serotypes increased from 26.4 cases/100,000 to 34.9 cases/100,000.3
Nonvaccine serotypes still cause concern
While the overall decline in IPD has been a public health success, the increase in incidence of disease caused by nonvaccine serotypes has been cause for concern. According to an analysis of 2007 data from the Centers for Disease Control and Prevention (CDC)’s Active Bacterial Core surveillance, 64% of IPD cases in children younger than 5 years of age in 2006-2007 were caused by serotypes 1, 3, 5, 6A, 7F, and 19A.6 Several of these replacement serotypes have high levels of resistance to penicillin and erythromycin. This trend is what led to the development of the PCV13, which adds these 6 to the 7 serotypes covered by Prevnar.
The dosing schedule is complicated
The recommended schedule for the older PCV7 vaccine has always been a challenge, because the number of doses depends on the age of the child when first vaccinated.7,8 The introduction of PCV13 adds to the complexity, because many children will be in the midst of a PCV7 series when they make the transition to PCV13.
The Advisory Committee on Immunization Practices (ACIP) recommendations on how many doses of PCV13 a child should receive depend now on the age at which the first PCV vaccine was received (either PCV7 or PCV13), the number of doses of each received, and the presence or absence of high-risk medical conditions. These recommendations are summarized below and illustrated in TABLE 1 and TABLE 2.
TABLE 1
PCV13: Routine vaccination schedule
| Age at first dose | Primary series* | Booster dose† |
|---|---|---|
| 2-6 months | 3 doses | 1 dose, 12-15 months |
| 7-11 months | 2 doses | 1 dose, 12-15 months |
| 12-23 months | 2 doses | None |
| 24-59 months, healthy children | 1 dose | None |
| 24-71 months for children with certain chronic diseases or immunocompromising conditions (see TABLE 3) | 2 doses | None |
| *Minimum interval between doses is 8 weeks, except for children vaccinated at <12 months for whom the minimum interval is 4 weeks. Minimum age for first dose is 6 weeks. | ||
| †Given at least 8 weeks after previous dose. | ||
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | ||
TABLE 2
In transition: From PCV7 to PCV13
| Infant series | Booster dose | Supplemental PCV13 dose | ||
|---|---|---|---|---|
| 2 months | 4 months | 6 months | ≥12 months* | 14-59 months† |
| PCV7 | PCV13 | PCV13 | PCV13 | None |
| PCV7 | PCV7 | PCV13 | PCV13 | None |
| PCV7 | PCV7 | PCV7 | PCV13 | None |
| PCV7 | PCV7 | PCV7 | PCV7 | PCV13 |
| *No additional PCV13 doses are indicated for children ages 12-23 months who have received 2 or 3 doses of PCV before age 12 months and at least 1 dose of PCV13 at ≥12 months. | ||||
| †For children with underlying medical conditions (see TABLE 3), a single supplemental PCV13 dose is recommended through age 71 months. | ||||
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | ||||
For a child who started PCV7 on time and is in mid series, the recommendation is to simply finish the series with PCV13.
If a child has completed a series of PCV7, the recommendation is to give him or her 1 dose of PCV13 up to age 59 months. (If the child has a chronic underlying medical condition, this age is extended to 71 months.1)
Infants between the ages of 1 and 6 months who have never received any PCV product should complete a series of PCV13 at 2, 4, 6, and 12 to 15 months—the same time line as the PCV7 series.
Children ages 7 to 59 months who have not been vaccinated with PCV7 or PCV13 previously should receive 1 to 3 doses of PCV13, depending on their age at the time when vaccination begins and whether underlying medical conditions are present (TABLE 3).
Healthy children ages 24 to 59 months without previous PCV vaccine should receive 1 dose of PCV13.
