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Pneumococcal Vaccine Product Inserts

• Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar^®
  FOR PEDIATRIC USE ONLY
• PNEUMOVAX^® 23 (PNEUMOCOCCAL VACCINE POLYVALENT) - For Adults

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.

References:

1. Wyeth-Lederle Product Manufacturer Insert (Pneumococcal 7-Valent Conjugate Vaccine (PREVNAR). Issued February 2000.
2. 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
3. Vaccine Adverse Event Reporting System (VAERS) Data
4. Aluminum Toxicity in Infants and Children (RE9607). Pediatrics. Vol. 97, No. 3 (March 1996).
5. Wyeth-Ayerst Laboratories. Sept. 25, 1998 press release: New Investigational Vaccine Demonstrates High Efficacy Against Pneumococcal Disease in Children.
6. Kaiser Permanente. May 4, 1999 press release: Investigational Vaccine Is First To Show Effectiveness Against Childhood Ear Infections.
7. O'Reiley T. Vaccine Tops Sales Chart. March 4, 2001. Daily Record (Morris County, NJ).