Meningitis B has been considered a rare but aggressive illness because it can bring about severe time disability or can kill within 24 hours of inception. Unfortunately, it can be hard for even a physician to easily diagnose the condition in its early phases because initial symptoms are vague and can be mistaken for flu.
In spite of appropriate treatment, around one in 10 people with the condition will die. Of those who live, about one in five people will suffer from life-long, devastating disabilities such as limb loss, hearing loss or brain damage.
There's good news, however. Vaccination has been regarded as the best defense against meningitis B.
The U.S. Food and Drug Administration (FDA) has given a Breakthrough Therapy designation to Bexsero®, a vaccine to assist in protecting people against the aggressive disease. The designation is the fourth for Novartis International. The designation will emphasize even more the leadership of the company in terms of developing groundbreaking vaccines and therapies.
Novartis International has made the announcement on Monday, April 7, after a historic decision from UK regulators. The Joint Committee on Vaccination and Immunisation endorsed to include the said vaccine in the UK's National Immunisation Programme for the routine use of babies beginning two months old. In fact, Bexsero has been considered as the only broad coverage meningitis B vaccine, which can be used on babies as young as two months old.
The potential of the vaccine to meet the urgent need for a licensed vaccine in the U.S. against the devastating and unpredictable condition of Meningitis B has been highlighted with the recent FDA designation. The said designation will accelerate also the development and analysis of new medicines that can treat life-threatening or serious health conditions. It has already been approved earlier in Australia, Canada and Europe.
Bexsero has been provided lately by Novartis to two universities in the U.S. under an Investigational New Drug designation in the past four months.
"The recent outbreaks on U.S. university campuses have shown that meningitis B is unpredictable and can strike at any time with devastating consequences," said division head Andrin Oswald of Novartis Vaccines.
"A U.S. license for Bexsero is the only sustainable solution to ensure timely responses to future outbreaks and to provide access to parents and physicians across the country. We will continue to work with the FDA to bring Bexsero to the U.S. as soon as possible," he added.
Bexsero has been given close to 30,000 doses of the vaccine to staff and students of University of California Santa Barbara and of Princeton University. The incoming freshman students at Princeton have been included as well in the at-risk bracket to receive the vaccine, as recommended by the U.S. Centers for Disease Control and Prevention.
