This Q&A is based on the December 9 webinar with Rabi Tawil, MD, and Ghinwa Dumyati, MD, from the University of Rochester Medical Center, and the January 15 webinar hosted by the National Organization of Rare Diseases with Stephen Hahn, MD, FDA commissioner; Peter Marks, MD PhD, director of the FDA’s Center on Biologics Evaluation and Research; and Amanda Cohn, MD, executive secretary of the Centers for Disease Control’s Advisory Committee on Immunization Practices. Note: This blog post was written when the only approved vaccines were by Moderna and Pfizer. We will update it as new vaccines are approved.
The record-breaking development of COVID-19 vaccines is a historic scientific achievement that we can all celebrate, but we are not yet out of the woods. COVID-19 remains deadly, and has mutated to be more communicable. Getting 270 million Americans vaccinated – the number Dr. Anthony Fauci thinks may be required to reach herd immunity – will take many months, given the limited supplies and logistical challenges. Bottom line: Everyone needs to keep their guard up for now – maintain social distance, wear masks, wash hands, avoid travel, and stick with their “pod.”
Are individuals with FSHD at higher risk for severe COVID-19 disease?
Individuals with FSH muscular dystrophy, especially anyone who is frail or has significant lung involvement (a forced vital capacity of 60 percent or less), should be considered to be at high risk. Read our blog post.
Where do people with FSHD fall on the vaccine priority list?
The CDC guidelines give the highest priority to older adults, especially those in long-term care facilities, and people whose jobs put them at risk for exposure to COVID-19. The next large group is people with underlying health conditions. Muscular dystrophies are not on the CDC’s list of conditions that increase the risk of severe disease, but this does not mean that people with FSHD are excluded. According to Dr. Amanda Cohn of the CDC, “On the list of people who should be vaccinated, we include language to say that, although we don’t have evidence to support this, many people with rare conditions are absolutely in that group. Anyone who is medically fragile, has diminished lung function, diminished neuromuscular function, particularly respiratory disease, is included.”
Can parents of children at high risk get vaccinated to protect their children?
Such individuals are not explicitly listed by the CDC, but talk to your healthcare provider to see if you can get the vaccine earlier.
If a person with FSHD catches COVID-19, will they get sicker?
The majority of people with COVID-19, including those with FSHD, will have mild or moderate symptoms. But if a person with FSHD ends up in intensive care, they won’t get much physical activity and will end up very weak. This happens to everyone, but for someone with FSHD, it will take much longer to regain strength.
Should people with FSHD get vaccinated?
Yes.
How effective are the vaccines?
In both the Pfizer and Moderna clinical trials, there were 95 percent fewer cases of COVID-19 among those who received vaccine versus placebo, and those who had vaccine and got COVID-19 had milder disease.
How safe are the vaccines?
The vaccines were tested in 40,000+ (Pfizer) and 25,000 (Moderna) volunteers in diverse populations. Some people develop soreness at the injection site, which lasts 24-48 hours. These reactions mean the body is doing its job and making antibodies.
What is the risk versus benefit of the vaccine?
COVID-19 vaccines are safe and effective, and will prevent you from getting COVID-19, which is known to cause life-threatening complications and/or death. Severe allergic reactions to the vaccine are rare and treatable and occur in about 2.5-11 per one million people who received the vaccine. (People at risk for severe reactions will be monitored for 30 minutes after vaccination.)
Can I get COVID-19 from the vaccine?
No you cannot. The Pfizer and Moderna vaccines are made using messenger RNA (mRNA), and they do not contain the COVID-19 virus, so they cannot cause COVID-19 disease. They also cannot change your DNA. mRNA instructs your cells to make a protein. It does not enter into the nuclei of your cells, which is where your genetic material (DNA) is located.
Could these vaccines interfere with eligibility for gene therapies for FSHD?
These mRNA packages are not like a viral vector that would be used for gene therapy, so they should not cause an immune response to these gene therapies. UPDATE: The Johnson & Johnson vaccine uses adenovirus as a vector, which should not create a problem for future gene therapies. There is an adeno-associated virus (AAV)-based Covid19 vaccine in development at Harvard. It has not been approved yet, but that particular vaccine could create problems for gene therapy later.
