I have been inundated with emails regarding questions of whether to take the vaccines or not. I really do believe that the vaccines offer the best means currently for helping reduce the risks of becoming severely ill from COVID-19. I hope this post will help allay fears.
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1.While these vaccines have been developed and approved quicker than any vaccine in history, and have used novel technologies, we do not have any reason at this time to question their safety. The RNA vaccine technology (more later) has been used for years in animal vaccines, just not human vaccines, and are extremely well studied. They really represent a major step forward in generating vaccines rapidly. They really are only limited by the need for cold temperatures for storage.
2.While the timelines for these vaccines have been very short, these vaccines are studied in large number of patients. (Pfizer: 40,000 in total in the pivotal trial: 20,000 vaccine vs 20,000 placebo; Moderna: 30,000 in total in the pivotal trial: 15,000 vaccine vs 15,000 placebo.) Most of our oncology drugs are approved using studies of 150-300 patients.
3.The RNA vaccines use RNA encapsulated in a lipid vesicle to deliver it to cells where it is taken up and transcribed (processed) like normal RNA into a protein that is placed on the surface of the cell for the immune system to see and recognized as foreign. This really replicates what the virus itself does. There is no means for the RNA to be changed into DNA, make it into the nucleus, or enter the cell's normal DNA. The Pfizer/BioNTech and Moderna vaccines are RNA vaccines.
4.The AstraZeneca/Oxford vaccine, approved this past week in the United Kingdom is different in that it uses a replication deficient virus. The virus infects cells and places its immunogenic proteins on the surface of cells for the immune system to react to. Even though this is not a killed virus vaccine, this vaccine should still be safe from a CLL perspective. The one issue with the AstraZeneca/Oxford vaccine is that there were some errors in the conduct of the clinical trial which might make the data suspect. One group of patients received a half-dose of vaccine. Interesting, these patients seem to be better protected when looking at the numbers. There are several theoretical reasons why this might occur, but it is counterintuitive. There were some differences in spacing the vaccine doses, which may also explain some of the benefit. The efficacy in the majority of the patients is lower, approximately 60%. What we are missing are the data with statistics to assess whether these are meaningful differences or possibly due to chance.
5.We have no reason to believe there is any advantage of the Pfizer/BioNTech or the Moderna vaccine over the other. Both vaccines did numerically very close (which is very reassuring) and none of the differences in outcomes is statistically meaningful.
6.We currently do not have efficacy or safety data for these vaccines in patients with CLL. With this being said, we do not have any reason to expect the safety to be different in patients with CLL. While we do have theoretical reasons for why the vaccine might be less effective, and therefore alter a risk-benefit assessment, these vaccines are very immunogenic and will hopefully be equally efficacious in patients with CLL. We also know had dangerous COVID-19 infection is and therefore any steps that could be taken to lessen the risk of morbidity or mortality is critical.
7.We should also remember that the vaccines were shown to reduce illness, but this does not mean that patients cannot get infected and still be contagious. The vaccines may lessen the duration of viral shedding, and therefore risk of spreading the virus, but may not limit it altogether. As such, people previously infected and people who have been vaccinated, still need to follow all of the safety protocols until "masks off" if declared.
8.Many patients are on different treatments during this period. We don't know whether any of these treatments will impair the immune response to the COVID-19 vaccine. While we have some anecdotal evidence of BTK inhibitors helping prevent severe COVID-19 illness, the clinical trial data are still emerging. The acalabrutinib trial in COVID-19 (non-CLL patients) did not show a benefit, but there were some issues with that trial that might not make it generalizable to everyone. I suspect that BTK inhibitors do help and have been continuing my patients on them. With regard to the vaccine, any temporary interruption will likely not be sufficient to make a difference and I would recommend just continuing the inhibitor. I am also recommending the same for the PI3K inhibitors and venetoclax. Anti-CD20 monoclonal antibodies would be different, and it might make sense to defer vaccination until after therapy is completed if there is an option.
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I hope this helps everyone. I do encourage everyone given an opportunity to accept the vaccine. Additionally, I do encourage everyone to still practice mask wearing and safety protocols.
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Happy and Healthy New Year to everyone. I hope we will be able to resume some normalcy this coming year.
Stay Safe.
Rick Furman, MD
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Len
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P.S. I have heard better estimates for the efficacy of the AstraZeneca/Oxford vaccine, but I understand it can be complicated working out figures on these things.
Thank you so much for sharing this valuable information with us. I shall share it with my oncologist so she can write me a letter with her approval of the vaccine to give to the pharmacist, nurse, doctor, or whoever will be giving then vaccines.
Thank you for posting this very important summary from Dr Furman, to which I'll add his addendum for those of us having IgG infusions:-
mRNA COVID vaccinations & IVIG/SQIG interference?
