Pneumococcal (Prevnar)

Pneumococcal disease is caused by a common bacterium, the pneumococcus, or also known as Streptococcus pneumoniae, which can attack different parts of the body. From the CDC Pink Book

 
Pneumococci are common inhabitants of the respiratory tract and may be isolated from the nasopharynx of 5% to 70% of healthy adults. Rates of asymptomatic carriage vary with age, environment, and the presence of upper respiratory infections. Only 5%–10% of adults without children are carriers. In schools and orphanages, 27%–58% of students and residents may be carriers. On military installations, as many as 50%–60% of service personnel may be carriers. The duration of carriage varies and is generally longer in children than adults. In addition, the relationship of carriage to the development of natural immunity is poorly understood.

Prevnar (PCV7) was licensed in 2000 for children under age 2 or for older high risk children. It was marketed to prevent invasive pneumococcal infections that can cause earaches, meningitis, blood poisoning and pneumonia, even though the chance of an infant contracting invasive pneumococcal disease was determined to be about 0.15%. Prevnar was also promoted as the ‘prevention of ear infections vaccine’ even though the package insert showed the vaccine decreases ear infections by only 9%.

Prevnar covers only 7 strains out of over 90. These strains are: 4, 9V, 14, 19F, and 23F and oligosaccharide from 18C, 6B. Prevnar was invented due to the routine use of Hib vaccine. Pneumococcal infections increased by filling the void left by the Hib vaccine.

There are two vaccines for adults and children over the age of 2 called Pneumovax and Pnu-Immune which cover 23 different strains of Streptococcus pneumoniae bacteria. The conjugate vaccine is used in the children’s version, Prevnar, and the polysaccharide vaccine is used in adult version.

Pneumococcus bacteria do not generally cause severe disease. Why it does cause more severe disease in some people is not widely understood.  The high risk groups would include: persons aged 65 and older; individuals with weak immune systems due to cancer, leukemia, Hodgkin’s disease or human immunodeficiency virus (HIV); persons with sickle cell disease or without a functioning spleen; individuals who have a chronic illness such as lung, heart, and kidney disease, diabetes and alcoholism; persons living in special environments or communities, such as Alaskan Natives and certain American Indian populations; and residents of chronic or long-term care facilities. (Facts About Pneumococcal Disease)

Efficacy and Safety Studies:

 

There used to be an FDA transcript and a chart that showed the low efficacy for AOM, but it appears to have been removed.  Here is an excerpt of what it said:
 

In summary, the Committee concluded that data derived from two efficacy trials are adequate to demonstrate efficacy of Prevnar® against AOM caused by vaccine serotype.   
However, the committee expressed concern about the low efficacy (7%) of the vaccine against AOM regardless of etiology and concluded that substantial clinical benefit of Prevnar in reducing AOM regardless of etiology had not been demonstrated. The Committee cautioned against including an indication statement as proposed by the sponsor into the label and suggested using qualifying language if an indication for AOM regardless of etiology were to be added. Committee members cautioned against promoting prevention of AOM as a benefit of Prevnar in direct-to-consumer advertising because of concerns about unrealistic public expectations.  

The Committee was concerned that promoting Prevnar as an “AOM vaccine” could potentially compromise confidence in the existing recommendations for the vaccine and trust in the labeling that FDA puts on a vaccine.

 What about the safety of Prevnar? 

 

In the clinical trials, the pneumococcal vaccine was compared against an experimental meningococcal vaccine. This means the clinical trial had no real placebo because the reaction profile was unknown for both experimental vaccines, which would compromise the scientific validity of the safety trial. Children in the Prevnar trial group had more seizures, irritability, high fevers, amongst other reactions. There were 12 deaths reported in the Prevnar group but were dismissed as “Sudden Infant Death Syndrome.” (REF: Wyeth-Lederle Product Manufacturer Insert Pneumococcal 7- Valent Conjugate Vaccine (PREVNAR). Issued February 2000. www.fda.gov/cber/label/prevnarLB.pdf). Also see: Prevnar -a critical review of a new vaccine.

