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Individuals & Families

COVID-19 & TSC Resources

Welcome to the Tuberous Sclerosis Alliance’s (TS Alliance’s) COVID-19 & TSC Resources page for people with tuberous sclerosis complex (TSC), their families and loved ones, healthcare professionals and others.  Please visit this page often as we will continually update it as needed.

If you or a loved one has tuberous sclerosis complex, be sure to scroll down this page to read and/or download our Coronavirus Disease 2019 (COVID-19) Questions and Answers (FAQs).

COVID-19 Resources

Click the following links to access additional information about:

Tuberous Sclerosis Alliance COVID-19 Vaccine Position Statement

December 18, 2020

The United States has faced unprecedented public health challenges during the COVID-19 pandemic. Tragically, this virus has claimed more than 300,000 lives in the U.S. Amazingly, vaccines from several pharmaceutical companies, including Pfizer and Moderna, have been recently developed, evaluated for safety and effectiveness, and granted emergency use authorization by the FDA for rapid deployment across the country. The vaccines confer >90% effectiveness against SARS-CoV2 (the virus that causes COVID-19) and are largely viewed by experts as safe for adults over the age of 16.

The Centers for Disease Control (CDC) has targeted prioritization of COVID-19 vaccinations for the following demographic sub-groups:

  • Healthcare personnel
  • Workers in essential and critical industries
  • People residing in congregate housing situations such as nursing homes
  • People at high risk for severe COVID-19 illness due to underlying medical conditions
  • People 65 years and older

The vaccine is not yet intended for administration to children under age 16.

COVID-19 Vaccines in Individuals with TSC

Adults (16 and up) with tuberous sclerosis complex (TSC) will be able to receive COVID-19 vaccinations in the upcoming months. As part of the mission of the Tuberous Sclerosis Alliance (TS Alliance) to keep you informed, we compiled the following information regarding the safety and efficacy of COVID-19 vaccination in individuals facing the multi-system challenges of TSC including LAM, kidney disease, epilepsy, and autism. Ultimately, getting the COVID-19 vaccine will be a personal decision, but the current data suggests the risk:benefit ratio of this vaccine is highly favorable with effectiveness greater than 90%. It is highly likely that receiving this vaccine will protect individuals from severe COVID-19 infection, and it seems prudent for use in individuals with TSC.

The TS Alliance asked a number of TSC clinical experts across the U.S. to evaluate the safety of the COVID-19 vaccine in TSC to help patients, families, and caregivers evaluate the vaccine in an informed manner. Of course, no trial to-date has specifically assessed the COVID-19 vaccine in TSC patients, so these opinions reflect best assessments of current knowledge and medical literature.

What Are the Public Health Goals of COVID-19 Vaccination?

The CDC endorses the following public health goals for COVID-19 vaccination:

  • Decrease death and serious disease as much as possible
  • Preserve functioning of society
  • Reduce the extra burden the disease is having on people already facing disparities
  • Increase the chance for everyone to enjoy health and well-being

Is the Vaccine Safe in TSC Patients?

Our TSC experts have reviewed the existing data from human COVID-19 trials and agree the vaccine is safe for administration in TSC patients. The CDC identifies at least 11 medical conditions that confer an increased risk of severe COVID-19 infection, meaning high likelihood of hospitalization, intensive care unit requirements, and even death. While TSC is not listed, chronic kidney disease and chronic lung disease are listed and provide support for the need for vaccination in TSC.

Can I Contract COVID-19 from the Vaccine?

No, both the Pfizer and Moderna vaccines are not live vaccines. Both use a messenger RNA (mRNA) technology to induce immunity, so it is not possible to acquire COVID-19 infection from either of these vaccines.

Will the Vaccine be Effective If I am on a mTOR Inhibitor Such as Everolimus (Afinitor) or Sirolimus (Rapamune)?

There is no specific data addressing the safety or effectiveness of the COVID-19 vaccine in patients receiving everolimus (Afinitor) or sirolimus (Rapamune). The concern is whether the immunosuppressive effect of these medications would alter the safety profile or effectiveness of the COVID-19 vaccine. Analyses of patients who are immunosuppressed for other reasons such as cancer or treatment with immunosuppressant medications to control organ transplant rejection suggest the COVID-19 vaccine will be safe with no added side effects and likely to be effective, or at least more effective than getting no vaccination. Interestingly, some medical literature suggests everolimus (Afinitor) or sirolimus (Rapamune) may actually enhance the effectiveness of vaccines such as the influenza (flu) vaccine.

What About Side Effects of COVID-19 Vaccines in TSC?

