Pneumococcal Disease

by Susan Fletcher, May 2003

Pneumococcal disease ...is caused by the bacterium, Streptococcus pneumoniae (commonly known as "strep", also referred to as "pneumococcus"), and presents as various illnesses including otitis media (ear infection or inflammation of the middle ear, also referred to as "earache"), sinusitis (inflammation of one or more nasal sinuses), pneumonia and invasive, ie: spreading, infections such as bacteremia (blood poisoning) and meningitis. (Please note that all of these illnesses can also be caused by other bacteria or viruses.) ^{(1, 2)}

Approximately 90 serotypes (ie: types with specific characteristics to which our immune systems respond) of S. pneumoniae have been identified and their occurrence varies among different age groups and locations. According to the Prevnar^TM; monograph, studies in the US and Canada have indicated that annually there are 10 to 30 cases of invasive pneumococcal disease for every 100,000 population, with most cases occurring in children up to 2 yrs and in the elderly. Approximately 7 of these cases are children under the age of 2 who contract p. meningitis. Of one million children who contract p. meningitis, 5 to 6 may die, 17 to 18 may develop neurological complications and 22 to 23 may suffer hearing loss.⁽²⁾

A concise summary of US annual incidence of pneumococcal disease comes from a year 2000 reference:⁽³⁾

1. - 3 thousand cases of p. meningitis
2. - 50 thousand cases of p. bacteremia
3. - 500 thousand cases of p. pneumonia
4. - 7 million cases of p. otitis media.

Pneumococci can be spread by airborne droplets from sneezing, coughing or speaking. Aside from being very young or elderly, other factors that increase risk of infection include diabetes, kidney or liver disease, HIV, cancer, damaged spleen and airway damage from air pollution. However, many people have pneumococci in the their noses and throats without becoming ill. ⁽⁴⁾

Pathogens, like all other living organisms, live in balance with each other; when the population of one organism decreases, another organism moves in to occupy the niches left vacant. Decades of aggressive antibiotic treatments caused a decrease in those pneumococci targeted, only to realize a parallel increase in pneumococci that had mutated into antibiotic resistant "superbugs". Furthermore, increases of pneumococcal disease occurred following introduction, in the early 1990's of Haemophilus influenzae B (Hib) vaccine and a subsequent decrease of Hib disease. One reason for this may be that Hib vaccine temporarily reduced children's immunity to other pathogens including the pneumococci they carried in their noses and throats; another reason may be that more pneumococci were able to survive because they could move into niches previously occupied by Hib. ⁽⁵⁾ The antibiotics and, very likely, Hib vaccine caused an alarming increase in children's illness. Since the only pneumococcal vaccine available couldn't be used for anyone under 2 yrs old, a new market was opened for another vaccine. Enter….

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Prevnar^TM
…a 7-valent conjugate vaccine, ie: it contains 7 different serotypes of pneumococcus and the outside polysaccharide (carbohydrate) coating of the strep bacterium is conjugated (joined) to a carrier protein (in this case, a non-toxic variant of diphtheria toxin) in order that the vaccine will work in infants. It was developed for use in infants and children 6 weeks to 9 yrs. A Canadian study of 2040 cases of invasive p. disease in several locations indicated the 7 vaccine serotypes matched disease serotypes best in cases in the 6 month to 5 yr age range. ⁽²⁾

Efficacy: As is common, vaccine trials were poorly designed; efficacy and risks were gauged against those of other vaccines, not true controls such as injections of saline solution. ^{(2, 3, 6)} This failing was compounded by the fact that, in at least one of the trials for otitis media, the control, Hepatitis B vaccine, is one of several vaccines that may cause this disease. ⁽⁷⁾

Prevnar was licensed in the US in Feb 2000 and in Canada the following year. US approval and marketing was notorious for its associated conflicts of interest. ^{(3, 6)} The US FDA only approved Prevnar for use against the invasive diseases, p. meningitis and p. bacteremia, not otitis media or pneumonia; the trials have indicated efficacy to be only 4% to 7% and 6% to 13% respectively against those diseases. ^{(2, 3)} According to international authority, Erden Cantekin, PhD, "Simple facts about otitis media are: about 60% of the cases are viral, less than 40% are bacterial and perhaps 25% of all otitis is due to pneumococcus." ⁽³⁾ The product monograph says that the seven Prevnar serotypes are found in only 12% to 24% of all cases of otitis media. However, despite this and the poor efficacy, since otitis media is by the far the most prevalent of pneumococcal infections in young children, the vaccine is being marketed as preventive of ear infection. ^{(8, 9)}

The monograph states "Immune responses elicited by Prevnar among infants born prematurely have not been studied."

