Nearly 1.5 million Americans are being vaccinated every day against COVID-19. Still, allergic reactions have led some people to question whether they should get the vaccine. Scant data on vulnerable populations gleaned from clinical trials for the currently approved vaccines means we don’t fully know how those with certain conditions will react. Does that mean those with allergies or conditions like HIV, multiple sclerosis, or cancer should pass on the shot? What about pregnant women? Barbara Alexander, MD, an infectious-disease specialist at Duke University in Durham, North Carolina, and the current president of the Infectious Diseases Society of America joins us to explore who should get the shot. Mark Turrentine, MD, a professor at the Baylor College of Medicine in Houston and cochair of the American College of Obstetricians and Gynecologists (ACOG) COVID-19 OB Expert Work Group also joins to explain whether the vaccine is safe for pregnant and nursing women. Listen and subscribe on Apple, Stitcher, Spotify, or Google so you don’t miss the next episode. And if you like what you hear, a five-star rating goes a long way in helping us Track the Vax! Barbara Alexander: I think there is definitely science emerging now. Actually, the most recent safety data was reviewed by the Advisory Committee on Immunization Practices (ACIP), the committee that advises the Centers for Disease and Control Prevention (CDC) on vaccine safety and efficacy. It’s true that it seems the second dose is more reactogenic than the first dose. Most symptoms do occur within the first three days after vaccination and most spontaneously resolve within a couple or three days. The most common side effects seem to be pain, fatigue, headache, and myalgias or muscle pains. Serena Marshall: Is it because of these vaccines’ mRNA (messenger RNA) technology, or is it something to do with the COVID antibody response that they’re generating? Barbara Alexander: I suspect it has more to do with the antibody response. With the first vaccine, most people don’t have too much of a reaction. It’s after that second vaccine that we see most people developing more side effects. Probably that’s because after the first dose our bodies begin to make an antibody response or an immune response. When it gets that second dose, the body’s really revved up. It’s really ready to act against the antigen that the vaccine is providing. In that scenario then, what we’re getting is an inflammatory response from the body. Serena Marshall: What would an allergic reaction to this vaccine be? Barbara Alexander: The most important and worrisome allergic reaction that we think about is an immediate allergic reaction — the scientific term we use is a type 1 hypersensitivity reaction. The majority of these types of reactions occur within 30 minutes after vaccination. The types of reactions that we’re talking about here are urticaria or hives; angioedema is swelling in the lower layers of the skin, and typically it involves the face and tongue or throat and wheezing. If you see one or two of these symptoms in combination with a low blood pressure or fast heart rate, then in that scenario that is anaphylaxis. Serena Marshall: Is it something that most people should be worried about? Barbara Alexander: Actually, no. When the vaccines were first rolled out, there were cases reported early on of anaphylaxis and it received a lot of attention. It was something that obviously we were very concerned about. But as we accrued more data, we know now that anaphylaxis is probably not as common as we thought it might be. The safety data is accruing not only from clinical trials, but from the real world. Serena Marshall: If you have a food, pet, or environmental allergy, is that an indication that you might [be at risk] for anaphylaxis and should pass on the COVID vaccine? Barbara Alexander: People have allergies to a lot of different allergens. Different food products, pet dander, bee venom, or even latex. None of these are contraindicated; even if you have anaphylaxis to these products, it’s safe to get the messenger RNA vaccines. The only major contraindication to the messenger RNA vaccines is if you’ve had an immediate allergic reaction, a hypersensitivity response, to the first dose or if you’ve had such a response to a component of the vaccine in the past. That includes polyethylene glycol because this component is in both vaccines, and some people will react to it. If you’re going to receive the vaccine, do it in a center that’s equipped to immediately treat it in case you did develop anaphylaxis. And all people with a prior history of an anaphylactic reaction should be monitored for at least 30 minutes after they receive the dose. Serena Marshall: Could the version of the vaccine you get dictate how you react to it? We’ve talked a lot about these mRNA ones because they’re the ones that have been released to the public. Looking forward, would we expect to see different reactions and perhaps different contraindicators for different styles of vaccines? Barbara Alexander: Absolutely. The Johnson & Johnson vaccine, specifically, is using an adenovirus vector. It’s a platform that has been used widely in vaccines before that we’ve used in teenagers, infants, and children. So we feel reasonably comfortable with adenovirus vector vaccines. We’ll just have to wait and see what the safety data looks like and, importantly, to see what their efficacy data looks like. Serena Marshall: What about those who are immunocompromised or have an autoimmune disease? Barbara Alexander: These populations — patients living with HIV infection, people with cancer, or patients who may have received a solid organ transplant — are receiving immunosuppressive drugs or chemotherapy, which can weaken their immune system. Accordingly, they may not have a robust immune response to the vaccine. But some degree of immunity is better than none. And particularly since these people are at certainly higher risk for severe disease, we are recommending that they get the vaccine.
Q&A With Dr. Mark Turrentine
Serena Marshall: Explain to us why there has been what appears to many people as a mixed message for moms-to-be. Mark Turrentine: Even before the COVID-19 vaccine trials, pregnant women have traditionally been excluded from clinical trials of new medications and vaccines. In 2013, the National Institutes of Health developed guidelines for protocol design and safety assessment for clinical trials conducted in pregnant women. In 2018, the U.S. Food and Drug Administration (FDA) published draft guidance that gave a framework for consideration of inclusion of pregnant women in clinical trials. The conclusions were that including pregnant and breastfeeding women is essential, unless there is some compelling, scientific reason to exclude them. We have this situation where we had these two large placebo-controlled randomized clinical trials with essentially no pregnant women or women breastfeeding. So with limited information to guide us, it comes down to expert consensus with mass medical ailments and the interventions we have had good clinical experience with. The World Health Organization initially on January 8 of this year stated that due to insufficient data they did not recommend the vaccination of pregnant women with the Pfizer COVID-19 vaccine at that time. Then on January 27, the WHO came out with a statement on the Moderna vaccine that recommended not getting a COVID-19 vaccine unless the woman was at a high risk of exposure. And this led to a lot of confusion in many parts of the world. Serena Marshall: So what are you hearing from your patients? Mark Turrentine: There’s definitely a lot of initial confusion. We’re all looking at the same information. And I think this is the challenge, when you have limited information to guide you and you’re trying to combat a potentially life threatening disease. As someone who’s been personally involved with guideline and policy development on a national level for many years, it’s complex. I can at least feel professional comfort in that the guidelines in the United States have been consistent to date. We tried to base them on the best evidence we have available to us, and hopefully we’ve reassured our pregnant patients, breastfeeding moms, and women contemplating pregnancy that if after some informed decision-making they either choose to obtain a COVID- 19 vaccine or not, they feel they’ve made the right choice. Serena Marshall: What’s your lasting message for those women? Bottom line: Do they get the vaccine? Mark Turrentine: Bottom line is yes, they should get the vaccine. But what I tell my pregnant patients is, first learn everything you can about the COVID-19 disease and the COVID-19 vaccine. The disease is dangerous, and it’s more dangerous for pregnant women. COVID patients who are pregnant are five times more likely to end up in the intensive care unit or on a ventilator than COVID patients who are not pregnant. And although the absolute risk is low, pregnant individuals are more likely to die of COVID than their non-pregnant peers who are the same age. The pregnant individual should be given the opportunity to make their own decision about whether they receive the vaccine, and barriers should not be put into place to prevent access or hinder the ability of a pregnant woman to protect herself from a virus that could be potentially life-threatening.