 

While the Pneumococcal vaccine may have reduced incidence rates, there has been a trade-off due to serotype replacement  The strains not covered in the current vaccine for children are proliferating. According to Science Daily:

The incidence of IPD caused by strains not included in the vaccine rose by 40%. One of the non-vaccine strains, 19A showed an increase of 264%… Disease caused by non-PCV7 serotypes, especially 19A, is emerging and accounts for nearly all IPD.

According to The Journal of Infectious Diseases 2008; 197:1016–1027: Emergent Streptococcus pneumoniae Serotype 19A in the United States 2005:

Conclusions.  PCV7 ineffectiveness against serotype 19A, antibiotic resistance, clonal expansion and emergence, and capsular switching have contributed to the genetic diversity of 19A and to its emergence as the predominant invasive pneumococcal serotype in the United States.

Another problem with the widespread use of Prevnar has been the emergence of antibiotic resistant bacterial strains. The introduction of Prevnar appears to have caused many strains to become highly resistant. A vaccine-resistant virulent strain of strep is causing ear infections in children that cannot be treated with antibiotics safe for use in children.

 

Michael E. Pichichero and Janet R. Casey of the University of Rochester in New York documented the emergence of an antibiotic-resistant strain of another bacterium known as Streptococcus pneumoniae, which causes common ear infections. Although all 11 children identified in the Rochester area with the microbe so far were successfully treated, five required an antibiotic approved only for adults, and one child was left with permanent hearing loss.

The researchers attributed the emergence of the strain to a combination of the overuse of antibiotics and the introduction of a vaccine that protects against the infection.

“The use of the vaccine created an ecological vacuum, and that combined with excessive use of antibiotics to create this new superbug,” Pichichero said.

 

Prevnar has not reduced the number of cases of meningitis. It has merely changed them to other types of meningitis.

Children with Bacterial Meningitis Presenting to the Emergency Department during the Pneumococcal Conjugate Vaccine Era. Volume 15 Issue 6 Page 522-528, June 2008 Academic Emergency Medicine 15 (6) , 522–528.

 Conclusions: Although now a rare infectious disease in United States, bacterial meningitis still causes substantial morbidity in affected children. Despite the introduction of PCV7, S. pneumoniae remains the most common cause of bacterial meningitis in U.S. children, with approximately half of cases due to nonvaccine serotypes.

 What is the answer to that? A new vaccine for Meningitis for toddlers and adolescents! This will simply try and fool Mother Nature and further mess with the bacterial balance of the body. This will not just affect those who choose to vaccinate because the strains not covered by the vaccine are in higher concentrations in those vaccinated, which will facilitate the spread of the bacteria to everyone.

 

MRSA is also a strain of the bacterium that usually causes staph infections that used to be easily treatable with common antibiotics in the penicillin family. Resistant strains of the organism have been increasing.

 

Natural immunity to pneumococcus may be more important for protecting against the disease than the vaccine according to research published in 2005. The researchers found that another mechanism, other than antibody protection, confers protection against the bacteria. What provides this protection? Researchers don’t quite know.

 these observations make a strong case for the importance of one or more factors other than [the development of] antibodies” is necessary to confer protection against pneumococcal disease.” So, children have an element of natural protection, beyond the perceived benefit of the pneumococcal vaccine, we do not understand.

Interesting!

 

If we are trading one disease for another, how do we stop it, and stop the need for more and more vaccines?  Is it already too late?  Stay tuned for more on pneumococcus…

 

Cumulative weekly number of reports of Invasive Pneumococcal Disease due to any of the serotypes NOT IN Prevenar™ : Children aged < 2 Years in England and Wales by Epidemiological Year: July-June (2003- To Date)

 

Source:

http://www.hpa.org.uk/webw/HPAweb&HPAwebStandard/HPAweb_C/1207821645727?p=1203409671876

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