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Overview

With the growing number of immunosuppressive and immunomodulating (ISIM) agents to treat MS there are more concerns around infection prevention and timing of vaccinations for people with MS. Many of these ISIM agents have specific vaccination recommendations within their prescribing information.

The American Academy of Neurology (AAN) published “Update: Vaccine-preventable Infections and Immunization in Multiple Sclerosis,” which provides recommendations for clinicians. The full guideline and clinician summary are available online. 

Specific vaccines

2020-2021 Seasonal Flu Vaccine 

The composition of US influenza vaccine is reviewed annually by the Centers for Disease Control and Prevention (CDC) and updated to match circulating influenza viruses. Routine annual influenza vaccination is recommended by the CDC for everyone over 6 months of age with rare exception.

The following recommendation is from the AAN guideline specific to the influenza vaccine:

  • Clinicians should recommend that patients with MS receive the influenza vaccination annually, unless there is a specific contraindication (e.g., prior severe reaction).
  • Clinicians should recommend against using live attenuated vaccines in people with MS who currently receive ISIM therapies or have recently discontinued these therapies. Some of these therapies also have restrictions from the US Food and Drug Administration (FDA) for the timing of a live vaccine after discontinuing an ISIM therapy. Refer to the ISIM therapy’s prescribing information for specific requirements.
  • Clinicians should delay vaccination of people with MS who are experiencing a relapse until clinical resolution or until the relapse is no longer active (e.g., the relapse is no longer progressive but may be associated with residual disability).

To learn more about the 2020-2021 seasonal flu vaccine, please visit the CDC website.

Hepatitis B vaccine
  • The hepatitis B vaccine is recommended for all infants, unvaccinated children under the age of 19 and adults at risk of contracting this potentially life-threatening disease.
  • In 2002, the National Academy of Sciences' Institute of Medicine (IOM) determined that there is no association between hepatitis B vaccination and the onset of MS. 
Human papillomavirus vaccine (Gardasil®)
  • This vaccine is indicated in girls and women ages 9 to 26 and is designed to prevent the HPV 6, 11, 16 and/or 18-related cervical cancer, cervical dysplasias, vulvar and vaginal dysplasias later in life.
  • One case report (Waldemann et al., 2009) described the onset of acute disseminated encephalomyelitis following the second immunization with Gardasil, and Sutton et al. (2009) reported five patients who presented with multifocal or atypical demyelination syndromes within 21 days of the second or third immunization (three of whom had previously experienced clinical isolated episodes of neurological dysfunction). However, a recent large-scale study of patient registries in Denmark and Sweden (see below) found no increased risk of developing MS among nearly 800,000 who received this vaccine. Use of Gardasil should be preceded by a discussion between patient and physician regarding benefits and risks.
Pneumococcal vaccines (Pneumovax® 23 - PPSV23 and Prevnar® 13-PCV13)
  • PCV13 protects against 13 types of pneumococcal bacteria; PPSV23 protects against 23 types of pneumococcal bacteria.
  • One dose of PPSV23 is recommended for all adults 65 years or older.
  • Both pneumococcal vaccines are inactivated and safe for people with MS.
  • According to the AAN recommendations on immunizations for people with MS, pneumococcal vaccine should be considered for individuals with compromised pulmonary function, including those who use a wheelchair on a full-time basis or are bed-bound.
Shingles vaccine (Shingrix®)
  • The CDC recommends Shingrix, a non-live vaccine for the prevention of herpes zoster (shingles) and related complications. The vaccine is recommended over Zostavax® (the previously approved vaccine for shingles) and is approved in adults 50 years of age and older.
  • No studies of Shingrix have been done in people with MS. However, in two clinical studies with Shingrix, there was no increase in immune-mediated conditions.
  • The CDC indicates that a person who is taking a low-dose immunosuppressive therapy or is going to begin taking an immunosuppressive medication can take Shingrix. It is very important to discuss this vaccine with the healthcare provider who is treating your MS to ensure that it is appropriate for you.
Shingles vaccine (Zostavax®)
  • Zostavax, is a live-virus vaccine to prevent shingles. MS healthcare providers do not recommend live-virus vaccines for people with MS because these vaccines can lead to an increase in disease activity. However, Zostavax is an exception because most people have had chicken pox earlier in their lives and therefore already have the virus in their bodies. Each person needs to discuss the potential benefits and risks of this vaccine with her or his healthcare provider.
  • As of July 1, 2020, Zostavax is no longer being produced, but may still be used until the supply expires on November 18, 2020.
Smallpox vaccine
  • While this vaccine has not been studied in people with MS, it should be made available to any person with MS directly exposed to smallpox as the risks associated with not getting vaccinated would be too great.
Varicella vaccine
  • This vaccine should be considered by people with MS who have never had chicken pox, lack evidence of prior immunity, and are considering starting a disease modifying therapy (DMT) that has the potential to suppress cell mediated immunity. Refer to the prescribing information for each DMT and the varicella vaccine.