Children ages 24 to 71 months without previous PCV vaccine who have a chronic medical condition that increases their risk for pneumococcal disease should receive 2 doses of PCV13, 8 weeks apart.1
TABLE 3
Underlying conditions that place kids at risk for pneumococcal disease
| Risk group | Condition |
|---|---|
| Immunocompetent children | Chronic heart disease* |
| Chronic lung disease† | |
| Diabetes mellitus | |
| Cerebrospinal fluid leaks | |
| Cochlear implant | |
| Children with functional or anatomic asplenia | Sickle cell disease and other hemoglobulinopathies |
| Congenital or acquired asplenia or splenic dysfunction | |
| Children with immunocompromising conditions | HIV infection |
| Chronic renal failure and nephrotic syndrome | |
| Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin’s disease; or solid organ transplantation | |
| Congenital immunodeficiency‡ | |
| *Particularly cyanotic congenital heart disease and cardiac failure. | |
| †Including asthma if treated with prolonged high-dose oral corticosteroids. | |
| ‡Includes B- (humoral) or T-lymphocyte deficiency; complement deficiencies, particularly C1, C2, C3, and C4 deficiency; and phagocytic disorders (excluding chronic granulomatous disease). | |
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | |
Recommendations for children at higher risk
Provisional recommendations from ACIP advise that children 2 through 18 years of age at increased risk for invasive pneumococcal disease should also receive 23-valent pneumococcal polysaccharide vaccine (PPSV23). Ideally, the child should have received all of the recommended doses of PCV13 before the physician administers PPSV23, with a minimum interval of at least 8 weeks after the last dose of PCV13.
However, some children will have previously received PPSV23. They should also receive the recommended PCV13 doses. A second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 for children who have sickle cell disease, or functional or anatomic asplenia, human immunodeficiency virus (HIV) infection, or other immunocompromising conditions. No more than 2 PPSV23 doses are recommended.9
The ACIP provisional recommendations also say that a single dose of PCV13 may be administered to children ages 6 to 18 years who are at increased risk for IPD because of sickle cell disease, HIV infection or other immunocompromising condition, cochlear implant, or cerebrospinal fluid leaks, regardless of whether they have previously received PCV7 or PPSV23.9 This, however, is an off-label recommendation.
The usual contraindications
PCV13 is contraindicated among individuals known to have a severe allergic reaction to any component of PCV13 or PCV7 or to any diphtheria toxoid-containing vaccine, because the pneumococcal antigens are conjugated to a diphtheria carrier protein.1
A useful vaccine, with its share of challenges
The pneumococcal conjugate vaccine combats infections such as pneumococcal pneumonia and meningitis, which are potentially serious—even though their incidence is relatively low.
The vaccine’s high private-sector cost—reported by the manufacturer to the CDC as $435 for the full, 4-dose series of PCV13—can be a drawback for the family physician trying to keep a full array of vaccine products on hand.10 Eligible low-income and uninsured children can receive free vaccine under the federal Vaccines for Children Program, and providers who choose to enroll in the program can access free vaccines and may charge for the expense of administering them.11
With this hurdle overcome, the remaining challenge for physicians will be to stay on top of the complicated dosing schedule.
A new, 13-valent pneumococcal conjugate vaccine (PCV13, Prevnar 13), from Wyeth Pharmaceuticals was licensed by the US Food and Drug Administration (FDA) in February for use in all children ages 6 weeks to 59 months. The new vaccine was licensed for the prevention of invasive pneumococcal disease (pneumonia, meningitis, and bacteremia) and otitis media.1 PCV13 is meant to replace the 7-valent PCV7 (Prevnar), and will offer protection against a wider array of pneumococcal serotypes.1
Invasive pneumococcal disease in kids has diminished substantially
Soon after PCV7 was included in the routine child immunization schedule, the incidence of invasive pneumococcal disease (IPD) began to decline.2-5 In 1 study, the annual rate of IPD among children younger than 5 years of age decreased from 98.7 cases/100,000 in 1998–1999 to 22.6 cases/100,000 in 2006-2007.3 This decline was due to a decrease in the rate of disease caused by the 7 vaccine serotypes, from 81.9 cases/100,000 to 0.4 cases/100,000.
