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Legislators Want to Subject NJ College Students to a Poorly Tested Vaccine

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Come Winter 2019, some NJ legislators are hoping to pass A1991/S941, a bill that would require all NJ college students to receive one of two fast-tracked meningococcal group B (MenB) vaccines. This is troubling, since a) even the federal Advisory Committee on Immunization Practices (ACIP) refrained from making a blanket recommendation for MenB vaccines, and b) this legislation would turn NJ college students into unwitting recipients of vaccines that haven't undergone sufficient testing through clinical trials and could put them at significantly higher risk of experiencing a serious adverse reaction than the risk of becoming ill from meningococcal bacteria.

MenB vaccines are already readily available to any college student in New Jersey who would like to receive them in the absence of proven clinical efficacy and a clear safety profile. In fact, the two available MenB vaccine brands, GlaxoSmithKlein's Bexsero[i] and Pfizer's Trumenba,[ii] were granted Breakthrough Therapy designation, making them eligible for the FDA's Fast Track to expedite availability to NJ students. Even prior to its accelerated approval by the FDA in 2015, Bexsero was cleared for "emergency" use during an outbreak involving eight cases of meningococcal meningitis at Princeton University in 2013, when all students were encouraged to receive the vaccine[1].

Meningococcal disease is extraordinarily rare, even though meningococcal bacteria are common denizens of the human throat. In fact, about 10 percent of the population is carrying these bacteria at any given moment, without developing invasive meningococcal disease. According to the CDC's "Enhanced Meningococcal Disease Surveillance Report, 2017," there were only 48 cases of meningococcal group B disease in the 16-23 age group, an incidence rate of about 1 in 1.4 million, and the overall incidence rate in the U.S. population is even lower (1 in 2.4 million).[iii] There were a total of 10 cases of meningococcal group B disease and no fatalities among college students in New Jersey (Princeton and Rutgers) between 2013 and 2017, [iv] so we are looking at a rather expensive and oppressive vaccine mandate aimed at preventing a rare disease that can be treated with antibiotics and prevented by less invasive health measures.

According to vaccine package inserts, 2.1% of participants who received Bexsero[v] and 1.8% of those who received Trumenba[vi] experienced serious adverse events. For the 413,779 students enrolled in NJ colleges and universities[vii], that would translate to the likelihood of between 7,448 and 8,689 serious adverse reactions depending on which vaccine is used, if all students are to be vaccinated. At $139-$170/dose with a recommended 2-dose series in the case of Bexsero or 3-dose series in the case of Trumenba, it would cost the NJ health care system upwards of $141 million[2] to attempt to prevent 2 annual cases of meningococcal group B meningitis on college campuses. And many students are likely to have severe adverse reactions, such as those experienced during clinical trials, necessitating further medical care costs. 

And even then, the success of such a massive preventative endeavor is doubtful: the first ever use of the MenB vaccine in the United States was a disappointment, as Bexsero failed to demonstrate an adequate immune response in 1 out of 3 students who received it.[viii] Furthermore, there are no data from pre-licensure clinical trials on the ability of MenB vaccines to prevent meningococcal disease. Their licensure by the FDA was based solely on immunogenicity data--that is, the ability to induce antibodies, not prevent disease. And the CDC states: "Today, meningococcal disease is at a historic low in the United States. Incidence of meningococcal disease has been declining in the United States since the 1990s. Much of the decline occurred prior to routine use of MenACWY vaccines. In addition, serogroup B meningococcal disease declined even though MenB vaccines were not available until the end of 2014."[ix] Hence, the epidemiologic trend in meningococcal disease reduction is not attributable to meningococcal vaccines.

Furthermore, vaccine package inserts acknowledge that the vaccine may not provide protection against all meningococcal group B strains and warn that individuals with altered immunocompetence, certain complement deficiencies or those receiving treatment that inhibit terminal complement activation (i.e. eculizumab) are less likely to be protected by the vaccine. These happen to be the same individuals that are considered to be the most "at risk" for meningitis... in other words, the very group that actually needs protection from meningococcal carriage. And according to research published in the Journal of Infectious Diseases in 2017, MenB vaccines "do not have a large, rapid impact on meningococcal carriage and are unlikely to provide herd protection."[x] Hence, it is futile to try to protect the immune-compromised by mandating the vaccine for the rest of the healthy student population.

