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Princeton University Meningococcal Disease Outbreak

Princeton University is experiencing a prolonged outbreak of serogroup B meningococcal disease, with eight cases and one outbreak-associated case in a Drexel University student reported. The last outbreak-associated case was reported in March 2014. CDC, the New Jersey Department of Health (NJDOH), Princeton University officials, and local health authorities have been working closely together since the first case of meningococcal disease associated with Princeton University was reported in March 2013. Get the latest information and additional questions and answers about the outbreak from the University and the New Jersey Department of Health [9 pages].

A serogroup B meningococcal vaccine (Bexsero®), which is licensed for use in Europe, Canada, and Australia, is being used at Princeton University. FDA allowed the use of the vaccine at Princeton University under an Investigational New Drug application. Since December 2013, more than 13,000 doses of the vaccine were administered at Princeton University. To date, there have been no unusual patterns of serious reactions associated with the vaccine.

Controlling Serogroup B Meningococcal Outbreaks in Institutional Settings

CDC has developed interim guidance for the control of serogroup B meningococcal outbreaks in institutional settings. View interim guidance.

Below are answers to commonly asked questions about this outbreak. Note that all vaccine information on this page is specific to Bexsero® unless otherwise noted.

Vaccine Recommendations

Q: Who is the vaccine recommended for and why?

A: The vaccine is recommended for all Princeton University undergraduate students (those who live in dormitories or off-campus) as well as graduate students who live in dormitories. Certain other individuals associated with the University can be evaluated for vaccination if they have specific medical conditions, including problems with their spleen (including sickle cell disease) or complement pathway (a specific type of immune deficiency). These groups are recommended vaccine because young adults and people with certain medical conditions are at increased risk of getting this infection, especially those who live in close quarters, such as dormitories.

New Serogroup B Meningococcal Vaccine Licensed

On October 29, 2014, the Food and Drug Administration (FDA) has licensed the first serogroup B meningococcal vaccine (Trumenba®). FDA approved this vaccine for use in people 10-25 years of age as a 3-dose series. Physicians can use the vaccine for people 10-25 years of age consistent with the labeled indication.

Meningococcal disease can be very serious and sometimes life-threatening. The best way to protect students during this outbreak is vaccination. It is important to get as many students vaccinated as possible to help stop the outbreak of serogroup B meningococcal disease at the University.

Q: Are those recommended to get the vaccine required to get it?

A: No, getting the vaccine is voluntary.

Q: Do people recommended to get this vaccine, but who have already gotten a meningococcal vaccine, need this one, too?

A: Yes. People who are recommended to receive the vaccine need it in addition to the meningococcal vaccine routinely administered in the United States. That vaccine protects against four serogroups ("strains"), known as serogroups A, C, Y, and W, but not against B. Bexsero® helps protect against serogroup B and can only be used during certain situations when allowed by the FDA, like during an outbreak of serogroup B meningococcal disease. During past serogroup B meningococcal disease outbreaks, people have not had the opportunity to get this vaccine because there wasn’t one available or licensed anywhere that would have been effective.

Q: I thought the school was doing other things, like telling students not to share cups, to help prevent the disease from spreading. Why is a vaccine needed?

A: The University and NJDOH have taken appropriate public health measures to prevent cases, including offering preventive antibiotics to close contacts of ill students and educating students about meningococcal disease. Students should:

  • Know the symptoms of meningococcal disease;
  • Avoid activities — like smoking or sharing respiratory secretions (such as saliva, by kissing or close coughing) — that can increase their risk of illness; and
  • Seek medical attention immediately if they have any symptoms of meningitis or a bloodstream infection. Symptoms may include sudden onset of a high fever, headache, stiff neck, nausea, vomiting, rapid breathing, or a rash. It is important to remember that someone with meningococcal disease may have a high fever and no other symptoms.

Getting plenty of rest and not sharing saliva are good general hygiene recommendations, but their effectiveness at protecting against meningococcal disease is probably limited. The best protection comes from getting vaccinated.

Q: Why are the residents of the town of Princeton not eligible to receive the vaccine?

Tracking for cases of meningococcal disease is very good and no cases have been seen in the town of Princeton during this outbreak, which indicates that members of the general public are not currently at increased risk. Rates of meningococcal disease have been declining in the United States since the late 1990s. There are now fewer than 1,000 cases reported each year, and more than 95 out of 100 cases are sporadic (not associated with an outbreak).

Since the vaccine used at Princeton University is not licensed for use in the United States, an Investigational New Drug application is being used to allow the vaccine for everyone associated with the University who is considered at increased risk for meningococcal disease. The vaccine cannot be given to anyone who does not fit the eligibility criteria established in the Investigational New Drug application. For that reason, only undergraduate students (regardless of where they live), graduate students who live in dormitories, and certain other individuals associated with the University who have a medical condition that puts them at increased risk for meningococcal disease can receive the vaccine.

