Vaccines

Pneumococcal

Updated: March 31, 2010

Table of Contents

    Understanding the Disease

    Streptococcus pneumoniae are a group of bacteria also known as pneumococci. Pneumococci live in the nose and throats of people of all ages. Pneumococci can infect many different sites, some common—like the middle ear and the sinuses—and some less common but more serious, including the lungs (pneumonia), central nervous system (meningitis), and blood stream (bacteremia).

    Serious pneumococcal infections are most common in infants, toddlers, smokers, and the elderly. In addition, people with certain health problems (e.g., immune deficiencies, sickle cell disease, lack of a functioning spleen) are at high risk for acquiring invasive pneumococcal disease. Children from African-American and Native American populations also have higher rates of invasive (serious) pneumococcal disease than white children.

    A heptavalent pneumococcal conjugate vaccine (PCV7 vaccine), containing the 7 most common pneumococcal serotypes causing invasive infections in children in North America was licensed in the US and recommended for routine use in infants in 2000. The PCV7 vaccine has dramatically reduced the rates of invasive pneumococcal disease, otitis media and nasal carriage of the vaccine serotypes among all age groups, including the immunocompromised and older individuals. The vaccine has also reduced the racial disparities in pneumococcal disease.

    PCV7 has proven to be a cost effective vaccine because of the disease it prevents in young children. Vaccinating children against pneumococcus also has provided protection to their family members and the communities where they live, making it a cost saving vaccine when its effects on community immunity are considered.

    However, while the PCV7 vaccine has reduced pneumococcal disease caused by the seven most common types causing infection in children, there are other pneumococcal types which can also cause serious infections in children. Surveillance suggests an increase in disease in children aged < 5 years due to these nonvaccine serotypes, especially serotypes 3, 7F, and 19A, some of which are antibiotic resistant. Because children are the reservoir for the serotypes that cause invasive disease in older people, broadening the coverage of serotypes in the vaccine is desirable.

    On February 24, 2010, the FDA licensed a 13-valent pneumococcal conjugate vaccine (PCV13). On the same day, the Advisory Committee on Immunization Practices recommended that this vaccine replace the PCV7 vaccine in the infant schedule when it becomes available. PCV13, will protect against the same seven strains that were in PCV7 but also has the potential to further reduce the amount of invasive pneumococcal disease in the United States caused by 6 additional strains, including 3, 7F and 19A.

    Available Vaccines

    The pneumococcal vaccine is available as:

    • 23-valent polysaccharide vaccine (PPS)
    • 7-valent conjugate vaccine
    • 13-valent conjugate vaccine (PCV13)

    Product: Pneumovax 23 (PPS)
    Manufacturer: Merck
    Year licensed: 1977

    Product: Pnu-Imune 23 (PPS)
    Manufacturer: Wyeth
    Year licensed: 1979

    Product: Prevnar (PCV7 - Conjugate)
    Manufacturer: Wyeth
    Year licensed: 2000 to be replaced by PCV13

    Product: Prevnar (PCV13 -Conjugate)
    Manufacturer: Wyeth
    Year licensed: 2010 to ultimately replace PCV7

    History of the Vaccine

    The pneumococcal PPS vaccine used today for older children and adults is “23-valent”— it is effective against 23 types of pneumococci. The 23-valent PPS vaccine protects against 85% to 90% of the types of the pneumococcus that cause invasive infections in these age groups.

    Because polysaccharide vaccines are not effective in children younger than two to three years of age, conjugate vaccines were developed. In February 2000, the FDA licensed Prevnar, a “7-valent” conjugate vaccine (PCV7). PCV7 targeted the seven most common types of the pneumococci, which accounted for 80-85% of invasive disease in infants and toddlers. Although the vaccine is generally begun at two months of age, children as young as six weeks of age may receive the conjugate vaccine.

    Because a number of other pneumococci are becoming increasingly more common in young children, the new pneumococcal conjugate vaccine (PCV13) containing 6 additional strains was developed to replace PCV7.

    Some cases of invasive pneumococcal disease have also been caused by strains not included in PCV 13, but which are included in PPSV23. Therefore, in addition to receiving PCV13, children with underlying medical conditions listed below should receive PPSV23 at age 2 years or as soon as possible after the diagnosis of chronic illness is made.

    Who Should and Should Not Receive the Vaccine

    Who should receive the 23-valent PPS vaccine?

