The first vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B has been approved for license in US, the Food and Drug Administration have announced.
Neisseria meningitidis can be transmitted from person to person by coughing, kissing or sharing eating utensils. The bacteria infect the bloodstream and the lining surrounding the brain and the spinal cord, causing meningococcal disease.
In 2012, the US saw about 500 cases of meningococcal disease, according to the Centers for Disease Control and Prevention (CDC) – 160 of these causes were found to be caused by serogroup B.
Risk of death or serious long-term problems can be reduced in infected people by treating them with antibiotics, but vaccination is vital for preventing meningococcal disease.
However, only four of the five main serogroups of N. meningitidis – A, C, Y and W – have previously been covered by vaccines approved for use in the US.
Dr. Karen Midthun, director of the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research, describes the approval of the new vaccine, Trumenba:
“Recent outbreaks of serogroup B meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease. The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”
The effectiveness of Trumenba was trialled in three randomized studies involving about 2,800 adolescents. After receiving three doses of Trumenba, 82% of the participants had antibodies in their blood that killed four different N. meningitidis serogroup B strains, whereas before vaccination, less than 1% of the participants had these antibodies.
To assess the safety of Trumenba, 4,500 participants were recruited in the US, Europe and Australia to receive the vaccine. The most commonly reported side effects were:
Because the clinical trials of the vaccine demonstrated that Trumenba can effectively kill the four strains of N. meningitidis serogroup B, the FDA fast-tracked approval for the vaccine using the “accelerated approval regulatory pathway.”
- Meningitis is the form of meningococcal disease that infects the lining of the brain and spinal cord
- Septicemia and bacteremia are bloodstream infection variants of meningococcal disease
- Symptoms of meningococcal disease include sudden fever, headache, stiff neck, nausea, vomiting and increased sensitivity to light.
According to the FDA, accelerated approval allows the agency to reduce the time it takes for needed medical products to become available to the public if evidence is able to predict the product’s clinical benefit.
Trumenba was also granted “breakthrough therapy” status, which expedites the development and review of medical products to combat life-threatening conditions. Consequently, the FDA were able to evaluate and approve the vaccine’s effectiveness in less than 6 months.
In 2011, the FDA approved Menactra – a meningococccal vaccine for infants from 9 months of age. The approval for that vaccine was granted after the agency examined the results of one phase 1 and three phase 3 modified single-blind, controlled, multi-center trials involving more than 3,700 participants.
And in 2013, the European Commission approved the vaccine Bexsero for treatment of individuals 2 months of age and older. Bexsero was produced by the drug company Novartis, following more than 20 years of vaccine research.