Adverse reactions to meningococcal vaccine are mild and consist principally of pain and redness at the injection site for 1 to 2 days.Pain at the site of injection is the most commonly reported adverse reaction, and a transient fever might develop in less than or equal to 2% ofyoung children.⁵

Adverse events reported by 150 adults following vaccination with Menomune - A/C/Y/W-135 vaccine are shown in Table 1.¹⁴ The subjects were observed for three weeks following vaccination. Local reactions resolved within 48 hours and no significant systemic reactions were reported.¹⁴

TABLE 1¹⁴
ADVERSE EVENTS (%) FOLLOWING VACCINATION OF 150 ADULTS WITH MENOMUNE - A/C/Y/W-135 VACCINE

In a clinical study involving 73 children 2 to 12 years of age, who received Menomune - A/C/Y/W-135 vaccine, local reactions consisting of erythema or tenderness were seen in approximately 40% of the children.¹⁵ In another clinical study involving 53 children 4 to 6 years of age, who received Menomune - A/C/Y/W-135 vaccine, erythema was seen in 89% of the children, swelling in 92% and tenderness in 64%. None of these reactions were considered serious or necessitated medical intervention.²⁶

On rare occasions, IgA nephropathy has occurred following vaccinations with Menomune - A/C/Y/W-135 vaccine. However, a cause and effect relationship has not been established.¹⁶

Menomune - A/C/Y/W-135 vaccine should NOT be given at the same time as whole-cell pertussis or whole-cell typhoid vaccines due to combined endotoxin content.^20,21

As with the administration of any vaccine, vaccine components can cause hypersensitivity reactions in some recipients.

Reporting of Adverse Events

The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other health-care providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine.^22,23,24

Reporting by patients, parents or guardians of all adverse events occurring after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by the health-care provider to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting Systems (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a toll-free number 1-800-822-7967.²⁴

Health-care providers also should report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.

If Menomune - A/C/Y/W-135 vaccine is administered to immunosuppressed persons or persons receiving immunosuppressive therapy, an adequate immunologic response may not be obtained.

REFERENCES

5. Recommendation of the Advisory Committee on Immunization Practices (ACIP). Control and prevention of meningococcal disease and control and prevention of serogroup C meningococcal disease: evaluation and management of suspected outbreaks. MMWR 46: No. RR-5, 1997

14. Hankins WA, et al. Clinical and serological evaluation of a Meningococcal Polysaccharide Vaccine Groups A, C, Y and W-135. Proc Soc Exper Biol Med 169: 54-57, 1982

15. Lepow ML, et al. Reactogenicity and immunogenicity of a quadrivalent combined meningococcal polysaccharide vaccine in children. J Infect Dis 154: 1033-1036, 1986

16. Data on file at Sanofi Pasteur Inc.

20. Kuronen T, et al. Adverse reactions and endotoxin content of polysaccharide vaccines. Develop Biol Standard, Vol. 34: 117-125, 1977

21. Peltola H, et al. Meningococcus group A vaccine in children three months to five years of age: adverse reactions and immunogenicity related to endotoxin content and molecular weight of the polysaccharide. J Pediatr Vol 92: No 5, 818-822, 1978

22. CDC. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37: 197-200, 1988

23. Food and Drug Administration. New reporting requirements for vaccine adverse events. FDA Drug Bull 18 (2), 16-18, 1988

24. CDC. Vaccine Adverse Event Reporting System - United States. MMWR 39: 730-733, 1990

26. Scheifele DW, et al. Local adverse effects ofmeningococcal vaccine. Can Med Assoc J 150: 14-15, 1994

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