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NLM Director’s Comments Transcript

FDA Approves Meningitis B Vaccine: 12/01/2014

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Greetings from the National Library of Medicine and MedlinePlus.gov

Regards to all our listeners!

I'm Rob Logan, Ph.D. senior staff U.S. National Library of Medicine for Donald Lindberg, M.D, the Director of the U.S. National Library of Medicine.

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The U.S. Food and Drug Administration (FDA’s) recent approval of a vaccination to prevent meningitis B provides the first U.S. clinically sanctioned vaccine to stop the bacterial illness that killed six college students within the past two years.

The FDA’s approval process, which occurred in less than six months, turns a page in a tragic episode where six college students died from meningitis B – perhaps stemming from a misperception about the safety of the previously, available meningitis B vaccine. 

For example, in a memorable address to the Association of Health Care Journalists’ (AHCJ) national meeting last spring, a prominent, Children’s Hospital of Philadelphia, pediatrician noted the then-recent deaths of college undergraduates may have occurred because they had little confidence in the safety of a previous meningitis B vaccine (which was approved in Europe and Australia –  but not by the FDA in the U.S.)

Paul Offit, an M.D. and author, told AHCJ he believed last spring’s deaths partially stemmed from a patient and public misperception of the prior meningitis B vaccine’s safety. He explained this misjudgment was reinforced by consistent press reports that the FDA had not approved a previous meningitis B vaccine, which rarely added evidence why the immunization was approved in Europe and Australia.

Dr. Offit noted the vacuum of information about the vaccine’s safety and low risk may have deterred some young persons to obtain the prior meningitis B preventive vaccine — even after the European/Australian vaccine became available in some university health clinics last spring (following a special waiver from the FDA).

In addition to journalists, Dr. Offit criticized some public health professionals, health care organizations, and pharmaceutical firms for not clarifying and communicating the evidence that suggested the meningitis B vaccine’s safety. He memorably explained the importance of communicating clinical evidence as an antidote to public anxiety and uncertainty.

Fittingly, in the news conference to announce the FDA’s first approval of a new meningitis B vaccine, FDA officials told several news organizations they hoped the FDA’s endorsement would increase confidence and remove any hesitation among young persons to receive a meningitis B immunization.

An FDA official also told the Washington Post the 2014 meningitis B outbreaks in different regions of the U.S. (and we quote) ‘underscored the urgent public health need’ (end of quote) for a U.S.-approved, evidence-based vaccine.

Meanwhile, MedlinePlus.gov’s meningitis health topic page explains meningitis B is one of several forms of meningitis, which is an inflammation of the thin tissue that surrounds the brain and spinal cord. Meningitis B bacteria can spread through close physical contact like coughing, kissing and sharing eating utensils. Hence, outbreaks are more common in places where people live in close quarters, such as residential colleges and universities.

A website from the U.S. Centers for Disease Control and Prevention discusses the types of bacterial meningitis in the ‘specific conditions’ section of MedlinePlus.gov’s meningitis health topic page. The CDC reports there are about 4,100 cases of bacterial meningitis – and about 500 deaths – annually in the U.S.

Some helpful information about meningitis vaccinations written for young persons (and provided by Boston Children’s Hospital) is available in the ‘teenagers’ section of MedlinePlus.gov’s meningitis health topic page.

MedlinePlus.gov’s meningitis health topic page additionally provides links to the latest pertinent journal research articles, which are available in the ‘journal articles’ section. Links to clinical trials that may be occurring in your area are available in the ‘clinical trials’ section. You can sign up to receive updates about meningitis as they become available on MedlinePlus.gov.

To find MedlinePlus.gov’s meningitis health topic page type ‘meningitis’ in the search box on MedlinePlus.gov’s home page, then, click on ‘Meningitis (National Library of Medicine).’ MedlinePlus.gov also has a health topic page on immunization.

Most of all, let’s hope the FDA’s approval reverses the recent cycle of meningitis B cases on the nation’s college campuses.

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