FDA approves new children’s vaccine from GlaxoSmithKline PLC

In Regulation and Policy by justineLeave a Comment

FDA, GlaxoSmithKline, vaccine, bacterial meningitis, MenHibrix

 

Today, the FDA approved a new children's vaccine that targets two causes of bacterial meningitis, meningococcal disease and Hib disease.  The vaccine, MenHibrix, had been rejected twice before by the FDA, but GlaxoSmithKline said "it had resolved regulators’ questions about the vaccine’s potency and efficacy" according to Reuters.

 

The stats:

4,100 cases of bacterial meningitis occurred in the United States each year from 2003 to 2007

500 people died from the disease from 2003-2007

It can cause severe brain damage and is fatal in 50 percent of cases if untreated

(according to the Centers for Disease Control and Prevention)

 

“(Meningitis) is one of those diseases that although not common, when it occurs it’s absolutely devastating and horrible,” said Dr. Len Friedland, vice president of clinical and medical affairs for GlaxoSmithKline in North America.

“It presents to the doctor when a child just looks ill, and within 18 to 24 hours, they’re on the deathbed in the hospital. … To be able to have a vaccine to prevent meningitis is really a great day,” he said.

 

Read the full article here

For more industry updates and information, join our LinkedIn Group: Vaccine Nation or follow us on Twitter @vaccinenation

Leave a Comment

Current ye@r *