Fact Check: Is the COVID-19 Vaccine Safe?
Over the course of 2020, the world’s leading scientists and researchers worked tirelessly to engineer COVID-19 vaccines. In recent weeks, the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization for both the Pfizer and Moderna vaccines — and, soon, AstraZeneca’s candidate might join them. Without a doubt, the rapid development of these vaccines is an unprecedented achievement. But this sense of triumph (and relief) has been marred by the conversation surrounding the vaccines’ safety.
As reported in U.S. News & World Report, a 2020 Gallup survey found that 11% of adults in the U.S. believe vaccines are "more dangerous than the diseases they prevent." While this survey was conducted before the novel coronavirus pandemic made headlines in the U.S., it’s undeniable that the vaccine rollout is happening amid a climate of mistrust and misinformation. Even though the FDA has deemed that both vaccines are "safe and effective," many Americans are still hesitant when it comes to vaccination. With this in mind, we’re taking a look at some of the most common concerns when it comes to the COVID-19 vaccine in our latest Fact Check.
Editor’s Note: Our research pertains to the Pfizer and Moderna COVID-19 vaccines only. We will update this information as others are approved for use.
Are the COVID-19 Vaccines Safe?
Before a vaccine is deemed safe, it goes through what the Centers for Disease Control and Prevention (CDC) calls "rigorous" testing. Initially, safety trials start in the lab, where experts run tests on (and research) cells and animals — and that’s all before human studies are given the greenlight.
Additionally, CDC guidelines require that "vaccines pass through six general stages of development: exploratory, pre-clinical, clinical, regulatory review and approval, manufacturing, and quality control. ...It’s not unusual for a vaccine to take 10 to 15 years to complete all the phases under normal circumstances." Obviously, these are not normal circumstances. Although speeding up the development process was necessary, leading experts, including Dr. Anthony Fauci, stated that attempts to fast-track a vaccine should not supersede the fact that a vaccine must be both safe and effective before distribution.
For example, Pfizer ran its own tests and clinical trials that included more than 44,000 adult participants, while Moderna ran a 30,000-person efficacy trial. After these trials and the FDA’s own analysis, which found "no specific safety concerns," the vaccines were authorized for emergency use. Dr. Fauci has gone on to say that he has "extreme confidence" in the safety of the approved vaccines and even received the Moderna vaccine on camera in late December 2020.
How Do the Vaccines Work?
Although there are quite a few different methods for developing vaccines, both the Pfizer and Moderna variations are made using the same technology — a new technology, in fact, that utilizes mRNA. Think back to high school biology for a moment: You might remember that DNA is the carrier of genetic information and that the similarly named mRNA (or messenger RNA) is essentially a set of instructions that tells the body how to make certain proteins to fight and prevent disease.
Once a recipient receives an mRNA vaccine, it tells their cells to create a viral protein that triggers an immune response. Unlike other vaccines, which use weakened or similar forms of a virus to trigger these responses, there is no live virus involved here, which means the vaccine can’t cause COVID-19 because it simply doesn’t contain the novel coronavirus. Instead, the vaccine teaches our immune systems to recognize and fight the virus to protect us from future exposure.
Does the Vaccine Have Any Side Effects?
No matter the vaccine — and no matter what a vaccine is fighting against — injection is often accompanied by mild side effects, including fatigue, swelling, pain and redness at the injection site, all of which usually clear up within 24 hours. In fact, these types of side effects "show that the vaccine is working, because it stimulates the immune system and the body forms antibodies against the infection that is only ‘feigned’ by the vaccination."
Recently, the Finnish Medicines Agency (FIMEA) found that headaches, mild fever and joint pain can accompany the COVID-19 vaccines; in particular, incidences of fever have been found to be higher after the second dose of the Pfizer vaccine. Additionally, organizations like the CDC and FDA will continue to monitor vaccine safety to catch and address emerging trends in adverse effects. As of now, however, there’s no evidence to indicate that the Pfizer and Moderna vaccines cause any long-term or harmful side effects, and less than 1% of Pfizer vaccine recipients had severe allergic reactions.
Is It Safe for Children, Pregnant People and Immunocompromised People to Receive the Vaccine?
First, it’s important to note that Pfizer’s vaccine has been approved for folks age 16 and up, while Moderna’s has been approved for folks age 18 and up. That means, anyone younger should not seek these vaccinations. According to the pediatric healthcare nonprofit Connecticut Children’s, kids’ immune systems — and immune responses — differ greatly from those in adults. In fact, infants have rather different immune systems and responses than teens.
