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

Public Ignorance and Ebola

Clipboard-Guy

In mid-October, a man – soon to be known as “Clipboard Guy” – was seen alongside four other health officers in hazmat suits, wheeling an Ebola patient for transfer from Dallas to Atlanta. He was wearing no protective gear, carrying a clipboard, and helping the HAZMAT-suited individuals with the patient. It caused an uproar on sites like Twitter, with people wondering why safety protocols seemed to be breached, why the virus was being taken lightly, and whether or not the man was infected and now a risk to society. As can be seen in this incident, mass hysteria is easily spurred by the media. As such, a lot of speculation about the Ebola virus has been based in ignorance and the human tendency to sensationalize.

Dr. Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases, was asked to explain the audacity of the man in a CNN interview. Continue reading

Quarantines in Newark and Princeton

Recently, there have been concerns that Ebola, the deadly virus that erupted in West Africa causing hemorrhagic fever, has made its way to Newark, New York, and Princeton. One such story is that of Ebola nurse Kaci Hickox who has been placed in quarantine for 21 days at the University Hospital in Newark, New Jersey because she helped to treat Ebola patients in Sierra Leone. However, she has been tested and has not contracted the disease. Still, New Jersey governor Chris Christie and New York Governor Andrew Cuomo require that anyone has who worked with or come into contact with Ebola patients must be quarantined, no matter how healthy they may appear.

This policy came into being after a recent New York City doctor was diagnosed with Ebola on October 23. Continue reading

Uncertainty of Ebola Concerns Princeton Citizens, Prompts Policies

The Ebola outbreak has resulted in global panic, making citizens question the safety of everything from public transportation to crowded events. Recent developments have brought the crisis directly to Princeton.

On October 1st, NBC cameraman Alexander Mukpo contracted Ebola while cleaning a car that had transported dead Ebola victims in Liberia. Continue reading

Editorial: Ebola

The American public, along with state and federal government officials, had sufficient cause to be frightened when the first case of Ebola knocked at its doorsteps. Amidst the panic and frenzy in response to the Ebola outbreak, a controversial quarantine was issued against 33-year-old nurse Kaci Hickox, who had served Ebola patients in West Africa before being held under a 21-day quarantine after her arrival in Newark.

The Princeton Public Health Review’s editorial board believes that while the principle behind issuing a mandatory quarantine against nurse Kaci Hickox was a valid one, the haphazard manner in which the Model State Emergency Health Powers Act was carried out suggests the need for enforcement to be improved and better amended to deal with the health risk at hand. Continue reading

Valley Fever: The Mysterious Fungus Infecting the Southwest without a Vaccine or Cure

Valley Fever or Coccidioidomycosis, also known as cocci, is a fungal disease endemic to the soils of the Southwest. Around 60% of those exposed never have symptoms. The majority of the other 40% have flu-like symptoms. About 5 to 10% of those exposed develop serious and long-term problems with their lungs. In about 1% of those exposed, the fungus spreads throughout the entire body, infecting areas such as the brain and bones (1).

Although the first diagnosis was in 1892, Valley Fever continues to infect people without a vaccine or cure. Continue reading

Ebola and Cultural Misunderstandings

The spread of the Ebola virus in West Africa has generated fear over the possible global spread of the disease due to traveling, improper health care, and the potential transmission of disease through bodily fluid exchange or, less likely, airborne contamination.

Experts generally trace the origins of Ebola to fruit bats which can carry the disease without being affected themselves. 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