News

Immunization Needs Approval

University officials announced late last month that UCSB will soon offer students a meningitis vaccine that has not yet been licensed for use in the United States, following use of the same vaccine in early December at Princeton University.

While working with the Centers for Disease Control and Prevention, university officials are filing an Investigational New Drug application with the Food and Drug Administration to eventually offer the foreign vaccine Bexsero. The vaccine protects against the rare B strain of meningococcal disease, which struck four UCSB students in November, including Aaron Loy, a freshman lacrosse player whose feet were amputated as a result of complications related to the disease. Loy also suffered blood poisoning and kidney failure, but is now making a successful recovery.

According to the Centers for Disease Control and Prevention, meningococcal bacteria — which causes meningococcal disease and resulting meningitis infections — consists of five strains that circulate and cause disease in the U.S., including strains B, C and Y. American meningitis vaccines are commonly approved and used against serogroups C and Y, but licensed usage of a vaccine against the B strain only exists in Europe, Canada and Australia. However, even in these countries, usage of the B vaccine is not routinely recommended and will only be suggested for people at high risk of the disease, according to the CDC. So far, the FDA has only allowed usage of the vaccine at Princeton University, where eight students were infected with meningococcal disease.

In late December, Chancellor Henry T. Yang and Student Health Director Dr. Mary Ferris said in an email that the university is working with the CDC, as well as state and local health officials, to accelerate the process for gaining access to the unlicensed vaccine.

“While we are reassured that no additional cases of meningococcal disease have occurred in community members since Nov. 21, 2013, the nature of the disease and the cases at Princeton University this fall support moving forward with vaccination,” Yang and Ferris said in an email.

In an earlier email sent on Dec. 9, Ferris said university and local public health officials have taken an aggressive approach to updating and notifying the student body, faculty and community members about the outbreak due to the severity of the disease.

“Even though we realize that providing information may result in increased anxiety, we believe this transparency is needed, and we are providing as much information as possible,” Ferris said in an email. “We have sent out multiple notices urging the community to be aware of the symptoms so that they can consult a doctor and get treatment if needed. We have also promoted basic precautions to prevent infection, posted information online and produced a video Q&A on meningococcal disease.”

The current move to obtain approval for a serogroup B meningococcal vaccine follows a previous administration of preventive antibiotics at the beginning of December. The antibiotics were distributed to more than 1,000 UCSB students during fall quarter.

While the process to gain access to the Bexsero vaccine has already taken weeks, Chancellor Yang said university officials are expecting the vaccine to soon be offered at Student Health since the Investigational New Drug application has been filed with the FDA.

“Since this vaccine is not licensed in the United States, it is considered ‘investigational’ and requires a special process in order to use it, similar to the one that took place at Princeton University earlier this fall,” Yang and Ferris said in an email.

According to Yang and Ferris, the university will give campus or community members access to the Bexsero vaccine so long as they are identified by state and local health officials as being at “increased risk” of the disease.

Charity Thoman, deputy health officer for the Santa Barbara County Public Health Department, said in a statement that CDC and California Department of Public Health officials visited UCSB in December to investigate the living patterns and surroundings of students who contracted meningitis, in order to identify who would potentially be at risk for contracting the deadly infection.

Yang and Ferris said, however, that amidst the rapidly progressing process of seeking vaccine approval, many steps will still need to occur in determining the population that receives the vaccine.

For more update details and general information about the meningococcal disease, visit the Student Health website’s “Meningitis Health Alert” page at studenthealth.sa.ucsb.edu/Meningitishealthalert.aspx.

 

A version of this article appeared on page 1 of January 6th’s print edition of the Daily Nexus.

 

Print Friendly
Tags: , , , , , , ,

2 Comments

  1. Eric Fauman says:

    I don’t know if you’re referring to the cost of the drug itself. Because Bexsero will be administered under an IND, Novartis can only charge for their “direct costs”, not the price they charge for Bexsero in Europe or any other region where it has been approved. Novartis is actually losing any money it would have made if Bexsero were already approved in the US.
    (FDA guidelines available here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM351264.pdf)

    Of course there are the not inconsequential costs of actually manufacturing the vaccine, getting ~40,000 doses to UCSB, and vaccinating and revaccinating 20,000 students. I have not seen any information on whether these costs will be borne by the state of California, the university or the health department.

  2. Will the University be charging a fee to administer Bexsero, an investigatory vaccine not approved by the US FDA?

Leave a Reply

Your email address will not be published. Required fields are marked *

*

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>