Special considerations

  • A person should not receive a live-virus vaccine following a course of Lemtrada®.
  • For patients testing positive in tuberculosis screening, treat by standard medical practice prior to therapy with Aubagio®. No clinical data are available on the efficacy and safety of live vaccinations in patients taking Aubagio. Vaccination with live vaccines is not recommended. The long half-life of Aubagio should be considered when contemplating administration of a live vaccine after stopping Aubagio. Advise patients that the use of some vaccines should be avoided during treatment with Aubagio and for at least 6 months after discontinuation.
  • Patients without a healthcare professional confirmed history of chickenpox or without documentation of a full course of vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV before initiating Gilenya®. VZV vaccination of antibody-negative patients is recommended prior to commencing treatment with Gilenya, following which initiation of treatment with Gilenya should be postponed for 1 month to allow the full effect of vaccination to occur. It is recommended that pediatric patients if possible, complete all immunizations in accordance with current immunization guidelines prior to initiating Gilenya therapy.
  • Human papilloma virus (HPV) infections, including papilloma, dysplasia, warts, and HPV-related cancer, have been reported in patients treated with Gilenya in the postmarketing setting. Vaccination against HPV should be considered prior to treatment initiation with Gilenya, taking into account vaccination recommendations. Cancer screening, including Papanicolaou (Pap) test, is recommended as per standard of care for patients using an immunosuppressive therapy.
  • Because vaccination with live-attenuated or live vaccines is not recommended during treatment and after discontinuation until B-cell repletion, administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of Ocrevus® for live or live-attenuated vaccines and, whenever possible, at least 2 weeks prior to initiation of Ocrevus for non-live vaccine. Reference the Ocrevus prescribing information for important warnings around vaccination of infants born to mothers treated with Ocrevus during pregnancy.
  • Vaccination of patients who are antibody-negative for varicella zoster virus is
    recommended prior to initiation of Mavenclad®. Administer all immunizations according to immunization guidelines prior to starting Mavenclad. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting Mavenclad, because of a risk of active vaccine infection. Avoid vaccination with live-attenuated or live vaccines during and after Mavenclad treatment while the patient’s white blood cell counts are not within normal limits.
  • Patients without a healthcare professional confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating Mayzent treatment. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with Mayzent, following which initiation of treatment with Mayzent should be postponed for 4 weeks to allow the full effect of vaccination to occur. The use of live attenuated vaccines should be avoided while patients are taking Mayzent and for 4 weeks after stopping treatment. Vaccinations may be less effective if administered during Mayzent treatment. Mayzent treatment discontinuation 1 week prior to and until 4 weeks after a planned vaccination is recommended.
  • Patients without a healthcare professional-confirmed history of chickenpox or without documentation of a full course of vaccination against VZV should be tested for antibodies to VZV before initiating Zeposia. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with Zeposia, following which initiation of treatment with Zeposia should be postponed for 4 weeks to allow the full effect of vaccination to occur. No clinical data are available on the efficacy and safety of vaccinations in patients taking Zeposia. Vaccinations may be less effective if administered during Zeposia treatment. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of Zeposia. Avoid the use of live attenuated vaccines during and for 3 months after treatment with Zeposia.
  • MS experts are not in agreement about the risks for a person with MS whose close family member receives a live-virus vaccine. The family should discuss with the healthcare provider how best to handle this situation. 

