The meningitis vaccine given to Princeton students last year has now been approved by the FDA. The decision was made on Friday, and announced straight away. Nine people were affected by the group B strain of the disease at the university campus, with one death occurring due to it.
Students and staff at Princeton University were advised to get the Bexsero vaccine. Despite not being approved by the FDA at the time, the administration agreed that it was an emergency. Bexsero vaccinated against the serogroup B of meningitis, and Novartis makes it. It was still going through testing by the FDA before being approved. However, Australian and European authorities both agreed that the vaccine was safe.
Princeton campus was affected by a severe case of the disease, putting lives of all at risk. There was no vaccine to protect people at the time approved by the FDA. In October 2014, the FDA did clear a Pfizer vaccine, which is very similar to Bexsero. That arguably helped pave the way for Bexsero to be approved.
Once the Princeton students and staff were informed about the emergency approval of the vaccine last year, thousands went to the makeshift clinic to receive it. Within four hours, over 1,200 people had received a shot of the vaccine. Officials had to make clear that the vaccine would not give an individual meningitis.
The decision for the FDA to approve the meningitis vaccine that was given to the Princeton students is a major accomplishment for publish health. Director of the FDA Center for Biologics Evaluation and Research, Karen Midthun, stated that it would help to prevent the disease, which can be life-threatening. Despite being rare, it is an aggressive bacterial infection. It starts like flue, but can cause disability or death within just 24 hours.
Many patients may not realize that they have the disease at first. A rash is usually the tell-tale sign of meningitis, as other symptoms can be very much like the flu. They include a stiff neck, sensitivity to light and fatigue. The Drexel student who died in March had been in close contact with other students for around a week before showing symptoms, putting the university on high alert. The disease spreads through throat fluids, and can be passed through saliva, kissing and coughing.
The new vaccine protects people between 10 and 25 years old. It now means that all five subtypes of meningitis are protected in the United States. Before October last year, there was no protection against serogroup B, making it extremely dangerous.
The first approval for Bexsero occurred in Europe. Since then, 31 countries now allow the vaccine to be administered, with the FDA approval being the latest. There is hope that other countries will follow suit. The FDA stated one of the reasons for approval was finding the “protective immune response” in young adults and adolescents during the second two phases of the studies. There is also the flexible dosing schedule between the two doses required, at least a month apart. Princeton University students have received the doses of the meningitis vaccine, which has now been approved by the FDA.
By Alexandria Ingham