Timing MS Medications with COVID-19 Vaccines
Source: National MS Society

General Vaccine Guidance:

The Pfizer BioNTech (Comirnaty®), Moderna (Spikevax™) and Janssen/J & J vaccines are safe for people with MS, and they are safe to use with MS DMTs.

The vaccines are not likely to trigger an MS relapse or have any impact on long-term disease progression. The risks of COVID infection far outweigh any potential vaccine risk, and persons with MS are encouraged to get the vaccine as soon as possible. Most DMTs are not expected to affect the responses to these vaccines, though some (see details below) may make the vaccines less effective. Coordinating the timing of vaccine administration with these DMTs may provide the best vaccine response.

Given the potential serious health consequences of COVID-19, getting the vaccine as soon as possible may be more important than optimally timing the vaccine with your DMT.


Read More

COVID-19 Vaccine Boosters and Additional Doses


People with MS age 12* and older who are fully vaccinated with an mRNA vaccine [Pfizer BioNTech (Comirnaty) or Moderna] may be eligible to receive an additional vaccine dose now. Talk with your healthcare provider to determine the best time to get your additional dose.

* Only the Comirnaty vaccine is authorized for age 12 and older and approved for age 16 and older.


The Centers for Disease Control and Prevention (CDC) has made the following recommendations on a booster dose of Comirnaty:


    > people 65 years and older and residents in long-term care settings should receive a booster shot at least 6 months after their second dose of Comirnaty,

    > people aged 50–64 years with underlying medical conditions should receive a booster shot at least 6 months after their second dose of Comirnaty,

    > people aged 18–49 years with underlying medical conditions may receive a booster shot of at least 6 months after their second dose of Comirnaty, based on their individual benefits and risks, and

    > people aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot at least 6 months after their second dose of Comirnaty, based on their individual benefits and risks.

Read More

Booster Vaccination Guidance


The following is a consensus statement developed by a committee of the NMSS including the CMSC in reaction to the new CDC guidance on COVID-19 vaccination boosters. The NMSS in collaboration with the CMSC is proud to provide all those affected by MS with evidence-based and timely updates.


Those age 18 and older who have received two doses of an mRNA vaccine (Pfizer BioNTech or Moderna) will be eligible for a COVID-19 vaccine booster starting in September. The booster is expected to be available eight months after their second dose of the mRNA vaccine. People with MS age 12* and older who are fully vaccinated with an mRNA vaccine may be eligible to receive an additional vaccine dose now. Talk with your healthcare provider to determine the best time to get your additional dose.

* Only the Pfizer/BioNTech vaccine is authorized for age 12 and older

The following guidance is based on available data from studies and expert consensus opinion.


Read More

Johnson & Johnson (J&J) COVID-19 Vaccine


The FDA and CDC have issued a pause on the administration of the J&J COVID-19 vaccine to give experts time to investigate reports of an extremely rare condition. It does not appear that there is any additional risk for those living with multiple sclerosis, and the Society’s COVID-19 vaccine advisory group will continue to monitor safety data.


Read More

Outcomes and Risk Factors Associated With SARS-CoV-2 Infection in a North American Registry of Patients With Multiple Sclerosis


March 19, 2021
Question: How do patients with multiple sclerosis (MS) who have COVID-19 fare and are there patient and disease characteristics associated with worse outcome?


Findings: In this registry-based cross-sectional study of 1626 North American patients with MS and COVID-19 infection, ambulatory disability, both nonambulatory and requiring assistance to walk, was independently associated with increased odds of poor clinical severity levels after adjusting for other risk factors. Other factors including older age, male sex, Black race, cardiovascular comorbidities, and corticosteroid use in the past 2 months were associated with increased odds of increasing clinical severity compared with those not requiring hospitalization or worse.


Meaning: Identification of risk factors can improve the treatment of patients with MS and COVID-19 by alerting clinicians of patients requiring more intense treatment or monitoring.


