November 28, 2013
Over the last week, there has been a lot of noise, eh, news about the meningitis outbreak at Princeton University and the “rush” to bring in an unapproved vaccine from Europe to mass vaccinate the kids on campus. Here are important considerations for you to know:
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.
2. Strain type: There are more than 12 serotypes (strains) of Neisseria bacteria. The cases at Princeton involves serotype B, the most common cause of bacterial meningitis and sepsis in infants in Europe and causes of up to 60% of cases in the U.S. Of note, none of the meningitis vaccines recommended for college admission (Menomune, Menactra or Menveo) produce antibodies against the serotype B strain. Interestingly, certain strains of meningococcal bacteria are actually beneficial. Read more here.
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.
After 15 years of research, Norvartis found a method it hoped would be a work-around by using computer sequencing to examine different segments of the cell wall. The result lead to the development of Bexsero, (a.k.a. 4CMenB), the first vaccine against serotype B. The Princeton infections, now a media-hyped “medical emergency”, would allow Novartis to push their new vaccine into the U.S. vaccination schedule without FDA approval, creating a financial coup for Novartis and giving the appearance of saving the day.
4. The CDC and the media are unnecessarily terrorizing parents into vaccinating their college-aged kids against meningitis. The media has made statements such as, “College freshmen living in dormitories were more than seven times as likely to acquire the infection leading to meningitis than college students in general and three and a half times as likely as the population of 18- to 23-year-old non-students.”
That’s interesting because CDC publications actually say something very different about the risk of meningitis when teens live in the dorm. It appears that the “risk” was created to develop a marketshare for the vaccine, after it was manufactured. Read what the CDC actually said:
Overall incidence of meningitis among college students usually is similar to, or somewhat lower than, than the risk observed among persons in the general population of similar age….
The earliest of these studies (done during academic years 1990–91 and 1991–92) indicated a low overall incidence of meningococcal disease among U.S. college students (1.0/100,000 population per year).
A retrospective cohort study conducted over 5 years (1992–1997) indicated that the overall incidence of meningococcal disease among college students was similar to that among the U.S. population of persons the same age. However, rates of disease among students living in dormitories were somewhat higher than rates among students living off campus (3.2/100,000 and 1.0/100,000, respectively — over 5 years).
So the risk going up from 1 to 3.2 per 100,000 is “three times” the risk. However, the reality of this increase needs to be put into perspective.
5. Parents on the news said, “Well, if Bexsero is approved in Europe, it must be OK for me.” Not so fast. On July 23, 2013, the The Joint Committee on Vaccination and Immunization (JCVI) in the UK refused to approve the Novartis vaccine, saying it was too costly and the manufacturer did not put forth enough proof that it works to prevent meningitis. The Director of Immunization, Professor David Salisbury said:
This is a very difficult situation where we have a new vaccine against Meningitis B but we lack important evidence. We need to know how well it will protect, how long it will protect and if it will stop the bacteria from spreading from person to person.
Wisely, the JCVI refused to approve the vaccine due to lack of clinical efficacy studies. The vaccine was approved in the EU and Australia from a trial involving 1,800 infants that showed a “robust” immune response when given Bexsero alone or along with other vaccines. This was based on something called “surrogate protection,” meaning, protection is assumed (but not proven) due to the presence of antibodies in the blood stream. The JCVI noted that efficacy against disease has not been established and interestingly, that Bexsero’s antibody response waned rapidly.
6. Like most things in the pharmaceutical industry, it’s all about the money. Novartis was flying high when Bexcero was approved by the European Union. Novartis stands to generate annual sales of $700 million by 2020 to $1.45 billion by 2016 from this vaccine alone, depending on which analyst you ask. However, their jubilee quickly faded after the rejection in the UK, as reported in Reuters:
The rejection of Bexcero by the JCVI represents a material setback to Novartis’s beleaguered vaccine division. In the absence of a successful appeal, Bexsero revenue will likely be restricted to a minimal private-payer market,” Citi analyst Andrew Baum said. “More importantly, it could force Novartis to sell, partner or more likely, integrate its vaccine business within its pharmaceutical infrastructure.