GSK’s MenHibrix Approval: What is Wrong with this Picture?

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GSK’s MenHibrix Approval: What is Wrong with this

Picture?June 17, 2012 By

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[saneVax: MenHibrix vaccine, manufactured by

GlaxoKline, was just approved for use in the U.S. based on data

gathered from the inoculation of 7,521 infants and toddlers in five

countries with 'at least one dose.' The problem is, this vaccine is given

in a four dose regimen. How did the FDA determine that this vaccine was

safe and effective in a four dose regimen when the trial participants

were only given 'at least one dose?'

Believe it, or not, it took GSK no less than three submissions to get

this vaccine approved. One has to wonder what their first and second

submissions looked like. Who is the FDA working for, again?]

Third Time’s the Charm for GlaxoBy Zack’s Equity

Research

Who does the FDA work for?

Recently, GlaxoKline

(

GSK -

Analyst Report) announced that the US Food and Drug Administration

(FDA) approved its combination vaccine MenHibrix (meningococcal groups C

and Y and Haemophilus b tetanus toxoid conjugate vaccine) for treating

children aged between six weeks and eighteen months. The FDA approved

MenHibrix, which is administered in a in a four-dose regimen, for the

prevention of invasive disease caused by Neisseria meningitidis

serogroups C and Y and Haemophilus influenzae type b.

The approval came on the basis of data from trials conducted over seven

years in the US, Mexico, Australia, Belgium and Germany. The trials

enrolled a total of 7,521 infants and toddlers and they received at least

one dose of MenHibrix.

We note that Glaxo received the approval in its third attempt.

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network

Vaccines -

http://vaccinationdangers.wordpress.com/ Homeopathy

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