Meningococcal Vaccine Safety

Key points

  • There are two types of vaccines that can prevent meningococcal disease.

Overview

Meningococcal disease can refer to any illness that is caused by a type of bacteria called Neisseria meningitidis, also known as meningococcus.

N. meningitidis is a leading cause of bacterial meningitis in children ages 2 through 18 years in the United States. There are six serogroups (a group of bacteria that are closely related) of N. meningitidis that cause most meningococcal disease in the world. They are referred to as serogroups A, B, C, W, X, and Y.

Available vaccines & manufacturer package inserts

MenACWY

Also known as quadrivalent meningococcal conjugate vaccines. Protects against meningococcal disease caused by serogroups A, C, W, and Y.

  • The FDA approved Menactra in 2005. Menactra® is approved for people aged 9 months through 55 years.
  • FDA approved Menveo in 2010. Menveo® is approved for people aged 2 months through 55 years of age.
  • FDA approved MenQuadfi in 2020. MenQuadfi™ is approved for people ages 2 years and older.

MenB

Also known as serogroup B meningococcal vaccines. Protects against meningococcal disease caused by serogroup B.

  • FDA approved Trumenba in 2014. Trumenba® is approved for people ages 10 through 25 years.
  • FDA approved Bexsero in 2015. Bexsero is approved for people ages 10 through 25 years.

Who should & should not get the vaccine

CDC recommends adolescents receive two doses of MenACWY vaccine. Younger children and adults usually do not need MenB vaccines.

Common side effects

Reminder‎

Most side effects are mild to moderate and last from 1 to 3 days.

MenACWY

  • Soreness, redness or swelling where the shot was given.
  • Muscle pain.
  • Headache.
  • Feeling tired (fatigue).

MenB

  • Soreness, redness or swelling where the shot was given.
  • Headache.
  • Feeling tired (fatigue).
  • Muscle or joint pain.
  • Fever.

When to call 911‎

Severe allergic reactions following vaccination are rare, but can be life threatening. If someone experiences symptoms of a severe allergic reaction, which can include hives, swelling of the face and throat, difficulty breathing, a fast heartbeat, dizziness, and weakness.

Vaccines, like any medicine, can have side effects. The most common side effects are usually mild and go away on their own.

Report possible adverse events to VAERS‎

The Vaccine Adverse Event Reporting System (VAERS) is an early warning system, co-managed by CDC and FDA, that monitors for potential vaccine safety problems. Healthcare providers and vaccine manufacturers are required by law to report certain adverse events (any side effect or health problem after vaccination that is concerning to you, even if you are not sure if the vaccine caused the event) following vaccination to VAERS; patients and caregivers can also submit reports.

A closer look at the safety data

Findings from vaccine safety monitoring systems and scientific studies have shown that MenACWY and MenB vaccines have a favorable safety profile—the body of scientific evidence overwhelmingly supports their safety. The Advisory Committee on Immunization Practices (ACIP) no longer considers a history of GBS to be a contraindication nor precaution for meningococcal vaccination.

In studies evaluating the possible relationship between Menactra and GBS, the risk of GBS after Menactra, if any, was small.1

Guillain-Barré and Menactra

Key points‎

Meningococcal conjugate vaccine (MenACWY-D; Menactra) was approved by the Food and Drug Administration in 2005 and became available for public use. Shortly after, case reports of Guillain-Barré after Menactra vaccination were reported to the Vaccine Adverse Event Reporting System (VAERS). In studies evaluating the possible relationship between Menactra and GBS, the risk of GBS after Menactra, if any, was small.

GBS is a rare disorder in which a person's own immune system damages their nerve cells, causing muscle weakness and sometimes paralysis. Many things can cause GBS, including common infections such as sore throats and other infections that occur in the community. While the cause is not fully understood, the syndrome often follows infection with a virus or bacteria.

Fact‎

Menactra Meningococcal Conjugate Vaccine does not cause Guillain-Barré Syndrome (GBS)

The vaccine manufacturers changed the package insert for Menactra to identify a history of GBS as a precaution to vaccination. Subsequently, this precaution was added to other MenACWY vaccines.

Studies were conducted to investigate whether GBS was caused by the vaccine or was coincidental with vaccination. These studies included a combined total of over 2 million vaccinated adolescents. The results of these studies showed that there was no link between Menactra and GBS and that the risk for GBS after Menactra vaccination was not increased over the usual (non-vaccine related) GBS rate among people ages 11 to 21 years. Based on these studies, the Advisory Committee on Immunization Practices (ACIP) no longer considers a history of GBS to be a contraindication nor precaution for meningococcal vaccination.12345

How CDC monitors vaccine safety

CDC and the Food and Drug Administration (FDA) are committed to ensuring that vaccines provided to the public are safe and effective. Once vaccines are licensed or authorized for emergency use in the United States, CDC and FDA continuously monitor them through several safety systems.

Resources

  1. Yih, W. K., Weintraub, E., & Kulldorff, M. (2012). No risk of Guillain-Barré syndrome found after meningococcal conjugate vaccination in two large cohort studies. Pharmacoepidemiology and drug safety, 21(12), 1359–1360. https://doi.org/10.1002/pds.3353
  2. CDC. Update: Guillain-Barré Syndrome among recipients of Menactra meningococcal conjugate vaccine–United States, June 2005-September 2006. MMWR. 2006 Oct 20:55(41);1120-1124.
  3. CDC. Update: Guillain-Barré Syndrome among recipients of Menactra meningococcal conjugate vaccine–United States, October 2005-February 2006. MMWR. 2006 Apr 7:(55(13);364-366.
  4. CDC. Guillain-Barré Syndrome among recipients of Menactra meningococcal conjugate vaccine–United States, June-July 2005. MMWR. 2005 Oct 6:54(Dispatch);1-3.
  5. Velentgas P, Amato AA, Bohn RL, Chan KA, Cochrane T, Funch DP, et al. Risk of Guillain-Barré syndrome after meningococcal conjugate vaccination. Pharmacoepidemiol Drug Saf. 2012 Dec;21(12):1350-8. Epub 2012 Jul 16.