Is one vaccine preferred over the other?
The two vaccines are very similar. You should get whichever one is available. Both vaccines require two doses, spaced a few weeks apart, so make sure the second dose is the same type as the first.
How long will it take to develop immunity?
People can expect to be protected by about two weeks after the second dose.
Is the vaccine available for children?
Research is needed to find the right dose and make sure it’s safe in children. There are trials underway, and we expect that the vaccine will become available for certain age groups of children and for adolescents by late 2021 or early 2022.
Does the vaccine prevent transmission of the virus?
We don’t know whether vaccines will prevent transmission from asymptomatic individuals with COVID-19. So even if you get vaccinated, continue to wear your mask and wash your hands to protect others.
If a person already had COVID-19, should they still get vaccinated?
The vaccine is recommended even for people who have had COVID-19 because it’s not yet known how long they will have immunity from the disease.
Is the vaccine safe for someone who is immunocompromised?
From the available evidence, there is no concern that the vaccine will harm individuals who are immunocompromised or have rare conditions. We don’t know if it will be as effective in an immunocompromised person. You should discuss this with your healthcare provider.
Who should NOT be vaccinated?
The only people who should not get the vaccine are those who have had a known allergic reaction to any of the components of the vaccine. If you have had allergic reactions to any medicine or vaccine, you should tell your healthcare provider. Also, if you’re sick with COVID-19, you probably should wait until you are better before getting the vaccine.
Where can I get information about vaccinations in my area?
Go to your health department website. Search on “[My State] health department COVID-19 vaccine” to get a list of healthcare services where you can get your vaccine. Getting an appointment is cumbersome, but it’s needed to ensure that people get the vaccine in a safe setting. The situation is constantly shifting. If you couldn’t get an appointment one week, ask again the next week. Also, some health care providers have more vaccine available than others. If your primary care provider is in short supply and you have doctors at a different hospital, ask them. One patient was unable to get the vaccine from her neurologist but succeeded in getting it from her oncologist.
Be patient, stay safe. Protect yourself and others. The vaccine is the light at the end of the long tunnel. – Dr. Ghinwa Dumyati
I’m 71 waiting to get the vaccine. I’m on Tramadoil, about 5 a day and Tizanidine, about 3 a day. Is it safe for me to get the vaccine with my other meds.?
We have not heard that the COVID-19 vaccine is unsafe for anyone taking these medications.
I’m am 61 just diagnosed about a year ago and have yet to get vaccinated. I know you say that it should not affect the ability to get gene therapy in the future if you get the Pfiszer, Moderna, or Johnson and Johnson. I guess the words should not cause issues with gene therapy this makes me nervous. Is your stance on the vaccines the same?
Have any studies been done on the effect of the Pfizer or Moderna vaccines on people with muscle-wasting diseases like FSHD?
I have similar questions. Would repeated RNA muscle injections and the inflammatory effects of the adjuvant cause autoimmunity to the muscle cells in the long term? I.e. break tolerance to muscle cells, in other words, the body sees the muscle cells witch expresses the viral peptide in an inflammatory environment, as a dangerous threat to the body? Would repeated RNA vaccine cause chronic muscle inflammation and induce tolerance break? Would FSHD patients, whose muscle cells are prone to cell death be at higher risk? Is FSHD society doing any research on this before recommending patients for the RNA vaccine? Could FSHD society help make the traditional vaccines available to FSHD patients?
Would repeated RNA muscle injections and the inflammatory effects of the adjuvant cause autoimmunity to the muscle cells in the long term? I.e. break tolerance to muscle cells, in other words, the body sees the muscle cells witch expresses the viral peptide in an inflammatory environment, as a dangerous threat to the body? Would repeated RNA vaccine cause chronic muscle inflammation and induce tolerance break? Would FSHD patients, whose muscle cells are prone to cell death be at higher risk? Is FSHD society doing any research on this before recommending patients for the RNA vaccine? Would a traditional vaccine or viral-protein-nanoparticle vaccine that does not involve muscle cells be safer for FSHD patients before more research is done on the RNA-muscle vaccine? Could FSHD society help make the traditional vaccines available to FSHD patients?