What is Pneumococcus? Pneumococcus is a bacteria commonly associated with pneumonia, but which can also cause meningitis, sinusitis, otitis media, osteomyelitis, and other infectious diseases.
Pneumococcus resides in the nasal passages and throats of about 10% of all adults and 40% of all healthy children at any given time. It is more prolific among groups in close proximity, including children in day care.
Prevnar, the Pediatric Pneumococcal Vaccine
Wyeth Lederle manufactures Prevnar, designed specifically for infants and children. It is recommended that infants receive four doses, at two months, four months, six months, and twelve months.
Prevnar’s Package Insert With scientists and health professionals both supporting and condemning childhood vaccinations, it can be difficult for parents to make an informed decision about whether or not to vaccinate their children. One often overlooked resource is package inserts. The makers of vaccines provide inserts with every vaccine that describe, among other things, the ingredients, intended usage, contraindications, adverse reactions, and dosage.
The package insert for Prevnar can be viewed in its entirety here.
Prevnar’s Ingredients
Prevnar is made using, among other things, a strain of Diptheria, against which people are vaccinated with the DTaP vaccine.
It also contains aluminum, frequently used in vaccines to activate the immune response.
According to WebMD, “Rome researchers compared adverse reactions from vaccines containing aluminum to those with no aluminum salts. The information they gathered was on children under 18 months and 10-16 years old. As expected, they found aluminum-containing DTP vaccines were more likely than plain vaccines to cause redness or skin hardening in the younger children. And the older kids had pain lasting up to 14 days with the aluminum-containing vaccines. But there was no evidence of any serious problems in either group getting vaccines with aluminum salts.” (source link)
However, a recent study published in the February 2007 issue of Neuromolecular Medicine shows a different story. Researchers set out to test theoretical link between the aluminum adjuvant in anthrax vaccines and Gulf War Syndrome. Test animals injected with aluminum experienced “significant motor neuron loss.” (source link )
Efficacy of Prevnar Prevnar protects against 7 out of 90 known strains of pneumococcus. This lack of protection against all types of meningitis, otitis media, etc is written in capital letters under the Warnings section.
Among the confusing tables listed to show efficacy studies, the package insert reveals that Prevnar only reduces cases of Otitis Media (ear infection) by 7%, even though Prevnar is often touted as an ear-infection vaccine.
Not Tested For The Ability To Cause Cancer As with every vaccine, Wyeth is not required by law to determine whether or not Prevnar can cause cancer or interfere with fertility, and specifically states “Prevnar has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility.”
Prevnar May Interfere With Other Vaccines When Prevnar is administered at the same time as vaccines for HIB, pertussis and polio, it may lower the efficacy of those vaccines.
Prevnar Precautions and Adverse Reactions Children who are immuno-compromised, receiving immunosuppressive therapies, HIV positive, or have a family history of such conditions may experience a reduction in vaccine efficacy.
Prevnar Reactions Reported to VAERS The government’s Vaccine Adverse Event Reporting System lists 13,912 adverse reactions that include the administration of Prevnar. However, since it is frequently given with other vaccines, it is difficult to determine which vaccine (or combination of vaccines) caused the reactions.
A specific search for vaccine-related deaths involving Prevnar results in 416 reports. Of those, 26 were related to Prevnar alone. The rest were in combination with other vaccines.
Other conditions associated with Prevnar alone include diabetes, hydrocephalus, encephalopathy, transverse myeltitis, respiratory distress, ataxia (loss of muscle control),cyanosis (blue skin/membranes) and foaming at the mouth.
The Prevnar Whistle Blower
Former Wyeth training director Mark Livingston alleged that employees were “signing off federally required documents and adopting procedure without the proper training.
He also reported unsafe work conditions. “I had many manufacturing technicians from 2000-2002 tell me they did not want to work in the Prevnar manufacturing area for fear of the chemicals used in the production process, including cyanide,” Livingston states.
The FDA itself fined Wyeth $30 million for violations that included insect infestations near the rooms where vilas were filled with the Prevnar vaccine. Wyeth reportedly addressed the problems and corrected them. Livingston claimed they did not.
When he complained, he was ordered to “back off.” He claims that he repeatedly communicated with higher ups about widespread quality control and training problems. He was consequently fired.
In 2003 Livingston filed suit against Wyeth. Wyeth responded that Livingston’s complaints were unfounded and that, given their nature, they do not fall under the protection of Whistle Blower laws, because those laws only pertain to matters affecting shareholders.
In 2004, Prevnar became the first vaccine to surpass $1 billion dollars in yearly sales, making it an important vaccine for Wyeth to protect.
As of 2006, the Livingston/Wyeth case was still unsettled. (source link)
A Final Word “The Prevnar pre-licensure clinical trials, which Wyeth Lederle paid Kaiser Permanente to conduct, compared two experimental vaccines against each other. To compound this basic methodological flaw, Kaiser and Wyeth Lederle, allowed most of the children in the trial to be given the more reactive DPT vaccine rather than use the safer, less reactive DTaP vaccine. This placed the children in that five-year experiment in greater danger and allowed the drug company to write off the seizures that occurred as being caused by DPT and not Prevnar, when in fact, they didn’t know. Even so, the groups of children who got Prevnar suffered more seizures, higher fevers, more irritability and other reactions than did the children who got the other experimental vaccine. It was a no-brainer as far as I was concerned: Kaiser and Wyeth Lederle had proved nothing about Prevnar vaccine safety.”–Barbara Loe Fisher
