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

Experts weigh in on new combination vaccine

TAMPA, Fla. - Parents usually dread taking their children in for vaccines. First of all, no one likes to see their infant cry, but also there is an ongoing controversy over potential side effects of these shots.

So, when the FDA approved a new combination vaccine for the prevention of two bacterial diseases, I brought a few questions to Florida Hospital's Head of Pediatrics Dr. James Orlowski.

First:  Is this a new vaccine or just a new combination? Dr Orlowski says, "It's really just a new combination of what's out there. In fact the company making this new MenHibrix vaccine made the two components separately before."

GlaxoSmithKline manufactures the MenHibrix vaccine. Dr. Leonard Friedland, who is GlaxoSmithKline's V.P., of North America Vaccines Clinical/Medical Affairs, responded to Dr. Orlowski's comment. 

Friedland says, "Outside of the United States, GSK has a licensed meningococcal ACWY vaccine for children 12 months of age and older (Nimenrix) and a licensed combination Hib-MenC vaccine for use in infants (Menitorix). 

"In the United States, before the approval of MenHibrix, GSK did not have a licensed Hib vaccine for infants - GSK's US Hib vaccine, Hiberix, is approved for use in children 12 months of age and older - nor a licensed meningococcal vaccine. Therefore, MenHibrix is in fact new for GSK and is not a combination of two existing vaccines.

"The vaccine also is the first and only combination vaccine in the United States approved to protect against both Hib and meningococcal diseases. To be very specific, there are two existing meningococcal vaccines available from other companies, but neither is approved for use in infants as young as 6 weeks of age, which is a very important distinction."

Doctor Orlowski stands by his statement and says, "It's less shots for the child when they combine them together."

Doctor Orlowski added that before, to cover for the same diseases, kids would need 8 vaccines in the first year of life. Now its reduced down to 4 by combining it together.

What does it protect against? Dr Orlwoski says, "It protects against the two major causes of meningitis and blood stream infections in young children."  

As Dr Freidland mentioned, the first dose can be given to an infant as young as 6 weeks.  Is that safe? And what about side effects? Doctor John McCormick is the Chief of Internal Medicine and Pediatrics at USF. He says, "There are complications from vaccine of course, but they are minimal compared to the actually disease state, so there's overwhelming evidence they are good for us."

Not all physicians agree. California-based Doctor Bob Sears - author of The Vaccine Book - doesn't think the new combination is necessary. He says, "This new vaccine is approved as a 4-dose regimen - 2, 4, 6, and 15 months. But the only problem is that the meningococcal portion is for strains C and Y - non-infant strains. Strain B is what hits and kills infants. But they haven't been able to make an effective infant vaccine for strain B. So, this new vaccine is completely unnecessary. "

Dr. Friedland's response to that is as follows, "Infants and toddlers younger than 2 years of age have the highest incidence of meningococcal disease, and infections by serogroups C and Y can be potentially serious and fatal among this age group.

"In infants younger than 2 years of age, an estimated 274 cases of meningococcal were reported annually between 1998 and 2007, 104 (38 percent) of which were caused by serogroups C and Y.  Across all age groups and all serogroups, meningococcal disease kills approximately one in eight of those infected. It is true that serogroup B is known to cause approximately 55 percent of meningococcal disease cases in infants younger than 2 years of age, yet there is no vaccine currently available in the United States to help protect against this serogroup."

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