[SaneVax: MenHibrix vaccine, manufactured by GlaxoSmithKline, 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 Glaxo
By Zack’s Equity Research
Recently, GlaxoSmithKline (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.