The US officially has two COVID-19 vaccines approved for emergency use by the US Food and Drug Administration: Pfizer's vaccine, which was approved for use in people as young as 16, and Moderna's vaccine, approved for those ages 18 and up. For right now, both vaccines are mainly being administered to those in the Centers for Disease Control and Prevention''s first-round priority group, which includes health care workers and those who work and reside in long-term care facilities.
It's a monumental accomplishment for science, having not one but two vaccines go through the vaccine development and approval process in less than a year, in order to fight the COVID-19 pandemic. But while many have widely praised the vaccines and the scientists behind them for their rigorous testing through vaccine trials, some still have questions about vaccine safety in specific groups. Here's what you need to know.
How do we know a vaccine is safe?
First and foremost: The CDC maintains that the US has a vaccine safety system that ensures all vaccines are as safe as possible. It's why the FDA was able to grant emergency use authorizations (EUAs) for both the Pfizer and Moderna COVID-19 vaccines after data from manufacturers and large clinical trials demonstrated that the potential benefits of the vaccines outweighed the known and potential harms of coming down with COVID-19.
When it comes to the safety testing in vaccine clinical trials—aka, determining whether the vaccine is safe to use in those participating in the trials, versus whether or not its effective—researchers track vaccine participants' health throughout the trial, Megan Ranney, MD, MPH, an emergency physician and director fo the Brown-Lifespan Center for Digital Health at Brown University, tells Health. Any time they get sick, hospitalized, or even die, experts investigate whether it had any possible ties to the vaccine. Trials like the ones for the Pfizer and Moderna COVID-19 vaccines also have independent monitoring boards made up of people who have no ties to the studies. "Their only job is to make sure that the drug is safe," she says.
It's also important to note that "safe" doesn't mean "zero side effects." Rather, Dr. Ranney explains, a vaccine is considered safe when it doesn't cause serious adverse events. "An 'unsafe' vaccine is one that causes permanent or serious harm—things that change the course of a person's life," Dr. Ranney says. Those things can include changing fertility, causing neurological problems, or causing ew infections. So, regarding the mild side effects that can accompany the coronavirus vaccine—fatigue, headaches, arm pain—they're a small price to pay to potentially avoid COVID-19's more serious symptoms and risks, and therefore don't worry doctors, Dr. Ranney says.
Further, it's possible that mRNA vaccines could be even safer than traditional vaccines. They don't contain common allergens, like eggs or metals, which may open them up to even more people who have had to forgo vaccination in the past. (The Pfizer vaccine does, however, contain polyethylene glycol (PEG), an inactive ingredient found in several foods and over-the-counter medications that can sometimes, rarely, cause allergic reactions, according to ABC News.)
So who has the vaccine been approved for—and which groups still need more info?
According to Pfizer's data specifically, the vaccine was approved for emergency use after it was deemed consistently effective across age, gender, race and ethnicity demographics for those ages 16 and older. Similarly, data from Moderna showed that that vaccine was also effective in a diverse pool of people 18 and over—about 37% of participants were from racial or ethnic minorities—per the National Institutes of Health.
But those demographics are very broad, and the clinical trials for both vaccines excluded a number of specific groups, including pregnant or breastfeeding women and children—though that's not necessarily an uncommon practice. "Pregnant women and children are considered vulnerable populations. You have to have pretty good proof that something works before you're allowed to do trials of new drugs with them," Dr. Ranney says.
But evidence of the vaccine's safety is stronger now, and trials are beginning, if they havent already. "There are going to be further trials of kids," Dr. Ranney says. Moderna will begin testing its vaccine in 3,000 children ages 12 through 17, according to The New York Times, with half getting the vaccine and half getting a placebo. Pfizer is already working on it: Children as young as 12 started getting the vaccine in trials back in October. Testing on younger children is expected to begin in early 2021, though it's unclear if vaccines will be widely available to children before the fall semester, according to the Associated Press.
And even though pregnant and breastfeeding women weren't specifically recruited to participate in clinical trials, it doesn't mean they were entirely absent from them. "Generally, vaccines are not intentionally tested in pregnant women and that data usually is accumulated over time as pregnant women get vaccinated accidentally or they choose to get vaccinated," Otto Yang, M.D., professor of medicine in the division of infectious disease at the David Geffen School of Medicine at UCLA, tells Health. The American College of Obstetricians and Gynecologists (ACOG) quickly supported the idea that both breastfeeding and pregnant women should have the choice to get the vaccine once it would otherwise become available to them.
Another population group that the vaccines weren't specifically tested on were immunocompromised people or those who are on immunosuppressants—but that's due to concern about efficiently testing the vaccine rather than concern about safety, Dr. Ranney says. "You worry that they're not able to mount as good of an immune response, so testing the vaccine in them is going to show less effect of the vaccine than you would expect," she explains. However, some immune-compromised groups were included—Pfizer included 120 people with HIV in their trial; Moderna included 176 people with HIV, according to POZ. No safety concerns from that those groups were reported. Ultimately, it's up to those who are somehow immunocompromised and their doctors if they want the vaccine.
People with a history of severe allergic reactions, however—while previously included in clinical trials—are being urged to use caution if and when they get the vaccine. According to the CDC, those who have had severe allergic reactions to any ingredients in either COVID-19 vaccine are urged not to get the vaccine—and they're the only group of people for which the CDC has issued this recommendation. Others who have had severe allergic reactions of any kind in the past, not related to vaccines in general, are urged to still get the vaccine, but with the proper safeguards in place (on-site monitoring by a medical professional who has access to emergency medications like epinephrine or antihistamines). These recommendations come after a handful of allergic reactions have been reported as the vaccine rolled out in the UK and US, and experts are trying to determine what caused them. Patients were treated and are all doing fine. "Right now there is no reason to avoid getting the vaccine just because you have a history of allergies," Dr. Ranney says, though it's worth bringing up previous reactions to vaccines to your doctor.
Overall right now, Dr. Ranney says that there's no reason to believe that either COVID-19 vaccine would be unsafe—as in, cause severe harm—for the large majority of people, including any groups who were left out of clinical trials. Rather, researchers and scientists haven't collected enough data yet to be able to issue a sweeping statement one way or another. If you have any questions about if or when you should get the COVID-19 vaccine, it's best to speak to your doctor and bring up any possible concerns.
The information in this story is accurate as of press time. However, as the situation surrounding COVID-19 continues to evolve, it's possible that some data have changed since publication. While Health is trying to keep our stories as up-to-date as possible, we also encourage readers to stay informed on news and recommendations for their own communities by using the CDC, WHO, and their local public health department as resources.
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