MenHibrix Side Effects: Vaccine for Hib and Meningococcal Disease

MenHibrix Side Effects: Vaccine for Hib and Meningococcal Disease. What are the side effects of Menhibrix, the new drug from GlaxoSmithKline which was recently approved by the Food and Drug Administration (FDA) as a vaccine for kids aged six weeks to 18 months old to protect them against meningococcal disease and Hib disease?

In the FDA’s Prescribing Information for the drug, the following MenHibrix side effects are listed in the Adverse Reactions section:

Rates of local injection site pain, redness, and swelling ranged from 15% to 46% depending on reaction and specific dose in schedule. Commonly reported systemic events included irritability (62% to 71%), drowsiness (49% to 63%), loss of appetite (30% to 34%), and fever (11% to 26%) (specific rate depended on the event and dose in the schedule).

The Prescribing Information also underscored the following MenHibrix side effects:

  • Syncope (fainting) can occur in association with administration of injectable vaccines, including MENHIBRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including MENHIBRIX, to infants born prematurely should be based on consideration of the individual infant’s medical status, and the potential benefits and possible risks of vaccination.

Menhibrix is the first meningococcal vaccine that can be given starting as young as six weeks of age according to Karen Midthun who serves as the director of the FDA’s Center for Biologics Evaluation and Research.

MENHIBRIX SIDE EFFECTS

According to Reuters, the drug has been rejected twice by the FDA in 2010 and 2011 apparently because the agency had questions about the vaccine’s potency and efficacy.

We guess it’s safe to assume that, with this approval, said questions on the part of the government regulator have been adequately addressed by GlaxoSmithKline.

Can Menhibrix be used for children under six weeks and over 18 months?

You should not use it for said children as the “safety and effectiveness of MENHIBRIX in children younger than 6 weeks of age and in children 19 months to 16 years of age have not been established”.

Meningococall disease is caused by the Neisseria meningitidis bacterium which is spread through the exchange of respiratory and throat secretions like spit or saliva. It is deadly if left untreated. Meanwhile, Hib disease which is caused by Haemophilus influenzae type b is also spread through respiratory droplets and is just as deadly as meningococall disease.

MenHibrix Side Effects: Vaccine for Hib and Meningococcal Disease posted 21 June 2012. Latest update on 21 June 2012.