By Bob Shepard
Many people still have questions regarding vaccination against COVID-19 as the vaccine is becoming available to the broader community. Medical professionals at the Department of Medicine at the University of Alabama at Birmingham answered some of those questions and concerns in a series of blog posts.
Concern: The vaccine was rushed in production. I don’t trust that it’s safe.
“It’s natural to wonder if the speed of vaccine development suggests that investigators, drug companies or the government might have cut some corners,” said Seth Landefeld, M.D., chair of the Department of Medicine. “Here are three scientific facts about the rapid development of the Pfizer and Moderna vaccines.”
- Investigators followed ALL clinical trial protocols to rigorously test safety and effectiveness.The Food and Drug Administration mandates that vaccine research follow stringent guidelines for determining whether a vaccine works as intended, and whether people can tolerate the vaccine. Each study is developed in phases, where increasing numbers of participants are enrolled. Their reactions — both positive and negative — are documented. The Pfizer/BioNTech vaccine demonstrated through each phase that side effects were generally mild to moderate intensity and resolved within 24 hours; and it is 95 percent effective in preventing COVID-19 infections.
- The Pfizer-BioNTech study enrolled more than 40,000 participants across 153 study sites in six countries.The numbers of clinical trial participants for COVID vaccine research are extremely high, due to the widespread nature of this infection and high motivation to find a way to prevent COVID. Similarly, the Moderna vaccine trial enrolled 30,000 participants in their study across 99 testing sites. Moreover, the FDA will continue to evaluate the safety of the vaccine as it is administered across the country.
- Vaccines based on messenger RNA have been around for a decade.While this is the first time many of us will have the opportunity to receive a vaccine that is based on messenger RNA — rather than a protein or an inactivated form of the virus — vaccine researchers have been working with mRNA vaccines for 10 years. As mRNA is taken up by muscle cells at the site of injection, these cells start producing the surface protein of the SARS-CoV-2 virus. The immune system recognizes the protein and reacts, producing antibodies that can recognize a potential SARS-CoV-2 infection and prevent COVID.
Concern: The COVID-19 vaccine may not be safe for pregnant women.
“Decision-making in pregnancy involves weighing the potential risks and benefits of vaccination against the potential risks of infection itself,” said Jodie Dionne-Odom, M.D., associate professor, Division of Infectious Diseases. “Women who are pregnant, or may become so, are encouraged to discuss these concerns with a trusted health care provider. Here are a few considerations, along with up-to-date scientific information, about COVID-19 and pregnancy.”
- COVID-19 infection during pregnancy carries risk of serious illness.Researchers have observed that pregnant women with COVID-19 had higher rates of severe disease — requiring ICU admission — compared to non-pregnant women. Some pregnant women have existing medical conditions (diabetes, obesity, hypertension) that contribute to this risk. Because of this, the Centers for Disease Control and Prevention lists pregnancy as a high-risk medical condition for COVID-19. Since there are persistently high rates of COVID-19 in our community, the risk of exposure to COVID-19 for women who are pregnant or planning pregnancy is high.
- Currently available mRNA vaccines for COVID have the benefit of safety and effectiveness in women of reproductive age.In clinical trials that enrolled tens of thousands of participants, mRNA vaccines were shown to be safe and effective in women and men of all ages. Although pregnant women were not included in the clinical trials, a small number of study participants became pregnant, and researchers are monitoring their health outcomes over time. Larger studies in pregnant women are now underway. National organizations for public health and women’s health support vaccination in women who are planning a pregnancy, pregnant or breastfeeding, including the Centers for Disease Control and Prevention, the American College of Obstetricians and Gynecologists, the Society of Maternal Fetal Medicine, and the American Society of Reproductive Medicine.
- Several vaccinations are routinely recommended in pregnancy due to documented safety and effectiveness for women and their infants.Routinely recommended vaccinations in pregnancy can have benefits for women and their infants since maternal antibodies can provide protection to their newborn that can last for months. Studies are underway to assess short- and long-term benefits, as well as potential risks, of COVID-19 vaccination in pregnancy.
