(Resources Page Updated April 7, 2022)
(Updated April 7, 2022)
Safety and tolerability of SARS-Cov2 vaccination in patients with myasthenia gravis – Vaccination Strongly Recommended
During the COVID-19 pandemic, Myasthenia gravis (MG) patients have been identified as subjects at high-risk of developing severe COVID-19, and thus were offered vaccination with priority. The lack of direct data on the safety and tolerability of SARS-CoV-2 vaccines in MG have contributed to vaccine hesitancy. To address this issue, the safety and tolerability of SARS-CoV-2 vaccines was assessed in a large cohort of MG patients from two referral centers.
Patients with confirmed MG diagnosis, consecutively seen between October and December 2021 in two MG centers were enrolled. Demographics, clinical characteristics, and information regarding SARS-CoV-2 infection/vaccination were extracted from medical reports and/or collected throughout telephonic or in person interviews.
Our data support the safety and tolerability of mRNA-COVID-19 vaccines, which should be strongly recommended in MG patients who could be at higher risk of complications if exposed to SARS-CoV-2 infection.
Review the published research in Doc Wire News.
https://www.docwirenews.com/abstracts/safety-and-tolerability-of-sars-cov2-vaccination-in-patients-with-myasthenia-gravis-a-multicenter-experience/
Read the actual full report in Wiley publishing and European Journal of Neurology
https://onlinelibrary.wiley.com/doi/10.1111/ene.15348
(Updated January 18, 2022)
U.S. Federal Government Soft-launches COVID-19 Test Request Website – At Home Tests
Associated Press: The Biden administration on Tuesday quietly launched its website for Americans to request free at-home COVID-19 tests, a day before the site was scheduled to officially go online.
The website, COVIDTests.gov, now includes a link for Americans to access an order form run by the U.S. Postal Service. People can order four at-home tests per residential address, to be delivered by the Postal Service. It marks the latest step by President Joe Biden to address criticism of low inventory and long lines for testing during a nationwide surge in COVID-19 cases due to the omicron variant.
https://apnews.com/article/biden-government-at-home-covid-tests-e98c4a7a4ee340345a5786c4c407c5fb
(CDC Statement on COVID-19 Booster - Update on November 29, 2021)
CDC Recommends Everyone Ages 18 and Older Should Get a Booster Shot
Although COVID-19 vaccination remains effective in preventing severe disease, recent data pdf icon[1 MB, 68 pages] suggest vaccination becomes less effective over time, especially in people aged 65 and older and at preventing infection or milder illness with symptoms.
The recent emergence of the Omicron variant (B.1.1.529) further emphasizes the importance of vaccination, boosters, and prevention efforts needed to protect against COVID-19. Early data from South Africa suggest increased transmissibility of the Omicron variant and the potential for immune evasion.
Emerging evidence also shows that among healthcare and other frontline workers, vaccine effectiveness against COVID-19 infections is also decreasing over time.
This lower effectiveness is likely due to the combination of decreasing protection as time passes since getting vaccinated, as well as the greater infectiousness of the Delta variant.
Data from clinical trials showed that a booster shot increased the immune response in trial participants who finished a Pfizer-BioNTech or Moderna primary series 6 months earlier or who received a J&J/Janssen single-dose vaccine 2 months earlier. With an increased immune response, people should have improved protection against COVID-19, including the Delta variant. For Pfizer-BioNTech and J&J/Janssen, clinical trials also showed that a booster shot helped prevent COVID-19 with symptoms.
READ THE LATEST CDC information concerning COVID-19 vaccines and booster shots.
(CDC Statement on COVID-19 Booster - October 22, 2021
CDC Expands Eligibility for COVID-19 Booster Shots
CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of COVID-19 vaccines in certain populations. The Food and Drug Administration’s (FDA) authorizationexternal icon and CDC’s recommendation for use are important steps forward as we work to stay ahead of the virus and keep Americans safe.
