Princeton University to Give Unapproved Vaccine to Staff and Students

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Princeton University is seeing an outbreak of a rare form of meningitis. Image by Quantockgoblin.

Princeton University is seeing an outbreak of a rare form of meningitis. Image by Quantockgoblin.

Princeton University has seen a outbreak of a rare form of meningitis since last March. This medical situation has Princeton University officials making the decision to offer a vaccine that has not yet been approved for some students and staff. Students who are living in dorms and staff who have sickle cell diseases and other illnesses that compromise their immune system are more vulnerable to the illness, and the CDC recommends giving them the unapproved vaccine.

Meningitis Symptoms and Infections

Meningococcus is a bacteria that lives in the lining of the throat and nose; when the bacteria enters the bloodstream, it causes a severe disease known as meningitis. There are different types of meningitis (viral, parasitic, bacterial) and different types of bacterial meningitis. There are five different types of bacterial meningitis, types A, B, C, Y, and W-135. According to the CDC, every year in the United States there are 4,100 cases of bacterial meningitis and 500 deaths. If you have this bacteria, you can spread it easily by kissing, coughing, or lengthy contact, such as sharing a dorm room.

Bacterial meningitis infects the blood stream, and the lining of the brain and spinal cord. This results in patients developing a bloodstream infection which can cause fever, chills, rash, low blood pressure, and dark purple spots on the arms or legs. Other symptoms of meningitis include fever, headache, confusion, and a stiff neck.

Meningitis is a serious illness that can be fatal; for those who do survive, many are left with disabilities for the rest of their lives. According to the Children’s Hospital of Philadelphia, about one out of five survivors have permanent disabilities such as seizures, hearing loss, loss of limbs, kidney disease, and mental disabilities.

Bacterial meningitis can infect you quickly and have severe and fatal consequences. There is a vaccine that protects against all forms of bacterial meningitis, except for type B. Type B accounts for two-thirds of all meningitis cases in infants and one-third of all cases in adolescents, but there is no approved vaccine for Type B.

Although the type B vaccine has not completed the drug approval process, the CDC is still recommending it to students who live in the dorms and staff at Princeton University who have compromised immune systems.

Bexsero Vaccine

Meningitis can be fatal or leave survivors with disabilities. Image by Mikael Häggström.

Meningitis can be fatal or leave survivors with disabilities. Image by Mikael Häggström.

According to FOX News, Princeton University officials said that the vaccine will be made available for staff with medical conditions and students who live in the dorms. Follow up doses will be made available in February, as the vaccine is most effective in two doses. Since March of 2013, seven cases of meningitis have occurred on the campus.

The B strain is more common in Europe, but not here in the United States. Europe approved the vaccine in January 2013 and Australia approved the vaccine in August 2013. Bexsero is the only vaccine for group B meningitis and is developed by the Novartis company. The Food and Drug Administration has approved importing the vaccine for use at Princeton University. So is the vaccine safe and effective?

Meningitis Vaccine Safety and Effectiveness

According to the European Commission, which is an equivalent of the National Institutes of Health here in the United States, they approved the vaccine in January 2013. The European Commission provided a document on the vaccine that talks about storage, dosage amounts, contraindications, and other topics on the vaccine. According to this document, each dose is 0.5ml and approved for people ages two months and older, but should not be given to people who have thrombocytopenia or any coagulation disorder. The manufacturers determined the safety of the vaccine with eight studies on 6,427 people ranging from infants to adults.

For those who are older, have a chronic medical condition or have a weakened immune system, the document states, “There are no data on the use of Bexsero in subjects with impaired immune responsiveness. In immunocompromised individuals, vaccination may not result in a protective antibody response.There are no data on the use of Bexsero in subjects above 50 years of age or in patients with chronic medical conditions.”

For women who are pregnant there is insufficient data available to determine whether or not the vaccine is safe. However, in a study using female rabbits who received ten times the human dose equivalent based on body weights, there was no evidence of maternal or fetal toxcitiy, no effects on pregnancy, maternal behavior, fertility, or postnatal development. Information on safety for women who are breastfeeding is unavailable. In the rabbits who were lactating, the researchers saw no adverse reactions in the mother or the offspring in the 29 days of nursing. They did find antibodies in the baby rabbits, but were unable to determine antibody levels in the breast milk.

The most common side effects that test subjects reported included fever, pain, nausea, and headache.

So how effective is this vaccine? According to the document, the trials did not evaluate the effectiveness of the vaccine, but did note that antibody response was high. An antibody is a fighter against a foreign substance that enters the body, such as the vaccine. When this occurs different types of cells respond and trigger the B lymphocytes to produce antibodies that help protect us from this foreign substance if it shows up again.

Meningitis Type B: Infection Rates and Prevention

This strain of meningitis is rare and doctors can misdiagnose it. This is particularly worrisome because Type B meningitis can kill someone within 24 hours of disease onset. The Bexsero vaccine is one way to potentially prevent group B meningitis. As health officials gather more data on the effectiveness of this vaccine, we’d all do well to utilize other preventative measures such as covering your cough, washing your hands, and not sharing drinking glasses and eating utensils.

Resources:

Centers for Disease Control and Prevention. Bacterial Meningitis. (2012). Accessed November 20, 2013.

Children’s Hospital of Philadelphia. Meningococcus: What you should know. (2012). Accessed November 20, 2013.

European Commission. Bexsero Summary of Product Characteristics. Accessed November 20, 2013.

FOX News. Princeton to give out vaccine not yet approved in US to control meningitis outbreak. (2013). Accessed November 19, 2013.

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