Results from 64,900 vaccines: Allergy Risk?
Journal of the American Medical Association Research Study: March 2021
(reference and link to the study are at the bottom of the page)
Easy-to-Read Results Summary:
- Researchers did this study based on the fact that many are nervous to get the vaccines due to having allergies themselves and all the media-hype regarding allergic reactions causes some people to avoid the vaccines.
So... what is the truth?
- Study was done at Massachusetts General Brigham (the Original Harvard hospital!)
- Studied what happened the 3 days after the first vaccine (the time of highest chances for allergy symptoms)
- 40% got Pfizer, 60% Moderna
Mild allergic reactions
- 1 out of every 50 vaccines caused mild allergic reactions (itch, hives, swelling)
- Moderna (2.2% of the shots caused mild allergy) vs Pfizer (2% of the shots): not much difference
- 98% of all people had no allergic reactions at all (that is a nice, safe number)
Significant allergic reactions (anaphylaxis)
- Occurred in 1 out of every 3700 Pfizer shots (i.e. .027% of the shots)
- Occurred in 1 out of every 4300 Moderna shots (i.e. .023% of the shots)
- In total, there were 5 anaphylactic reactions per 20,000 vaccines (that is a really safe number compared to many other drugs)
Timing for significant allergic reaction (anaphylaxis)
- An average of 17 minutes after the shot
- The range was from immediately after the shot up to 2 hours later at the latest
- 7 of the 16 patients had mild skin reactions
- 9 of the 16 patients had "measurable" but not life-threatening reactions
- 3 did not seek any medical attention
- 1 went to the ICU and recovered
- 9 out of 16 patients needed an epinephrine shot (EpiPen) and all recovered
- There were no severe anaphylactic reactions (having shock or requiring intubation)
Who was most likely to get anaphylaxis?
- Out of 16 patients in total, 5 (31%) had a history of anaphylaxis
- 10 out of 16 (61%) had a history of allergies (probably not significantly different than the usual population)
"I have a history of anaphylaxis, what is my risk?"
- Assuming there were 4000 individuals with severe food or drug allergies in this group (this is the expected #)
- Only 5 out of 4000 people with a history of anaphylaxis get an anaphylactic reaction (1 out of every 800)
- Knowing that this is a group of people who are used to planning for anaphylaxis and should have an EpiPen, and who know they have to use it when exposed to a known allergen (like me when I accidentally eat shrimp), that is an incredibly low number.
- I took my EpiPen with me when I got mine. No problems! Only 1 out of every 800 times would someone need to use it
- Since the results were reported by the employees themselves, and not confirmed by doctors, we cannot ensure that these were truly anaphylactic reactions (people do tend to overestimate such responses = my opinion)
- The researchers, Harvard-famous allergy experts, stated, "... the overall risk of anaphylaxis to an mRNA COVID-19 vaccine remains extremely low"
If you have had an anaphylactic reaction in the past (like I have), I recommend:
- Just take your EpiPen and wait a while after your shot if you have had anaphylaxis before. However, don't sweat it.
You have a higher chance of getting into a car accident on the way to the shot than you do of getting an anaphylactic reaction
Did you get your vaccine? How did you do?
COMMENT BY CLICKING ON "Comments" ABOVE
Reference: Blumenthal KG, Robinson LB, Camargo CA, et al. Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA. Published online March 08, 2021. doi:10.1001/jama.2021.3976
This is a list of recommendations on what to do with immunosuppressant drugs and COVID vaccine
The above come from the FEB 2021 ACR published guidelines. You can find the entire article here
You only need to adjust methotrexate, Xeljanz, Olumiant, Rinvoq, Orencia, cyclophosphamide, and rituximab
Please check with your doctor and ask before implementing these. Your medical condition may dictate otherwise
Resource: American College of Rheumatology ACR COVID-19 Vaccine Clinical Guidance Task Force (2/8/21). COVID-19 Vaccine Clinical Guidance Summary for Patients with Rheumatic and Musculoskeletal Diseases. Retrieved on 2/25/21 from https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf
New guidelines from the American College of Rheumatology for the COVID-19 vaccine
February 2021, the American College of Rheumatology released recommendations on what to do with immunosuppressant drugs around the time of your COVID-19 vaccine. The reason for these recommendations is that some of our medicines can blunt the effects of the vaccine. Timing the drug to the vaccine to your medication can make a big difference.
ALSO: They make other important recommendations as listed below. Make sure to share this with your family, friends, and other patients
- Do not do any of these without asking your rheumatologist first (let them know that you did read these up to date recommendations here)
- PRINT these out for future reference for other vaccines
- I also recommend these to my patients who get any vaccine, IF they are in remission or at low risk of flaring when they get the vaccine (again, do not do this without talking to your rheumatologist first)
- I agree with all of these, except, I differ with the methotrexate recommendation, as per below
The link to the full recommendations is below at the bottom of the post.