The COVID-19 vaccines are associated some mild-moderate side effects. For example, some individuals will experience only pain at the site of the injection, while others may experience fever, chills, malaise, or headaches. These symptoms typically last approximately 24 hours and stop spontaneously. You can take over-the-counter medications such as acetaminophen (Tylenol) to help reduce symptoms. There is no evidence these side effects will be more severe in individuals with TSC or that TSC patients are at risk for more severe or dangerous side effects. In a very small number of individuals with known allergic hypersensitivity reactions (i.e., those who carry an EpiPen for allergic reaction to peanuts, eggs, or shellfish), there is a chance you might have an allergic reaction to the vaccine. The risk-benefit ratio of COVID-19 vaccination in these individuals should be discussed with care providers. Other unexpected or more severe side effects are not out of the question with any vaccine, including any of the COVID-19 vaccines, but we suspect these will be rare and that the benefits of vaccination to our patients, their family members and close contacts, and society as a whole, far outweigh the likelihood of the risk of any severe, unexpected side effects.

Will Children be Vaccinated?

To date, large trials in children under age 16 have not been completed. The current vaccine approval is for individuals >16 years of age. We expect that children and early teens eventually will get vaccinated for COVID-19, when distribution channels and supplies allow for it and after gathering more safety and efficacy data on the vaccine in adults. It is likely that the FDA will want to assess safety data from a future vaccine trial in children.

Should I Receive the COVID-19 Vaccine?

The decision to receive the COVID-19 vaccine is a personal one. However, in view of the clear and documented effectiveness (>90%) of the vaccines in clinical trials and relatively benign safety profile, it is highly likely the COVID-19 vaccine will lead to immunity from COVID-19 infection. Since COVID-19 infection can lead to hospitalization, long-term post-infection consequences to bodily function, and death (>300,000 Americans have died from COVID-19), all clinical indicators and prudence would dictate you and your loved ones should receive the vaccine to protect you from COVID-19 infection.

If I Get the Vaccine, Will Everything be “Normal Again”? Can I Stop Social Distancing? Can I Stop Wearing a Mask?

The CDC and other experts have stated clearly the COVID-19 vaccine is yet another means to prevent COVID-19 infection and should be viewed as additive to social distancing and mask wearing. Data to-date demonstrates maximum immunity following the COVID-19 vaccine will not be attained until 2 weeks following the second vaccination or about 5-6 weeks after the first vaccination. Currently it is recommended that even after you have received the vaccine, you should continue practicing social distancing and mask wearing, avoid large social gatherings, continue good handwashing practices, and quarantine yourself if you have been exposed to someone with known COVID-19 infection, or if you develop symptoms of COVID-19 infection, such as fever, chills, cough, loss of taste or smell, diarrhea, headache.

Medical Review Note

This information was reviewed and approved by:

  • Peter B. Crino, MD, PhD, Chair, TS Alliance Board of Directors
  • Darcy A. Krueger, MD, PhD, Chair, TS Alliance Professional Advisory Board
  • Mustafa Sahin, MD, PhD, Chair, TS Alliance International Scientific Advisory Board and Co-Chair, TS Alliance Science and Medical Committee
  • John J. Bissler, MD, TS Alliance Professional Advisory Board
  • Nishant Gupta, MD, Director of LAM Clinic Network
  • Elizabeth Petri Henske, MD, TS Alliance Professional Advisory Board
  • Elizabeth A. Thiele, MD, PhD, TS Alliance Professional Advisory Board

Novel Coronavirus Disease 2019 (COVID-19) Frequently Asked Questions and Answers (FAQs)

Updated December 4, 2020

The Department of Health & Human Services (HHS), in coordination with NIH and Operation Warp Speed, has launched a central web portal called Combat COVID (https://combatcovid.hhs.gov/).

The portal is a one-stop resource to help members of the public and doctors find information about different stages of COVID-19 illness, NIH-supported COVID-19 prevention and treatment clinical trials, and locations to donate plasma.  The website provides clear and easy-to-understand information for:

Visit combatCOVID.hhs.gov to learn more.

Updated March 20, 2020

View the video recording of our TSC/LAM VIRTUAL TOWN HALL: A COVID-19 UPDATE with Drs. Peter Crino, MD, PhD, University of Maryland School of Medicine, Frank McCormack, MD, University of Cincinnati School of Medicine, Darcy Krueger, MD, PhD, Cincinnati Children’s Hospital Medical Center, and John Bissler, MD, St. Jude Pediatrics Research Hospital, who share considerations for impact of COVID-19 on management of TSC and LAM.

Updated May 20, 2020
Due to quickly evolving information, recommendations may be subject to change and will be updated as needed.

