COVID-19 Vaccination and Celiac Disease

COVID-19 Vaccination and Celiac Disease

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Happy holidays from the Center  for Celiac Research and Treatment.   I'm Susie Flaherty, communications director for  the center and we have Dr. Alessio Fasano with   us today to answer questions on COVID-19 and  the vaccine. In the first part of this video,  

Dr. Fasano will present the scientific  facts behind the new technology   in the mRNA vaccines to fight COVID-19. In  the second part, he addresses questions that   have come in from our social media platforms and  other avenues with concerned patients and others.   Good day everybody. At the Center for Celiac  Research and Treatment at Massachusetts General   Hospital, we've been receiving a lot of questions  concerning the COVID-19 vaccines that the FDA   authorized for emergency use in the past few days.  I believe that there are a lot of questions that   are really stemming from a lot of confusion  about these vaccines-- what exactly they mean,   who is entitled to take the vaccines,  their efficacy and so on and so forth. So  

before I really go through the questions  that we received, I want to make a few   clarifications about these vaccines. So far,  we have two vaccines that have been authorized   for emergency use by the FDA. One from Pfizer  BioNTech and the other one from Moderna. And   two more will probably be authorized at the end  of January 2021. So I have to say that these are   extraordinary circumstances and these two are  extraordinary vaccines, because these vaccines   really apply technologies that are almost a decade  old but have never been deployed in humans before   in such a short period of time. So they are really  one of a kind and I want to say that in an ideal   world a good vaccine is something that you can  deliver in a single shot at room temperature   that can really cover a lot of people and will  protect for a longer time, even forever. But  

these are not ideal circumstances and there are  no vaccines that fulfill all these criteria.   So let's start by saying, first of all,  about these two vaccines-- what are   their characteristics, what is their bottom line  efficacy and safety (that is something that is in   the mind of everybody) and then we'll go through  the questions that we received. First of all,   because of the number of doses that we have  available and because of the timing of the   vaccination, the target population right  now is the population that is at risk:   healthcare professionals, elderlies and so  on and so forth. Because for a herd coverage   we really need to vaccinate at least 75 percent of  the population. And I will explain why we are not   there quite yet. The Pfizer vaccine has  been tested for people age 16 and older,   while the Moderna is being tested and approved  for people 18 and older. So a good part of the  

pediatric population is not involved and approved  for the use of these vaccines. They are based on a   brand new technology, as I was telling you, that  is what is called the messenger RNA. In general,   vaccines are made by the microorganisms (in this  case the virus) that can be killed or attenuated,   as we use for polio or measles vaccines, so  that the entire bug is injected in the host   and this will instigate the immune system to  build an immune response against this enemy   and therefore we develop protection against  that. Here is a very different story.   Here, both these vaccines use this technology  called messenger RNA vaccines. These are   vaccines in which genetic information, that  is this messenger RNA, coming from the virus   that will translate in a product (in this case the  protein is called spike) that is necessary for the   vaccine to bind to the target cell and start  to reproduce itself and spread is the target   component of the SARS-CoV-2 virus. So what happens  is that they are injected as messenger RNA in a  

vehicle (little lipid droplets) that are called  nanoparticles that will protect the messenger   RNA against destruction from the host. And here is  another major difference between the two vaccines.   These droplets have been developed with much more  accuracy (because they have more time) by the   Moderna company. So there is no need to maintain,  for stability, these vaccines in extremely cold   conditions as with the Pfizer vaccine that has  droplets that are less efficacious in protecting   the messenger RNA. So that's the reason why the  Pfizer vaccine [requires extreme cold for storage]   while a regular refrigerator is okay for the  Moderna vaccine. In both vaccines, once this   messenger RNA is injected it will be eventually  picked up by cells of the host that use their   own machinery to translate this messenger RNA into  the product (in this case the spike) that is seen   as something that doesn't belong to our body  and therefore instigates an immune response.  

