A Critical Look at Bexsero

Although a host of different bacteria, viruses, and fungi can all potentially cause the onset of meningitis, the eight Princeton cases have all been determined to be the work of N. meningitides serotype B1. In a void of FDA approved vaccines, the University is turning to Bexsero, the work of the Swiss pharmaceutical company Novartis.

Because, left untreated, the effects of meningitis can escalate to permanent brain damage, hearing loss, and death2, there has been clear opportunity for vaccine development to reduce this risk.  According to a Reuters report, Novartis has sought to alleviate the losses of its vaccine-making division with the introduction of Bexsero3.  The ongoing outbreak is only the latest of proving grounds; their results will reverberate in both the health of communities affected and the division’s bottom line.

Drug agencies in Australia, Europe, Britain, and the United States have been keenly examining Bexsero’s clinical trials. As with any new drug, regulatory agencies hammer out conclusions from purported costs and benefits gleaned from clinical research. Even after analyzing more or less the same data, these agencies have not ruled uniformly.

Though a Novartis published study of Phase III results of the Meningococcal Group B Vaccines exhibited, in some cases, a 95% protective response to the vaccine components4, the same study also mentions side effects of administration. According to a European Medicines Agency FAQ5, the most common side effects in children are loss of appetite, fever, swelling, and redness. Similarly in adolescents, headache, nausea, and joint pain were reported in more than one patient in ten.

Overall, such mild side effects are positively gentle compared to the effects of meningitis and relatable to those of other vaccines. For example, slight rash and temporary fever are possible results of the current NJ state-mandated meningococcal vaccine6. Though each vaccine may carry a minute degree of risk (often exaggerated by the media), public health institutions have upheld the principles behind vaccination time and time again.

While the European Medicine Agency and the Australian Therapeutic Goods Administration have approved the use of Bexsero in the treatment of MenB, the U.K.’s Joint Committee on Vaccination and Immunization did not recommend its inclusion to the UK’s vaccination schedule7. As members of the University community that may have to elect whether to receive the vaccine, it is worthwhile to assess the possible reasons for the differing results.

In regards to Bexsero, the UK’s JCVI explicitly examined the merits of routine vaccination rather than in “epidemiological circumstances.”8 To this end, it scrutinized the benefits of reducing the prevalence of a disease that affects about two out of one hundred thousand Britons per year. Based on its analysis, the JCVI determined that it would not be cost effective to recommend this vaccine on a mass scale.  A lack of evidence specifically regarding adolescent immunization contributed to the committee decision to not recommend.

It is important to distinguish the fundamental differences between the scenario driving the JCVI’s report and the outbreak in Princeton. The increased risk of contracting meningitis undoubtedly corresponds to greater benefit incurred by protection from meningitis. Even more salient to the discussion is the University’s commitment to the health of its community; costs are not so restrictive in light of the resources available.

Whereas the precise efficacy of Bexsero in particular circumstances is still contested, the relative safety of the vaccine has thus far been accepted. Bexseroappears to significantly reduce the risk of contracting serotype B meningitis.  Combined with a prudent approach, a widespread application thereof may be an effectual step towards curbing the outbreak.

References

  1. Meningitis information. Princeton University. Retrieved from http://web.princeton.edu/sites/emergency/meningitis.html
  2. Meningitis. Mayo Clinic. Retrieved from http://www.mayoclinic.com/health/meningitis/DS00118/DSECTION=complications
  3. Retrieved from http://www.reuters.com/article/2013/07/24/us-novartis-vaccine-Bexsero®-idUSBRE96N0JF20130724
  4. Retrieved from http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/002333/WC500137857.pdf
  5. Pivotal study in The Lancet shows potential of Navartis vaccine Bexsero to help provide broad protection to infants against MenB. Novartis. Retreived from http://www.novartis.com/newsroom/media-releases/en/2013/1670001.shtml
  6. Helfand, C. Novartis’ Bexsero left off U.K. immunization schedule. FiercePharma. Retrieved from http://www.fiercepharma.com/story/novartis-Bexsero®-left-uk-immunization-schedule/2013-07-25
  7. Meningococcal vaccine for adults. WebMD. Retrieved from http://www.webmd.com/vaccines/meningococcal-vaccine-for-adults
  8. JCVI interim position statement on use of Bexsero meningococcal B vaccine in the UK. Retrieved from https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/224896/JCVI_interim_statement_on_meningococcal_B_vaccination_for_web.pdf