Authors:

  • Amber Salter, PhD
  • Robert J. Fox, MD
  • Scott D. Newsome, DO
  • June Halper, MSCN
  • David K. B. Li, MD
  • Pamela Kanellis, PhD
  • Kathleen Costello, MSCN
  • Bruce Bebo, PhD
  • Kottil Rammohan, MD
  • Gary R. Cutter, PhD
  • Anne H. Cross, MD

  • View the Complete Article

    MS and COVID-19: A Webinar Series for Healthcare Providers


    March 3, 2021 - The National MS Society and the Consortium of MS Centers led a discussion of COVID-19 vaccines and MS. We reviewed vaccine safety, efficacy and considerations for timing the vaccine with certain disease modifying therapies.


    Speakers:
    Nancy Sicotte, MD, Chair of the National MS Society’s National Medical Advisory Committee, Cedars-Sinai Medical Center
    Scott Newsome, DO, President of the Board of Governors of the Consortium of MS Centers, Johns Hopkins University


    Moderator:
    Rachael Stacom, ANP-BC, Independence Care System


    View the recording

    Timing MS Medications with COVID-19 mRNA Vaccines

    Based on expert consensus and available data, we offer the following guidance regarding COVID-19 vaccination for people on MS disease modifying therapies (DMTs).


    The Pfizer BioNTech and Moderna vaccines are safe for people with MS and they are safe to use with MS DMTs1. Most DMTs are not expected to affect the responses to the Pfizer BioNTech or Moderna vaccines, though some (see details below) may make the vaccines less effective and coordinating the timing of vaccine administration with these DMTs may provide the best vaccine response2.


    Given the potential serious health consequences of COVID-19 disease, getting the vaccine when it becomes available to you may be more important than optimally timing the vaccine with your DMT.


    The decision of when to get the COVID-19 vaccine should include an evaluation of your risk of COVID-19, including your occupation, and the current state of your MS. Work with your MS healthcare provider to determine the best schedule for you. If the risk of your MS worsening outweighs your risk of COVID-19, do not alter your DMT schedule and get the vaccine when it is available to you.



    Click here to view the COMPLETE Timing MS Medications with COVID-19 mRNA Vaccines

    Overall Society Statement on Vaccination

    Vaccination against COVID-19 is critical for public safety and, especially, the safety of the most vulnerable among us. Get your vaccine as soon as it is available to you. If you have MS, visit nationalMSsociety.org/covid19 to learn the latest about COVID-19 vaccines and MS.



    COVID-19 mRNA vaccine guidance for people living with MS

    People living with multiple sclerosis (MS) are seeking peace of mind on the safety and effectiveness of the COVID-19 vaccines. In response, the Society convened a group of expert researchers and medical professionals to review the available science and make fact-based recommendations.


    We do not know how many people in the vaccine clinical trials had MS, so data on the safety and effectiveness of COVID-19 vaccines in those with MS is not yet available. Our guidance is based on data from the general population in the vaccine clinical trials and data from studies of other vaccines in MS. Our guidance will be updated and become more detailed as more is learned from scientific studies of the vaccines.


    This guidance only applies to the approved mRNA vaccines in the United States, Pfizer BioNTech and Moderna. As there are different vaccines available in other countries, this guidance may not apply to those living outside of the US.



    People with MS should get a COVID-19 vaccine

    The science has shown us that the COVID-19 vaccines are safe and effective. Like other medical decisions, the decision to get a vaccine is best made in partnership with your healthcare provider. Most people with relapsing and progressive forms of MS should be vaccinated. The risks of COVID-19 disease outweigh any potential risks from the vaccine. In addition, members of the same household and close contacts should also get a COVID-19 vaccine when available to decrease the impact of the virus.


    People with progressive MS, those who are older, those who have a higher level of physical disability, those with certain medical conditions (e.g., diabetes, high blood pressure, obesity, heart and lung disease, pregnancy), and Black and Hispanic populations are among groups with the highest risk for hospitalization due to COVID-19. Individuals in these high risk groups are especially encouraged to get the vaccine as soon as it becomes available to you.