For individuals who received a Pfizer-BioNTech or Moderna COVID-19 vaccine, the following groups are eligible for a booster shot at 6 months or more after their initial series:
(MGFA Statement - August 16, 2021)
CDC Announces Authorization of Additional COVID-19 Vaccine Dose for People with Compromised Immune Systems, including patients with myasthenia gravis (MG) taking immunosuppressive treatment(s)
The CDC has announced authorization of an additional COVID-19 vaccine dose for people with compromised immune systems, including patients with myasthenia gravis (MG) taking immunosuppressive treatment(s). This recommendation is specifically for patients that completed the mRNA vaccines (Moderna and Pfizer). The recommendation does not apply to the Johnson & Johnson vaccine because available data are insufficient at this time.
Recent data suggests that patients with weakened immune systems, such as those on immune suppressing medication(s), may have a reduced protective immune response to the COVID-19 vaccine. An additional vaccine dose can increase the immune response to the vaccine. Although similar data specifically for patients with MG is lacking, given the currently available information, the widespread increase in the more contagious and severe delta variant, and the good safety profile of available SARS-coV2 vaccines, the potential benefit of the additional vaccine outweigh the risks. Therefore, the MGFA supports the CDC authorization of SARS-coV2 vaccines for patients with compromised immune systems and recommends that patients with MG taking immunosuppressives discuss getting an additional mRNA vaccine dose with their treating provider. SARS-coV2 vaccines may not be available in all areas. The MGFA continues to strongly support the use of recommended precautions to reduce the risk of getting a COVID infection (e.g., masking, social distancing, frequent handwashing, avoiding close interactions with non-immunized individuals, etc).
**Regardless of whether you are vaccinated, if you get a COVID infection, it is very important to immediately notify your treating provider(s), including your MG provider, to determine whether there should be changes to your treatment, such as a monoclonal antibody treatment.
We continue to recommend that you reference the CDC site.
https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html
U.S. FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised People
FDA Press Release
(Updated August 13, 2021)
The FDA has made its latest announcement concerning COVID-19 Vaccine doses. You can read the full statement in the following URL. The MGFA will make its official statement concerning vaccines for those living with MG during week of August 16 to 20.
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-certain-immunocompromised
New MGFA “What’s New in MG Research” Webinar – Long COVID
Presented by MG expert Dr. James “Chip” Howard
We invite you to view the MGFA’s latest “What’s New in MG Research” webinar titled “Long COVID.” This webinar focuses on the longer-term concerns and considerations in dealing with COVID-19 – especially for immunocompromised people such as myasthenia patients. Hear about these issues and learn how to stay healthy during this ongoing pandemic. You can find the playback video at: https://myasthenia.org/Webinars/Whats-New-in-MG-Research
NORD WEBINAR: FDA and CDC Leaders Discuss the COVID-19 Pandemic and Vaccines
(Updated June 25, 2021)
Our rare disease partner, the National Organization for Rare Diseases (NORD) has created a new webinar available to the MG Community. This resource is titled: “FDA and CDC Leaders Discuss the COVID-19 Pandemic and Vaccines.” The content focuses on the latest COVID-19 vaccination information as applied to those living with rare diseases such as myasthenia. We hope you can tune into this informative webcast. https://www.youtube.com/watch?v=WKHPsQXBRmk
If you have any additional feedback about htis webinar or suggestions for future webinar topics, please email education@rarediseases.org.
MGFA Medical Professionals Recommend Continued Caution for MG Patients
(Updated May 17, 2021)
The CDC has provided new guidance on COVID-19 vaccinations, face coverings, and the lifting of certain, select guidelines for managing the pandemic. The MGFA medical team continues to stress its recommendation that all MG patients get the COVID-19 vaccine as soon as possible. We must reinforce that researchers still do not have adequate data on the level of protection that the vaccine provides patients that are on immunosuppressive treatments. Most MG patients are using a form, or multiple forms of immunosuppressants. Therefore, we will continue to recommend that MG patients follow the CDC guidance for unvaccinated people (that is, masking, social distancing, hand washing) – particularly when patients are in close proximity to people with an unknown vaccination status.
