Regulatory Focus™ > News Articles > New Combination Vaccine Approved by FDA

New Combination Vaccine Approved by FDA

Posted 15 June 2012 | By Alexander Gaffney, RAC 

A new combination vaccine that protects infants against meningococcal disease and Hib disease received approval from the US Food and Drug Administration (FDA) on 14 June, the agency said.

Reuters reports the vaccine, GlaxoSmithKline Biologicals'Menhibrix, had twice been rejected by the agency in both 2010 and 2011 after regulators raised questions about the benefit:risk profile of the product. The questions seemed to be resolved-or at least mitigated-during the product's third round at FDA, which applauded the vaccine's life-saving potential in a statement announcing the product's approval.

"With today's approval of Menhibrix, there is now a combination vaccine that can be used to prevent potentially life-threatening Hib disease and two types of meningococcal disease in children," said Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research (CBER).

Menhibrix underwent clinical testing for safety in approximately 7,500 infants in toddlers in the US, Australia and Mexico, and efficacy testing in several hundred US patients. FDA said the side effects were relatively minor-pain, redness and swelling at the injection site, irritability and fever-and patients exhibited immune responses comparable to an existing vaccine solely formulated to prevent Hib disease.

Read more:

FDA approves new combination vaccine that protects children against two bacterial diseases

Reuters - U.S. approves Glaxo meningitis vaccine for children

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