Contents

12 Meningococcal disease

12.7 Expected responses and adverse events following immunisation (AEFI)

Frequent adverse reactions after meningococcal conjugate and polysaccharide vaccines include localised pain, irritability, headache and fatigue.23, 35  Fever is reported by 2 to 5 percent of adolescents who receive either MCV4-D or 4vMenPV.

12.7.1 Meningococcal group C conjugate vaccine

The most frequent response to MenCCV in the UK school programme was transient headache in 12 percent of students in the first three days after vaccination.24 This is more commonly reported by secondary students than primary school students. Mild to moderate local reactions at the injection site consisting of pain, tenderness and occasional redness were also reported. These peaked on the third day after the vaccine and resolved within a day.

A Cochrane Review assessed the safety of MenCCVs against group C disease.36 MenCCVs were shown to have an excellent safety profile in infants. The events more frequently reported in infants were: fever (1–5 percent), irritability (38–67 percent); crying more than expected (1–13 percent); redness at the site of vaccination (6–97 percent); tenderness at the site of vaccination (11–13 percent); and swelling at the site of vaccination (6–42 percent). The adverse events were similar in groups vaccinated with MenCCV and with the hepatitis B control vaccine, but following booster doses they were more frequent in the MenCCV group in one trial. Adverse events were rare. Anaphylaxis was reported at a rate of one per 500,000 doses distributed.24

12.7.2 Quadrivalent meningococcal conjugate vaccineTop

The safety of two doses of MCV4-D was assessed in a phase III trial of infants: dose one was administered at age 9 months and dose two was administered at age 12 months, with or without routine childhood vaccines.37 The percentage of participants with solicited systemic reactions after MCV4-D administration alone at age 12 months (60.6 percent) was lower than after the vaccination at age 9 months (68.2 percent), lower than the control groups at age 12 months (75.2–84.1 percent, depending upon the control vaccine), and lower than when MCV4-D was administered concurrently with the routine childhood vaccines (68.3–73.2 percent).

​The safety profile of MCV4-T (Nimenrix) is very similar to other meningococcal conjugate and polysaccharide vaccines.23 However, the tetanus toxoid component of MCV4-T may contribute to a higher incidence of local reactions in older age groups (11–55 years) when compared to the polysaccharide vaccine. 

Guillain-Barré syndrome

In 2005, shortly after MCV4-D (Menactra) was licensed in the US, several cases of Guillain-Barré syndrome (GBS) were reported to the US Vaccine Adverse Event Reporting System (VAERS).20 Because the risk of GBS following vaccination was unknown, the Food and Drug Administration (FDA) considered a previous history of GBS to be a contraindication to MCV4-D, and the contraindication was added to the vaccine data sheet. The US Advisory Committee on Immunization Practices (ACIP) also added precautionary language to its vaccine information statement.

Large safety studies, during which over 2 million doses of MCV4-D were administered, found there was no risk of GBS after MCV4-D in the general population. This data was extrapolated to conclude that people with a history of GBS are not at higher risk than they are after other vaccines that have no association with GBS.38

In June 2010, after reviewing the safety studies, the ACIP removed its precaution for individuals with a history of GBS because the benefit of vaccination outweighs the risk for recurrent GBS in these individuals.20 However, a history of GBS continues to be listed as a contraindication/ precaution in the MCV4-D data sheet.

This information should be discussed with individuals with a history of GBS who are considering immunisation with MCV4-D.

12.7.3 Quadrivalent meningococcal polysaccharide vaccineTop

Generalised reactions to 4vMenPV are rare, but are more common in children than in adults. Up to 80 percent of recipients will have some local reaction, but most reactions are minor.39 Approximately 10 percent of recipients will develop local reactions at the injection site within 24 hours of the injection.

The Canadian campaign delivered over a million doses of 4vMenPV, with reported allergic reactions in 9.2 per 100,000 doses, anaphylaxis in 0.1 per 100,000 doses, and neurological reactions in 0.5 per 100,000 doses; there were no reports of long-term sequelae or of encephalopathy, meningitis or encephalitis.40

12.7.4 Meningococcal vaccinations during pregnancyTop

The available data does not suggest that giving meningococcal vaccine to pregnant women causes any adverse effects. Nevertheless, as with any vaccine in pregnancy, careful consideration of the risks and benefits of immunisation to the mother and fetus is needed. Maternal antibodies will protect the newborn for the first few months, and the subsequent response to the vaccine is not altered.41