Continue consulting with your treating neurologist to discuss your individual situation and risks. And also continue encouraging those with whom you live with, or people you socialize with, to get vaccinated to keep you safe. CDC Vaccine statements and updates can be accessed at this webpage.
Myasthenia Experts Provide Updated Guidance for MG Patients
An abundance of caution is still the required approach for patients on immunosuppressant therapies.
(Updated April 28, 2021)
“If you have a condition such as myasthenia gravis, or are taking medications that weaken your immune system, you might NOT be fully protected from COVID-19 even if you are fully vaccinated. Talk to your healthcare provider, doctors, and specialists. Even after vaccination, you may need to continue taking all precautions such as face-coverings, social distancing, cleaning, and quarantining.”
We still do not know if the vaccines are completely effective for patients on immunosuppressant therapies, which accounts for the majority of MG patients. There is imperfect data on this issue. We do not believe that fully-vaccinated MG patients on full doses of immunosuppressants should return to unmasked activities, especially with unvaccinated people or in more crowded settings.
Read the latest CDC article concerning COVID prevention in this Link.
**Disclaimer: MG patients should always speak to their own doctors and specialists first in order to build a health strategy during this COVID-19 pandemic. The aforementioned guidance contains general medical opinions from MG experts and should not be used as direct, specific requirements for every MG patient. Every case of MG is different...we are all snowflakes.
Hot News: Apply for the Emergency Broadband Benefit
The FCC announced that on May 12, 2021, eligible households will be able to apply for the Emergency Broadband Benefit.
“Families in every corner of the country have been struggling to get online throughout this pandemic. For those families, we now say ‘help is around the corner.’ In less than two weeks, we will have a new way for disconnected Americans to access the internet to carry out their day-to-day life, so they can reach the virtual classroom, take advantage of telehealth, and seek new employment opportunities.”
Beginning on May 12 households can apply in three ways:
- Contact your preferred participating broadband provider directly to learn about their application process.
- Go to GetEmergencyBroadband.org to apply online and to find participating providers near you.
- Call 833-511-0311 for a mail-in application, and return it along with proof of eligibility to: Emergency Broadband Support Center
P.O. Box 7081
London, KY 40742
Materials that partners can use to help promote the Emergency Broadband Benefit to the communities they serve will be available soon on www.fcc.gov/emergency-broadband-benefit-outreach-toolkit.
CDC Recommends Lift on Pause of Johnson & Johnson Vaccine
CDC Website
April 23, 2021
Federal authorities have strongly recommended eliminating the pause on the Johnson & Johnson COVID-19 vaccine after a detailed study and assessment. The U.S. federal government recommends that vaccines should resume. The pause was instituted after cases of blood clots were discovered in some COVID patients. This CDC press release highlights the announcement.
U.S. Federal Government Urges Pause on Johnson & Johnson COVID-19 Vaccine
STAT
April 13, 2021
Federal authorities on Tuesday recommended that states stop using Johnson & Johnson’s Covid-19 vaccine while an investigation is conducted into six rare but serious cases of clotting problems that were reported among women who received the vaccine. This STAT article reports on federal recommendations.
When You've Been Vaccinated, You Can Go Back to Some Things You Did Before
CDC Website
April 9, 2021
CDC guidance is showing that after you've been vaccinated, two weeks after your second vaccination you can begin going back to doing some things you did before, but remain cautious and avoid direct contact to large crowds. See the latest recommendations from CDC.
MGFA CARE-MG Onoing COVID Survey Shows Strong Global Data
MGFA Website
April 9, 2021
The MGFA CARE-MG survey is for medical professionals that are reporting out on their MG patients who contract COVID-19. Strong global data updated every couple of weeks. Review Survey Results.
Pfizer Vaccine Reported to Protect Teens 12-15 at High Efficacy Rate
Associated Press
March 31, 2021
Pfizer announced Wednesday that its COVID-19 vaccine is safe and strongly protective in kids as young as 12, a step toward possibly beginning shots in this age group before they head back to school in the fall. READ AP ARTICLE.
