- Pneumococcal disease is a bacterial infection caused by S. pneumoniae (Streptococcus pneumonia). It is the most common cause of bacterial pneumonia and middle ear infection (otitis media) in the U.S., and is the third most frequent cause of bacterial meningitis. [i]
- Pneumococcal bacteria are often found in the upper area of the throat behind the nose in about 5 to 10 percent of healthy adults and 20 to 40 percent of healthy children. However, when pneumococcal bacteria cause invasive infection, serious complications can lead to inflammation of the brain, blood infections, pneumonia and death.[ii].[iii]
- Pneumococcal bacteria are primarily transmitted through respiratory secretions by coughing and sneezing. Children and adults living in crowded conditions with poor sanitation and ventilation, such as in daycare centers, military barracks, prisons and homeless shelters, are at higher risk for pneumococcal disease.
- Each year in the U.S., pneumococcal disease is reported to cause about 4,000 cases of blood stream infections (bacteremia), meningitis (brain inflammation) and ear infections in children under five years old. Some children average one or more middle ear infections (otitis media) each year and many of these ear infections are caused by S. pneumoniae.[iv]
- Globally, 98 percent of pneumonia deaths are caused by pneumococcal infections, primarily in malnourished children living in poverty in underdeveloped countries with inadequate access to healthcare, where S. pneumoniae is the Number One killer of children under age five.. In the U.S. the majority of pneumococcal deaths occur in persons over age 75. In 2008, there were 210 deaths reported in babies under one year old, 118 deaths in children ages one to four years old and 57 deaths in children ages five to 14 years old.[v]
- Symptoms of pneumococcal infection include sudden onset of fever and fatigue, sneezing and cough with mucus and shortness of breath. The infection may start with start with a general feeling of being unwell, a low grade fever and a cough that doesn’t include mucus before symptoms worsen. Symptoms of pneumococcal meningitis (brain inflammation) include stiff neck (inability to touch the chin to chest without moderate to severe pain in the back of the neck and head); headache; extreme fatigue or seizures.[vi] Symptoms of otitis media include a painful ear, red or swollen eardrum, fever, and irritability.[vii]
- There are two types of pneumococcal vaccines licensed and used in the U.S. today: Pneumococcal polysaccharide vaccine (PPSV) and Pneumococcal conjugate vaccine (PCV). PPSV vaccine contains 23 strains of pneumococcal and is recommended by the CDC for adults over 64 years old and PCV13 vaccine contains 13 strains of pneumococcal and is recommended for children between two months and 18 years old. For more information see links to vaccine manufacturer product inserts.
- The CDC recommends four doses of pneumococcal vaccine (PCV-13) for infants and children, with a dose given at two, four, and six months old and between 12 and 18 months old. One or two doses of pneumococcal vaccine is recommended for children ages two through 18 years, depending on how many doses the child received as an infant. [viii]
- Although pneumococcal vaccine (PPSV-23) is recommended for adults over 64 years old, in 2011 the FDA expanded its approval of PCV-13 vaccine to include adults over age 49 years.[ix]
- By 2008, eight years after pneumococcal vaccine containing seven pneumococcal strains (PCV-7) was licensed in the U.S. and recommended by the CDC for all children, public health officials reported that pneumococcal vaccination programs had been responsible for decreasing the rates of invasive pneumococcal disease in children under age five to about one-fifth of what it was in 1998.[x] However, there was also evidence that mass use of PCV-7 vaccine by American children had put pressure on some of the 80 other pneumococcal strains to cause invasive disease and was responsible for increasing the rates of otitis media caused by serotypes not included in the seven-valent vaccine.[xi] In an attempt to prevent the six additional pneumococcal strains from causing invasive disease, the new pneumococcal vaccine for children (PCV-13) now contains six more pneumococcal strains.
- As of July 2012, there had been more than 34,000 reported adverse events following pneumococcal vaccinations (PCV-7, PCV-13) given to children in the U.S. with 90% of the reported PCV-7 vaccine adverse events occurring in children under age three and 95% of the PCV-13 vaccine adverse events occurring in children under age six. There have been more than 1,000 deaths and more than 2,000 cases involving convulsions reported following receipt of PCV-7 and PCV-13 vaccines. Reported pneumoccocal vaccine reactions include fever, severe local reactions (swelling, redness, pain at site of injection), irritability, drowsiness, restless sleep, vomiting, diarrhea, rash, decreased appetite, convulsions, asthma, pneumonia and sudden infant death syndrome (SIDS).
- Pneumococcal Vaccine, Polyvalent Merck & Co. Inc. Pneumovax 23 and Licensing Information
- Pneumococcal 7-Valent Conjugate Vaccine (Diphtheria CRM197Protein) Pfizer/ Pharmaceuticals Inc. Prevnar and Licensing Information
- Pneumococcal 13-Valent Conjugate Vaccine (Diphtheria CRM197Protein) Pfizer/Wyeth Pharmaceuticals Inc. Prevnar 13 and Licensing Information
- CDC on Pneumonia
- CDC on Pneumococcal Vaccination
- CDC Vaccine Information Sheets: Pneumococcal 13-Valent Conjugate Vaccine (Prevnar) andPneumococcal Polysaccharide Vaccine (Pneumovax 23)
Quick Facts Endnotes
This statement was originally prepared in response to planned legislation to mandate the Pneumococcal 7-Valent Conjugate Vaccine (Prevnar) in some states.
