Update: FDA Drags Feet on Approval of Internationally-Accepted Vaccine While Drexel Student Dies of Meningitis B

Drexel University

Drexel University

The Centers for Disease Control and Prevention (CDC) have concluded that a Drexel University student who died in early March was infected with the same strain of meningitis, “serogroup B,” that some Princeton University students contracted in late 2013. The two schools are separated by about an hour in the greater Philadelphia area.

We discussed the outbreak at Princeton, as well as another one at the University of California Santa Barbara, and the need for those schools to “import” a meningitis B vaccine from overseas, in a December 19 post, The Meningitis B Outbreak: Heavy Doses of Government Can Be Costly. The vaccine had to be imported under an emergency exception because the Food and Drug Administration (FDA) has still not approved its use in the United States.

The situation at Drexel could parallel the developments at Princeton as opposed to those at UCSB. The Drexel student was reportedly in contact with Princeton students who had visited her at Drexel just a week before her death. In response, Princeton, which obtained and administered Novartis’s Bexsero vaccine after a lengthy federal government-required process, will be offering another round of vaccinations next week. News reports do not indicate whether the Princeton students in contact with the deceased Drexel student had received the inoculations that were made available on their campus, but only 80% of Princeton students have received both recommended doses of vaccine. One hopes that any students who bypassed the inoculations last time around have learned their lesson and will take full advantage of the next round of inoculations being offered.

Meanwhile, students at Drexel and their families will have to be satisfied with CDC’s conclusion that because there are no other meningitis B cases identified at the university, “members of the Drexel community are not considered to be at increased risk.” 

As noted in our post last December, federal officials didn’t exactly respond with urgency to the meningitis B cases at UCSB either. The process to obtain FDA and CDC approval for vaccinations at UC Santa Barbara, which began in mid-December, finally resulted in Bexsero being administered at that school on February 24.

Perhaps the CDC is correct that the Drexel student’s death is an isolated incident. We join the entire Drexel community in hoping that proves to be the case. But many Drexel parents may be rightfully wondering, if the kids at Princeton and UCSB have access to Bexsero, why can’t my son or daughter be inoculated too? After all, one student has already died. Why, as one practicing doctor commenting on a New Jersey Star-Ledger story about the Drexel case suggested, must Drexel parents and their kids consider taking two expensive trips to Toronto or Montreal, where the vaccine is available? Why, in other words, does the federal government get to decide whether my child’s risk of exposure is high enough to deserve access to a vaccine that has been demonstrated as safe in widespread use abroad? Finally, how long is it going to take—and how many more students must die—before FDA approves this valuable vaccine?

These are urgent questions that FDA, which is already under fire for its failure to approve drugs for other illnesses widely available overseas ought to answer—during dedicated Congressional oversight hearings if necessary.

Also published at WLF’s Forbes.com contributor page.

2 thoughts on “Update: FDA Drags Feet on Approval of Internationally-Accepted Vaccine While Drexel Student Dies of Meningitis B

  1. Pingback: Finger on the Pulse: From Our Blogroll and Beyond | The Legal Pulse

  2. Pingback: FDA’s Proposed Regulation of Brewers’ Spent Grains is All Wet | The Legal Pulse

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