Vaccines in multiple sclerosis

Guidelines for Administration of Human Papillomavirus (HPV) Vaccine (Gardasil®) to Multiple Sclerosis Patients
(Developed by the Executive Committee of the National Clinical Advisory Board, National MS Society USA)

November 30, 2007—Gardasil® (Merck) is available as a prophylactic vaccine, designed to prevent the following conditions in girls and women 9 to 26 years of age:

HPV 6, 11, 16 and /or 18-related cervical cancer
cervical dysplasias
vulvar and vaginal dysplasias
condyloma acuminata
Gardasil is a vaccine prepared from noninfectious purified virus-like particles of recombinant major capsid (L 1) protein of HPV types 6, 11, 16, and 18. The product information states that individuals with impaired immune responsiveness may have reduced antibody response to active immunization due to:
immunosuppressive therapy
genetic defect
HIV infection
Immune response to vaccines may be reduced due to immunosuppressive therapy, including:
irradiation
antimetabolites
alkylating agents
cytotoxic drugs
corticosteroids (used in greater than physiologic doses)
This vaccine has been tested exclusively in 9 to 26-year-old healthy females (it has not been tested in an MS population):
Safety and efficacy information is available only for healthy girls/women of that age group.
Studies of the vaccine are now being done in boys/men and women older than 26 years of age.
FDA consideration for licensing the vaccine for other groups will take place when there are data to show that it is safe and effective for them.
It is important for girls and women to get HPV vaccine before they become sexually active.
Immunizations and Multiple Sclerosis*, a clinical practice guideline published by the Multiple Sclerosis Council for Clinical Practice Guidelines in 2001, presents conclusions based upon available research data. The expert panel used the recommendations of the Centers for Disease Control and Prevention (CDC) as a foundation for the development of its guideline. The consensus of the panel, based on available research data, was that:

People with MS should not be denied access to health-preserving and potentially-life saving vaccines because of their MS.
Vaccinations that do not contain live viruses can be given to MS patients unless they are currently experiencing an exacerbation.
The immune modulators approved by the FDA for use in MS are not believed to contraindicate vaccination with Gardasil:
Glatiramer acetate (Copaxone® )
Interferon beta1a (Avonex® and Rebif®)
Interferon beta1b (Betaseron®)
Natalizumab (Tysabri®) also should not contraindicate vaccination with Gardasil. Mitoxantrone (Novantrone®), like other immunosuppressive agents, would be likely to interfere with effective immunization by Gardasil.
*Available from the ProfessionalResource Center by calling our toll free number 866-MS-TREAT (866-678-7328) or by emailing: MD_info@nmss.org or healthprof_info@nmss.org.


--The Executive Committee of the National Clinical Advisory Board