Needless to say, the vaccines simply haven’t been tested or developed with younger folks in mind. Connecticut Children’s reiterates that "young adults and kids aren’t typically at high risk for severe illness from COVID-19" and, as such, even young adults who are within the vaccines’ age ranges will likely be in the last group to receive the vaccine — unless an individual has a high-risk health condition or is an essential worker. Additionally, we may see a pediatric vaccine toward the end of 2021 at the earliest.
If an individual is pregnant or lactating, the guidance is a little less clear. The CDC notes that pregnant people with COVID-19 have an increased risk of severe illness and, potentially, an increased risk of adverse pregnancy outcomes. With this in mind, getting vaccinated does seem important because pregnant people are particularly vulnerable. However, the CDC also states that "There are currently few data on the safety of COVID-19 vaccines, including mRNA vaccines, in pregnant people."
So, what does that mean? While there were some trials in the animal testing phase that addressed reproductive health concerns such as pregnancy, there simply aren’t enough data from the other test periods. Instead, the CDC recommends individuals consult with their doctors before choosing to get vaccinated to assess their COVID-19 risk factors.
Similarly, although some clinical trials did include folks with stable HIV infection or other immunocompromising conditions, there still isn’t a lot of data, so consulting with a doctor or other healthcare provider is recommended. Finally, the CDC states that "There are no data on the safety of COVID-19 vaccines in lactating people or the effects of mRNA COVID-19 vaccines on the breastfed infant or milk production/excretion." However, there isn’t evidence to suggest that a vaccine would cause harmful effects in lactating individuals.
Should People Who Have Had COVID-19 Still Get Vaccinated?
A resounding "Yes" from the CDC and other healthcare experts on this one. Re-infection is possible, so if the vaccine is offered to you, regardless of whether you’ve already had COVID-19, you should get vaccinated. It’s still unclear how long immunity lasts and, in general, the length of a person’s natural immunity can vary greatly.
Currently, the CDC is providing recommendations to federal, state and local governments as to which groups of people should be vaccinated first. If you’re part of one of those early-stage groups, vaccination is important regardless of your history with COVID-19, and health officials recommend the extra safety precaution. "Both natural immunity and vaccine-induced immunity are important aspects of COVID-19 that experts are trying to learn more about," the CDC has stated. "And [we] will keep the public informed as new evidence becomes available."
Does Getting Vaccinated Mean Life Can Return to “Normal”?
Both the Pfizer and Moderna vaccine formulations are remarkably effective, with a 94-95% efficacy rate. While that doesn’t mean getting a vaccine means you're completely immune to contracting COVID-19, it will help build herd immunity — a state at which enough people are immune to the virus that spreading the pathogen from person to person becomes less common. But it’s essential that, regardless of your vaccination status, you continue to practice social distancing, mask wearing and sheltering in place.
As NPR points out, "studies of the new vaccines only measured whether vaccinated people developed symptoms, not whether they got infected. It's possible that they got light infections — not enough to make them ill, but enough to pass the virus on to others." That is, experts need to learn more about what benefits immunity provides before folks "return to normal." Additionally, the vaccine is being rolled out in stages: If you have the vaccination but come into contact with someone who doesn’t, that could be dangerous for the unvaccinated person.
Another complication? Both vaccines require two rounds of shots — if you’ve only had the first round, you haven’t completed the regimen and, therefore, the vaccine won’t be as effective in protecting you. Finally, although the efficacy rates of both vaccines are impressively high, they aren’t foolproof; with hospitals and other healthcare facilities still overwhelmed with COVID-19 patients, it’s important to continue practicing safe behaviors so more strain isn’t placed on these systems.
Is One Vaccine “Better” Than the Other?
During the initial rollout, which has been criticized for being slow and wasteful, it’s unlikely that individuals who qualify for early immunization will be able to choose between the Pfizer and Moderna variations. Generally, the vaccines are also quite comparable in terms of efficacy. While the Pfizer vaccine is authorized for individuals age 16 and older, Moderna is authorized for individuals age 18 and older; Pfizer boasts a 95% efficacy rate across different racial, ethnic, gender and age groups, whereas Moderna boasts a 94% efficacy rate.
In terms of administering the vaccine, both require two rounds of doses: Pfizer vaccines require a 21-day interval between shots, whereas Moderna’s require a 28-day interval. Although the Pfizer version contains 30 micrograms of the vaccine — compared to Moderna’s 100 micrograms — it is getting slightly better efficacy results, but at a cost.
That is, according to Stat, the Pfizer vaccine must be stored at -94 degrees Fahrenheit and, after thawing, it must be administered within five days. In this regard, Moderna’s variation seems to have a slight edge: It should be shipped at a more manageable -4 degrees Fahrenheit but can be stable at fridge temperature for 30 days. All things considered, the two vaccines are quite comparable, and receiving immunization from either is a great step toward ending the devastation of the COVID-19 pandemic.