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TSC Alliance COVID-19 Vaccine Position Statement

COVID-19 Vaccination Addendum, May 18, 2021

Pfizer’s COVID-19 vaccination has now been authorized for use by the FDA under EUA in individuals 12 years of age and older, concluding that there is no evidence suggesting a need to change or delay medications because of vaccinations.

Frequently Asked Questions

Do I need to stop taking my mTOR before my vaccine?

Outside of a small solid organ transplant study, we currently do not have consistent evidence to change mTOR inhibitor management during vaccination phases. We strongly defer recommendations to the prescribing provider preference.

After my vaccination should I have my child’s antibodies tested?

Outside of a small solid organ transplant study, we currently do not have consistent evidence to suggest obtaining antibody testing after the vaccination phases. We strongly defer recommendations to the prescribing provider preference.

Will my child’s seizures worsen with the vaccine?

As with any vaccination that can lower seizure threshold, it is possible to have a breakthrough febrile associated seizure. However, there is currently no evidence that any of the COVID-19 vaccinations worsen preexisting seizure baseline. Defer to your seizure action plan defined by your current provider.

My child has advanced end-stage renal disease and is being worked up for a renal transplant. Can my child still get vaccinated?

Yes, it is recommended. We strongly defer recommendations to the local transplant team for further directions. (Reference: National Kidney Foundation)

Can my child receive the COVID-19 vaccination at the same time of their other childhood vaccinations?

Yes. The American Academy of Pediatrics confirms that COVID-19 vaccines can be administered at the same time – or within 14 days – as other vaccines. This is contrary to the previous recommendations that COVID-19 vaccines should not be given within 14 days of other vaccines. If your child is on an altered schedule or there are additional concerns, we strongly recommend discussing this with your local pediatrician and or pediatric neurologist.

Medical Review Note

This information was reviewed and approved by:

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

For additional questions or concerns please reach out to Ashley Pounders MSN, FNP-C, TSC Alliance Director, Medical Affairs at apounders@tscalliance.org or (240) 472-4302.

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