Although medical conditions such as complement deficiency greatly increase a person’s risk of getting meningococcal disease, the vast majority of people who get MenB infection have no risk factor. Also many people who do have risk factors do not find out that they are at risk until after they get meningococcal disease.
Is the vaccine safe?
As with all drugs, vaccines can cause side effects. Vaccine side effects may include soreness/redness/swelling or hardness of skin at the injection site, fever, lack of appetite, muscle aches, irritability, sleepiness and rashes. Almost 8,000 people, including more than 5000 infants and toddlers, have had the new MenB vaccine during clinical trials[1-3, 6-8]. Results from these trials have shown that Bexsero® has a good safety profile. A review of the data by the European Commission resulted in vaccine licensure in January 2013 on the basis of the benefits of the vaccine outweighing the risks.
Real-world experience of using Bexsero is growing. Nearly 17,000 students in the US were vaccinated in response to an outbreak of MenB disease at Princeton University in late 2013 and the University of California, Santa Barbara in early 2014. Additionally, in the summer of 2014 over 45,000 people between 2 months to 20 years of age, were vaccinated as part of a public immunisation program in the Saguenay-Lac-St-Jean region of Quebec, Canada. No serious adverse events were reported following the program and rates of fever and local reactions were similar to that of other routine immunisations.The vaccine has also been administered to nearly 4,000 students at the University of Bristol with no serious adverse events being reported. From 2013 to the time of writing (June 2015) over 1 million doses of Bexsero have been distributed in 19 countries worldwide.
Is it safe for Bexsero® to be given at the same time as other routine vaccines?
Yes. The side effects seen when Bexsero® is given with other vaccines in the routine childhood schedule are the same as those commonly seen with vaccines in general. This is also true when the vaccine is given at the same time as hepatitis B and varicella vaccines.
Fever is more common in babies when Bexsero® is given alongside other vaccines although taking paracetamol after getting vaccinated (or at the same time) reduces the likelihood and severity of fever without affecting the immune response to any of the vaccines.
What are the active ingredients in the vaccine?
The active ingredients that equip our immune system to fight MenB bacteria include four main components of meningococcal bacteria. Three of them are proteins found on the surface of the bacteria:
- Factor H Binding Protein (fHbp)
- Neisseria Heparin Binding Antigen (NHBA)
- Neisserial Adhesin A (NadA)
These three components help meningococcal bacteria invade and survive within the human body. In vaccinated people, the immune system can recognise and ‘neutralise’ these components, so the bacteria cannot make them ill.
The final ingredient is the New Zealand MenB Vaccine (MenZB) derived from the New Zealand outbreak strain of MenB (strain NZ 98/254).
All of these components have been processed and inactivated and are not part of any living bacteria, but can still stimulate the immune system.
Other ingredients in the vaccine include:
- Aluminium hydroxide (the active ingredients of the vaccine are adsorbed to this to improve immunogenicity)
- Histidine (used to regulate the PH of the vaccine)
- Sodium chloride*
- Water for injections*
* Used to make an isotonic solution (a solution with a similar salt concentration as cells and blood in the body
Are there any safety reasons not to have the vaccine? What about allergies?
People who have previously had an anaphylactic reaction to any of the vaccine components listed above should not get the vaccine.
Anaphylaxis to current vaccines is very rare and is estimated to occur in one in a million doses given, although a recent study found no reports of anaphylaxis following more than 5 million preschool and infant immunisations over an entire year in the UK and Ireland.
People with severe immune system problems cannot have live vaccines, but the new MenB vaccine is not live. Food allergies are not a reason to avoid vaccination, except people with egg allergies who may need to avoid some flu vaccines. People often worry that eczema, asthma, epilepsy and a family history of reactions to vaccinations are a reason to avoid vaccinations, but this is not true.
The tip cap of the syringe may contain natural rubber latex. The risk of developing an allergic reaction is very small, but you should speak to your doctor or nurse before being vaccinated.
Will this vaccine be offered to adolescents free of charge within the health service?
There is no current UK or Irish recommendation for adolescents to be vaccinated.
Typically, meningococcal disease is most common in babies and children under five, with a second peak in adolescence. However, at present the peak age for meningococcal disease is at 5 months of age, and the number of cases in adolescents is even lower than usual.
In theory, vaccinating teenagers could have benefits for the whole population, in addition to directly protecting those vaccinated. Teenagers are the main carriers of meningococcal bacteria, so if vaccinating them could prevent them from carrying the bug and passing it on, it could protect everyone, including people who aren’t vaccinated.
However, in the UK the JCVI concluded that there was not enough evidence about the extent to which the MenB vaccine would stop teenagers from carrying and transmitting the bug, nor how long vaccination would directly protect this age group. For these reasons the JCVI recommended that a carriage study should be undertaken in adolescents to show whether the vaccine could stop them acquiring the bacteria in their throats. The results from this study will help them decide whether the vaccine should be offered to all teenagers in future.
How can I get the vaccine for my child if s/he is not eligible for it free of charge within the health service?
GPs and travel clinics throughout the UK and Ireland have been informed that the vaccine is available. Start by asking your own GP for the vaccine, as if they can provide it, this is likely to be the least costly option. GPs may not be able to offer the vaccine to their own patients, but they may be able to arrange it via another surgery on private prescription. You can also get the vaccine from a travel vaccination clinic in your area, or a private GP practice. It is worth asking more than one clinic as prices can vary considerably.
The manufacturer has a customer service line in the UK for healthcare professionals only.
GPs or other health professionals can ring to get the vaccine: 08457 451500, Mon-Thu 8am-4.45pm and Fri 8am-1pm, http://www.bexsero.co.uk/healthcare-professional/ordering-bexsero.htm
. The manufacturer is prohibited by law from speaking to members of the public on this line and any patients who call will be referred back to their healthcare practitioner
In Ireland, Bexsero® is available to order through a company called Allphar Services based in Dublin. Health professionals can ring to get the vaccine on 014688456.