TheNational FDA approves first vaccine against serogroup B Meningococcal disease

FDA approves first vaccine against serogroup B Meningococcal disease

Oct 31, 2014 Ruchira Dhoke News 0

The U.S. Food and Drug Administration has announced the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Meningococcal disease is term used for life-threatening illness caused by certain bacteria’s that infect the bloodstream causing sepsis and the lining that surrounds the brain and spinal cord (meningitis).

N. meningitidis is a leading cause of bacterial meningitis. It is transmitted via contact through respiratory or throat secretions (e.g., by coughing, kissing, or sharing eating utensils).

Symptoms of meningococcal disease include sudden fever, headache, stiff neck, nausea, vomiting and increased sensitivity to light.

Although the meningococcal is treated with antibiotics to reduce the risk of death or serious long-term problems, but it requires immediate medical attention. In such scenario vaccination seems to be the most effective way to prevent meningococcal disease. Until today, meningococcal vaccines approved for use have only covered four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y, and W in the US.

The trail carried out to check the efficacy of the Trumenba was done 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 4,500 participants were recruited in the US, Europe and Australia to receive the vaccine Trumenba.

Vaccine granted Fast-track approval by FDA

Since the clinical trial of the vaccine successfully 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.”

Accelerated approval allows the agency to reduce the time it takes for medical products to become available to the public, according to the FDA. By getting a breakthrough therapy status Trumenba was granted a quick review were FDA was able to evaluate and approve the vaccine’s effectiveness in less than 6 months.

meningitis, meningococcal disease, N. meningitidis, septicemia, spinal cord, Trumenba, vaccine

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Ruchira Dhoke

A qualified medical microbiologist with an avidity to read enchant a deep passion for creating a good impacting masterpiece with my words .I am very fond of good old English literature and like listening to music and paint in my free time.