The Tuberous Sclerosis Alliance prepared these FAQs to address concerns from the TSC community and healthcare professionals regarding the novel coronavirus disease 2019 (COVID-19) outbreak.  For more comprehensive and up-to-date information refer to the Centers for Disease Control and Prevention (CDC) website.

SYMPTOMS OF COVID-19

People with COVID-19 have had a wide range of symptoms reported – ranging from mild symptoms to severe illness. Symptoms may appear 2-14 days after exposure to the virus. People with the following symptoms may have COVID-19:

  • Cough
  • Shortness of breath or difficulty breathing
  • Fever
  • Chills
  • Muscle pain
  • Sore throat
  • New loss of taste or smell

This list is not all possible symptoms. Other less common symptoms have been reported, including gastrointestinal symptoms like nausea, vomiting, or diarrhea.

RISKS OF ILLNESS

1. Can I get sick by touching a surface or object that has the virus on it?

  • According to the CDC, coronaviruses are generally thought to be spread from person-to-person through inhalation of respiratory droplets produced when an infected person coughs or sneezes.
  • It may be possible for a person to become ill by touching a surface or object that has the virus on it and then touching their own mouth, nose, or eyes. Wash your hands often and try not to touch your face unless you have just washed your hands.
    • Use bar or liquid soap and water and wash for at least 20 seconds.
    • If soap and water are not available, use an alcohol-based hand sanitizer with at least 60% alcohol.

2. Who is at higher risk for serious illness from COVID-19?

  • People aged 65 years and older
  • People with a serious chronic medical condition such as:
    • Diabetes
    • Heart disease
    • Lung disease (e.g. lymphangioleiomyomatosis [LAM])
    • Hypertension
  • Individuals on immunosuppressants (see below)

3. What should people at higher risk of serious illness from COVID-19 do?

  • The CDC recommends contacting your healthcare provider to ask about obtaining extra necessary medications* and supplies in case of an outbreak of COVID-19 in your local community, which may require you to stay home for a prolonged period. You may want to consider a mail order vendor if you cannot obtain extra medication.
  • Keep away from others who are sick.
  • Put distance between yourself and other people outside of your home.
  • Stay at least 6 feet (about 2 arms’ length) from other people.
  • Avoid touching your eyes, nose, and mouth with unwashed hands.
  • Wash hands often with soap and water, especially after you have been in a public place, or after blowing your nose, cough, or sneezing.
  • If an outbreak occurs in your community (e.g. workplace, school, church), stay home as much as possible and follow any specific recommendations made by local authorities.

*FDA DRUG SHORTAGES: The TS Alliance is not aware of any seizure medication shortages caused by COVID-19.  Refer to the FDA Drug Shortage website for current information.

4. Should I wear a facemask to prevent contracting COVID-19?

  • The CDC recommends that everyone 2 years and older wear a cloth face covering that covers their nose and mouth when out in public. Wearing a mask is intended to PREVENT the spread of the virus if someone is infected but does not have symptoms.
  • Anyone who has trouble breathing or unable to remove the face covering without assistance is exempt from this recommendation.

5. Is it safe for me or my loved one to go to work or school?

  • Refer to COVID-19 updates from your local government websites for guidance. Continue to maintain physical distancing of at least 6 feet between yourself and other people, wear a facemask, and wash your hands often with soap and water.  For reference see the CDC’s guidance on Returning to Work.
  • The CDC has a school decision-making tool to help you assess your child’s risk of returning to school.
  • Contact your local school’s administration to see what steps they may be taking to keep students healthy.  For reference, see the CDC’s Checklists for In-Person Classes and Virtual or At-Home Learning.

6. Is it safe for me or my loved one to travel by car or airplane?

  • The CDC recommends limiting non-essential travel as much as possible. In the absence of symptoms or recent exposures, it is safe for you and family members you live with to be in a car together. Be careful to maintain good hand hygiene and distancing at rest stops along the way and take care to avoid large crowds at restaurants or pit stops. Be particularly vigilant about hand hygiene before entering your vehicle. Try to limit public transportation such as airplanes, buses or trains to essential trips while following strict hand hygiene and social distancing. Please refer to the CDC and Johns Hopkins maps for the latest information on affected areas.  

7. Is it safe for me or my loved one to continue going to clinic appointments?

  • Each institution/clinic has specific rules and recommendations regarding clinic visits. Many are conducting telehealth visits when possible to protect the clinic staff’s and your health.  If you have questions or concerns about an upcoming clinic appointment, we recommend contacting your TSC Clinic for further instructions.
  • Please refer to the CDC and Johns Hopkins maps for the latest information on affected areas.