    • All people age 65 years or older.
    • Adult cigarette smokers.
    • Adults with chronic pulmonary diseases (such as asthma, emphysema and chronic obstructive pulmonary disease).
    • People two years or older who are at increased risk for pneumococcal disease due to the conditions listed below. Please note that children under five with some of these conditions should receive the PCV7 first, and the PPS vaccine two months later.
      • Chronic illness, including chronic heart, lung, kidney, or liver disease; brain or spinal fluid leaks; diabetes; or alcoholism.
      • HIV infection (whether symptomatic or not).
      • Weakened immune system due to cancer, long-term kidney failure, nephrotic syndrome, organ or bone marrow transplantation, AIDS, chemotherapy or radiation treatment, or other conditions. A second dose of PPS is recommended 5 years after the first dose of PPS for these persons who are over >2 years of age.
      • Sickle cell disease. A second dose of PPS is recommended 5 years after the first dose of PPS for these persons who are over >2 years of age.
      • Spleen that does not function correctly or spleen that has been removed. A second dose of PPS is recommended 5 years after the first dose of PPS for these persons who are over >2 years of age.
      • Living in special environments or social settings, such as residents of nursing homes.
      • Routine use off PPS is no longer recommended for Alaska Native or American Indian persons younger than 65 years of age unless they have another medical condition that is an indication for PPS. In special circumstances, however, public health authorities may recommend PPS for these groups of persons who are aged 24 through 59 months or those who are over the age of 50 years.

    Who should not receive the 23-valent PPS vaccine?

    • People who have had a serious reaction, such as anaphylaxis, to a previous dose of the vaccine should not receive a second dose. Serious reactions are very rare.
    • Pregnant women should consult with their physician before immunization, as the vaccine’s safety for pregnant women hasn’t been studied.
    • People who are moderately or severely ill should consult with their physician before receiving any vaccine.

    Who should receive the 13-valent conjugate vaccine (PCV13)?

    • Infants and children 2 through 59 months of age who have not previously received PCV7 or PCV13.
    • Infants and children who are unvaccinated or who are incompletely immunized with PCV7 immunizations: please see the CDC schedule for transition from PCV7 to PCV13.
    • Children 14 through 59 months of age and older who are completely immunized with PCV7. A supplemental dose of PCV13 should be given at least 8 weeks after the last PCV7 dose. This can be given at their next medical visit. o Children 14 through 71 months of age who have underlying medical conditions (see above) should receive a supplemental dose of PCV13.
    • Although only licensed for use through 71 months of age, the CDC also states that a single dose of PCV13 may be administered to children 6 through 18 years of age who are at increased risk of invasive pneumococcal disease because of the medical conditions (see above), regardless of whether they have previously received PCV7 or PPSV23.

    Who should receive the 7-valent conjugate vaccine (PCV7)?

    • Until PCV13 is available, PCV7 should continue to be used. Once PCV 13 is widely available, it will completely replace PCV7.
    • All children 2 to 23 months of age.
    • All children 2-59 months of age who are to begin immune-compromising therapy, or are going to have a cochlear implant or removal of their spleen.
    • Previously unvaccinated children ages 2 to 5 years who are at increased risk for pneumococcal disease due to the conditions listed below should receive the appropriate series of the PCV7 vaccine before receiving the PS vaccine.
      • Chronic illness, including chronic heart, lung (including asthma treated with high-dose oral corticosteroid therapy), kidney, or liver disease; brain or spinal fluid leaks; diabetes; or alcoholism.
      • HIV infection (whether symptomatic or not).
      • Weakened immune system due to cancer, long-term kidney failure, nephrotic syndrome, organ or bone marrow transplantation, AIDS, chemotherapy or radiation treatment, or other conditions.
      • Sickle cell disease.
      • Spleen that does not function correctly, or spleen that has been removed.

    Other children who might benefit from receiving the 7-valent conjugate PCV7 vaccine:

    • All children 24 to 35 months.
    • Children of Alaskan Native, Native American, or African-American descent ages 36 to 59 months.
    • Children ages 36 to 59 months who attend childcare.

    Who should not receive the 7-valent (PCV7) or the 13-valent (PCV13) conjugate vaccines?

    • People who have had a serious reaction, such as anaphylaxis, to a previous dose of the vaccine should not receive a second dose. Serious reactions are very rare.
    • People who are moderately or severely ill should consult with their physician before receiving any vaccine.

    This vaccine is recommended by:

    • Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention
    • American Academy of Pediatrics
    • American Academy of Family Physicians

    The complete childhood and adult immunization schedules can be found at the CDC site.

    Dose Schedule

    The 23-valent PPS vaccine is given in one shot. Five years after the first shot, a booster is recommended for some individuals. For infants and children, until PCV13 is available, PCV7 should continue to be used. Once PCV 13 is widely available, it will completely replace PCV7, given as a series of four shots at 2, 4, 6, and 12 through 15 months of age.

    Completing the primary series (i.e., the first 3 doses) of PCV7 (and ultimately PCV13) vaccine within the first year of life gives very good protection, but a child is not as fully protected until after the booster dose is given after their first birthday (i.e., 12-15 months of age).