Latest COVID-19 Blog
COVID-19 has been with us for over a year, and research about the virus - its effects, and how to fight it - continues to grow. This is great news for patients! We have come a long way since the pandemic began in March 2020. READ THE BLOG HERE
Major European Nations Suspend AstraZeneca; Novavax in Phase 3
The United States is investigating whether AstraZeneca has included outdated trial data in its latest efficacy reporting. (March 23, 2021) Several major European nations have suspended use of the AstraZeneca COVID-19 vaccine this week (March 15, 2021). The suspension is over reports of dangerous blood clots in some recipients, though the company and international regulators say there is no evidence the shot is to blame. On the new vaccine front, Novavax is in phase 3 trial and the U.S. FDA may be evaluating emergency use in the coming months.
Latest news on AstraZeneca
https://apnews.com/article/germany-suspends-astrazeneca-vaccine-blood-clotting-0ab2c4fe13370c96c873e896387eb92f
Latest COVID-19 vaccine information from the CDC
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html
Q&A: COVID-19 and MG: The Latest on Vaccines and More
with Srikanth Muppidi, MD
Clinical Associate Professor, Neurology & Neurological Sciences, Stanford Health Care
Dr. Muppidi spoke as part of a regional conference in early 2021. He outlined key thoughts and medical suggestions concerning the COVID-19 virus and its impact on MG patients. We would always suggest that you speak to your own primary and specialist doctors before making health decisions that will impact your MG, but Dr. Muppidi’s responses are informative, and will help you live your life during this pandemic.
Q: Should I stop my immunosuppressant medicine so I’m less likely to get COVID-19?
Stopping your treatment may worsen your MG symptoms. If you get weak and you must be hospitalized, you might increase your risk of getting COVID. We don’t recommend stopping your treatment unless advised by your physician.
Q: How would catching COVID-19 affect my MG?
Data from the CARES-MG patient registry, which tracks people with MG who have had COVID-19 or COVID-like symptoms, shows that the virus tends to worsen myasthenia gravis symptoms. Patients report increased fatigue and weakness. https://myasthenia.org/Professionals/Resources-for-Professionals/CARE-MG
Q: What is the efficacy of the COVID-19 vaccines for MG patients, and what are the risks?
All three vaccines currently authorized for emergency use in the United States are very effective. The vaccines manufactured by Pfizer and Moderna are mRNA vaccines that require two shots, the Pfizer vaccine given three weeks apart, and the Moderna vaccine given four weeks apart. The remarkable thing about these two is that about 12-14 days after the first jab, you have clinically significant immunity. It only gets stronger after the second shot.
The Johnson and Johnson vaccine uses a different technology and only requires one shot. Overall the vaccine is highly effective.
None of the vaccine trials included people who were immunocompromised or immunosuppressed. For that reason, we aren’t sure what the vaccine efficacy is for the MG population. Certain therapies do reduce the efficacy of the vaccine, including Rituximab.
In terms of safety, the clinical trial data was very strong, and there have been no reports of serious side effects from those millions around the world who have so far had the vaccine. Pain at the injection site is the most commonly reported side effect, along with some fatigue, aches, and low-grade fever.
Per CDC data, there have been no reported bad outcomes of immunosuppressed people who have received the vaccine. For that reason, I recommend all MG patients get the vaccine, unless there is a specific reason they can’t, like a history of allergies to a component of the vaccine.
Q: What if you do plasma exchange therapy? Will that effect vaccine efficacy?
Plasma exchange is a treatment for MG in which we remove a patient’s blood, filter out the antibodies that cause myasthenia, and then give it back to you. This is done for both acute patients who are hospitalized, as well as for patients who are not responsive to other therapies.
We don’t know yet if COVID-19 antibodies could be removed from the blood through this process, but researchers have reviewed this issue for other vaccines and found that sufficient antibodies were present to prevent disease. Anecdotally, one of our patients who receive outpatient plasma exchange has continued her therapy, and we’ve found that she still has antibodies against COVID (for many months now).
