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.
