Category Archives: FDA

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

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 Approving Trumenba: Why Not Bexsero?

The impact of restrictions on pain relief

Late last year, the Food and Drug Administration published an official online statement, proposing new restrictions that will make regulations on some of the most commonly prescribed pain medicines, such as Vicodin, stricter. According to the official statement, the “FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States1.”

The classification of “epidemic” is not an exaggeration. Centers for Disease Control and Prevention (CDC) reported that there were more than 36,000 deaths from drug overdoses in 2008, and most of these deaths were the result of prescription drug overdose2. Continue reading The impact of restrictions on pain relief