The latest vaccine approved by FDA is MENHIBRIX, from Glaxo, and is planned to be given to 2,4,6,12 month babies.
Package insert can be found here: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM308577.pdf
Notes from package insert:
– control used in studies: another vaccine
– adverse event and efficacy monitoring: 6 months
– not evaluated for mutagenic, carcinogenic or impairment of fertility
– 2% of study participants reported at least one serious adverse reaction within 31 days
– 5% of study participants reported at least one serious adverse reaction within 6 months
– serious adverse reactions included: extensive swelling of limb, anaphylaxis, seizures, apnea
– effectiveness of the vaccine was declared simply by measuring antibody titers 1 month after dose 3, or 6 months after dose 4
–beyond 6 months the safety and efficacy effects of the vaccine are unknown.
Read press release from Glaxo on the approval: http://www.gsk.com/media/pressreleases/2012/2012-pressrelease-1134059.htm
Read about Glaxo Fraud: http://www.guardian.co.uk/business/2012/jul/02/glaxosmithkline-drug-fraud?newsfeed=true
Note: This information is presented as educational material only. It is not meant to be taken as medical advice.
Extreme care should always be taken to protect any newborn baby from potential illness. This includes breastfeeding and seclusion; ask visitors to bathe and wear clean clothing before handling any baby less than 6 weeks old.
Meningococcal disease is potentially fatal and always should be viewed as a medical emergency. Also, children with invasive Haemophilus influenzae disease require careful attention and, often, intensive care. To prevent serious neurologic morbidity and death, admission to a hospital is necessary and prompt institution of antibiotic therapy is essential when the diagnosis of bacterial meningitis is suspected.