SUNDAY, SEPTEMBER 25, 2016

GSK seeks approval to administer flu vaccine to children 6 months and older

The application is to request that children 6 months to 35 months be able to receive the vaccine. | File photo

Officials at GlaxoSmithKline (GSK) recently submitted the paperwork for a supplement Biologics License Application for the Flulaval Quadrivalent influenza vaccine to the Food and Drug Administration.

As of today, the vaccine has received approval to be used as an active immunization in adults and children 3 and older. The vaccine is meant to protect against influenza type B viruses and A subtype viruses.

The application is to request that children 6 months to 35 months be able to receive the vaccine. If this submission receives approval, then health professionals will be allowed to give children 6 months and older the same dose of the vaccine.

As evidence, the application cites a single Phase III pivotal study as well as three supportive clinical studies. These studies involved children 6 months old to 35 months old. The submission includes the results of these studies, which have been given to the Pediatric Academic Societies so they can discuss them at their annual meeting.

Seasonal influenza, a contagious respiratory illness, is the result of flu viruses infecting the body. A and B are the two main kinds of influenza viruses, and the sickness can cause illnesses that vary from mild to severe, making it important that people receive protection against it.

Organizations in this story

GlaxoSmithKline 5 Crescent Dr Philadelphia, PA 19112

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