While anyone can get meningococcal disease, adolescents and college-aged adults are at increased risk. The bacteria that cause meningococcal disease require prolonged (lengthy), close contact in order to spread. The bacteria are much harder to spread than the virus that causes the flu and cannot live outside of the body for very long. The bacteria are not spread by casual contact like being in the same room as someone who is sick or carrying the bacteria or handling items that they touched. You must be in close contact with the person’s saliva (spit) or other respiratory secretions in order for the bacteria to spread. Close contacts include people in the same household, roommates, or anyone with direct contact with a patient's saliva (such as a boyfriend or girlfriend through French kissing).

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Getting the Vaccine

Q: When and where can I get the vaccine?

A: Eligible University community members who still need a first or second dose of the vaccine should contact University Health Services to discuss options for getting the vaccine.

Q: Who is paying for this vaccine?

A: Princeton University is covering the cost of the vaccine for all eligible individuals who receive it.

Q: What kind of consent is needed to get the vaccine?

A: Those who are 18 years of age and older give their own informed consent. Those younger than 18 years old of age need a signed consent form from their parent or guardian before receiving the vaccine. Before the vaccine campaign began, the University provided further information to everyone who is recommended to get the vaccine and parents of students to assist in the decision-making process.

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Safety of the Vaccine

Q: How safe is the vaccine?

A: More than 8,000 infants, children, adolescents, and adults were safely vaccinated with the vaccine as part of the studies that resulted in its approval in Europe, Canada, and Australia. Like any vaccine, this one can potentially cause a serious problem such as a severe allergic reaction, though the risk of serious harm from the vaccine is extremely small.

Common side effects in adolescents and young adults
The most common side effects take place where the shot was given (in the arm), which can include pain and tenderness, swelling, and hardness of the skin. Other common side effects for adolescents and young adults include nausea, feeling a little run down, and having a headache. These reactions usually last a short amount of time and get better on their own within a few days. Among adolescents, there is also a risk of fainting after getting this vaccine or any shot.

Common side effects in children up to 10 years of age
The most common side effects are loss of appetite, sleepiness, unusual crying, diarrhea, vomiting, rash, fever, and irritability, as well as tenderness, swelling, hardness, and redness of the skin where the shot was given (in the arm or leg). These reactions usually last a short amount of time and get better on their own within a few days.

Q: Does the Food and Drug Administration (FDA) think it’s safe to get this vaccine?

A: Yes. FDA has stayed informed about development of serogroup B meningococcal vaccines over the years and recently reviewed the latest available data. From this review, FDA has concluded that the benefits of using Bexsero® to prevent meningococcal disease outweigh the risks of possible adverse events in certain outbreak situations like the one at Princeton University.

FDA and CDC monitor safety whenever the vaccine is allowed to be used to help shorten the duration of an outbreak.

Q: Can the vaccine give someone meningococcal disease?

A: No. Since the vaccine does not include any live bacteria, but is instead made of inactivated parts of the Neisseria meningitidis bacteria, the vaccine cannot give someone meningococcal disease.

Q: Is it safe to get the vaccine right after getting another meningococcal vaccine, like Menveo® or Menactra®, or after getting a flu vaccine?

A: Yes, it is safe to get the vaccine after receiving another meningococcal vaccine or a flu vaccine.

Q: Is there anything someone should tell the doctor or nurse before getting the vaccine?

A: Yes. They should tell the doctor or nurse if they:

  • Are not feeling well. If the person has a severe infection with a high temperature, vaccination should be delayed. But the vaccine should be given on time if there is only a minor infection, such as a cold.
  • Have a chronic medical problem, like hemophilia.
  • Have a severe (life threatening) allergy to any vaccine component.
  • Are pregnant or breastfeeding.
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Vaccine Effectiveness

Q: Will the vaccine help protect students against the strain of meningococcal disease identified at Princeton University?

A: Yes. Lab testing has been done to establish that the vaccine will help protect against the exact strain of meningococcal bacteria that is causing the outbreak at the University. The outbreak strain at Princeton University is ST409.

Q: How many doses of the vaccine are needed?

A: Two doses are needed for maximum protection. The second dose should be given one to six months after the first dose (but not sooner).

Q: How long does it take to get protected after getting the first dose of the vaccine?

A: After getting the first dose of the vaccine, it will take about 2 weeks for the body’s immune system to develop enough protection (antibodies) to help prevent serogroup B meningococcal disease. Since that protection declines over time, a second dose is needed to maintain protection. It is critical that high levels of protection are achieved during an outbreak.