Pneumococcal disease is a bacterial infection that can cause serious illness, including inflammation of the brain, blood infections and pneumonia. The Prevnar vaccine manufactured by Wyeth Lederle Laboratories (of American Home Products Corporation, Wyeth-Aherst Lab) is the one being considered for mandate in some states. It contains only 7 of the more than 90 strains of the pneumococcal organism that causes disease in humans and cannot prevent meningitis or blood infections caused by other strains.1
Most children and adults harbor pneumoccocal organisms in their noses and throats. It is not clear why some individuals will go on to develop severe pneumococcal disease and others do not, although those with weakened immune systems are at very high risk. Over-use of antibiotics during the past quarter century has caused at least 7 strains of the pneumococcal organism to mutate into antibiotic resistant forms and these 7 strains are contained in the Prevnar vaccine. Whether the Prevnar vaccine will place pressure on the pneumococcal organism to develop vaccine-resistant strains or make other strains of the bacteria more virulent is unknown.
The CDC states that pneumococcal infections cause approximately 700 cases of meningitis, 17,000 cases of blood stream infections and 200 deaths in American children under age five every year, with 35 of these deaths being caused by pneumococcal meningitis.2
Why NVIC Opposes a Pneumococcal Vaccine Mandate:
Flawed Clinical Trials Did Not Prove Safety: Wyeth Lederle and Kaiser Permanente compared one experimental vaccine (pneumococcal) against another (meningococcal)1, which seriously compromised the scientific validity of the trial. Children in groups who got the pneumococcal vaccine suffered more seizures, irritability, high fevers and other reactions. There were 12 deaths in the Prevnar group, including 5 Sudden Infant Death Syndrome (SIDS) deaths. [Since the vaccine was licensed in 2000, there have been 3,243 Prevnar-related adverse events reported to the federal government (VAERS), including 476 serious events and 79 deaths.]3
No Long Term Studies: There were no long term studies to evaluate whether Prevnar vaccine given alone or in combination with other vaccines is associated with chronic illness or disability, such as the development of diabetes, asthma, seizure disorders, learning disabilities, ADHD, or autism.
Vaccine Components Not Thoroughly Evaluated: Each 0.5ml dose of Prevnar contains 0.125 mg. of aluminum, a metal that is neurotoxic. The vaccine manufacturer states that “Prevnar has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility.” 4,1
Efficacy Low For Preventing Ear Infections: Despite the suggestion by the manufacturer and Kaiser Pemanente officials in pre-licensure press releases that Prevnar vaccine is an ear infection vaccine, the vaccine has never been licensed by the FDA to prevent ear infections. Clinical trials showed that the vaccine decreases a child’s chance of getting an ear infection by only 7 percent.5, 6
Prevnar May Interfere With Efficacy of Other Vaccines: The manufacturer product insert indicates that when Prevnar is given at the same time as HIB, pertussis and polio vaccines, it may lower the efficacy of those vaccines for some children. There is no data on what happens when Prevnar vaccine is given in combination with MMR or chicken pox vaccines.1
Voluntary Use of the Vaccine Is High: Wyeth Lederle, the CDC and AAP have done an excellent job promoting the mass use of this vaccine by children. Prevnar topped the sales charts as the number one best selling new pharmaceutical among all pharmaceuticals brought on the market in the year 2000, generating $461 million in sales.7 Voluntary uptake of the vaccine is so high that there are Prevnar vaccine shortages and the CDC recently temporarily revised its recommendations to urge that only high risk groups of children should receive all four doses of the vaccine.2 This experience shows that mandates are not needed.
- Wyeth-Lederle Product Manufacturer Insert (Pneumococcal 7-Valent Conjugate Vaccine (PREVNAR). Issued February 2000.
- Centers for Disease Control. Dec. 10,2001 press release: ACIP Votes to Temporarily Revise Recommendations for Pneumococcal Conjugate Vaccine, www.cdc.gov/nip/news/shortages/default.htm
- Vaccine Adverse Event Reporting System (VAERS) Data
- Aluminum Toxicity in Infants and Children (RE9607). Pediatrics. Vol. 97, No. 3 (March 1996).
- Wyeth-Ayerst Laboratories. Sept. 25, 1998 press release: New Investigational Vaccine Demonstrates High Efficacy Against Pneumococcal Disease in Children.
- Kaiser Permanente. May 4, 1999 press release: Investigational Vaccine Is First To Show Effectiveness Against Childhood Ear Infections.
- O’Reiley T. Vaccine Tops Sales Chart. March 4, 2001. Daily Record (Morris County, NJ).