    These COVID-19 vaccines require two doses. You need to get both doses for it to work. If you’ve had COVID-19 and recovered, you should also get the vaccine. We don’t know how long someone is protected from getting COVID-19 again.



    Click here to view the COMPLETE COVID-19 mRNA vaccine guidance for people living with MS

    Several weeks ago, Team Rubicon (TR), in collaboration with Patient Advocate Foundation (PAF), announced the COVID-19 Emergency Food Assistance Program funded by the Bristol Myers Squibb Foundation, and we are amazed by its early success! The program already has provided critical assistance to roughly 2,500 immunocompromised patients across the country during the COVID-19 Pandemic. As the pandemic continues to affect our nation, we again invite you to share this critical resource with patients living with cancer, multiple sclerosis or rheumatoid arthritis whose ability to access or afford food and other nutritional needs is at risk. The program flyer is available with this link for use in sharing the program.

    Below are some helpful details about the application process as well as some enrollment support tips.

    Application Process Summary

    There are two ways the program may be able to assist eligible patients:
    1. Team Rubicon is mobilizing volunteers to provide food pick-up and delivery assistance.
    2. Patient Advocate Foundation is providing a one-time $500 financial assistance grant for those in need to purchase food.

    Patients or their designated representative can begin the process of requesting either form of assistance or both by visiting here on the Team Rubicon website. Patients who need food delivery assistance will complete the intake form on Team Rubicon’s site, providing the required details needed to facilitate the volunteer food delivery service. Patients who wish to apply for the $500 in financial assistance, regardless of whether they requested food delivery assistance, will be redirected to PAF’s online portal to complete the financial assistance application. This application is separate from Team Rubicon’s form and must be completed to be eligible for financial assistance.

    Enrollment Support Tips

    Based on early analysis, it appears that some patients who completed the intake form hosted by Team Rubicon, and identified a need for financial assistance, may not have also initiated the required application for financial assistance with PAF and instead only completed the Team Rubicon form. Enhancements were made to the Team Rubicon intake form last Friday to enhance the effectiveness of the transfer of patients who need financial assistance to the PAF application portal.

    Even though it is unlikely, if a patient contacts your organization reporting that they are still awaiting financial assistance from the program, but never received confirmation of their eligibility from Patient Advocate Foundation, then one probable cause is that they did not get transferred from Team Rubicon’s site to PAF’s application portal for a number of possible reasons. If you have a patient reach out to you in this situation, then please send an email to emergencyassistancefund@patientadvocate.org to inquire about the status of their financial assistance application. PAF will confirm if an application has been submitted. If not, PAF will provide information to facilitate the completion of their application.

    Thank you for all you do to help patients and their caregivers!

    Patient Advocate Foundation and Team Rubicon


    E-Newsletter Released on April 3, 2020

    The U.S. Food and Drug Administration (FDA) released a new webpage of information to help address questions patients and caregivers may have about FDA-regulated medical products (drugs, biologics, and devices) during the coronavirus (COVID-19) outbreak. The webpage is a source of information for patients during this time of crisis. Visitors to the page can find information on:
      • FDA COVID-19 resources, such as questions and answers on hand sanitizers;
      • How patients can report a drug, biologic, or medical device product shortage; and
      • Information on clinical trials and the FDA’s Expanded Access program.

    Please visit the webpage at https://www.fda.gov/patients/coronavirus-disease-2019-covid-19-resources-patients .

    For additional questions you may have, please contact the FDA’s Patient Affairs Staff at 301-796-8460 or email patientaffairs@fda.hhs.gov.

