• Vaccines against the coronavirus are likely to be as safe for people with amyloidosis as they are for those in the general population.
• Although some amyloidosis treatments may reduce the effectiveness of the vaccines to some degree, they will possibly still offer significant protection against the coronavirus.
• Those who have not yet started treatment for amyloidosis or who will be finishing a course of treatment soon may speak to their doctors about timing their COVID-19 vaccines.
• Those who have undergone a stem cell transplant are advised to wait at least three months after the procedure before receiving a COVID-19 vaccine.

Ever since the U.S. Food and Drug Administration (FDA) approved the first COVID-19 vaccines in December 2020, people living with amyloidosis have had questions about whether these inoculations will be safe and effective for them.

On February 27, the FDA approved the Johnson & Johnson COVID-19 vaccine, providing a third option to the Pfizer and Moderna COVID-19 vaccines. This new vaccine requires a single dose and works in a different way than the first two vaccines.

Because the vaccines are still relatively new, some MyAmyloidosisTeam members may be curious about whether they should get vaccinated against COVID-19. To answer questions on this topic, MyAmyloidoisisTeam sat down with Dr. Sascha Tuchman. Dr. Tuchman is a board-certified hematologist and medical oncologist and serves as director of the Multiple Myeloma and Amyloidosis Program at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, North Carolina.

The COVID-19 vaccines are so new that there is not yet any specific data on results or side effects in people with amyloidosis. How can we know whether the vaccines are safe and effective for this population?

As far as safety goes, they should be very safe for virtually everyone. That's based on data from prior vaccines that are similar to COVID vaccines and have proven to be very safe, as well as what we know about amyloidosis and amyloid therapies. There’s good reason to expect that COVID vaccines should be as safe for anybody with amyloidosis as they are for somebody who does not have amyloidosis. At this point, the vaccines have been given to millions of people and have shown an excellent safety profile. So they’re generally safe, amyloidosis or no amyloidosis.

As far as effectiveness goes, that's where things may be a little bit different. For vaccines to work, you need a functional immune system. Vaccines expose your immune system to a viral particle, and your system responds to that exposure and protects you against the real infection later. Many patients with amyloidosis are on medications that suppress the immune system. Vaccines probably won't work quite as well for people who are on intensive amyloidosis therapy.

We know from chemotherapy studies, for example, that vaccines such as those for influenza or pneumonia are less effective in patients on chemotherapy.

We don’t know for sure, but it may well be the same with COVID vaccines. But importantly, those vaccines still offer some protection. For COVID, even if the vaccine works 50 percent or 75 percent as well in someone on amyloid therapy versus someone who’s not on amyloid therapy, that's still better than zero percent. So I favor virtually all of my patients getting the vaccine, with very few exceptions.

The Johnson & Johnson vaccine is an adenovirus vector vaccine, while the Pfizer and Moderna vaccines are both messenger RNA (mRNA) vaccines. Do we know whether these vaccines might affect the disease process in amyloidosis?

There's no reason to think that any of these vaccines should interfere with amyloidosis. Viral particles have nothing to do with amyloidosis or amyloid therapies. The one exception could be that people who have a lot of amyloidosis symptoms may feel a little bit worse for 24 to 48 hours due to the immune response to the vaccine. Things like mild fever, joint pain, or malaise that go away with some Tylenol or on their own. But it’s important to understand that’s not because the vaccines are causing amyloidosis to get worse. It’s just a temporary, non-dangerous, usually mild worsening of symptoms that goes away after a day or so, and shouldn’t have any long-lasting consequences.

Could any of the three available COVID-19 vaccines impact the effectiveness of amyloidosis treatments such as proteasome inhibitors [Velcade, Ninlaro, and Kyprolis], biologics [Darzalex and Empliciti], or immunomodulatory drugs [Synovir, Revlimid, and Pomalyst]? Could any amyloidosis treatments potentially reduce the effectiveness of the vaccines?

Virtually all of those medications we use to treat light-chain amyloidosis suppress the immune system. As I said earlier, you need a functional immune system to respond to vaccines. So it makes sense that virtually everything that we use to treat amyloidosis will suppress the immune system, and therefore reduce vaccine effectiveness. Beyond that, we really don't have a whole lot of data to say which medications reduce vaccine effectiveness and by how much, other than to say that all these medications likely reduce vaccine effectiveness — COVID or otherwise — somewhat, and more therapy likely reduces the effectiveness more.

