Policy Tip Sheet No. 8 – Infant Meningitis Vaccine

Published July 8, 2011

Problem

Meningitis, or meningococcal disease, is inflammation of the fluid membrane surrounding the brain and spinal cord. N. Meningitidis is the leading cause of bacterial meningitis in children 2 to 18 years of age in the United States. In 1999, meningococcal disease was added to the Centers for Disease Control and Prevention’s (CDC) priority list of vaccines to be developed due to high mortality and injury rates of infants. Currently, the Advisory Committee on Immunization Practices (ACIP) of the CDC recommends routine meningococcal vaccination of all persons 11 to 18 years of age.

Over the past decade, meningococcal disease rates in the U.S. have fallen due to current immunization programs of young adults. Currently, federal authorities in Washington and the CDC are reconsidering whether to recommend a recently FDA-approved infant meningicoccus vaccine.

Historically, the CDC has consistently recommended FDA-approved vaccines for children. However, the CDC is hosting a series of public meetings in New Hampshire, Colorado, Illinois, and Washington state to decide whether to recommend the meningicoccus vaccine and add it to the infant vaccination schedule.

New government cost-effectiveness policies under the Patient Protection and Affordable Care Act could be discouraging the CDC’s approval and availability of the vaccine. Cost-effectiveness is a new tier of regulatory analysis under the FDA and Center for Molecular Medicine (CMM) that compares costs and health benefits. Many drug and medical industry experts reject cost-effectiveness analysis because it depends on unreliable population studies and can be a pretext for rationing care. Cost-effectiveness analysis also can negatively affect future medical innovation, as drug companies will be discouraged from producing new vaccines and life-saving drugs.

Solution

Doctors and their patients, not unelected bureaucrats, should be the ones making vaccination and health care decisions.

Questions

1:  Why is the CDC hesitating when it has historically always recommended an FDA-approved vaccine?

2: Is cost-effectiveness analysis being used to decide whether the meningitis vaccine should be put on the infant immunization schedule?

3:  How would that analysis affect consumer choice?

4:  Could that analysis deter drug manufacturers from coming up with new vaccines?

5:  Is this an example of how the CDC will decide whether to recommend future vaccines?

Facts

1:  There are 1,000 to 2,600 cases of bacterial meningitis annually in the United States.

2:  10 to 15 percent of individuals who contract bacterial meningitis die from the disease.

3:  11 to 19 percent of those who survive bacterial meningitis sustain a permanent disability such as brain damage, loss of limb, or hearing loss, or suffer seizures or strokes.

4:  Anyone can contract meningococcal disease, but it is most common in infants less than one year old and individuals with certain medical conditions.

5:  The cost of the infant vaccine has not been determined. However, the vaccine currently available for young adults, preventing both viral and bacterial meningitis, costs roughly $100.