Vaccine Information

Entry last updated: May 28, 2004

- Understanding the Disease
- Available Vaccines
- History of the Vaccine
- Who Should and Should Not Receive the Vaccine
- Dose Schedule
- Effectiveness of the Vaccine
- Known Side Effects
- Related Issues
- Key References and Sources of Additional Information
- State Vaccine Requirements
- Important Facts for Parents to Know
- Frequently Asked Questions
- CDC Vaccine Information Statement

Understanding the Disease

Streptococcus pneumoniae is a group of �strep� 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, and the elderly.Each year in the United States among children younger than five years of age, pneumococcal disease accounts for at least 1,400 cases of meningitis; 17,000 cases of bacteremia; 71,000 cases of pneumonia; and 5 to 7 million middle ear infections. Each year among Americans of all ages, there are an estimated 150,000 to 570,000 cases of pneumococcal pneumonia; 16,000 to 55,000 cases of pneumococcal bacteremia; and 3,000 to 6,000 cases of pneumococcal meningitis.

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, Alaskan Native, and specific Native American populations also have higher rates of invasive pneumococcal disease than white children.

Available Vaccines

The pneumococcal vaccine is available as:

• 23-valent polysaccharide vaccine (PS)
• 7-valent conjugate vaccine

Product: Pneumovax� 23 (PS)
Manufacturer: Merck
Year licensed: 1977

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

Product: Prevnar� (Conjugate)
Manufacturer: Wyeth�
Year licensed: 2000

For information on the thimerosal content in these vaccines, see the Food and Drug Administration at www.fda.gov/cber/vaccine/thimerosal.htm#t3
or Johns Hopkins University's Institute for Vaccine Safety at
www.vaccinesafety.edu/thi-table.htm

History of the Vaccine

The first pneumococcal PS vaccine, licensed in 1977, was effective against 14 of the 90 types of pneumococci. The PS vaccine used today for older children and adults is �23-valent�� it is effective against 23 types of pneumococci. The 23-valent PS vaccine protects against 85% to 90% of the types of the pneumococcus that cause invasive infections in this age group.

Because polysaccharide vaccines are not effective in children younger than two to three years of age, a conjugate vaccine was developed. In February 2000, the FDA licensed Prevnar�, a �7-valent� conjugate vaccine. It targets the seven most common types of the pneumococcus, which account for 80% of invasive disease in infants and toddlers. Although the vaccine is generally given at two months of age, children as young as six weeks of age may receive Prevnar�.�

Who Should and Should Not Receive this Vaccine

Who should receive the 23-valent PS vaccine?

• All people age 65 years or older
• 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 7-valent conjugate vaccine first, and the PS vaccine two months later.
  - Chronic illness, including chronic heart, lung (except asthma), 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
  - Living in special environments or social settings, such as residents of nursing homes
  - Being a member of an ethnic group with an increased incidence, such Alaskan Natives or certain Native American populations

Who should not receive the 23-valent PS 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 7-valent conjugate vaccine?

• All children 2 to 23 months of age
• 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 7-valent conjugate vaccine before receiving the PS vaccine.
  - Chronic illness, including chronic heart, lung (except asthma), 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 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 conjugate 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.
• 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 immunization schedule can be found at:
www.cdc.gov/nip/recs/child-schedule.PDF
The summary of adolescent/adult immunization recommendations can be found at: www.cdc.gov/nip/recs/adult-schedule.pdf

Dose Schedule

The 23-valent PS vaccine is given in one shot. Five years after the first shot, a booster is recommended for some individuals.

For infants, the 7-valent conjugate vaccine is given as a series of four shots at 2, 4, 6, and 12 to 15 months of age. If the first dose is delayed, other schedules apply; please consult with your health care provider.

Effectiveness of the Vaccine

The 23-valent PS vaccine�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 vaccine is 97% effective in preventing invasive pneumococcal disease caused by the seven types of the pneumococcus contained in the vaccine. The vaccine is 89% effective in preventing invasive disease caused by all strains of the pneumococcus. The vaccine reduces the incidence of ear infection by about 10% and the need for tubes in the middle ears of children by 20%.

Known Side Effects

The 23-valent PS 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 conjugate vaccine:
Those vaccinated with the 7-valent conjugate vaccine 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

• American Academy of Pediatrics (AAP), Committee on Infectious Diseases. (2003). Pneumococcal infections. In LK Pickering (Ed.), Red Book: Report of the Committee on Infectious Diseases (26th ed., pp. 490-500). Elk Grove Village, IL: Author.
• AAP, Committee on Infectious Diseases. (2000). Policy statement: Recommendations for the prevention of pneumococcal infections, including the use of pneumococcal conjugate vaccine (Prevnar), pneumococcal polysaccharide vaccine, and antibiotic prophylaxis. Pediatrics, 106(2), 362-366.
• AAP, Committee on Infectious Diseases. (2000). Prevention of pneumococcal infections, including the use of pneumococcal conjugate and polysaccharide vaccine and antibiotic prophylaxis [Technical Report]. Pediatrics 106(2), 367-376.
• 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.
• Centers for Disease Control and Prevention (CDC). (1997). Pneumococcal polysaccharide vaccine: What you need to know [Vaccine Information Statement (VIS)].
• CDC. (2004). Pneumococcal disease. In Epidemiology and prevention of vaccine-preventable diseases (�The Pink Book�) (8th ed.). Atlanta: Author.
• Centers for Disease Control and Prevention (CDC). (2001). Pneumococcal conjugate vaccine: What you need to know [Vaccine Information Statement (VIS)].
• CDC, Advisory Committee on Immunization Practices (ACIP). (1997). Prevention of pneumococcal disease: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 46(RR-08), 1-24. 
• CDC, ACIP. (2000). Preventing pneumococcal disease among infants and young children: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR, 49(RR-09), 1-38.  
• 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.
• 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.
• Rubin LG. (2000). Pneumococcal vaccine. Pediatric Clinics of North America, 47(2), 269-285.

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