Rick Loftus, MD:
Most of the concern about anaphylaxis was for the Pfizer vaccine and its first week in the United Kingdom. The data shows that the risk of anaphylaxis is 11 per million people, and it does not appear that a history of autoimmunity or anaphylaxis, per se, is a risk factor. People with autoimmune issues do not seem to have a contraindication to getting vaccinated. Those who do may wish to premedicate with Benadryl and be observed for 60 minutes rather than the standard 15. About 70% of patients who have anaphylaxis reactions to the Pfizer vaccine will have the reaction in the first 15 minutes. We recommend that people use Tylenol rather than ibuprofen or naproxen for any vaccine side effects. Generally, nobody gets much of anything except perhaps a mild sore arm at the injection site after the first dose; a substantial minority of people get a reaction after their second dose, usually low-grade temperature, myalgias, fatigue, headache. Those symptoms are mild and they generally resolve after about 30 hours. Many of the nurses are taking the day off from the day they’re getting their second dose as a precaution. I would also suggest that those with autoimmune conditions should not premedicate with corticosteroids, as they will screw up antigen presentation from the vaccine.
We’ve had approximately 70,000 people get a full course of therapy of the RNA vaccines, between the two products. Those patients included patients with HIV, as well as a substantial number of patients with chronic autoimmune diseases and rheumatological disorders. There has been no observation of any difficulties with vaccine response in any of these populations. That data is not published yet and it will probably be the better part of a year before we see reports on subpopulations. Those populations in the studies are smaller, so their ability to claim statistical significance is somewhat dicey, but I think laypersons have a different standard for reassurance then do finicky scientists like me.
If someone is on immunosuppressive drugs, that does raise a concern that the ability to mount an immune response may be compromised somewhat, but those patients will likely still get some degree of response- which is definitely still better than your first introduction to Covid being the live virus that will try to kill or disable you. Vaccines, by definition, do not propagate, and will not invade the organs. If you could introduce some helpful immune responses, even in someone on immune-suppressive drugs, that will put them at a lesser risk of hospitalization. Again, it will be a year or two before we have data that backs up what I am saying, but I feel confident based on my immunology background in predicting this. Those with autoimmune conditions should probably proceed with a vaccine because there’s not much reason to suspect harm, and even if they are at a disadvantage in developing a robust immune response, even if they get only half a response, they’ll still be better off. That’s my two cents. I hope that helps.
New England Journal Of Medicine’s FAQ’s About The Covid-19 Vaccine
To piggyback on Rick Loftus, MD’s response to those who are immunocompromised and concerned about getting the Covid vaccine, yesterday’s New England Journal of Medicine answers a plethora of frequently asked questions about the Covid vaccine. Here’s their response to how to deal with immunocompromised patients:
The CDC considers immunocompromised patients to be at increased risk for severe Covid-19. This is broadly defined as patients with histories meeting the following criteria, which are not 100% inclusive:
- Bone marrow transplant
- Solid-organ transplant
- Stem cells for cancer treatment
- Genetic immune deficiencies
- Use of oral or intravenous corticosteroids or other medicines called immunosuppressants that lower the body’s ability to fight some infections (e.g., mycophenolate, sirolimus, cyclosporine, tacrolimus, etanercept, rituximab)
The American Society of Hematology and the American Society for Transplantation and Cellular Therapy has a similar list with additional details. Because of the heightened risk of severe Covid-19 in this population, immunocompromised patients should receive the Covid-19 vaccines if there are no contraindications. That’s the easy part.
What’s more challenging is estimating the safety, and particularly the efficacy, of the vaccines in this population, since neither clinical trial included large numbers of people in these individual categories. Since the Pfizer/BioNTech and the Moderna vaccines don’t include live virus, there is no risk of virus dissemination. Whether the antigens in the vaccine will trigger either an increased risk of rejection (for transplant patients) or autoimmune disease (for those with rheumatologic or other autoimmune conditions) is unknown, but it is reassuring that such adverse effects are infrequent with other vaccines. Furthermore, the clinical trials did not see a difference in the occurrence of autoimmune conditions or inflammatory disorders in study participants who received the vaccine as compared with placebo.
Vaccine effectiveness depends on an intact host response; as a result, immunization might be less effective in immunocompromised hosts than in the general population. When immunizing immunocompromised patients for Covid-19, we should counsel them about this potential difference and hence about the continued importance of other prevention measures, such as mask wearing, social distancing, avoidance of crowds, and hand washing. Household members of those with weakened immune systems should also be immunized if possible.
Clinicians may wonder about delaying or stopping immunosuppressive therapies or chemotherapy before starting the Covid-19 vaccine series and then resuming once the two shots have been administered. Although such strategies have theoretical appeal, no general guidance can currently be given applicable to this diverse group. We will need to consider holding or delaying immunosuppression on a case-by-case basis, depending on the seriousness of the underlying condition and the urgency of its treatment.
Both clinical trials included small numbers of clinically stable people with HIV who were on antiretroviral therapy — 120 and 176 in the Pfizer/BioNTech and Moderna trials, respectively. Although these numbers are too small to make any conclusions about safety and efficacy in people with HIV, there is no theoretical reason why someone with well-controlled HIV should have problems with these vaccines, and immunization is recommended. For people with HIV who are not on antiretroviral therapy, especially those with low CD4 cell counts, my opinion is that prioritization of HIV treatment over Covid-19 vaccination is warranted — both for prevention of HIV-related complications and to improve vaccine responsiveness. (Last reviewed/updated on 11 Jan 2021).
You can read the NEJM’s answer to other FAQ’s here.