Results from 64,900 vaccines: Allergy Risk? Hives (urticaria) photo credit: James Heilman, MD, Wikipedia, "Hives" 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)  Pfizer and Moderna were pretty similar in how often they caused allergic reactions: very low numbers 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 Anaphylaxis severity - 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 Bottom lines - 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 AuthorDon Thomas, MD author of "The Lupus Encyclopedia" and "The Lupus Secrets" ______________________________________________________________
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
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10.5% of lupus and rheumatic disease patients died  Lupus patients and other rheumatic disease patients shown to have higher death rates per a recent large research study Results of a world-wide study of 3729 rheumatic disease patients and COVID-19 - Earlier reports in early 2020 suggested that lupus patients may not have been at higher risk of COVID-19 complications. This report (referenced below) questions this. - This report looked at 3729 patient. It included patients with systemic lupus, but it did not specify how many lupus patients nor how they did compared to other patients. However, it looked at the risk for death in patients receiving various drugs, patients with certain comorbidities, disease activity risks, sex, and countries of residence.  FIRST THE BAD NEWS BAD FINDINGS FROM THE STUDY Rheumatic disease patients at highest risk for death after infected with COVID-19 (listed in order) (these results will be given in odds ratios. To figure out how to word this (odds ratio findings): Subtract 1 from the number, move the decimal point 2 to the right, then say "___ greater odds of dying from COVID-19." For example, for an 80 year old with a rheumatic disease, they have a 518% greater odds of dying from COVID-19. A man with a rheumatic disease has a 68% greater odds of dying from COVID-19 infection than a woman does.") - Age >75 years old, OR 6.18 - Rituximab (Rituxan) treatment, OR 4.04 - Sulfasalazine treatment, OR 3.60 (see commentary below) - Age 66-75, OR 3.00 - Immunosuppressant treatments listed below, OR 2.22 (tacrolimus, mycophenolate, cyclosporine, cyclophosphamide, azathioprine) - Not on a disease modifying agent immunosuppressant, OR 2.11 (compared to patients on methotrexate) - Moderate to high disease activity, OR 1.87 (compared to patients in remission and low disease activity) - High blood pressure plus heart disease, history of stroke, or hardening of the arteries, OR 1.89 - Prednisone more than 10 mg daily (or more than 8 mg methylprednisolone), OR 1.69 (compared to no steroids) - Chronic lung disease (like COPD, asthma, interstitial lung disease, pulmonary fibrosis), OR 1.68 - Men, OR 1.46 (compared to women) United Kingdom had the highest death rate followed by Germany ________________________________________________________________ Commentary about sulfasalazine (SSZ): Do not take away from this that SSZ increases deaths from COVID-19. SSZ is often prescribed by rheumatologists to sicker patients who are at higher risk for infections in the first place. For example, there were more smokers in the SSZ group. SSZ does not suppress the immune system. Also, SSZ is a weak drug (most often used to treat rheumatoid arthritis). Patients on just SSZ are less likely to be in remission or low disease activity (and therefore at higher risk of death from a COVID-19 infection). I suspect that this is an "association" and not a "causality."  NOW, THE GOOD NEWS POSITIVE FINDINGS FROM THE STUDY - Hydroxychloroquine (Plaquenil) and belimumab (Benlysta) treatments were not associated with higher death - TNF inhibitor, leflunomide, abatacept (Orencia), tocilizumab treatments were not associated with higher death - The United States had the lowest death rate of all countries in the study - After the US, countries (in order) of lowest death rates = Germany, then France, then Spain  The Bottom Line: What you should do BOTTOM LINE AND WHAT YOU SHOULD DO TO PROTECT YOURSELF: - It is most important to keep your lupus under control. Do NOT stop any medications. - Abide by all nondrug ways to lower lupus disease activity so you don't need as many steroids. - Work hard with your doctor to control your disease better so you can lower your steroid dose. - Get vaccinated against COVID-19! - Ask everyone around you to get vaccinated (the cocoon strategy) - Even after vaccination, abide by all isolation, separation, social distancing strategies Reference: Strangfeld A, Schäfer M, Gianfrancesco MA, et al. Factors associated with COVID-19-related death in people with rheumatic diseases: results from the COVID-19 Global Rheumatology Alliance physician-reported registry. Annals of the Rheumatic Diseases Published Online First: 27 January 2021. doi: 10.1136/annrheumdis-2020-219498 AuthorDon Thomas, MD, author of "The Lupus Encyclopedia" and "The Lupus Secrets" This is a list of recommendations on what to do with immunosuppressant drugs and COVID vaccine American College of Rheumatology Clinical Guidance Summary FEB 2021 The above come from the FEB 2021 ACR published guidelines. You can find the entire article here Bottom Line: 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 AuthorDon Thomas, MD, author of "The Lupus Encyclopedia" and "The Lupus Secrets" |
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.
AuthorDONALD THOMAS, MD Archives
April 2021
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