Concern: The U.S. health care system, past and present, has been known to disproportionately harm Black and Latinx communities.
“I admit that I had some hesitation about the vaccine myself,” said Latesha Elopre, M.D., assistant professor, Division of Infectious Diseases. “My family is from Georgia, and my grandparents were sharecroppers. I have personal experience dealing with racist systems, and with that, there is a natural hesitation. As physicians and scientists, we mustn’t be upset when people come to us with skepticism, though. We have to be patient and do our best to answer questions, explain the science and set an example for others to follow.
- Do you recommend the vaccine to people of color?The impact of COVID-19 is primarily in communities of color, so I feel like we have to act now. This is not a moment when we can hesitate with this vaccine. In my own family, my mom has a history of strokes, so she was in a high-risk group. I had multiple conversations with her about the vaccine, explaining the data behind why it’s important. I am happy and proud that she was able to overcome her hesitancy, and she got vaccinated.
- How did the vaccine affect you, personally?I actually hate shots! It is something I dread every year when flu season comes around. But after my first dose, I cried with relief and gratitude. It’s been overwhelming having seen so many suffer alone, not just patients, but in my own family. And my side effects from the first dose were tolerable. I was pretty tired, and I got a headache and had some chills. But it only lasted a day, then I was better. I was more tired and sleepy after the second dose, but I kept looking at the big picture. I was willing to have those side effects, rather than becoming infected, or experiencing long-term side effects from COVID infection, or worse, passing away of COVID.
Concern: I have an underlying health condition.
“I was diagnosed with asthma at 25, and I use an inhaler every day,” said Brittani Edwards DeLoach, a program manager in the Department of Medicine. “I have a nebulizer that I can use if things get out of hand. But sometimes, like it did on Christmas Day, it gets so bad that I have to go to the emergency room. “
- Does asthma factor into your decision whether to get vaccinated?Absolutely it does. I have a background in industrial and systems engineering, so I always have a risk analysis going on in the back of my mind. It is phenomenal that this vaccine has been developed so that it can drive down the number of cases we are seeing. But not knowing how my body will respond, how the vaccine might impact me personally, has made me anxious.
- When the vaccine is available, will you take it?Honestly, I have been struggling with this decision. I decided I would talk to my pulmonologist, Dr. Veena Antony, about it, and she was so reassuring. She explained about how the vaccine is 95 percent effective, and how important it is for someone with asthma to protect themselves from getting COVID. She also said that I would be carefully watched after getting the shot, and that they would know what to do if anything happened. Talking with her convinced me this is the right thing for me to do.
Concern: I’m worried about possible side effects.
“I received my first dose while on service at the VA,” said Seema Kumar, M.D., chief resident in the Department of Medicine. “In the 24 hours afterward, I noticed pretty significant fatigue. I was also a little nauseated and achy. But I took some Tylenol, and was able to come in and work a full shift. I was back to normal within 48 hours. A few of my fellow residents felt a little worse than I did. They had similar fatigue and muscle pain, but more intense, and they ran a fever. They missed a day or two from work, but they’re doing just fine now.
- Some people say it’s worse after the second dose. Was that true for you?That’s exactly what the clinical trials showed us — that reactions are more likely after the second shot. But that wasn’t true for me. I got my second dose and have felt fine ever since. Everybody reacts a little bit differently, though; so some people might be fine after the first shot, and feel bad after the second dose.
- Why did you choose to get vaccinated, knowing that you might not feel well afterward?I felt grateful to be able to get the vaccine and do my part to help keep my patients, colleagues, friends and community safe and healthy. I was not concerned at all about the potential mild side effects of the vaccine when I thought about the many lives that have been lost because of this virus. The vaccine represented a ray of light and hope for a brighter path ahead, and it was an easy decision for me to get vaccinated.