Measuring up a Vaccine: The Meningitis B Immune Response Study

This past November, students from Princeton University’s incoming freshman class lined up atop Icahn Laboratory’s Oval Lounge to participate in an immune response study to the meningitis B vaccine. That clinic was the second round of a large-scale public health study being conducted by Professor Nicole Basta, an infectious disease epidemiologist in the Department of Ecology and Evolutionary Biology.

After nine cases of meningitis B broke out at Princeton in 2013, University Health Services (UHS) worked with the Centers for Disease Control and Prevention (CDC) to approve an emergency vaccination campaign. Continue reading

FDA Q&A: The Approval Process for Vaccines and Trumenba With Rachael Conklin: Communications Officer

Last month, the FDA approved Trumenba, a vaccine for meningitis B. Meanwhile, the vaccine that was administered to Princeton students last year, Bexsero, continues to be under review. Below, PPHR discusses the vaccine approval process with FDA Consumer Safety Officer Rachael Conklin.

PPHR: What considerations does the FDA have when approving a new vaccine?

Conklin: The main considerations are the same for approving a vaccine as for approving any other drug product: safety and efficacy. Continue reading

EXCLUSIVE: Interview with the CDC on the Approval of New Meningitis Vaccine

Last year, almost all of the Princeton students received two doses of the meningitis B vaccine called Bexsero, which was developed by Novartis. Bexsero, while not formally approved by the FDA in the US, had been approved in other nations globally and as a result, was recommended by the CDC and FDA for use to control the Princeton outbreak. Data was also collected by Princeton and CDC on the effect of the vaccine on the Princeton outbreak.

However, recently, the FDA approved Trumenba, developed by Pfizer, as a vaccine for meningitis B. At the same time, Bexsero, used at Princeton, has still not been approved by the FDA. Why has the vaccine which was used not only at Princeton but also as UCSB not approved by the FDA? Does data suggest that Trumenba performs better than Bexsero? Or are there other reasons behind approving Trumenba?

Below is a Q&A with Dr. Manisha Patel, who has been involved been involved with the Princeton meningitis outbreak. The discussion focuses on the differences between the two vaccines, reasons why Bexsero was recommended for the Princeton outbreak and reasons why Trumenba was approved first by the FDA.

PPHR: What makes meningitis B so difficult to vaccinate against? I understand that in morbidity and mode of transmission, all serogroups of meningitis are relatively similar.

PATEL: The main question is “Why don’t we have a meningitis B vaccine when vaccines for serogroups A, C, W and Y are available?” Continue reading

Approving Trumenba: Why Not Bexsero?

DSC03308-C2-PURPLELast Wednesday, the FDA approved a vaccine for Meningitis B1,2, the same strain of bacterial meningitis that Princeton students faced last year. Yet the newly-approved drug is not Novartis’ Bexsero, which thousands of students at Princeton and UCSB have received in the past year. Instead, the FDA approved Pfizer’s Trumenba. This forces us to wonder why the FDA decided to approve Trumenba first, even though Bexsero has now been used safely and effectively in the United States and is approved in Canada, Europe, and Australia3.

The most straightforward explanation for the earlier approval of Trumenba is that Pfizer filed for approval before Novartis4. Continue reading

Hear from the scientist who discovered the meningitis vaccine

Don’t miss this chance to listen to and speak with Dr. Rappuoli, the developer of the Meningitis B vaccine that you received last winter! It will be an incredible lecture that you don’t want to miss with a Q&A session designed to give students an opportunity to engage in a discussion about the vaccine with the developer himself. The event is co-sponsored by the Princeton Public Health Review and the Woodrow Wilson School.
Join the event on Facebook and spread the word!: https://www.facebook.com/events/1401903213422241/

Public lecture: “Towards a Meningitis-free world” – Rino Rappuoli, PhD

Thursday, Apr. 24 – 4:30pm – 6:00 – Lewis Thomas Laboratory Auditorium (LTL 003)
Public reception to follow

Rino Rappuoli is Global Head of Vaccines Research for Novartis Vaccines & Diagnostics. He discovered and developed the Meningitis B vaccine recently administered at Princeton.

This event is free and open to the public.

PPHR

Meningitis Forum–Get Your Questions Answered

Want your questions about meningitis answered? After reviewing the literature, consulting information from the CDC, and/or speaking with experts, an editor from PPHR will respond to posts on this page within 48 hours. We encourage all questions as well as a productive discussion about the situation on campus.

Check it out here: https://pphr.princeton.edu/forums/forum/open-anonymous-forum-for-meningitis-outbreak-princeton-university/

DISCLAIMER: The Princeton Public Health Review is not affiliated with the CDC and is a publication operated by undergraduates. While editors’ responses will be based on thorough research, please bear in mind that our views might not necessarily coincide with those of the University or the CDC.

Exclusive Q&A with CDC’s Head of Meningitis and Vaccine Preventable Disease Branch Dr. Thomas Clark

Recently, a student at Drexel passed away from meningitis caused by the serogroup B bacteria which caused an outbreak here at Princeton. The student had been in close contact with Princeton students a week before becoming ill. Further studies revealed that the bacterial strain in the Drexel student was the same as the outbreak strain at Princeton, according to the Centers of Disease Control and Prevention (CDC). Find out about the concerns regarding the transmission of the bacteria and further steps to be taken directly from Dr. Thomas Clark, head of the meningitis vaccine initiative at CDC.

PPHR: Are there any concerns about spreading the disease even after students are vaccinated (both doses)?

Dr. Clark: Yes. When it comes down to it, we study vaccines and learn if they work or not, and whether they are effective at protecting against disease in people. Continue reading

A Critical Look at Bexsero

Although a host of different bacteria, viruses, and fungi can all potentially cause the onset of meningitis, the eight Princeton cases have all been determined to be the work of N. meningitides serotype B1. In a void of FDA approved vaccines, the University is turning to Bexsero, the work of the Swiss pharmaceutical company Novartis.

Because, left untreated, the effects of meningitis can escalate to permanent brain damage, hearing loss, and death2, there has been clear opportunity for vaccine development to reduce this risk. Continue reading

The Benefits of Bexsero at Princeton

In the past few weeks, Princeton University has found itself a hot topic in the media for what has now been described as an outbreak of meningitis B1. Although Princeton currently requires all students to be vaccinated against meningitis, the current vaccine does not protect against serogroup B. There is no currently approved vaccine against serogroup B, but Bexsero, a Novartis-produced vaccine that has been licensed in Europe and Australia, has been granted special approval for use on our campus, due to the nature of the outbreak.

It has been particularly difficult to make a vaccine against meningitis serogroup B. Continue reading

Q&A with Head of CDC’s Meningitis and Vaccine Preventable Disease Branch Dr. Thomas Clark

Meningitis is an infection in the membrane layers surrounding the brain and the spinal cord called the meninges. It is airborne and is spread through close contact such as coughing or sneezing. The outbreak is related to type B (serogroup B) meningococcal bacteria which is the cause of the eight cases of meningitis at the University. The vaccine Bexsero has recently been developed and licensed in Europe and Australia to protect against type B (serogroup B) meningococcal disease. As has been announced by the Centers of Disease Control and Prevention (CDC) and Princeton University, the meningitis cases have been declared to be an outbreak. As a result, the CDC is importing Bexsero for use among students at Princeton University.

PPHR spoke with Dr. Thomas Clark, the head of CDC’s meningitis and vaccine preventable disease branch. Continue reading