Risks: Again, as is usual with vaccine trials, length of follow-up to detect adverse reactions was too short to be able to detect all reactions that might have occurred. According to immunologist, Bart Classen, insulin dependent diabetes (IDDM) may take up to 10 years to develop after vaccination; he has found correlations between IDDM and several of the childhood vaccines, Hib vaccine being one.⁽¹⁰⁾ Dr Classen has warned that, since Prevnar is similar in structure to Hib vaccine but contains 7 times the number of serotypes, it may be 7 times more likely than Hib vaccine to cause IDDM. He predicts there will be 400 to 700 new cases of IDDM per 100,000 children vaccinated with Prevnar. ⁽¹¹⁾

The product monograph informs doctors and medical personnel that:

"Prior to administration of any dose of Prevnar… the parent, guardian… should be asked about the personal history, family history, recent health status, and immunization history of the patient to be immunized to determine the existence of any contraindication to immunization with pneumococcal vaccine….
The health care professional should also take all known precautions for the prevention of allergic or any other reactions. This includes: a review of the patient's history regarding possible sensitivity, the ready availability of epinephrine 1:1000 and other appropriate agents used for control of immediate allergic reactions; and a knowledge of the recent literature pertaining to use of the biological concerned, including the nature of side effects and adverse reactions that may follow its use."

Although it doesn't suggest avoidance of vaccination of such children, the monograph also states that "Children receiving therapy with immunosuppressive agents (large amounts of corticosteroids, antimetabolites, alkylating agents, cytotoxic agents) may not respond optimally to active immunization procedures."

During trials, short term local reactions were common with the highest rates being: 39.4% of recipients experienced a change in their ability to move the injected arm or leg, 41.9% - a fever, 72.8% - irritability, 50.8% - drowsiness, 29.9% - restless sleep, 33% - decreased appetite, 17.9% - vomiting, and 12.1% - diarrhea. There was a great variety of rare events including febrile illness, gastroenteritis, trauma, otitis media (!), hypotonic-hyporesponsive episode, seizures and death. ⁽²⁾

The monograph states "Prevnar has not been evaluated for its carcinogenic or mutagenic potential, or impairment of fertility." The fact that the vaccine contains an aluminum salt is worrisome since aluminum increases the poisonous effects of fluorides children's bodies receive from many sources. ⁽¹²⁾ It has been implicated in many different disorders including learning disabilities, degeneration of kidneys and liver, and motor paralysis. ⁽¹³⁾

The administration of Prevnar together with other vaccines, usually at 2, 4, 6, and 12 to 15 months, gives rise to another problem: trial data revealed that such combination may result in lower efficacy of Hib, pertussis and polio vaccines. No data for the effect on the performance of MMR is available. ⁽²⁾

Finally, since Prevnar is very similar to the vaccine for Hib, it seems quite likely that its widespread use will also be followed by a change in the types and distribution of pathogens. We can expect another surge of disease and yet another vaccine… and so the vaccine merry-go-round will continue.

References

1. Mosby Medical Encyclopedia, 1996; Signet.
2. Prevnar^TM monograph (package insert), Wyeth-Ayerst Canada Inc, May 2001.
3. National Vaccine Information Center 2nd International Conference on Vaccination, Sept 2000; Arlington, Virginia - speech by Erdem I. Cantekin, Professor of Otolaryngology, U of Pittsburgh.
4. What Your Doctor May Not Tell You About Children's Vaccinations, 2001 by Stephanie Cave, MD, FAAFP; pgs 217-218.
5. 'The Perilous Haemophilus, or is it …Pneumonia', July 1996, by Hilary Butler; http://www.vran.org/vaccine/pneumonia/pne_butler.htm
6. 'Prevnar: A Critical Review of a New Childhood Vaccine', Sept 19, 2000 by Michael Horwin, MA, mhbiomed@aol.com.
7. Recombivax HB® product monograph, Merck Frosst.
8. 'What do ear infections and meningitis have in common?' - Prevnar^TM brochure, Wyeth-Ayerst Canada Inc; 71400026-E-00.
9. 'New vaccine programs announced', press release; Vancouver Coastal Health Authority; April 13, 2003; Coast Reporter, Sechelt, BC.
10. 'New Tuskegee Experiment Planned With Pneumococcal Pneumonia Vaccine', press release; Feb 18, 2000; Classen Immunotherapies Inc., Baltimore, Maryland, U.S.A; tel (410) 377-4549; 'Vaccine Safety' website, http://vaccines.net.
11. Bart Classen, MD, in testimony to the US FDA's Vaccines and Related Biological Products Committee, Nov 1999.
12. Parents of Fluoride Poisoned Children website: http://bruha.com/pfpc.
13. Immunization: History, Ethics, Law and Health, 1999 by Catherine J M Diodati, MA; pg 71.

Vaccination Risk Awareness Network http://www.vran.org, May 2003