Prevnar Vaccine Nearly Approved for Ear Infections
A U.S. advisory panel on May
21, 2002 recommended approval of Wyeth's Prevnar pneumonia vaccine for
preventing some ear infections in children.
Prevnar hit the U.S. market in 2000 for combating seven strains of bacteria
that cause pneumonia.
Already given routinely to U.S. infants, winning Food and Drug Administration (news - web sites) approval for ear infections would allow Wyeth to promote Prevnar for the common childhood malady.
The FDA usually follows the advice of its advisory panels.
Ear infections are common in U.S. children, occurring in more than 60 percent in their first year of life and about 90 percent by age 5. Pneumococcus is the bacteria most often reported as responsible for ear infections, but they also can be caused by other bacteria or viruses.
The advisors voted 13-3 to recommend Prevnar for ear infections, despite concern by some panel members that the drug has limited effectiveness.
Wyeth estimates Prevnar could eliminate 1 million to 1.5 million doctor visits a year and cut ear-tube placements, a treatment for recurrent ear infections, by 60,000 a year.
Reuters May 21, 2002
| DR. MERCOLA'S COMMENT: |
This is the same vaccine that was inappropriately dramatized on ER last year.
Very disappointed to see that the drug company was able to get this vaccine approved for an indication that is clearly inappropriate.
Dr. Cantekin summarized this nicely two years ago:
Prevnar is a new vaccine against pneumococcus. The alleged benefits are greatly exaggerated and the risks are significant.
The least of the risks is the cost. A wholesale cost of about $58 make this the most expensive routine vaccine to date.
There are over 90 different serotypes (strains based on cell wall antigens) of pneumococcus. The vaccine has only 7 serotypes assumed to be common, but there is no way to know if this will be covering all of the strains.
In the US pneumococcus causes the following:
- 3,000 cases of meningitis
- 50,000 cases of bacteremia
- 500,000 cases of pneumonia
- 7 million cases of ear infections
The FDA approval states the drug is ONLY approved for invasive cases of pneumococcal disease such as bacteremia and meningitis. It is NOT approved for ear infections.
This is most peculiar because bacterial meningitis is primarily seen in adults not in infants, and it is infants for whom this vaccine is recommended.
The HMO trial in which Prevnar was approved had no placebo group. The control group received another experimental vaccine for mennigococcus. This was the ONLY trial that was done to establish the safety and efficacy to recommend this vaccine for every newborn in the US.
There is an important concept known as serotype drift, which describes the ability of the virus to actually shift and mutate. This phenomenon is well documented in many HIV trials.
Just how well did the vaccine work in the HMO trial? In the first 17 cases of bacteremia it worked perfectly.
However it was NOT effective for any cases of ear infections.
Ear infections are a BIG business in the US. It is estimated that 5 billion dollars a year are spent in treating ear infections.
If Prevnar could have stopped this, or even reduced the problem, it would have been great. But that was not the case.
The FDA data from the HMO trial in Finland showed that the prevention benefit is less than 4%.
The efficacy claims of Prevnar in ear infections and pneumonia remain unproven.
What about adverse side effects of Prevnar?
The children who received Prevnar in the trial were
- 4 times more likely to have seizures
- 4 times more likely to have stomach problems
Also, in the Prevnar group, significantly more children developed asthma. There was also one death in the Prevnar group and none in the other.
Prevnar alters the developing immune system. Additionally, it will put selective pressure on the pneumococcal serotypes and has the potential to change the natural pattern of strep infections.
With over one trillion dollars are under the watchful eyes of the FDA, CDC and the NIH, these three pillars of our public health care system have become more and more controlled by "expert panels" advisory committees.
Such experts dictate policy and control the complex biomedical system. They directly influence taxpayers health and wealth.
However, there is a huge conflict of interest because most of these experts serve the special interest groups who profit from their decisions. Many are in financial relationships with various manufacturers and/or are registered as paid speakers, in other words - lobbyists.
Related Articles:
Prevnar Vaccine: Nearly Half a Billion In Sales Last Year
Prevnar, Pneumococcal (Strep) Vaccine Does NOT Prevent Ear Infections and Has Major Side Effects