However, during that same time period, the rate of IPD caused by nonvaccine serotypes increased from 16.8 cases/100,000 population to 22.1 cases/100,000.3 The percentage of IPD caused by nonvaccine serotypes rose from 20% to 90% among children younger than 5 years of age during that time period.3
Fewer cases in adults, as well
In addition to the decline of IPD in children, there has also been a decline in adults. In those older than age 65, the rate of IPD decreased from 60.1/100,000 to 38.2/100,000 between 1998 and 2007—most likely because routine use of the PCV7 vaccine in children has resulted in decreased carriage and transmission of infection from children to adults.3 As in children, the decline was due to a decreasing incidence of infection from PCV7 vaccine serotypes, from 33.7 cases/100,000 to 3.3 cases/100,000. At the same time, the rate of disease caused by nonvaccine serotypes increased from 26.4 cases/100,000 to 34.9 cases/100,000.3
Nonvaccine serotypes still cause concern
While the overall decline in IPD has been a public health success, the increase in incidence of disease caused by nonvaccine serotypes has been cause for concern. According to an analysis of 2007 data from the Centers for Disease Control and Prevention (CDC)’s Active Bacterial Core surveillance, 64% of IPD cases in children younger than 5 years of age in 2006-2007 were caused by serotypes 1, 3, 5, 6A, 7F, and 19A.6 Several of these replacement serotypes have high levels of resistance to penicillin and erythromycin. This trend is what led to the development of the PCV13, which adds these 6 to the 7 serotypes covered by Prevnar.
The dosing schedule is complicated
The recommended schedule for the older PCV7 vaccine has always been a challenge, because the number of doses depends on the age of the child when first vaccinated.7,8 The introduction of PCV13 adds to the complexity, because many children will be in the midst of a PCV7 series when they make the transition to PCV13.
The Advisory Committee on Immunization Practices (ACIP) recommendations on how many doses of PCV13 a child should receive depend now on the age at which the first PCV vaccine was received (either PCV7 or PCV13), the number of doses of each received, and the presence or absence of high-risk medical conditions. These recommendations are summarized below and illustrated in TABLE 1 and TABLE 2.
TABLE 1
PCV13: Routine vaccination schedule
| Age at first dose | Primary series* | Booster dose† |
|---|---|---|
| 2-6 months | 3 doses | 1 dose, 12-15 months |
| 7-11 months | 2 doses | 1 dose, 12-15 months |
| 12-23 months | 2 doses | None |
| 24-59 months, healthy children | 1 dose | None |
| 24-71 months for children with certain chronic diseases or immunocompromising conditions (see TABLE 3) | 2 doses | None |
| *Minimum interval between doses is 8 weeks, except for children vaccinated at <12 months for whom the minimum interval is 4 weeks. Minimum age for first dose is 6 weeks. | ||
| †Given at least 8 weeks after previous dose. | ||
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | ||
TABLE 2
In transition: From PCV7 to PCV13
| Infant series | Booster dose | Supplemental PCV13 dose | ||
|---|---|---|---|---|
| 2 months | 4 months | 6 months | ≥12 months* | 14-59 months† |
| PCV7 | PCV13 | PCV13 | PCV13 | None |
| PCV7 | PCV7 | PCV13 | PCV13 | None |
| PCV7 | PCV7 | PCV7 | PCV13 | None |
| PCV7 | PCV7 | PCV7 | PCV7 | PCV13 |
| *No additional PCV13 doses are indicated for children ages 12-23 months who have received 2 or 3 doses of PCV before age 12 months and at least 1 dose of PCV13 at ≥12 months. | ||||
| †For children with underlying medical conditions (see TABLE 3), a single supplemental PCV13 dose is recommended through age 71 months. | ||||
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | ||||
For a child who started PCV7 on time and is in mid series, the recommendation is to simply finish the series with PCV13.