Beyond that, I wouldn't worry too much. I recommend going ahead and getting the vaccine, after asking your amyloidosis physician if they have specific thoughts about when and how to get it. Your specialist knows your situation and treatment program, and may have specific, individualized recommendations for you about COVID vaccines.

Is there any guidance on timing COVID-19 vaccines around amyloidosis treatments, for instance, for those who are undergoing chemotherapy?

I wouldn't worry too much about timing in general. We may get data on this eventually, but right now we don't have data to say that there's a specifically good time to get it for people who are on amyloid therapy. The suppressive effects of these medications on the immune system last long beyond the time they’re in the body, and it takes the immune system a while to recover after one is off them. On typical amyloid treatment regimens, which are long-term and fairly continuous, there's really no right way to time them in a way that makes sense biologically; one just isn’t off therapy long enough for the immune system to likely recover to a degree that it would make a difference with a vaccine response. The week or two that one gets between chemotherapy cycles is probably not enough.

All that being said, the best time to get vaccinated for COVID is ideally before starting amyloidosis therapy, if possible. I wouldn’t usually delay starting therapy so one can get the vaccine, but for those who are undergoing diagnostic testing or waiting to start therapy because they’re not that sick with amyloidosis, and it’s progressing very slowly, those people may want to get the vaccine in that window before they actually start treatment. Conversely, patients who are finishing up therapy may want to wait a couple months after finishing to help the vaccines work better. Unlike a week or two between cycles of therapy, which are unlikely to make a difference, being off for a few months after completing therapy may well enable the immune system to regain enough function to respond better to the vaccine, and thereby offer more protection.

If someone with amyloidosis is on dialysis, is it important to try and time the vaccine around their dialysis appointments?

I've talked to the nephrology [kidney specialist] colleagues who are part of our amyloidosis program, and they say there is no reason to think that dialysis would impact coronavirus vaccine effectiveness, mostly because the vaccine goes from the needle into muscle cells. It’s not removed by dialysis, which operates by filtering the blood. But completely hypothetically, it may be good to get vaccinated right after dialysis. But I wouldn’t worry about this issue.

How long after a stem cell transplant does someone with amyloidosis need to wait before receiving the COVID-19 vaccine?

The National Comprehensive Cancer Network (NCCN) guidelines recommend waiting three months after receiving stem cell transplantation, and our program follows the same practice. The idea is that transplant really suppresses the immune system, and again, you need a functional immune system for a vaccine to work. The immune system recovers function in the months after transplant. By waiting at least three months, we let the immune system recover hopefully to the degree that the vaccine will work better. If we do it too early, the vaccine won’t likely induce a response and one won’t be protected from COVID infection.

For people with AA amyloidosis due to an underlying condition like rheumatoid arthritis or spondylitis, are there concerns around getting the COVID-19 vaccine? For instance, during an active disease flare, or if they are taking immunomodulatory medications?

The vaccine itself should not interfere with the condition or the medications. A lot of the treatments that we use for those conditions do suppress the immune system, so it's the same situation for light-chain amyloidosis. COVID vaccines should be perfectly safe, but those treatments for rheumatoid arthritis, for instance, may reduce the effectiveness of the vaccine. The best thing is, of course, to ask your physician to get a sense of how long you will be on this therapy. Would it make sense to hold off and get the vaccine when you’re finished with this treatment? Talk to your physician and get specific recommendations on your situation and when to get the vaccine.

Is one vaccine or another considered safer or more effective for people with amyloidosis?

Not as far as we know, as it specifically relates to amyloidosis. Speaking for all people (not just those with amyloidosis), it looks like the Pfizer and Moderna vaccines are somewhat more effective in reducing symptomatic infection with COVID — getting sick with the virus. But the Johnson & Johnson vaccine has been shown to reduce transmission rates. And the Johnson & Johnson is just one shot, whereas Pfizer and Moderna are two. Based on that, if I were a patient getting the vaccine now, I’d likely do Pfizer or Moderna, assuming I can come in for two shots. If I can only do one dose, then Johnson & Johnson. But most important is to just get a vaccine.

The first two approved COVID-19 vaccines both require two doses, timed 21 days after the first for Pfizer and 28 days later for Moderna. Is it important to get the second dose for the vaccine to be effective?