Q: How long is this vaccine effective for?

A: Based on clinical trials, it is known that the first dose provides protection for a few months, but protection wears off. So it is important for those who are recommended the vaccine to receive the second dose in the recommended time window.

For short-term efficacy, studies show that almost all adolescents have a robust response to the vaccine after getting 2 doses. This means that almost all adolescents who get both doses of the vaccine will likely be protected against serogroup B meningococcal disease. Longer-term data are not available.

The goal is that vaccination during a serogroup B outbreak will help protect these individuals for a long enough period of time to interrupt disease spread and stop the outbreak caused by a specific strain.

Q: If enough people get this vaccine will there be herd immunity?

A: People have ("carry") many germs in their noses and throats. Some vaccines can protect against both disease and carriage of the germs. When carriage is reduced by vaccination, the risk of disease can be reduced even in people who were not vaccinated, called "herd immunity."  We do not know if this vaccine can protect against carriage; therefore, there is no known target percentage of people that need to get vaccinated to achieve herd immunity. We rely on as many people as possible to get the vaccine and help protect themselves during an outbreak.

Q: How long can someone be a carrier after getting this vaccine?

A: Since this vaccine is relatively new, we do not have enough data to know what the impact is on carriage. For meningococcal bacteria in general, we are not certain for each person how much time he or she can carry the bacteria. We do know that carriage is not permanent and generally lasts weeks to months. The length of time may vary by person and with each specific strain of the bacteria. We do not have specific data on the duration of carriage, or what the maximum duration of carriage is, for all strains.

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Vaccine Approval

Q: Is this an approved vaccine?

A: Bexsero® is not approved in the United States. However, the FDA has allowed the use of this vaccine to help control outbreaks at Princeton University and University of California, Santa Barbara under an Investigational New Drug application, which refers to the FDA review process that authorizes use in certain situations of a medication or vaccine that is not licensed (approved) in the United States. FDA considers the circumstances of each outbreak individually when determining if use of this vaccine should be allowed. Clinical trials in other countries have shown the vaccine to meet safety and efficacy standards to allow licensure in the European Union, Canada, and Australia.

Q: Why is the vaccine referred to as an "investigational new drug"?

A: This is a term FDA uses to describe a medication or vaccine that is not licensed (approved) in the United States, but which may be used in certain specific situations.

Q: Is the vaccine being offered to conduct a research study?

A: No. The vaccine is being provided for prevention of serogroup B meningococcal disease during this outbreak given the lack of an available, adequate, and approved preventive alternative in the United States.

Q: Where is the vaccine licensed and how new is it?

A: The vaccine is currently licensed in Europe, Canada, and Australia. The European Union approved its use in January 2013, Australia approved its use in August 2013, and Canada approved its use in December 2013. These countries have higher rates of meningococcal disease caused by serogroup B compared to countries like the United States. Before these countries approved the vaccine’s use, their regulatory agencies — those similar to the FDA in the United States — completed a thorough review and concluded the vaccine was effective and met safety standards. Approvals in additional countries are expected soon.

Q: Have vaccines similar to this one been used before?

A: Yes. The vaccine is similar to, but likely more effective than, a serogroup B vaccine (MeNZB) that was used for several years in New Zealand. The vaccine used in New Zealand protected against one type of serogroup B. More than 1.1 million people were vaccinated with MeNZB in New Zealand from 2004-2011, helping to stop a country-wide outbreak of serogroup B meningococcal disease. No unusual pattern or occurrence of serious reactions was seen with the MeNZB vaccine.

Q: Where has this vaccine been used in the United States?

A: The vaccine was used for the first time in the United States under an Investigational New Drug application in response to outbreaks at Princeton University and University of California, Santa Barbara. Since December 2013, approximately 30,000 doses of the vaccine were administered at these universities.  To date, there have been no unusual patterns of serious reactions associated with the vaccine.

Q: Will a serogroup B meningococcal vaccine eventually be licensed for use in the United States?

A: Two serogroup B meningococcal vaccines have been in development for use in the United States. The manufacturers are Novartis and Pfizer.

Pfizer’s serogroup B vaccine (Trumenba®) was licensed for use by FDA on October 29, 2014. Clinicians can administer it according to its FDA-approved indication for use in people ages 10-25 years as a 3-dose series.

Novartis’ U.S. licensure application for Bexsero® is still pending FDA’s final decision. An announcement regarding licensure is expected by March 2015, if not sooner.

Questions regarding Novartis' and Pfizer's vaccines should be directed to the firms.

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Role of Antibiotics in Meningococcal Outbreaks

Q: Why can't antibiotics be used for everyone?