Studies of Vaccines with Specific Disease Modifying Therapies

  • A blinded, randomized, multicenter, placebo-controlled study, published in Neurology in 2015, evaluated the effectiveness of the flu vaccine in fingolimod-treated patients. Researchers found that most fingolimod-treated patients with MS were able to mount immune responses with the vaccine, and the majority met criteria indicating seroprotection. However, response rates were reduced compared with placebo-treated patients.  Overall, there was some decrease in vaccination-induced immune responses among the fingolimod treated patients. 
  • A study, published in Neurology in 2013, investigated the effect of teriflunomide on the efficacy and safety of the influenza vaccine and found that teriflunomide-treated patients generally mounted effective immune responses to seasonal influenza vaccination. Researchers concluded that teriflunomide generally does not adversely impact the ability of MS patients to mount immune responses to influenza vaccination. 
  • A small case-control study, published in Neurology in 2013, assessed immunocompetence in patients after alemtuzumab treatment by measuring antibody responses to several vaccines before and after treatment.  Researchers concluded that serum antibodies against common viruses remained detectable after treatment, and there was retained ability to mount an immune response against new antigens after treatment with alemtuzumab. 
  • A study published in Neurology in 2020 compared the immune response in people treated with ocrelizumab to a control group treated with interferon-β or no disease modifying therapy. The study investigators concluded standard non-live vaccines, including the influenza vaccine, can be expected to be protective in people taking ocrelizumab.
  • A study published in Neurology in 2017 assessed influenza and pneumococcal vaccine response in three groups taking siponimod who do not have MS compared to another group without MS taking placebo. The study found no effect on response to the pneumococcal vaccine in those taking siponimod. Stopping siponimod at least 7 days before vaccination and resuming at least 2 weeks after may improve response to the influenza vaccine. The investigators concluded siponimod has limited effect on vaccine efficacy.
  • A study from Neurology Neuroimmunology & Neuroinflammation in 2018 investigated vaccine response in individuals taking dimethyl fumarate (DMF) compared to those taking nonpegylated interferon (IFN). The immune response in DMF-treated individuals was comparable those treated with IFN.
  • In a review of multiple studies of immune response to vaccines in individuals taking DMTs, the authors concluded those taking natalizumab may mount an inadequate immune response to some vaccines. View the paper to learn more about immune responses in people taking other DMTs.

Studies of Vaccine Safety and Effectiveness in People with MS

Some, but not all, immunizations have been evaluated for safety and efficacy in people with MS:

  • A study by the Vaccines in Multiple Sclerosis Study Group published in 2001 in the New England Journal of Medicine found that vaccination for tetanus, hepatitis B or influenza  did not appear to increase the short-term risk of relapses (also called attacks or exacerbations) in people with MS.
  • A study by the National Immunization Program of the Centers for Disease Control and Prevention, published in the Archives of Neurology in 2003, found that vaccination against hepatitis B, influenza, tetanus, measles, or rubella did not increase a person’s risk of developing MS or optic neuritis (which is often a first symptom of MS). 
  • A small, unblinded study, published in the Archives of Neurology in 2011, of people with relapsing-remitting MS who received the yellow fever vaccination prior to travel, found a significantly increased risk of MS relapses during the six weeks following the  vaccination when compared to the remainder of the two-year follow-up period. For people with MS who must travel to areas where yellow fever is common, the increased relapse risk needs to be carefully weighed against the likelihood of exposure to yellow fever – which is a potentially fatal illness.
  • A study of nearly four million females aged 10 to 44 years identified in nationwide patient registries in Denmark and Sweden, published in the Journal of the American Medical Association, found no increased risk of developing MS among nearly 800,000 who received quadrivalent human papillomavirus vaccine (Gardasil®), designed to prevent cervical cancer. 
  • A review of data from the complete electronic medical health records of Kaiser Permanente Southern California between 2008 and 2011, published in JAMA Neurology, found no long-term association of vaccines with MS or any other acquired central nervous system demyelinating disease.

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