I recommend that you stick to your regular regimen of treatment while you are getting a COVID vaccine.
Q: Could I get COVID-19 antibodies through IVIG treatment?
In IVIG therapy, a patient receives an infusion of a donated blood product called gamma globulin that helps those with autoimmune disorders get antibodies to fight their illness. Donor blood is pooled from thousands of individuals. Given the level of COVID-19 spread in the United States today, it’s unlikely you could get enough COVID-19 antibodies in one bag of plasma to give you antibodies. I suspect that donation centers may also be screening COVID-19 patients out of their donor pools at present to obtain plasma for treatment of actual patients with COVID.
[Link to your page on IVIG - https://myasthenia.org/What-is-MG/MG-Materials-Webinars/Learn-More-About-MG/intravenous-immunoglobulin-ivig]
Q: Will IVIG treatment reduce the efficacy of the vaccine?
We don’t know. But the reality is that if you’re on IVIG, that means you need it, and you might get weaker by delaying it or canceling. I recommend that my patients stick to their regular treatment plan while getting vaccinated.
Q: Will immunosuppressed patients be included in future vaccine trials?
I am not sure, but we can do population studies, which look at those people who are immunosuppressed and have received the vaccine. What was efficacy like for them? Did side effects differ from the general population? Over time this adds to the pool of knowledge and helps us better understand how MG affects all kinds of vaccines.
MGFA CARE-MG Registry Providing COVID-19 Data with MG Patients
Electronic health record derived-impact of COVID-19 on myasthenia gravis
Journal of Neurological Sciences
April 2021
Despite not having data from COVID-19 vaccines in MG currently, multiple studies suggest that the influenza vaccine is safe in MG patients for instance [4,5]. Additionally, both work by triggering immune response regardless of preparation differences, and would be expected to have similar safety in MG patients as in the general population. Considering present data available, patients with MG should be prioritized for SARS-CoV-2 vaccination with additional consideration of best practice standards.
READ MORE HERE
MGFA Official Statement on the COVID-19 Vaccine for the MG Community
(Updated on April 13, 2021)
There are multiple vaccines for Covid-19 currently being developed. Receiving a vaccine for Covid-19 and following existing public health measures will reduce the likelihood of contracting the virus. The vaccine will also reduce the spread of disease from one person to another. In the United States, vaccines manufactured by pharmaceutical companies Pfizer, Moderna, and Johnson & Johnson were approved by the U.S. Food & Drug Administration (FDA). These are non-live vaccines that use modified RNA. The Johnson & Johnson vaccine is a "1 dose" vaccine while the Pfizer and Moderna vaccines are "2-dose." There are other global pharmaceuticals that are manufacturing and distributing vaccines in other countries. Please note that vaccines involving both the Johnson & Johnson and AstraZeneca products have been held due to additional, needed research on potential symptoms including blood clots.
The vaccines were tested in people age 12 to 85 years. The majority of study subjects did not have underlying medical conditions. Patients with autoimmune conditions, like myasthenia gravis, were not included in the early testing of these vaccines to date. The most common side effects for people enrolled in the vaccine study were pain at the injection site, fever, chills, and muscle aches. In some cases, these side effects lasted for a few days. There is no risk of developing Covid-19 infection from the vaccine.
At this time, we would recommend these Covid-19 vaccines for patients with autoimmune conditions like myasthenia gravis and for those patients who take medications that suppress the immune system. The Covid-19 pandemic has severely affected people with some underlying medical conditions. It is unknown at this time whether myasthenia gravis (MG) or treatments for autoimmune MG increase the risk of contracting Covid-19 or experiencing more severe disease. However, like with other viruses, getting sick with a Covid-19 infection can bring on a MG exacerbation or crisis. We suggest that patients discuss the Covid vaccine with their neurologist and primary care provider.
Covid-19 vaccines is being distributed by each state according to guidance from the Centers for Disease Control. Certain groups, such as health care workers, nursing home residents, and those with underlying medical conditions, are receiving the vaccine now. In the United States, each state’s health department website will have further information on distribution plans as they become available. It is important to stay in contact with your physicians and monitor your state health department guidelines as the vaccination process unfolds.