A: Antibiotics are only given to close contacts of those who have been diagnosed with meningococcal disease; this practice is known as prophylaxis. Anyone who is a close contact of a person with meningococcal disease is at highest risk for getting the infection. Close contacts are identified by asking people about the extent of their contact and interactions with the person who got meningococcal disease. For example, living with the person who got sick puts you at high risk, but working together in an office or attending class together generally does not.

Recommending antibiotics to an entire student body is not an effective strategy to stop an outbreak. To understand why, it is important to know how this disease spreads in a community. Meningococcal bacteria are spread from person to person and can cause "carriage" in the nose and throat rather than disease. Carriage means that the bacteria live in the nose and throat, but do not invade your body and make you sick. Since you do not have any symptoms you would not know if you are a carrier. At any given time only a very small number of people may carry the outbreak strain (less than 5 people out of 100).

If you wanted to try and control an outbreak with antibiotics, you would have to treat every single person at risk in the outbreak at the same time. Otherwise, if one carrier doesn't receive antibiotics, then the bacteria can continue to spread since antibiotics do not give people lasting protection. Antibiotic prophylaxis only protects someone for about 2 days after finishing the medicine. In addition, antibiotics are only about 85% effective at eliminating the carried bacteria in the nose and throat. This means that even if you do treat everyone at the same time, the bacteria could still survive and continue circulating among the population. Lastly, treating many people unnecessarily with antibiotics also carries risks, possibly causing more harm than good. About 1 in every 100 people is allergic to an antibiotic. Some may not even know it. To help prevent the growing threat of antibiotic resistance, it is critical that antibiotics only be used when necessary and appropriate. For those reasons, antibiotic prophylaxis is not an effective or recommended strategy to stop a meningococcal disease outbreak.

Q: Should we test and treat people for carriage to stop an outbreak?

A: No, CDC does not recommend routine testing for and treating people with antibiotics who are carriers of meningococcal bacteria. Finding meningococcal bacteria in your nose and throat is not usually considered dangerous. When you carry meningococcal bacteria in the back of your nose and throat, it is rare for these bacteria to move and invade other parts of your body and make you sick. Plus, by the time someone got their test results back, their carriage status may have changed (e.g., those who tested negative may now be carriers, and vice versa). If antibiotics were recommended, this would result in some people unnecessarily getting treatment since they would no longer be a carrier, (see risks of antibiotic use in previous question) while new carriers would not get treatment. Spread of the bacteria would continue.

People who have been carriers for more than a week or so are at low risk for disease from the carried strain (even if it is a strain known to cause disease) because of the immunity they have developed. We are not certain how long someone can carry these bacteria; and the length of time may vary from case to case. But we do know that if you are exposed, you either develop disease within a few days or you develop immunity and the carried bacteria eventually disappear from your nose and throat.

Q: Should people at institutions currently experiencing an outbreak take antibiotics before travelling home in order to protect their family and friends in case they are carrying meningococcus bacteria?

A: No. CDC does not recommend that students, staff, or faculty take antibiotics based on concern for exposing others back home. We know from prior experience with meningococcal disease outbreaks at universities that the risk of the outbreak spreading outside to the community or to family members is very low. Public health authorities carefully investigate all reported cases of meningococcal disease.

At any given time during an outbreak, very few individuals carry the outbreak strain of these bacteria in their noses and throats. Treating many people unnecessarily with antibiotics carries risks, possibly causing more harm than good. To help prevent the growing threat of antibiotic resistance, it is critical that antibiotics only be used when necessary and appropriate. The resistance might occur in meningococcus bacteria or in other bacteria the person carries. In addition, antibiotics wipe out the "good" bacteria that protect us from colonization and infection with more harmful microbes. Plus, about 1 in every 100 people is allergic to an antibiotic.

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Contact with Institutions Experiencing Serogroup B Outbreaks

Q: Should students at institutions experiencing serogroup B meningococcal disease outbreaks cancel their plans or be quarantined until the outbreak is over?

A: We recognize that when cases of meningococcal disease occur, there is increased concern about the potential spread of disease and desire to take appropriate steps to prevent additional cases. There is no evidence that family members and the community are at increased risk of getting meningococcal disease from casual contact with students, faculty, or staff at institutions experiencing outbreaks. Therefore, CDC does not recommend limiting social interactions or canceling travel plans as a preventive measure for meningococcal disease. Instead, we continue to recommend that people remain vigilant to the symptoms of meningococcal disease and seek treatment immediately if they experience any of those symptoms.

Q: Should outside sports teams, clubs, or other people who plan to visit or host students from institutions experiencing an outbreak of serogroup B meningococcal disease cancel their plans?

A: No, plans should not be cancelled or delayed. Please see more information about this question here [2 pages].

If you have further questions, please email meningvaccine@cdc.gov.

References

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