Bexsero Special Precautions

As with other vaccines, administration of Meningococcal Group B Vaccine (Bexsero) should be postponed in subjects suffering from an acute severe febrile illness. However, the presence of a minor infection, such as cold, should not result in the deferral of vaccination.
The vaccine must not be injected intravascularly, subcutaneously or intradermally.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine.
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a psychogenic response to the needle injection (see Adverse Reactions). It is important that procedures are in place to avoid injury from fainting.
As with any vaccine, vaccination with Meningococcal Group B Vaccine (Bexsero) may not protect all vaccine recipients.
Meningococcal Group B Vaccine (Bexsero) is not expected to provide protection against all circulating meningococcal group B strains (see Pharmacology: Pharmacodynamics: Pharmacodynamic effects under Actions).
The vaccine should not be given to individuals with thrombocytopenia or any coagulation disorders that would contraindicate intramuscular injection unless the potential benefit clearly outweighs the risk of administration.
As with many vaccines, healthcare professionals should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age). Prophylactic administration of antipyretics at the time of and closely after vaccination can reduce the incidence and intensity of post-vaccination febrile reactions. Antipyretic medication should be initiated according to local guidelines in infants and children (less than 2 years of age).
Individuals with impaired immune responsiveness, whether due to the use of immuno-suppressive therapy, a genetic disorder, or other causes, may have reduced antibody response to active immunisation. Immunogenicity data are available in individuals with complement deficiencies, asplenia, or splenic dysfunction (see Pharmacology: Pharmacodynamics: Pharmacodynamics effects: Immunogenicity under Actions).
Individuals with complement deficiencies (for example, C3 or C5 deficiencies) in addition to individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) remain at increased risk of invasive disease caused by Neisseria meningitidis group B even following vaccination with Meningococcal Group B Vaccine (Bexsero).
The safety and efficacy of Meningococcal Group B Vaccine (Bexsero) in individuals above 50 years of age have not been established.
There are limited data in patients with chronic medical conditions.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture. If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose. The safe use of Meningococcal Group B Vaccine (Bexsero) in kanamycin-sensitive individuals has not been established.
Ability to perform tasks that require Judgement, Motor or Cognitive Skills: Meningococcal Group B Vaccine (Bexsero) has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under Adverse Reactions may temporarily affect the ability to drive or use machines.