If a child has completed a series of PCV7, the recommendation is to give him or her 1 dose of PCV13 up to age 59 months. (If the child has a chronic underlying medical condition, this age is extended to 71 months.1)
Infants between the ages of 1 and 6 months who have never received any PCV product should complete a series of PCV13 at 2, 4, 6, and 12 to 15 months—the same time line as the PCV7 series.
Children ages 7 to 59 months who have not been vaccinated with PCV7 or PCV13 previously should receive 1 to 3 doses of PCV13, depending on their age at the time when vaccination begins and whether underlying medical conditions are present (TABLE 3).
Healthy children ages 24 to 59 months without previous PCV vaccine should receive 1 dose of PCV13.
Children ages 24 to 71 months without previous PCV vaccine who have a chronic medical condition that increases their risk for pneumococcal disease should receive 2 doses of PCV13, 8 weeks apart.1
TABLE 3
Underlying conditions that place kids at risk for pneumococcal disease
| Risk group | Condition |
|---|---|
| Immunocompetent children | Chronic heart disease* |
| Chronic lung disease† | |
| Diabetes mellitus | |
| Cerebrospinal fluid leaks | |
| Cochlear implant | |
| Children with functional or anatomic asplenia | Sickle cell disease and other hemoglobulinopathies |
| Congenital or acquired asplenia or splenic dysfunction | |
| Children with immunocompromising conditions | HIV infection |
| Chronic renal failure and nephrotic syndrome | |
| Diseases associated with immunosuppressive drugs or radiation therapy, including malignant neoplasms, leukemias, lymphomas, and Hodgkin’s disease; or solid organ transplantation | |
| Congenital immunodeficiency‡ | |
| *Particularly cyanotic congenital heart disease and cardiac failure. | |
| †Including asthma if treated with prolonged high-dose oral corticosteroids. | |
| ‡Includes B- (humoral) or T-lymphocyte deficiency; complement deficiencies, particularly C1, C2, C3, and C4 deficiency; and phagocytic disorders (excluding chronic granulomatous disease). | |
| Source: CDC. MMWR Morb Mortal Wkly Rep. 2010.1 | |
Recommendations for children at higher risk
Provisional recommendations from ACIP advise that children 2 through 18 years of age at increased risk for invasive pneumococcal disease should also receive 23-valent pneumococcal polysaccharide vaccine (PPSV23). Ideally, the child should have received all of the recommended doses of PCV13 before the physician administers PPSV23, with a minimum interval of at least 8 weeks after the last dose of PCV13.
However, some children will have previously received PPSV23. They should also receive the recommended PCV13 doses. A second dose of PPSV23 is recommended 5 years after the first dose of PPSV23 for children who have sickle cell disease, or functional or anatomic asplenia, human immunodeficiency virus (HIV) infection, or other immunocompromising conditions. No more than 2 PPSV23 doses are recommended.9
The ACIP provisional recommendations also say that a single dose of PCV13 may be administered to children ages 6 to 18 years who are at increased risk for IPD because of sickle cell disease, HIV infection or other immunocompromising condition, cochlear implant, or cerebrospinal fluid leaks, regardless of whether they have previously received PCV7 or PPSV23.9 This, however, is an off-label recommendation.
The usual contraindications
PCV13 is contraindicated among individuals known to have a severe allergic reaction to any component of PCV13 or PCV7 or to any diphtheria toxoid-containing vaccine, because the pneumococcal antigens are conjugated to a diphtheria carrier protein.1
A useful vaccine, with its share of challenges
The pneumococcal conjugate vaccine combats infections such as pneumococcal pneumonia and meningitis, which are potentially serious—even though their incidence is relatively low.