Both vaccines have turned out to be extremely  efficacious, way beyond our most optimistic   expectation. For an emergency use authorization  the FDA requires at least 50 percent of efficacy.   And as you've heard, both these vaccines go  way above 90 percent efficacy in preventing   COVID-19 in subjects that have  been injected by these vaccines.   The vaccines seem to be a little bit less  efficacious in people 65 and older, mainly   because the immune system in the younger folks  is more crisp in mounting an immune response.  

Both vaccines seem to reduce the risk of severe  COVID-19 disease, but we don't know yet if they   also prevent asymptomatic infections with  SARS-CoV-2 virus. It's too early to say.   Both vaccines require two doses: a priming dose,  or a first dose, followed by a booster. The   interval is a month (28 days) for Moderna and  three weeks for the Pfizer vaccine. Both of them   have shown some side effects and these have been  raising concerns in a lot of people who have been   reading about these vaccines. But in terms of  vaccinology, a good vaccine should typically  

show some reactions that are actually signs that  the immune system sees an enemy and is mounting   an immune response. And indeed both vaccines  fall into this reactogenic category of vaccines.   So the most common side effects are pain at  the site of injection, fatigue, headache, some   muscle pain and joint pain. A few have reported  fever. And again, these are symptoms that are   more common after the second dose that are signs  that the immune system is really kicking into   gear to start to build an immune response  and is exactly what we want to achieve.   However, the reactions that have been raising  the concerns have been this allergic reaction   to the Pfizer vaccine. These reactions, and some  are very severe to what we call anaphylaxis (a   severe allergic reaction), were not seen in the  clinical trial, but were severe enough to require   hospitalization of the people that received  the vaccine. All these people --actually two,   three cases-- were people with a history of  severe allergic reaction and they both carry the   EpiPen because of their history (an injection of  adrenaline in case they have a severe reaction).  

So we've discussed about the storage requirements  and the reason why there is a difference between   these two vaccines. [Let's talk about]  what we don't know yet. We don't know   the duration of protection. Again, these are  vaccines that have been tested relatively early.   These are the first messenger RNA vaccines  that are being deployed in clinical trials   at such a large scale and therefore we are  in uncharted territory here in terms of if   this vaccine will protect for a short period  of time or a long period of time or forever.  

That's something that we will learn on the  go. And we will watch the reports that people   have been immunized and when the numbers get  large enough to understand what's going on. So   all in all, I think that I can say with a great  level of confidence that this vaccine seems to be   extremely safe, extremely well tolerated,  extremely efficacious in what we've seen so far.  

There's a lot we don't know yet, but the  reactions to the vaccine are the ones expected   when you use something that mounts an immune  response. The severe side effects are allergic   reactions that've been seen only in people  with history of severe allergies and therefore   are not generalizable. And finally, because  of what I discussed at the very beginning,   the limited supply of these doses  hopefully will increase over time.  

And because this vaccine has never been tested  in a pediatric population, right now the goal is   NOT to reach herd immunization so that everybody  can be without the mask and just relax with the   physical distance and washing hands and so on and  so forth. This will be a goal that will be reached   only when we will have this vaccine tested in the  pediatric population (and therefore they will be   part of the people that will be vaccinated) and  we have enough doses to vaccinate 70 percent of   the population worldwide, because it's not just  a matter of the United States. We're in a global   village and therefore this can be achieved not  only when you know nations can afford the vaccine,   but when everybody will be able to have  access to this vaccine to reach that level   of protection. So this is the factual information  that we have about these vaccines at this point.   I think that we need to just have the patience  and wait to see how eventually these unanswered   questions in terms of the the few issues that  I discussed (about durability of protection,   particularly when we can really reach the herd  protection) will be achieved. In the meantime,  

let's keep our masks on. Let's keep our physical  distance as a rule of living and of course   continue hand hygiene. These are the three pillars  that really have been able, when implemented, to   really minimize the impact in terms of morbidity  and mortality of this virus. Thank you Dr. Fasano.   Now we will turn to questions that have come in  about the vaccine from our social media platforms   and other avenues. The first question-- Do any  of the potential vaccines contain gluten? The   answer's no. There is absolutely no gluten in  these vaccines. There is no need to add gluten.   As I told you, these vaccines are mainly made  by genetic material from the SARS-CoV-2 virus   along with lipid droplets that by definition don't  contain gluten. Why is it that some people with  