U.S. FDA Officially Approves J&J Janssen Biotech COVID-19 vaccine for Immediate Use
The committee met on Friday, February 26, 2021 to discuss EUA of the Janssen Biotech Inc. COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years and older. This one-dose vaccine has been officially approved for distribution and use by the FDA, and will be in distribution soon. Read more from the FDA WEBSITE HERE.
Two Myasthenia Patients Proudly Rolled Up Their Sleeves for COVID-19 Vaccination
In a recent new MGFA Insider Blog post, read about two nurses and MG patients who recently were administered thier COVID-19 vaccinations and learn about their unique perspective on getting the vaccine vs contracting full-blown COVID. Check out the link below.
https://myasthenia.org/About-Us/Blog/two-myasthenia-patients-proudly-rolled-up-their-sleeves-for-covid-19-vaccination
New COVID-19 Vaccine Guidance: AANEM Outlines New Data for Patients with Neuromuscular Disorders
With COVID-19, there is a potential for reduced efficacy of immunizations in patients with reduced immunocompetence. The recent vaccination program for Coronavirus Disease- 2019 (COVID-19) raises several questions regarding the safety and efficacy of this vaccine in individuals with NMDs. In this Practice Statement from the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM), we address the role of vaccine-preventable infections in NMDs and vaccine safety. View this new study in the link below:
https://www.aanem.org/getmedia/fb378437-3e1c-412c-8104-3b805cbd8367/COVID-Vaccine-NM-Disorders.pdf
CDC Provides Guidance on COVID-19 Vaccine – Mixing Doses and Immunocompromised Patients
There is new information from the CDC concerning COVID-19 vaccines. The CDC says that the vaccines “may be administered to persons with underlying medical conditions who are not allergic or have no contraindications to vaccination.”
“Clinical trials demonstrated similar safety and efficacy profiles in persons with some underlying medical conditions, including those that place them at increased risk for severe COVID-19, compared to persons without comorbidities. Information on groups with specific underlying medical conditions is included below,” according to the CDC. The organization also strongly recommends against mixing doses of several different COVID-19 vaccines.
Read this very informative article from the CDC below.
https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html
Links to a Selection of Published Studies on COVID-19 Vaccines
Centers for Disease Control & Prevention (CDC) Vaccine Webpage
CDC vaccination webpage is a valuable resource on vaccine information. This page also links to other strong resources from the CDC and the World Health Organization (WHO).
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/index.html
MGFA Published Survey
How is the novel coronavirus pandemic impacting people with rare diseases and their families? Complete the 20-minute research survey from home or learn more at this link. The Rare Diseases Clinical Research Network (RDCRN) is conducting this study. The network is funded by the National Institutes of Health. It includes 23 research teams working to advance diagnosis and treatment of groups of rare diseases. The Myasthenia Gravis Foundation of America and Conquer MG partners with RDCRN through its work with the Myasthenia Gravis Rare Disease Network (MGNet).
MGNet Webinar- "Myasthenia Gravis and the COVID-19 Epidemic: Things for you to know"
MGFA Program
Presenters: Hana Axelrod, MD, MPH; Henry J. Kaminski, MD; Helen Girma, George Washington University Department of Neurology
We are pleased to share that the MGNet webinar, “MG and COVID-19: Things for you to Know” has been recorded and is available for viewing. We apologize for any technical difficulties in registering or participating in the webinar on March 18.
To view the recording of this webinar, please see here
COVID-19 (Coronavirus)- General Information and Management
MGFA New Resources
March 2020
Due to the recent news regarding COVID-19 (coronavirus), we are providing some guidance around COVID-19, as well as reliable sources for information. See more information here.
Centers for Disease Control & Prevention (CDC) website:
https://www.cdc.gov/
World Health Organization (WHO) website:
https://www.who.int/
United States Food & Drug Administration (FDA) website:
https://www.fda.gov/home