From: Rick Furman
Date: Fri, 01 Jan 2021 05:46:33 ACDT
I knew I forgot one topic...
IVIG or SQIG are typically produced using human plasma collected up to a year earlier. There really was no sizeable amount of anti-COVID-19 antibodies in the population when the current lots were manufactured. Whether future lots will have significant levels remains to be seen. We are using convalescent plasma from patients recently infected with COVID-19 as a therapy for those acutely infected, but the levels anti-COVID virus immunity are far higher in these plasma preparations than what we would see in IVIG.
There has always been some anti-coronavirus immunity in the population as coronaviruses (same family as COVID-19 but a different virus) cause approximately 50% of the common colds. We do not have any data whether these antibodies may play a role in helping to protect against COVID-19. One major issue, that is extremely relevant to COVID-19 immunity, is that the immunity to the coronaviruses that cause the common cold tends to not be lifelong. This might indicate a need for annual vaccinations.
Thank you for sharing this. I always feel so much calmer and confident reading important advice from CLL specialists so as to know which way to go. I love this site! 😊
Hopefully governments follow Spain / France and record who isn't vaccinated and share that information with other governments. This will limit travel for those not vaccinated and thus protect us all.
Thank you for this information! I was just called yesterday by my primary Physician's office to come on Monday 1/4/21 for a Covid Vaccine. I cried I was so happy. However my oncologist is also calling me Monday to schedule an IVIG infusion. Isn't there something about the timing of IVIG infusions and vaccinations?
I also recall reading about that conflict but I can’t recall the details but I’m certain someone here will. I’m curious what state do you reside in? It’s wonderful that the roll out is beginning.
Well I wouldn't have gotten the vaccine quite so soon, but I am a member of an American Indian Tribe here in Minnesota. Tribal Nations were given their own supplies so I am SO fortunate to be getting this vaccine this early. I had spoken to my Oncologist on Wednesday and she was hoping we would see Vaccines by February for her patients. I am also a social worker for a county agency where I believe I would be vaccinated in not too long due to being an essential worker and the at-risk populations I work with, although mostly remotely now. I didn't know which one of these would come first. I am just so relieved and will pray that all of you get your vaccines as soon as possible! You could go to this website to get this article to help advocate for early vaccination! I just copied this from the article in the CLL Society's Website:
Should I get the vaccine?
Even though their immune response may be less predictable, CLL Society is joining
AACR, ASCO and ASH in recommending that all CLL patients, with their doctor’s
approval, get vaccinated ASAP. As Dr. Fauci stated at ASH 2020 Annual Meeting: Some
immunity is better than none. We recommend CLL patients be vaccinated among the
earliest tiers as their case fatality rate is among the highest even when compared to other
high risk groups with different comorbidities.
This is important. After vaccination, do not stop any of your COVID-19 safety precautions
including mask wearing, social distancing and hand washing until your doctor advises you that it’s safe to stop in your community and with your circumstances.
Thank you for that explanation. That timing now makes sense. Based upon what I am reading I think I’ll be offered the vaccine here in Massachusetts in February or March. Stay safe.
I am not medically trained, so this is my guess: I suspect you are recalling that infusions of the monoclonal antibodies like Rituximab/Rituxan or Obinutuzumab/Gazyva are thought to reduce the likely response of your immune system in producing antibodies. -
Dr. Furman mentions this in his orginal post Anti-CD20 monoclonal antibodies would be different, and it might make sense to defer vaccination until after therapy is completed if there is an option.
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He also mentions IVIG in his addendum added by AussieNeil but does not discourage using the vaccine along with IVIG IVIG or SQIG are typically produced using human plasma collected up to a year earlier. There really was no sizeable amount of anti-COVID-19 antibodies in the population when the current lots were manufactured. Whether future lots will have significant levels remains to be seen. We are using convalescent plasma from patients recently infected with COVID-19 as a therapy for those acutely infected, but the levels anti-COVID virus immunity are far higher in these plasma preparations than what we would see in IVIG
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I suggest you discuss this with your doctor, but expect that there will not be a reason to reschedule either the vaccination or the IVIG infusion- IMO However I would not do them on the same day.
OK thanks so much for this. I will definitely let my Oncologist know Monday morning that I am receiving the vaccine that day. They have yet to schedule the IVIG infusion but she was hoping for next week also but too late to be Monday so I am guessing I should be fine. I will definitely ask her. 😊 Thanks again!
IVIG infusions can reduce the effectiveness of live (attenuated) vaccinations. With the exception of COVID-19 vaccines being developed in India and Turkey, all the current vaccines are non-live, so IgG infusions should not be an issue with any of the vaccines being distributed.
Oh thanks so much for that information. I was so blessed to get my first dose of the Moderna vaccine this morning. I am so grateful. Praying this community all gets theirs very very soon!🙏💚
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