A plan to import a meningitis vaccine not currently approved in the United States for use at Princeton has been in the works since the summer.
The Centers for Disease Control first contacted the U.S. Food & Drug Administration in late July or early August with an informal phone call to initiate the process of bringing the vaccine, called Bexsero, to Princeton, where seven people have been hospitalized with the disease since March.
“We’ve talked for several years that someday there might be an outbreak for which we would recommend or consider recommending a serogroup B vaccine,” CDC meningitis and vaccine preventable diseasesbranch head Dr. Thomas Clark said.
“You always think about vaccination,” Clark added. “The art of it is determining when the occurrence of cases starts to suggest that more are likely.”
The University announced Monday that it will approve the Bexsero vaccine for use in the campus community.
The University Board of Trustees discussed at their meeting this weekend whether to allow the vaccine to be used at Princeton. No officials from the New Jersey Department of Health or the CDC were present at those meetings, agency representatives said.
Currently, state law requires college students to receive a licensed meningococcal vaccination, but current FDA-licensed vaccines only protect against meningitis types A, C, Y and W-135, not B. Bexsero has been licensed in Australia and in the European Union, where the burden of disease caused by serogroup B is higher.
At the time of the first informal request, five cases of meningitis type B linked to Princeton had been reported. The CDC has been involved in the response to the outbreak since May 8, soon after the third case was reported, when the New Jersey Department of Health reported the Princeton cluster of cases to the federal agency.
The incidence of the disease on campus after the summer break prompted additional concern from health authorities, Clark said.
“What was most concerning was the occurrence after the new school year,” Clark said, referring to the sixth case of the outbreak, reported on Oct. 3. “That means transmission is continuing even though students went home and for the most part dispersed over the summer.”
“Outbreaks always stop, and certainly kids going away for the summer should interrupt transmission” Clark explained. “The fact that it didn’t made us worried there would be more transmission.”
Bexsero was licensed in the European Union on Jan. 22 and in Australia on Aug. 15. CDC, state and local health authorities had been in talks with Bexsero maker Novartis — a Swiss-based drug company — about the possibility of using the vaccine at Princeton since May.
Bexsero’s current lack of FDA licensure is simply an indication that Novartis has not actively pursued licensure in the U.S., Clark said. He added that the fact that Bexsero had been licensed for use in the EU was “a threshold that seemed reasonable for everybody’s comfort level.”
“This is not an experiment. It’s not a study. It’s access to a vaccine so doctors can recommend it to patients,” he said.
The process was formalized in September, when the CDC sent a letter to the FDA detailing the situation at the University and asking for guidance on how to make Bexsero available to Princeton.
The FDA responded with guidelines for an Investigational New Drug application protocol. An IND application is also part of the regular process for FDA approval.
The CDC submitted a type of IND called a “treatment IND” in October. According to FDA regulations, a treatment IND is meant to make available experimental drugs or vaccines “showing promise in clinical testing for serious or immediately life-threatening conditions.”
On Thursday, the FDA gave the go-ahead for the CDC’s application, a move that Clark said means the IND is “in place.”
An FDA spokeswoman would not confirm or deny the existence of the IND application Monday, citing agency regulations.
Clark added that the entire four-month process had been “quite efficient.”
“We even had discussions about the IND proposal during the government furlough, because this is what an emergency is,” Clark said.
Since the third case of the outbreak on May 7, the University has sent email health advisories to the student body with each new case informing them of the continued outbreak and encouraging students to take appropriate hygienic measures.
In addition, the Student Health Advisory Board distributed reusable drinking cups to the student body in September. The red cups said, “Mine. Not Yours.” and were intended to remind students not to share cups with other students. SHAB’s cups were an independent effort, SHAB president Michael Kochis ’15 said, adding that SHAB had no interaction with the CDC or state health authorities.
The male student hospitalized Nov. 10 for symptoms of meningitis in the seventh and latest case is still hospitalized but is improving, New Jersey Department of Health Director of Communications Donna Leusner confirmed. All six previous cases have recovered.