celiac disease do not respond to the hepatitis  B vaccine or they require revaccination with the   hepatitis B vaccine? The reason why the hepatitis  B vaccine sometimes doesn't induce an immune   response in celiac is not completely understood.  But it looks like it has to do with the capability   specifically of that vaccine against the hepatitis  B, because that's not shared with other vaccines   that we have available that are mandatory to be  used. So it's probably due to the fact that this   is something that is pertinent to the hepatitis  B that is not inducing the immune response at   the first vaccination. I have to say that the  second boost, if we see low levels of hepatitis  

B antibodies, in general is successful to  mount a proper protective immune response.   Is there a chance that people with celiac  disease may not respond to the COVID-19 vaccine   or might need to be re-vaccinated before it is  effective? Again, this is related to the previous   question and the answer is that we don't know yet  because we don't have a critical number of people   with autoimmunity in general, celiac disease  specifically, who have been vaccinated to answer   this question. But the expectation is that that's  not the case, because this is a messenger RNA   vaccine. When this messenger RNA is put in motion  and starts to produce a large quantity of these   spike proteins it will be just a matter of time  before immune system will see this enemy and it   will start to mount an immune response against it.  So the capability to mount an immune response to  

non-self proteins by celiac disease patients is  comparable to the general population, so I would   not anticipate anything like this. Can you tell us  if there has been any consideration given to what   vaccine candidate would be the best  vaccine for people with celiac disease?   Well in terms of safety and efficacy these  two first two vaccines based on messenger   RNA are equally effective and therefore I  think they are interchangeable. If we get   one or the other vaccine, they should work equally  effectively so I don't think there's going to be a   difference. There are many other vaccines in the  making with different technologies, including to   use other viruses like adenoviruses as a vector to  deliver this spike protein or attenuated vaccines.  

But also in those cases I don't think that  there's going to be any difference in terms of how   a person would see the disease  and respond to one versus others.   Which vaccine technology is most  likely to activate an immune response,   otherwise known as immunogenicity? Well I have to  say these two messenger RNA vaccines that, again,   it was a concept that was initiated almost 10  years ago at the University of Pennsylvania   and never saw the lights of clinical application  because of some technical hurdles in terms of the   stability of messenger RNA, how to deliver this  messenger RNA, how to protect against degradation   because messenger RNA are very fragile when  injected. All these real technical hurdles have   been resolved in an astonishingly short period of  time. And I have to say in terms of immunogenicity   so far based on the number of people that  have been vaccinated in the United Kingdom   and now here, it seems to be quite effective  in inducing an immune response. Of course,  

only time will tell us in terms of the duration  [of protection], which in my humble opinion is   the major question mark of this vaccine. How  long are they immunoprotected and that this   protection will stand. And here is our last  question. Dr. Fasano, how likely are the mRNA   vaccines to be more or less effective than  more standard vaccines? Well this is a good   question to which we will have an answer when  we can compare vis-a-vis the mRNA vaccine-based   remedies for COVID-19 compared to more  traditional vaccines with attenuated SARS-CoV-2   or vaccine vectors like adenovirus in which  they carry these proteins from the SARS-CoV-2.   We can't compare the past. First of all because  we never had a messenger RNA based strategy and   secondly because each different microorganism  reacts differently when it comes to immune   response so we have to wait when these other  generation vaccines against the SARS-CoV-2 will   become available and people will be vaccinated.  So we will see if there is difference in terms of  

effectiveness, particularly in terms of protective  time against the vaccine. So this is the status of   the arts concerning vaccination. Again, there  is a brand new horizon that is opening with   the event of these vaccines that were able to be  deployed in such a short period of time. I think   that this will change completely with landscape  starting with protecting the ones that will be   receiving the vaccines and then hopefully moving  to the herd protection of the entire population.   With that, I want to wish you all happy holidays.  Stay safe, stay well. Thank you for joining Dr.   Fasano and myself today. We wish you a safe,  healthy and happy holiday season and new year.  

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2021-01-01 19:59

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