Serogroup B Meningococcal Vaccine and Outbreaks
Questions and Answers
Three serogroups, or strains, of meningococcal bacteria (serogroups, B, C, and Y) circulate and cause disease in the United States. In certain outbreaks, vaccination against meningococcal disease is recommended to help stop the disease from spreading. In the United States, vaccines are approved and routinely used against serogroups C and Y (in addition to A and W, which circulate globally), but not B. A serogroup B meningococcal vaccine that is licensed for use in Europe, Canada, and Australia has been used in the United States to help control 2 outbreaks of this disease:
- Princeton University Meningococcal Disease Outbreak
- University of California, Santa Barbara Meningococcal Disease Outbreak
Learn more about the serogroup B meningococcal vaccine below.
What is meningococcal disease?
Meningococcal disease can refer to any illness that is caused by the type of bacteria called Neisseria meningitidis, also known as meningococcus. Fewer than 1,000 cases of meningococcal disease occur each year in the United States.
These bacteria can cause serious infections like meningococcal meningitis (infection of the protective membranes of the brain and spinal cord) and meningococcal septicemia (bloodstream infection causing bleeding into the skin and organs).
There are five main serogroups ("strains") of meningococcal bacteria: A, B, C, Y, and W. The most common ones that cause disease in the United States are B, C, and Y. In 2012 there were about 500 total cases of meningococcal disease, and 160 of those cases were caused by serogroup B.
View CDC’s guidance for evaluating and managing meningococcal disease outbreaks.
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 serogroup B meningococcal 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 the vaccine to prevent meningococcal disease outweigh the risks of possible adverse events in certain outbreak situations. For example, the FDA allowed its use during the serogroup B meningococcal disease outbreaks at Princeton University and University of California, Santa Barbara.
FDA and CDC monitor the safety of the serogroup B meningococcal vaccine whenever the vaccine is allowed to be used to help shorten the duration of an outbreak.
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: Can the vaccine give someone meningococcal disease?
A: No. Since the serogroup B meningococcal 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.
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 serogroup B meningococcal 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. The serogroup B meningococcal vaccine 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: 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: Is this an approved vaccine?
A: The serogroup B meningococcal vaccine is not approved in the United States. However, the FDA has allowed the use of the 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 the serogroup B meningococcal 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. Before these countries approved the vaccine’s use, their regulatory agencies — those similar to the FDA in the United States — completed a thorough review of the available data.
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: Will a serogroup B meningococcal vaccine eventually be licensed for use in the United States?
A: It is possible that manufacturers will get this type of vaccine licensed in the United States in the future. In April 2011, an FDA advisory committee discussed the data available at that time about serogroup B meningococcal vaccines and approaches for getting those vaccines licensed in the United States. In spring 2014, Novartis and Pfizer both publicly acknowledged that they have received FDA Breakthrough Therapy designation for their serogroup B meningococcal vaccines. Novartis plans to submit a license application for their serogroup B meningococcal vaccine to FDA for review as early as the second quarter of 2014; Pfizer by mid-2014. Questions regarding Novartis' and Pfizer's plans to seek licensure in the United States should be directed to them. Learn more from the FDA.
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.
The company (Novartis) who makes the serogroup B vaccine produces another meningococcal vaccine (Menveo®) that has been licensed and recommended for use in the United States since 2010 to help protect against serogroups A, C, Y, and W. However, Menveo® does not offer protection against serogroup B. If recommended, people need to get the serogroup B vaccine in order to be best protected during serogroup B outbreaks.
Q: Where has this vaccine been used in the United States?
A: The serogroup B meningococcal vaccine is being 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. More than 5,000 Princeton University students received the first dose of the vaccine in December 2013; more than 4,700 students received the second dose in February 2014. More than 9,000 UCSB students received the first dose in February and March 2014. To date, there have been no unusual patterns of adverse events associated with the vaccine.
Q: When recommended, 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 specific outbreaks given the lack of an available, adequate, and approved preventive alternative in the United States.
Q: How soon is someone protected after getting this vaccine?
A: It takes up to 2 weeks after vaccination for the body to mount an immune response and have protection against serogroup B meningococcal disease.
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 serogroup B meningococcal 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 the serogroup B vaccine can protect against carriage; therefore, there is no known target percentage of people that need to get the vaccine to achieve herd immunity. We rely on as many people as possible to get the vaccine and help protect themselves during an outbreak.
Vaccine Use for Others
Q: Will the vaccine be offered to other people?
A: No. As of this time, the vaccine is only able to be used for groups identified in an Investigational New Drug application as being at increased risk for getting meningococcal disease in specific outbreaks. The vaccine is not broadly available because it is not approved in the United States.
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 (possibly as few as 1 or 2 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.
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].
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