Division of Bacterial Diseases (DBD) News Bulletin

MVPDB Responds to Simultaneous MenB Outbreaks in the United States

Outbreaks of meningococcal disease are rare, so having outbreaks at two universities on opposite sides of the country in 2013 made for an exceptional and challenging year for the Meningitis and Vaccine Preventable Diseases Branch (MVPDB).

Meningococcal disease is a serious and life-threatening infection, with 10-15 out of 100 cases dying; survivors will often lose limbs or suffer brain damage. While three serogroups of meningococcal bacteria circulate widely in the United States (B, C, and Y), there are only vaccines available and recommended in the United States to protect against two of those serogroups (C and Y).

According to DBD director Rana Hajjeh, “With nearly a third of the 500 annual cases of meningococcal disease in this country caused by serogroup B, the absence of a B vaccine has been a gap in our ability to control this disease.”

The first vaccine to protect against a wide variety of serogroup B strains (MenB vaccine) was licensed in Europe in early 2013.*

Not long following this European licensure, Princeton University, along with New Jersey public health officials, alerted CDC that two students and one prospective student tested positive for serogroup B meningococcal disease (MenB). Scientists in MVPDB recognized the importance and challenges of making the European MenB vaccine available in New Jersey to prevent additional cases of this devastating disease.

At Princeton University, 8 cases of meningococcal disease occurred over a 9-month period spanning 2 academic years. School-based clusters and outbreaks of meningococcal disease are rare, typically accounting for only 2 to 4 cases annually and cases usually cease during summer breaks when students are no longer in close quarters or contact. It was evident to MVPDB scientists that this outbreak was not typical. The attack rate at Princeton University was over 130 per 100,000 persons, the highest reported for a MenB outbreak in the United States.

“The data related to this outbreak was troublesome,” said Tom Clark, acting branch chief of MVPDB at the time. “To have cases return after the summer break indicated that transmission had not been interrupted.”

Following an Epi-Aid in early October 2013, CDC recommended MenB vaccination for groups identified at increased risk. Because the only currently available MenB vaccine was not licensed in the United States, access to the vaccine required an Expanded Access Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA). While the IND process was underway, staff across CDC worked quickly to implement the required actions for expert legal review of all documentation; submit an institutional review board application; develop a logistics plan to import the MenB vaccine from Europe and operational plans for on-site vaccine clinics; design recruitment, communications and patient education materials; and, importantly, plan for adverse event reporting. Many of these activities took place during the lapse in appropriations in October 2013.

In the midst of these activities, CDC was contacted by the University of California, Santa Barbara (UCSB) who reported 4 confirmed cases of MenB among its students. For the first time ever, there was the occurrence of 2 simultaneous MenB outbreaks in the United States.

CDC staff collaborated with UCSB, along with state and local public health officials, to carefully review current and historical data of meningococcal disease at the university and in the local community. Based on this information, CDC concluded that additional MenB cases were likely to occur. A process was set in motion to gain access to the MenB vaccine for those identified as at increased risk.

Throughout December and the first several months of 2014, MVPDB continued to work closely with the universities in New Jersey and California, along with state and local public health officials in both states to implement first and second-dose MenB vaccination campaigns and conduct extensive safety monitoring. On-site vaccination campaigns garnered significant participation from the targeted population. To date there have been no unusual patterns of adverse events associated with administering the vaccine at either university.

“Given the clear public health need for a licensed MenB vaccine in the United States, CDC’s response to these outbreaks has increased the visibility of MenB vaccines and may help reduce the time for a vaccine to be licensed for outbreak response or routine immunization in the United States,” says Hajjeh.

In June 2014, two manufactures submitted license applications to FDA for their serogroup B meningococcal vaccines.

*The MenB vaccine was licensed in Europe in early 2013, and by Australia and Canada later the same year, under the name Bexsero®.