Sunday, November 17, 2013

Princeton/meningitis

There has been a cluster of cases of meningitis (7 cases in since March 2013) at Princeton, leading to talk of recommending mass vaccination with a vaccine (Bexsero) that is not approved in the US.


In an article by Dr. Tenpenny:
1. This is not an epidemic: Only 7 cases of have occurred since March (9 months). The media needs to stop spreading hysteria. This is the definition of an epidemic:
Widely prevalent; Spreading rapidly and extensively by infection and affecting many individuals in an area or a population at the same time;  An outbreak of a contagious disease that spreads rapidly and widely.”
The bacteria is not spread through the air and it doesn’t live outside the human body for very long. You cannot get meningitis from casual contact. The infection occurs randomly and will not spread rapidly across the campus to other students. (1) 

While it is good to be aware of the risks of this illness in this (well, any) population, it is
equally important to know the risks of vaccination. Parents and young adults who are faced
with deciding whether or not to take a vaccine need to be able to weigh the risks/benefits,
pros/cons of taking or not taking a vaccine.

More from Dr. Tenpenny's post (link to original article is available below):
3.  There has been no approved vaccine for serotype B for many years. Why? Meningitis vaccines for strains A, C, Y, and W-135 are made from a fragment of the bacteria’s cell wall. In the event the bacteria gets past the body’s external barriers of defense and into the blood stream, the vaccine-induced antibody seeks out the fragment sequence on the surface of the bacteria and “kills it” by a process called lysis.
Manufacturing a similar cell-wall antigen vaccine is not possible for serotype B bacteria. The sugar sequences on the surface of this bacteria are very similar to the sugar sequences on the surface of human brain and nerve cells. Therefore, vaccine-induced antibodies can attack the brain and the nerves, causing a debilitating, life-long, autoimmune reaction. (1) 
Since there is so much similarity between the sugar sequences on the serotype B
bacteria and sugar-structures in the cell walls of our neural cells it is understandable
that vaccine-makers have been hesitant to attempt to produce a vaccine with this
type of target for antibody production.

It is not in us in the United States, but the FDA has approved the import of Bexseros
as their Investigational New Drug Application program. (3)

Those who choose to take this vaccine should be informed that it is not FDA approved
and that it is only available through the Investigational New Drug program - they may then infer
that any use of this vaccine is essentially post-marketing surveillance - another way of saying
a clinical trial that occurs after a medication is in wide-spread use.

Bexsero, the vaccine in question has been approved in the European Union, but not in the United Kingdom. Their reasons for not accepting it into their schedule included lack of data for efficacy (point 10), and not meeting cost effectiveness criteria (point 16); (2)

As Dr. Tenpenny noted, presence of an antibody response following administration of a vaccine is **presumed** as "protective"; It seems using the term "risk reduction" might be a bit more accurate. Protection is not the same as risk reduction. This blogger wonders if/when vaccines will be tested in the real world with double-blind randomized controlled trials (with saline as a placebo, not another vaccine!)

Because of the questions surrounding efficacy and safety, vaccination should be voluntary, not mandatory. 

The beauty of a free market is that it reflects the collective wisdom of individual choices. Let the demand for vaccination be determined by the free market, and the pharmaceutical companies can, and will adjust. This will require more and better data for clinicians to be able to discuss risk/benefit ratios with their clients who can then decide if they want the product. 


Here's a link to another story (not related to Princeton) about use of texts messages to increase vaccination rates among the poor in Guatemala: 

Ultimately we will not vaccinate our way to good health, and the dear people of Guatemala (and elsewhere) deserve the same benefits and resources that have helped so many in the developed world achieve good health: economic development and education, both of which lead to better living conditions that help decrease disease through access to clean water and better sanitation. 


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2 comments:

  1. It is my understanding that the Administration of Princeton is pressuring families to vaccinate their children against this bacteria. Has there been any effort to educate the students or parents as to the risks associated with this vaccine, such as neurological impairments, and auto immune response? What about an effort to get the administration to give equal time to vaccine risk education?

    What about contacting the media that is hyping this story and requesting that they give equal time to risk education associated with using this unapproved vaccine... ?

    ReplyDelete
    Replies
    1. I don't know that anyone is being "pressured", thought that is certainly possible. Many of these students may already have been vaccinated using one of the two vaccines for meningitis that are currently approved in the US - though neither of them target the type of meningitis that is occurring in this cluster. I wonder if Princeton requires students to be vaccinated prior to admission.

      My primary concern is that vaccination should be voluntary due to the fact that it is a risk reduction strategy (not protection), and also because there are legitimate questions about vaccine safety;

      Delete

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