During the last two years, there have been a couple of outbreaks and sporadic cases of bacterial meningitis that federal health agencies failed to address with sufficient aggressiveness. It could have been much worse, and the experience should serve as a wake-up call.
Meningitis is a devastating infectious disease, often misdiagnosed as flu, and it can become debilitating so quickly that by the time it is recognized, the patient may be too sick for effective treatment.
Over the last four decades, the threat from several types of bacterial meningitis has been significantly reduced by immunization. The first vaccine was approved in 1974, and a newer version was introduced in 2005. However, a vaccine for meningitis B, or MenB, has taken much longer to develop. The first MenB vaccine, brand name Bexsero, was not approved until 2013 by the
MenB primarily infects those under the age of 25. College students and prisoners are particularly vulnerable because of their close quarters. About 10% of those infected die, and survivors can suffer brain damage, hearing loss and limb amputations. Those infected with less severe or no symptoms may become carriers.
Single fatalities from MenB occurred in New York in 2012, Michigan in 2013 and Pennsylvania this year. Since March of last year, there have been nine cases at
In order to make the unapproved vaccine available to the Princeton and UCSB students, the
This process has inherent delays. The CDC had to prepare and file the INDs, establish treatment protocols, involve an institutional review board and the manufacturer, get the necessary patient or parental consents, and ensure that the vaccine would be covered for any potential liability under the National Vaccine Injury Compensation Program.
Two drug companies, Pfizer and
Had the East and West Coast MenB outbreaks been more extensive, hundreds or even thousands of people could have died or been maimed. We need policy changes to address such threats more efficiently in the future. For example, the delayed access to Bexsero would have been avoided if the FDA had had "reciprocal" authority to rapidly approve a drug or vaccine approved abroad in the face of a public health threat in the United States. Such reciprocity would derive from the prior approval by a major foreign regulatory authority, such as Canada or the EU.
There will be other health crises. It's time for
Up to now, we have been lucky. But recalling Louis Pasteur's admonition that "luck favors only the prepared mind," we need to prepare.