Drug recommendations summary:
Abatacept IV (Orencia): Time vaccine administration so that the 1st vaccine occurs 4weeks after Orencia IV (i.e., the entire dosing interval), and postpone the subsequent IV Orencia by 1 week (i.e., a 5-week gap in total); no medication adjustment for the second vaccine dose
Abatacept SQ (Orencia self injectable): Hold SQ abatacept both one week prior to and one week after the first
COVID-19 vaccine dose (only); no interruption around the second vaccine dose
Azathioprine (Imuran): No modification needed
Belimumab (Benlysta): No modification needed
Cyclophosphamide: No modification needed for pills. For the IV form, time CYC administration so that it will occur approximately 1 week after each vaccine dose, when feasible.
Hydroxychloroquine (Plaquenil): No modification needed
IVIG: No modification needed
JAK inhibitors (Xeljanz, Olumiant, Rinvoq): Hold JAKi for 1 week after each vaccine dose
Kineret: No modification needed
Leflunomide (Arava): No modification needed
Methotrexate: Hold MTX 1 week after each vaccine dose, for those with well-controlled disease
NOTE Dr. Thomas' recommendations to his patients: "Hold MTX dose for 2 doses after each vaccine if you are doing well and in remission" (do not do without talking to your own doctor). This is based on the latest study results with the flu shot and methotrexate.
Mycophenolate (CellCept, Myfortic): No modification needed
Prednisone: No modification needed
Rituximab (Rituxan): Assuming that patient's COVID-19 risk is low or is able to be mitigated by preventive health measures (e.g., self-isolation), schedule vaccination so that the vaccine series is initiated approximately 4 weeks prior to next scheduled rituximab cycle; after vaccination, delay RTX 2-4 weeks after 2nd vaccine dose, if disease activity allows.
Sulfasalazine: No modification needed
Tacrolimus and cyclosporine A: No modification needed
TNF inhibitors (adalimumab, etanercept, infliximab, golimumab, certolizumab): No modification needed
Tocilizumab (Actemra): No modification needed
Voclosporin (Lupkynis): No modification needed
Other important recommendations from the ACR:
- There is no preference of getting one vaccine over another (Pfizer, Moderna, J&J, AstraZeneca): Get whatever is available for you
- Lab testing is NOT required after vaccines to assess response to the vaccine
- Ask all household members, friends and loved-ones to get vaccinated to protect you (the cocoon effect)
- If you don't believe in the vaccine, get vaccinated at least to protect those you love (Dr. Thomas' addition)
- Get vaccinated even if your disease is active
REFERENCE: ACR, COVID-19 Vaccine Clinical Guidance Summary for Patients with Rheumatic and Musculoskeletal Diseases. Developed by the ACR COVID-19 Vaccine Clinical Guidance Task Force.
This draft summary was approved by the ACR Board of Directors on February 8, 2021.. A full manuscript is pending journal peer review.
Dr. Thomas recommends not waiting to his patients, read below...
Full answer below:
"I'll tell you what I tell my patients, "PLEASE, get your COVID-19 vaccine as soon as it is your turn! However, make sure to ask your doctor first" Why? People are dying left and right. People who did not ever think they would get it - get it. Just this week, I have had 3 patients tell me the horrible, sad story of a loved one or friend who recently died. One was on a ventilator 12 weeks.... 12 weeks! Guess how many similar stories I've heard about the COVID-19 vaccine... none.
The COVID-19 vaccines are the most studied vaccines EVER. No vaccine comes close. Over 70,000 people were in the clinical trials for Pfizer and Moderna. And now... millions have been given out with no bad safety signals. Sure, you will have a very sore arm for a week. Sure, you may have achiness, headache, and low-grade fever for a few days. There is always the chance for an allergic reaction (true for any medicine or vaccine ... I took my EpiPen with me, just in case.) I'll take these mild side effects any day over being in the ICU on a ventilator where I could die alone, only able to see my loved ones on FaceTime.
True, patients with autoimmune diseases were excluded from the clinical trials. True, immunosuppressed patients were as well. However, that goes with all vaccine phase I-III clinical trials. If you want to wait for research on lupus patients. You will wait a very long time.
Caveats ... there is always the possibility you may not have as strong of a response. However, thus far, lupus patients respond very well to other vaccines.
Bottom line: Fear COVID-19 ... don't fear the vaccine.
"Fear COVID-19; Embrace the vaccine!"
Thanks to Kelli Roseta of "More Than Lupus" for publishing "Ask Dr T"
*for informational purposes only.
New study shows the answers: FREE study to read
Note that Dr. Thomas' posts are for informational purposes only, and are not meant to be specific medical advice for individuals. Always seek the advice of your healthcare provider with any questions regarding your own medical situation.
DONALD THOMAS, MD