(Updated, February, 2011)
Pneumococcal diseases are associated with the bacterium, Streptococcus pneumoniae (commonly known as “strep”, also referred to as “pneumococcus”). Pneumococcal diseases include: otitis media (also called “ear infection”, “earache”, and “inflammation of the middle ear”); sinusitis (inflammation of one or more nasal sinuses); pneumonia; bacteremia (blood poisoning); and meningitis. However, all of these illnesses can also be associated with other bacteria or viruses.
Approximately 90 serotypes (commonly referred to as “strains”) of Streptococcus pneumoniae have been identified. Their occurrence varies among different age groups and locations. According to the 2008 Product Monograph for Prevnar®, the pneumococcal vaccine used for Canadian vaccination schedules, various studies done in USA and Canada from 1986 to 1997 indicated a yearly incidence of only 10-30 cases of invasive pneumococcal disease (bacteremia and meningitis) for every 100,000 people. How well this represents today’s prevalence is anybody’s guess.
In affirmation of the general decline in children’s health in recent decades, the monograph states: “It was shown in the Canadian multicentre pediatric study [an analysis of data collected at 11 centres from 1991 to 1998] that the proportion of children with an underlying condition increased with age, from 15.9% in those under 2 years of age, to 30.4% in those 2-5 years of age, and to 44.5% in those over 5 years of age.” The monograph notes that such underlying disease increases risk of invasive pneumococcal disease.
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. And, as is the case for other infectious diseases, use of fever-suppressing drugs during the initial stages of pneumococcal disease can result in a more serious outcome than would otherwise have resulted. However, despite the fact that some people develop significant illness, it’s common for pneumococci to be carried in the nose and throat without any outward evidence of infection.
Like all other living organisms, pathogens 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. 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 Prevnar®.
As usual for vaccine trials, those for Prevnar® were poorly designed; efficacy and risks were gauged against those of other vaccines, not true controls such as saline solution. In US clinical trials with 37,816 infants an “investigational meningococcal group C Conjugate Vaccine” was used as the control. The fact that both Prevnar and the “control vaccine” were “investigational” makes outcomes even more questionable. But even this failing was compounded by the fact that, “Routinely recommended vaccines were also administered which changed during the trial to reflect changing AAP [American Association of Pediatricians] and Advisory Committee on Immunization Practices (ACIP) recommendations.”
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. The US FDA only approved Prevnar® for use against the invasive diseases, p. meningitis and p. bacteremia, not otitis media or pneumonia. The 2008 Prevnar® monograph tells us that, in the US clinical trials, pneumonia cases were reduced by only 10% and “The estimated reduction for all AOM [acute otitis media] episodes was 7%”. An even lower, 6% reduction found in Finnish trials may actually be an overvaluation since the control used in those trials was Hepatitis B vaccine, one of several childhood vaccines that can cause otitis media. According to a year 2000 speech by 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.” 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 has been and is being marketed in Canada as preventive of ear infection.
Regarding risks, the monograph warns that “Healthcare professionals should administer this product with caution to patients with a possible history of latex sensitivity since the vial stopper, the syringe plunger stopper and the syringe tip cap contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected into persons with known or possible latex sensitivity.” And, “As with all injectable [sic] pediatric vaccines, the potential risk of apnea [absence of automatic breathing] should be considered when administering the primary immunization series to premature infants.” And, “Prevnar has not been evaluated for its carcinogenic or mutagenic potential, or impairment of fertility.”
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. Dr Classen has warned that, since Prevnar® is similar in structure to Hib vaccine but contains seven times the number of serotypes, it may be seven times more likely than Hib vaccine to cause IDDM. He’s predicted there will be 400 to 700 new cases of IDDM per 100,000 children vaccinated with Prevnar®.