    Other Patient Resources:

    For Patients:
    https://www.fda.gov/patients

    Questions and Answers for Patients About Clinical Trials During COVID-19 Outbreak:
    https://www.fda.gov/patients/coronavirus-disease-2019-covid-19-resources-patients/questions-and-answers-patients-about-clinical-trials-during-covid-19-outbreak



    Patient Affairs Staff (PAS)
    Office of the Commissioner
    U.S. Food and Drug Administration
    Tel: 301-796-8460
    Email: PatientAffairs@fda.gov

    The Centers for Disease Control and Prevention (CDC) are following the outbreak of coronavirus (COVID-19), which causes a respiratory disease. This is a rapidly evolving situation and questions regarding the use of MS disease modifying therapies during this outbreak are being raised.

    The National MS Society’s National Medical Advisory Committee (NMAC) recommends the following:

    1. People with MS should follow CDC guidelines and these additional recommendations for people at risk for serious illnesses from COVID-19.

    2. People with MS should continue disease modifying therapies (DMTs) and discuss specific risks with their MS healthcare provider prior to stopping a DMT.

    3. Before starting a cell depleting DMT* or a DMT that carries warnings of potentially severe increase in disability after stopping**, people with MS and their MS healthcare providers should consider specific risks (e.g. age, comorbid health conditions, location) and benefits.


    These recommendations are the expert opinion of the National Medical Advisory Committee and are based on their clinical experience and assessment of the limited data available regarding COVID-19 and MS DMTs. They have been endorsed by the Consortium of Multiple Sclerosis Centers (CMSC) and members of the MS Coalition***.

    We are continuing to monitor this quickly evolving situation and these recommendations may be modified as more data becomes available.

    * Cell depleting therapies include: Lemtrada, Mavenclad, Ocrevus and Rituxan (used off-label in MS)

    ** DMTs with a warning of potentially severe increase in disability after stopping include: Gilenya and Tysabri

    *** Members of the MS Coalition include: Accelerated Cure Project for Multiple Sclerosis, Can Do MS, Consortium of Multiple Sclerosis Centers, International Organization of Multiple Sclerosis Nurses, MS Views and News, Multiple Sclerosis Association of America, Multiple Sclerosis Foundation, National Multiple Sclerosis Society and United Spinal Association

    As part of our commitment to ensuring healthy lives and promote well-being, we are providing you a list of resources related to coronavirus (COVID-19).

    • A live-tracker of the spread of the disease from Johns Hopkins University.
    • The latest updates from the WHO on the virus.
    • WHO’s recommendations for the public to reduce exposure.
    • The Center for Disease Control’s (CDC) recommendations for traveling.
    WHO's rolling updates on coronavirus disease (COVID-19).

    We are currently preparing systems and processes to be put in place to manage this issue during the meeting. More detailed information will be posted on our website as soon as we have them confirmed.

    We will continue to monitor the situation and will update you on any changes regarding the 2020 CMSC Annual Meeting.


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    COVID-19: What You Need to Know

    What is COVID-19?

    Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 illness is a new coronavirus (a type of virus that causes respiratory infections) that was first identified in Wuhan, China in December 2019. Since then, there has been worldwide spread of COVID -19 to nearly every continent. Initially spread appeared to be from those who had traveled from Wuhan, China to other parts of the world. However, at this time it is known that COVID-19 is affecting individuals who have not traveled or have had any contact with travelers. This is considered “community spread.”

    What are the symptoms of COVID-19?

    Most people who contract COVID-19 will have mild symptoms. Symptoms can include fever, cough, increased fatigue and difficulty breathing (shortness of breath).

    How does COVID-19 spread?

    COVID-19 can be spread from person to person; particularly if there is close contact (within 6 feet) with someone who is infected. This spread occurs from respiratory droplets produced when the infected person coughs or sneezes directly on another person. COVID-19 can also spread when droplets (from coughs, sneezes or contaminated hands, land on surfaces and another person touches the contaminated surface with their hands and then touches their nose, mouth or possibly eyes with their hands. Spread is more likely when groups of people congregate together. We are following the recommendations from President Trump to avoid gatherings of greater than 10 people.

    Are people with MS considered a “higher – risk” group?