Most people don't know that the discrepancy between the preponderance of healthy meningococcal carriage and the infrequency of meningococcal disease lies in its association with personal risk factors. Meningitis is a disease of invasion. Meningococcal bacteria cause disease only if they gain access to the central nervous system and cause inflammation of the meninges, which is the lining around the brain and spinal cord. Healthy respiratory and immune systems can readily prevent meningococcal bacteria from becoming invasive.

An education campaign would likely be far more useful to college students than mandatory vaccination. It would be much more fruitful and cost-effective to focus on addressing personal lifestyle risk factors as a means of preventing meningococcal disease on college campuses. For example, smoking and exposure to second-hand smoke cause oxidative damage to the body, impairs immunity at the respiratory tract and the integrity of the blood-brain barrier, putting a person at higher risk for invasive bacterial disease. In fact, second-hand smoke is a well-established risk factor for meningococcal disease in children.[xi] It also helps to explain why most meningococcal disease cases are isolated and why meningococcal disease incidence in general went down once stricter smoking laws and policies came into effect across the U.S. 

Since Bexsero and Trumenba were fast-tracked, their manufacturers are required to study the post-marketing data on clinical effectiveness and safety to supplement insufficient pre-licensure data. Early indicators are demonstrating unfavorable cost-benefit analysis, which may be why the ACIP voted for a "Category B" recommendation. Based on the CDC's website, this means "MenB vaccine may be administered based on individual clinical decision to adolescents not at increased risk age 16-23 years (preferred age 16-18 years)."[xii] Yet, if A1991/S941 becomes law, students at NJ higher education institutions will be forced to become part of the post-marketing data surveillance for vaccines that are not even recommended without an individual clinical decision. 

Again, New Jersey already provides accessibility to the MenB vaccine in accordance with the ACIP's current recommendation and students are welcome to do the risk/benefit analysis for themselves before choosing to receive it. Students pursuing a degree in New Jersey deserve the right, enshrined in the Nuremberg Code, to choose whether or not they want to be subjects in post-marketing vaccine surveillance. A1991/S941 would deprive them of that right.


References

[1] https://www.fiercepharma.com/pharma/princeton-weighs-emergency-vaccine-campaign-novartis-bexsero-shot

[2] https://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html

[i] https://www.gsk.com/en-gb/media/press-releases/gsk-s-meningitis-b-vaccine-bexsero-receives-breakthrough-therapy-designation-from-us-fda-for-prevention-of-invasive-meningococcal-disease-in-children-2-10-years-of-age/

[ii] https://www.streetinsider.com/Corporate+News/Pfizer+%28PFE%29+Announces+FDA+Breakthrough+Therapy+Designation+for+TRUMENBA+for+Prevention+of+Invasive+Meningococcal+B+Disease+in+Children+Ages+1+to+9+Years/14081931.html

[iii] https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report-2017.pdf

[iv] https://www.nmaus.org/wp-content/uploads/2017/01/College-Cases-Map.pdf

[v] https://www.fda.gov/vaccines-blood-biologics/vaccines/bexsero

[vi] https://www.fda.gov/vaccines-blood-biologics/vaccines/trumenba

[vii] https://www.state.nj.us/highereducation/documents/pdf/statistics/bygender/ENR2018Race.pdf

[viii] https://www.webmd.com/vaccines/news/20160720/meningitis-b-vaccine-falls-short-of-expectations#1

[ix] https://www.cdc.gov/vaccines/vpd/mening/hcp/about-vaccine.html

[x] https://academic.oup.com/jid/article/216/9/1130/4095063

[xi] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2998445/

[xii] https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html#note-mening-b

Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of GreenMedInfo or its staff.
Sayer Ji
Founder of GreenMedInfo.com

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