The vaccine’s high private-sector cost—reported by the manufacturer to the CDC as $435 for the full, 4-dose series of PCV13—can be a drawback for the family physician trying to keep a full array of vaccine products on hand.10 Eligible low-income and uninsured children can receive free vaccine under the federal Vaccines for Children Program, and providers who choose to enroll in the program can access free vaccines and may charge for the expense of administering them.11
With this hurdle overcome, the remaining challenge for physicians will be to stay on top of the complicated dosing schedule.
1. CDC. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59:258-261.
2. Hicks LA, Harrison LH, Flannery B, et al. Incidence of pneumococcal disease due to nonpneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998-2004. J Infect Dis. 2007;196:1346-1354.
3. Pilishvili T, Lexau C, Farley MM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;201:32-41.
4. Whitney CG, Farley MM, Hadler J, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med. 2003;348:1737-1746.
5. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease—United States, 1998-2003. MMWR Morb Mortal Wkly Rep. 2005;54:893-897.
6. CDC. Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine—United States, 2007. MMWR Morb Mortal Wkly Rep. 2010;59:253-257.
7. CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2000;49(RR-9):1-35.
8. CDC. Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for use of 7-valent pneumococcal conjugate vaccine (PCV7) in children aged 24-59 months who are not completely vaccinated. MMWR Morb Mortal Wkly Rep. 2008;57:343-344.
9. ACIP provisional recommendations for use of 13-valent pneumococcal conjugate vaccine (PCV13) among infants and children. March 3, 2010. Available at: www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed May 24, 2010.
10. CDC vaccine price list. Available at: www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm. Accessed May 22, 2010.
11. Vaccines for Children Program. FAQs from providers. Available at www.cdc.gov/vaccines/programs/vfc/providers/faq-hcp. htm. Accessed May 22, 2010.
1. CDC. Licensure of a 13-valent pneumococcal conjugate vaccine (PCV13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Morb Mortal Wkly Rep. 2010;59:258-261.
2. Hicks LA, Harrison LH, Flannery B, et al. Incidence of pneumococcal disease due to nonpneumococcal conjugate vaccine (PCV7) serotypes in the United States during the era of widespread PCV7 vaccination, 1998-2004. J Infect Dis. 2007;196:1346-1354.
3. Pilishvili T, Lexau C, Farley MM, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;201:32-41.
4. Whitney CG, Farley MM, Hadler J, et al. Decline in invasive pneumococcal disease after the introduction of protein-polysaccharide conjugate vaccine. N Engl J Med. 2003;348:1737-1746.
5. Direct and indirect effects of routine vaccination of children with 7-valent pneumococcal conjugate vaccine on incidence of invasive pneumococcal disease—United States, 1998-2003. MMWR Morb Mortal Wkly Rep. 2005;54:893-897.
6. CDC. Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine—United States, 2007. MMWR Morb Mortal Wkly Rep. 2010;59:253-257.
7. CDC. Preventing pneumococcal disease among infants and young children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2000;49(RR-9):1-35.
8. CDC. Updated recommendation from the Advisory Committee on Immunization Practices (ACIP) for use of 7-valent pneumococcal conjugate vaccine (PCV7) in children aged 24-59 months who are not completely vaccinated. MMWR Morb Mortal Wkly Rep. 2008;57:343-344.
9. ACIP provisional recommendations for use of 13-valent pneumococcal conjugate vaccine (PCV13) among infants and children. March 3, 2010. Available at: www.cdc.gov/vaccines/recs/provisional/downloads/pcv13-mar-2010-508.pdf. Accessed May 24, 2010.
10. CDC vaccine price list. Available at: www.cdc.gov/vaccines/programs/vfc/cdc-vac-price-list.htm. Accessed May 22, 2010.
11. Vaccines for Children Program. FAQs from providers. Available at www.cdc.gov/vaccines/programs/vfc/providers/faq-hcp. htm. Accessed May 22, 2010.