    The CDC identifies certain conditions as placing people at “higher risk” for infection or complications from COVID-19. This includes people with neurological conditions, such as MS. MS itself does not increase the risk of getting COVID-19, however, certain factors associated with your MS may increase your risk of infection or complications:
      • Taking certain disease modifying therapies
      • Chronic medical conditions, such as lung disease or heart disease
      • Significantly restricted mobility, such as needing to spend most of your day seated or in bed
      • Age 60 or older

    Sometimes, the body’s response to infections, including COVID-19, may cause a temporary worsening of MS symptoms. For example, you may have more trouble with fatigue, thinking, mobility, vision or other symptoms. Typically, these symptoms settle down once the infection clears up.

    How can I protect myself and others?

    There are actions you can take to help prevent the spread of respiratory viruses, including COVID-19.
    These include:
      • Wash your hands often with soap and water for at least 20 seconds. Use an alcohol-based hand sanitizer that contains at least 60% alcohol if soap and water are not available.
      • Avoid touching your eyes, nose, and mouth.
      • Cover your cough or sneeze with a flexed elbow or tissue, then throw the tissue in the trash.
      • Clean and disinfect frequently touched objects and surfaces.
      • Practice 'social distancing'. Based upon recommendations from President Trump, social distancing means avoiding gatherings (greater than 10 people) and maintaining distance (approximately 6 feet) from others when possible.
      • Stay home and contact your primary care provider if you develop symptoms of COVID-19, have been in close contact with a person known to have COVID-19, or if you have recently traveled from an area with widespread or ongoing community spread of COVID-19.

    Is it ok for my family members or other close contacts to go to work or other types of social gatherings?

    Care partners and family members who live with, or regularly visit, a person with MS should also follow the same recommendations to reduce the chance of bringing COVID-19 infection into the home.

    What should I do about my MS disease modifying therapies (DMT) because of COVID-19?

    There are recommendations about DMTs and COVID-19 coming from multiple individuals, groups and organizations. While each has attempted to provide clarity and sound guidance, differences in the recommendations have created a significant amount of confusion. Decisions regarding disease modifying therapies (DMTs) are made based upon multiple factors, including:
      • Your MS disease course
      • Other medical conditions you may have
      • Allergies to DMTs
      • Other medications that are not compatible with certain DMTs
      • Risks (including infections) vs. benefit of DMT
      • Your values and risk tolerance


    The National MS Society, based upon advice from our National Medical Advisory Committee, has developed guidance on the use of DMTs during the COVID-19 pandemic. In addition, we endorse the global advice provided by the MS International Federation (MSIF) – but emphasize that DMT decision making must be individualized and based upon multiple factors, including those listed above.

    Both the National MS Society DMT guidance and the MSIF global advice are endorsed by the Consortium of MS Centers and the MS Coalition.

    Additional Resources:
    CDC Warns Community Spread of Coronavirus is Likely

    Nancy Messonnier, director of the CDC's National Center for Immunization and Respiratory Diseases, urged Americans, businesses and hospitals to prepare for potential community spread of the emerging coronavirus, noting "disruption to everyday life might be severe." CDC Principal Deputy Director Anne Schuchat and HHS Secretary Alex Azar said the immediate risk in the US remains low, but rising cases in other countries suggest the US will see an increase beyond the current 57 documented cases.

    Full Story: REUTERS (02/25), CNN (02/26)

    [Post courtesy of ANA SmartBrief (02/26)]
    The MS International Federation (also known as MSIF) has compiled information and a video (see link below) which sufficiently addresses:

    1) what the coronavirus is and how to protect against it; and
    2) guidance for people living with MS who are taking a disease modifying therapy (DMT) and exposed to or confirmed to have the coronavirus infection

    We encourage you to access this information and provide it to individuals affected by MS who may contact the National MS Society (NMSS) with questions about coronavirus and MS.

    Any inquiries not addressed by the information/video within the MSIF link can be sent to HealthProf_Info@nmss.org.

    CLICK HERE TO VIEW COMPLETE INFORMATION AND ACCESS THE VIDEO