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Risk and Reporting for NeisVac-C

Adequate medical treatment and provisions should be available for immediate use in the rare event of an anaphylactic reaction. For this reason the subject should remain under supervision for the appropriate length of time after vaccination.

NeisVac-C SHOULD UNDER NO CIRCUMSTANCES BE INJECTED INTRAVENOUSLY OR SUBCUTANEOUSLY. 

Because of the risk of bleeding or hematoma at the injection site, benefits and risks should be carefully weighed when considering use of the vaccine in individuals with any coagulation disorder (e.g., thrombocytopenia) or concomitant anticoagulant therapy.

The potential risk of apnoea and the need for respiratory monitoring for 48-72 h 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.

This medicinal product contains less than 1 mmol sodium (23 milligrams) per dose, i.e. essentially “sodium-free”. 

No data on the applicability of the vaccine to outbreak control are as yet available.

The benefit-risk assessment of vaccination with NeisVac-C depends on the incidence of N. meningitidis serogroup C infection in a given population before the institution of a widespread immunisation programme.

Vaccination should be postponed in subjects with acute clinical conditions (with or without fever) that could be aggravated by adverse reactions to the vaccine or could impair the interpretation of possible adverse reactions to the vaccine. 

In subjects deficient in producing antibody (e.g. due to genetic defect or immunosuppressive therapy) this vaccine may not induce protective antibody levels following vaccination. Hence, vaccination may not result in an appropriate protective antibody response in all individuals. 

It would be anticipated that individuals with complement deficiencies and individuals with functional or anatomical asplenia would mount an immune response to meningococcal C conjugate vaccines; however, the degree of protection that would be afforded is unknown. 

Although symptoms of meningism such as neck pain/stiffness or photophobia have been reported there is no evidence that meningococcal group C conjugate vaccines cause meningococcal C meningitis. Clinical alertness to the possibility of co-incidental meningitis should therefore be maintained.

This vaccine does not substitute for routine tetanus immunisation. 

NeisVac-C will only confer protection against group C of Neisseria meningitidis and may not completely prevent meningococcal group C disease. It will not protect against other groups of Neisseria meningitidis or other organisms that cause meningitis or septicaemia. In the event of petechiae and/or purpura following vaccination, the aetiology should be thoroughly investigated. Both infective and non-infective causes should be considered. 

There are no data on the use of NeisVac-C in adults aged 65 years or more.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pfizer Medical Information on 01304 616161 or emailed to [email protected]