    Booster dose(s) extend the period of time over which a child is protected later in life. They are given since the protection received from a primary series given during infancy begins to wear off over time.

    If the first dose is delayed, other schedules apply as described by the CDC.

    Effectiveness of the Vaccine

    The 23-valent PPS vaccine is not effective in children younger than 2 years of age. It’s effectiveness at preventing disease ranges from 57% to 75%. Protection lasts between three and five years.

    A full series of the 7-valent conjugate PCV7 vaccine is 97% effective in preventing invasive pneumococcal disease caused by the seven types of the pneumococci contained in the vaccine. The vaccine is 89% effective in preventing invasive disease caused by all strains of the pneumococci. The vaccine reduces the incidence of ear infection by about 10% and the need for tubes in the middle ears of children by 20%. Since PCV7 immunization of young children began in the US, there has been a decrease in the number of invasive pneumococcal infections due to the strains in the vaccine (but not to strains that are not in the PCV7 vaccine) in all age groups, including among those who are over the age of 65 years.

    PCV13 should be as effective for the original PCV7 serotypes of pneumococci and will be more effective than PCV7 for prevention of invasive pneumococcal infections because it will provide protection against an additional 6 serotypes.

    Known Side Effects

    The 23-valent PPS vaccine:

    About half of those immunized with the 23-valent PS vaccine will experience no reactions. Approximately 50% of those vaccinated experience mild reactions, such as soreness and redness where the shot was given. Less than 1% report fever, chills, and a general sense of being ill that lasts for one to two days.

    In very rare cases (far less than 1 out of 10,000) serious allergic reactions occur. These may include trouble breathing, hives, becoming pale or weak, having a very fast heartbeat, or feeling dizzy.

    The 7-valent PCV7 and 13-valent PCV13 conjugate vaccines:

    Those vaccinated with the PCV7 or PCV13 vaccines may have mild reactions that include soreness or redness where the shot was given, irritability, drowsiness, and decreased appetite. Twenty-one percent get a fever over 100.3 degrees F.

    Seizures have been reported after the use of the 7-valent conjugate vaccine in less than 1 in 10,000 immunized. Almost all seizures occurred less than four days after receiving the vaccine. Over half of the children had experienced previous seizures (55%) or had a fever at the time of the seizure (68%).

    Related Issues

    Until recently, pneumococcal infections could be treated effectively with certain antibiotics. However, more and more of these infections are becoming antibiotic-resistant. For this reason, it is especially important to prevent pneumococcal infections with vaccines.

    Key References and Sources of Additional Information

    • Robinson KA, Baughman W, Rothrock G, Barrett NL, Pass M, Lexau C, Damaske B, Stefonek K, Barnes B, Patterson J, Zell ER, Schuchat A, and Whitney CG. (2001). Epidemiology of invasive Streptococcus pneumonae infections in the United States, 1995-1998: Opportunities for prevention in the conjugate vaccine era. Journal of the American Medical Association, 285(13), 1929-1935.
    • Black S, Shinefield R, Fireman B, Lewis E, Ray P, Hansen JR, Elvin L, Ensor KM, Hackell J, Siber G, Malinoski F, Madore D, Chang I, Kohberger R, Watson W, Austrian R, and Edwards K. (2000). Efficacy, safety and immunogenicity of heptovalent pneumococcal conjugate vaccine in children. Pediatric Infectious Disease Journal, 19(3), 187-195.
    • O’Brien KL, Swift AJ, Winkelstein JA, Santosham M, Stover B, Luddy R, Gootenberg JE, Nold JT, Eskenazi A, Snader SJ, and Lederman HM. (2000). Safety and immunogenicity of heptavalent pneumococcal vaccine conjugated to CRM 197 among infants with sickle cell disease. Pediatrics, 106(5), 965-972.
    • Hsu HE, Shutt KA, Moore, MR, et al. 2009. Effect of pneumococcal conjugate vaccine on pneumococcal meningitis. N Engl J Med 360: 244-56.
    • CDC. 2009. Pneumonia hospitalizations among young children before and after introduction of pneumococcal conjugate vaccine—United States, 1997-2006. MMWR 58(1): 1-4.
    • Park SY, Van Beneden, CA, Pilishvile T, et al. 2010. Invasive pneumococcal infections among vaccinated children in the United States. J Pediatrics 156: 478-83.
    • CDC. 2010. Invasive pneumococcal disease in young children before licensure of 13-valent pneumococcal conjugate vaccine—United States, 2007. MMWR 59(9): 253-7.
    • CDC. 2010. Licensure of a 13-valent pneumococcal conjugate vaccine (PCVB13) and recommendations for use among children—Advisory Committee on Immunization Practices (ACIP), 2010. MMWR 59(9): 258-61.

    CDC Information

    http://cdc.gov/vaccines/pubs/vis/default.htm#pcv