3 Essential Facts About COVID-19 Vaccine Safety
Yes, the new COVID-19 vaccines were developed at record speed. But that doesn’t mean the process was rushed—or that any corners were cut. Here’s a look at the science—and safety—behind these innovative immunizations
In 1956, Elvis Presley had an interesting opening act on The Ed Sullivan Show: He received the new polio vaccine live on air. The goal? To help dispel safety concerns raised by media personality Walter Winchell. On Dec. 16, 2020, Joe Park, M.D., a New York City anesthesiologist and heartthrob from the latest season of The Bachelorette, did something similar. He documented himself on Instagram getting the Pfizer/BioNTech coronavirus vaccine.
In the following days, Dr. Park returned to Instagram to report his only side effect—a sore arm—along with a quip: “Just so we’re clear, I’ve not grown a tail.” A few days later, after running four miles in 20-degree weather, he announced that he felt “perfect.”
Dr. Park’s easy-breezy experience is no surprise to Robert Hopkins, M.D., an internist with University of Arkansas for Medical Sciences, who also felt completely fine after getting his Pfizer/BioNTech shot. “I am looking forward to the time when I can get my family members and patients vaccinated,” says Dr. Hopkins, who is also chair of the National Vaccine Advisory Committee of the U.S. Department of Health & Human Services.
That said, it’s normal for the general public to have questions about the new Pfizer/BioNTech and Moderna COVID-19 shots. These vaccines are the first of their kind, and wanting to be informed before you roll up your sleeve means you’re being proactive about your health. Below, we’ve addressed some of the most common concerns with evidence-based answers that will help put your fears to rest.
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The Concern: The Process Was Too Fast
The Facts: Unprecedented Support Fueled Vaccine Development
In mid-December, the U.S. Food and Drug Administration (FDA) issued emergency use authorization (EUA) for the Pfizer/BioNTech and Moderna vaccines. The single-dose Johnson & Johnson’s vaccine recently received EUA. The phrase “emergency use authorization” makes some people nervous—it sounds like things could have been rushed or that the shots weren’t fully tested.
In reality, medical products are considered for EUA when there is a public health emergency (like a pandemic) and there are no “standard approval” options available that will allow a product to reach the public as quickly as it is needed. But the FDA did its due diligence: The organization published the specific criteria it would use to authorize vaccines in this emergency and carefully evaluated research on tens of thousands of people to determine the vaccines’ safety and efficacy. “The phase 3 trials are large, which helps us have confidence in the vaccines’ safety,” says Dr. Hopkins. “We are introducing these vaccines on a shorter time frame because of the terrible impact of COVID on society.”
And that shorter time frame was possible for several reasons—none of which involved skipping any steps in the process:
- Previous scientific advancements. “Lessons learned over the past 20 years in efforts to develop vaccines for other coronavirus diseases, such as MERS and SARS, have contributed to the speed of this effort,” says Dr. Hopkins. In addition, scientists were able to apply findings from other fields, like cancer research and structural biology, to propel vaccine development.
- A huge financial investment. Money has come from all corners to create effective and safe vaccines. Researchers and leaders from academia, private industry, nongovernmental organizations (NGOs), and the U.S. government have all worked together toward this common goal.
- A new parallel approach to phased trials. Typically, vaccines are developed according to a linear timeline, says Dr. Hopkins. Due to the added urgency and extra funding, the coronavirus vaccine projects were able to tackle several steps at the same time, rather than waiting for one phase to be completed before moving on.
“The risk of allowing the pandemic to continue far outweighs the potential benefits of waiting six months (or longer) for more data,” adds Dr. Hopkins.
The Concern: The Shot Could Make You Sick
The Facts: Serious Reactions Are Rare
Stories of severe adverse reactions have made headlines in recent weeks. That’s because they earn lots of clicks, not because they’re common. In a report released on Jan. 6, only 21 cases of a severe allergic reaction called anaphylaxis had occurred among the nearly 1.9 million administered doses of the Pfizer/BioNTech vaccine (that translates to 0.0011%), and no one died. And 71% of the allergic reactions occurred within 15 minutes of receiving the vaccine. That’s why COVID-19 vaccine recipients are required to stay for observation for at least that long after getting their shot—or for 30 minutes if they have had an allergic reaction to other vaccines or injectable medicines in the past. (There isn’t comparable date on adverse reactions for the Johnson & Johnson vaccine yet because not enough people have received it yet. However, a New England Journal of Medicine report on the subject suggests most negative reactions to the Johnson & Johnson vaccine were mild and lasted less than a day.)
What’s more, most people receiving either the Pfizer/BioNTech or Moderna shot reported only mild, short-term effects like pain at the injection site, fever, or fatigue.
The Centers for Disease Control and Prevention is recommending that almost everyone get the vaccine when they’re eligible—especially people with underlying health conditions like diabetes or high blood pressure, since the risk of them becoming very sick if they get COVID-19 is much greater.
That said, there are a few groups of people who should hold off: children and anyone with a known allergy to an ingredient in the shot. Trials on kids ages 12 to 17 are underway, but this age group wasn’t included in the first round of phase 3 studies. (Get all the specifics on who’s eligible for the vaccine and why here.)
The Concern: The Studies Didn’t Include Different Populations
The Facts: Vaccine Trial Participants Were Racially Diverse
In a survey last fall, the Kaiser Family Foundation found that only 50% of Black adults would “definitely” or “probably” get a COVID-19 vaccination, even if it were deemed safe, while about 60% of Hispanics and 65% of whites were on board.
“There have been many injustices in health care in our past, and unfortunately, people of color have suffered more than their white neighbors,” says Dr. Hopkins. This pandemic was no different: It has disproportionately caused serious illness and death among Black Americans, which is why it’s all the more important for them to get vaccinated as soon as possible.
As for safety, the breakdown of races and ethnicities in the clinical trials was designed to mimic that of the U.S. population. These trials showed that the vaccine is as safe and effective for people of color as it is for white populations.
Many Black adults are sharing their experiences of getting the vaccine in hopes of breaking down this barrier. This includes civil rights leader Xernona Clayton and CNN correspondent Stephanie Elam, who reported on and wrote about being part of a phase 3 vaccine trial. “I believe in science, and I hope my decision to join a trial and my transparency about the process will help more people trust today’s medicine,” Elam wrote in her CNN article.
The information in this story is accurate as of press time and posting. To limit the spread of the coronavirus, it’s important to continue practicing social distancing (keeping at least 6 feet away from people outside your household) and washing your hands frequently. You should also be appropriately masked per CDC guidelines. Because the situation surrounding COVID-19 continues to evolve, we encourage readers to follow the news and recommendations for their own communities by using the resources from the CDC, WHO, and their local public health department.