QUESTIONS ABOUT COVID-19 AND TSC (May 12, 2020)

1.  Does TSC put me at greater risk for COVID-19?

The sample size is limited. Based on a handful of reported infections in patients from a small number of large TSC Clinics in the United States and abroad, there isn’t any evidence currently that having TSC puts one at greater risk for COVID-19. We continue to monitor for new reported cases and will update the TSC community should infection or complication rates change.

2.  Does everolimus/sirolimus put me at greater risk for COVID-19?

There is no evidence yet.  More studies needed to answer this question.

3.  Should I keep taking everolimus/sirolimus for epilepsy or SEGA?

The current position from TSC care providers is to continue taking everolimus/sirolimus for seizures or SEGA.  If you develop COVID-19, you would want to have a discussion with your doctor to decide if you should suspend your treatment for a period of time.

4.  What happens if I develop COVID-19?

The presence of TSC will probably complicate the course of the illness because of potential involvement of other organs, TAND, and current medications you are taking. This will require a conversation with your primary care doctor and a TSC expert at a regional TSC center, if possible.

5. Can COVID-19 make my seizures worse?

If you have a high fever, are receiving antibiotics, or are unable to take your seizure medications, your seizures may worsen.

6.  Will COVID-19 affect SEGA growth?

There is no evidence that COVID-19 infection will cause SEGA to start growing or to grow faster.

7.  Will COVID-19 affect autism?

There is no data yet showing that COVID-19 infection will worsen autism or intellectual disability; however, those with an infection may develop a febrile or systemic illness, which can make some of those symptoms worse.

8.  For those who are taking immunosuppressants should there be any concerns about taking the vaccine when it becomes available?

It depends on how the vaccine is generated, e.g., live attenuated, inactivated, or recombinant, or a combination antigen/antibody. There are different vaccine strategies – so we need to wait and see which one(s) will be deployed in the United States.

9.  Should people who are on immunosuppressant drugs self-isolate even when stay-at-home orders are lifted?

We recommend people with TSC continue practicing safe social distancing when possible.

10.  Do any of the treatments proposed for COVID-19 interact with antiepileptic medications or mTOR inhibitors?

There is a possibility that some anti-epileptic drugs (AEDs) such as phenytoin (Dilantin), carbamazepine (Tegretol), phenobarbital, and primodone may activate liver enzymes that metabolize certain drugs currently in trials to treat COVID-19 such as remdesivir and rotinivir.  Thus, if you are taking any of these AEDs, the level of remdesivir in the body may be lower.  Further studies will be needed to define pharmacological interactions between mTORi and COVID-19 anti-viral agents and mTOR inhibitor.

USE OF AN ORAL IMMUNOSUPPRESSANT DRUG
(e.g. Afinitor®, Rapamune®, Zortress®, everolimus, sirolimus, Acthar Gel®, steroids)

  1. I have LAM, should I stop taking sirolimus (or other mTOR inhibitor drugs)?
    Whether being on mTOR inhibitors, such as sirolimus or everolimus, increases the risk of complications from COVID-19 is not known. Given the potential for lung function decline of sirolimus, pulmonologists strongly recommend that people with LAM do not stop taking sirolimus as a precautionary measure during COVID-19. Certain circumstances, such as active infection with COVID-19, may necessitate a dose reduction or interruption in sirolimus use. In such circumstances, the decision to change dosing or hold sirolimus should be made on an individual basis in close consultation with your LAM physician.
  2. My child or I am taking Afinitor® (or other mTOR inhibitor drug). Do I stop it?
    Based on current CDC statements and how recent influenza outbreaks like the H1N1 in 2009 were managed, it’s recommended to stay on drug unless your child/you or an immediate family or close contact (e.g. schoolmate or work colleague) is diagnosed with COVID-19. Local school/community authorities who provide different recommendations specific to the community/region should also be followed. Consult with your doctor for further guidance.
  3. My child is taking Acthar Gel®. Should I continue to administer?
    If taking Acthar Gel or steroids for infantile spasms, do not discontinue without discussing with your healthcare provider.

RESOURCES AND REFERENCES

American Thoracic Society Patient Information Sheet

The CDC: Coronavirus Disease 2019 (COVID-19)

Johns Hopkins COVID-19 Global Cases Map

Cystic Fibrosis Foundation

The LAM Foundation: COVID-19 Updates for the LAM Community

MEDICAL REVIEW NOTE

These FAQs were reviewed and approved by Peter Crino, MD, PhD, University of Maryland School of Medicine; Darcy Krueger, MD, PhD, Cincinnati Children’s Hospital Medical Center; and Mustafa Sahin, MD, PhD, Boston Children’s Hospital.

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