ATLANTA — The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to remove language from its meningococcal vaccine statement warning that a history of Guillain-Barré syndrome should be considered a “precaution” to administering meningococcal conjugate vaccines.
The action followed the presentation of final results of a study conducted at Harvard Medical School/Harvard Pilgrim Healthcare involving nearly 12.6 million individuals aged 11–21 years. No cases of Guillain-Barré syndrome (GBS) occurred within 6 weeks of vaccination in any of the 1.4 million participants who received quadrivalent meningococcal conjugate vaccine (MCV4, Menactra) doses, Priscilla Velentgas, Ph.D., of Harvard Medical School and the Harvard Pilgrim Health Care Institute, Boston, reported.
“This study provided no evidence of increased risk of GBS associated with MCV4,” she said.
Concern over a link between meningococcal conjugate vaccines and GBS arose in 2006. In October of that year, the CDC published findings from the Vaccine Adverse Event Reporting System (VAERS) indicating that the observed rate of GBS within 6 weeks of vaccination appeared to be elevated among adolescents aged 15–19 years. The passive VAERS thus generated a “signal” of a possible problem, which triggered a CDC investigation using the Vaccine Safety Datalink. That investigation also found no link between MCV4 and increased risk of GBS.
On the recommendation of the ACIP meningococcal working group, the committee voted to remove all precautionary language from the meningococcal statement, and background language will include relevant VAERS information and data from the studies showing no increased risk of GBS after meningococcal conjugate vaccine administration in the general population. Additionally, the matter will be sent to the ACIP General Recommendations Working Group to address the risks and benefits of receiving any vaccine in a person with a history of post-vaccine GBS.
Disclosures: Dr. Velentgas said both Harvard Pilgrim Care and Outcome Sciences have accepted research funding from vaccine manufacturers, and that she is an employee of both. The study was funded by Sanofi Pasteur through a contract with Harvard Pilgrim.