Specific instructions re administration of Prevnar® include the following: “The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel. The needle should be long enough to reach the muscle mass and prevent the vaccine from seeping into the subcutaneous tissue; but not so long as to involve underlying nerves and blood vessels or bone. Healthcare professionals should be familiar with the anatomy of the area into which they are injecting vaccine. An individual decision on needle-size and site of injection must be made for each person on the basis of age, the volume of the material to be administered, the size of the muscle, and the depth below the muscle surface into which the material is to be injected.”
Wyeth describes its vaccine as: “Individual polysaccharides of the capsular antigen of Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F individually conjugated to diphtheria CRM197 protein. … CRM197 is a non-toxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7…grown in a casamino acids and yeast extract-based medium…purified through ultra-filtration, ammonium sulfate precipitation, and ion-exchange chromatography… .” Apart from the seven antigens it also contains aluminum phosphate and sodium chloride. It doesn’t contain a preservative since it is supplied in single-dose vials or pre-filled single-dose syringes.
Now, despite widespread use of Prevnar pneumococcal vaccine since its introduction in Canada in the year 2001, health authorities are warning about a new highly antibiotic-resistant strain of pneumococcus, a sub-type of which first appeared in BC in 1996. In October, 2007, the Journal of the American Medical Association reported a New York outbreak of a different sub-type of the same strain. A Nov 11, 2007 Canadian Press article quoted Dr. Ron Dagan, director of the pediatric infectious disease unit of Soroka University Medical Center in Beer-Sheva, Israel as saying, “19A can be a really, really bad bug. And it can get to be a very, very highly (drug) resistant bug. It’s definitely one of the six or seven most important (pneumococcal) serotypes in childhood infections. . .It is becoming more important because of antibiotic resistance. And it’s a trend worldwide – it’s not only in Canada and the U.S.”
On Nov 7, 2007, the Globe & Mail reported a case of severe 19A infection: “A 14-month-old child being treated at the Hospital for Sick Children in Toronto may be the first person in this province to have been infected by the superstrain. The child was healthy, fully vaccinated and had not travelled, but doctors believe the child picked the strain up in the community and developed a severe case of bacterial meningitis, a serious infection of the fluid around the spinal cord and brain that can lead to deafness and neurological damage.”
Prevnar can only possibly prevent illness associated with the seven strains of pneumococcus represented in its formulation. The disease causing potential of strain 19A was well known while the vaccine was being developed, but it was thought that the vaccine strain, 19F, might provide some protection against 19A and therefore, the latter could be excluded. Infectious disease “expert”, Dr Allison McGeer, expressed her disappointment, saying, “We were really hoping there would be some cross-coverage of 19A and there doesn’t seem to be.”
Not only is the Toronto 19A sub-type resistant to all antibiotics except a fluorinated one not recommended for children, it also can cause severe disease, as the meningitis case demonstrates. Yet, seemingly oblivious to reality, when asked what parents can do about it, Dr McGeer told the Canadian Press, “Get your vaccines. …These are the things we know work and these cases are why we say it.”
By November, 2010, the National Advisory Committee on Immunization (NACI) was recommending an upgrade to the vaccine. They conceded: “Given the …increased burden of serotypes…in particular 19A, NACI concludes there is good evidence to recommend that PNEU-C-13 vaccine [pneumococcal vaccine with 6 additional serotypes for a total of 13] be the current product of choice for routine infant immunization schedule”. Hedging their bets, they also recommended: “Taking into account herd immunity (indirect protection), serotypes replacement, and the relative cost of vaccines, the choice of pneumococcal vaccine for the primary infant series in a jurisdiction may change over time and will depend on the local serotype and age-specific epidemiology of IPD [infant pneumococcal disease]. NACI therefore concludes that in the future there is good evidence to recommend that a pneumococcal conjugate vaccine be part of the infant immunization schedule, in accordance with circulating serotypes.” (emphasis ours)
How many adverse events and/or replacement vaccines will it take before the NACI realizes that the risks of vaccination against pneumococcal disease far outweigh the benefits?