Definitely get the second dose. It looks like one dose may provide some level of protection, but it's probably not as good as two doses. I'm a big believer in finding something that works and then sticking with the program as much as possible. I don’t deviate from programs that work without a good reason.

Some people have expressed worry about the fast-tracked development of the COVID-19 vaccines. Do you have any concerns about the speed or nature of how the vaccines were developed? And if not, why not?

I don't have any concerns about it. The fast-tracking reflects success in the scientific arena and in the regulatory arena, meaning the FDA and other regulatory agencies worldwide. In terms of the science, lots of vaccines have been developed in the past, so we know how to make a vaccine quickly and effectively. Although the coronavirus was a new pathogen, we already had a lot of the processes for figuring out the genetics of the virus, for designing a vaccine, and for figuring out how to administer it safely. It wasn't completely reinventing the wheel, because it’s a new organism. Ninety percent of the science of how to create a COVID vaccine was worked out before we even knew this specific coronavirus existed. The wheel was largely built, and we just had to put a couple more spokes in, so to speak.

As far as the regulatory part of this goes, a lot of what takes medications and new vaccines so long to become approved is waiting on the red tape. With this one, given the pandemic, the vaccines basically cut the line. The vaccines were fast-tracked, and thereby approved more quickly than virtually anything else has been done before, because the FDA, of course, recognized that it was a public health emergency to get this vaccine approved as soon as possible.

This vaccine came quickly because the scientific foundation to do this was built long before COVID, and the FDA cut through the red tape to process its review at maximum speed. This shows us how quickly we can get something like this done when industry and government unify and work together. It's a good thing. I'm not concerned. No shortcuts were taken to create and approve these vaccines. I’ve had the vaccines myself and almost everyone I know who’s in medicine or science and is eligible has received a COVID vaccine. The fact that people who know this stuff are opting to get it is a sign of how confident we are in this.

Do you have any concerns about potential long-term side effects of the COVID-19 vaccines?

It's always possible that long-term side effects could come up, but I don't think they will. Most often, when people have problems with vaccines, they happen relatively early. They don't happen years down the road.

Millions of people have gotten these vaccines to date. We've seen some rare severe side effects, but most people do just fine. We see rare, severe side effects with all vaccines, including influenza and pneumonia, and we still get those vaccines because the benefit of protection against the infection is greater than the risk of rare side effects. As for COVID vaccines, there's really not a lot of reason to think that we'll see weird and severe, rare, chronic side effects come up later.

Many people state that they would rather wait until more is known about the vaccine’s side effects. Is there any benefit to waiting until later to receive the COVID-19 vaccines, in your opinion?

No. I present virtually everything in medicine to patients in terms of risks and benefits. The vaccine is a medical decision, much like chemotherapy, stem cell transplant, and anything else we use to manage amyloidosis. When we think about the risks of this vaccine, they're relatively small. It should be safe for virtually everyone, including patients with amyloidosis on therapy. And then we get to the benefit side of the coin. People with amyloidosis who are on medicines that suppress the immune system may get 50 percent effectiveness or 75 percent effectiveness, but that's still better than zero.

When I look at this big picture, these vaccines have some theoretical risks, but in general, they’ve proven to be very safe. On the other hand, we have this virus out there currently, and it's killing a whole lot of people. And we know with fairly good certainty that patients on medicines that suppress the immune system are at higher risk for bad outcomes, including death, from COVID. The vaccines can protect against infection and reduce that risk for everyone, including people with amyloidosis.

So the COVID-19 vaccination has a small, theoretical risk, versus a very real benefit of offering protection against an infection that is killing people right now. I recommend getting the vaccine, amyloidosis or not.

If someone has had a bad reaction to the flu vaccine in the past, is that an indication they might have a bad reaction to the COVID-19 vaccine?

We have no data to support that. There's really nothing to say that people that have had severe reactions to certain vaccines in the past should have a more severe reaction to this one. As far as we know, that's not an issue.

What would you say to people with amyloidosis who are hesitant about getting the COVID-19 vaccine?

The vaccines are relatively new, and of course we're all a little bit afraid of things that are new that don't have a lot of long-term data behind them. I think the risk of getting the vaccines is relatively low. I think they're very safe from what we know so far. The vaccine should help to protect against COVID-19 infection. I ultimately decided to get the vaccine because this virus is killing a whole lot of people. I'll take my chance with a relatively new vaccine as opposed to the virus. I tell my patients the same thing. I understand the skepticism, but people should get the vaccines.

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