By Alex R. Thiersch, JD, CEO, American Med Spa Association (AmSpa); and Katje Lattik, Executive Assistant, AmSpa

Like almost everything else about 2020, the timeline for the development of the COVID-19 vaccines was unprecedented. Robin Patel, MD, director of the Infectious Disease Laboratory at the Mayo Clinic and a recent guest on AmSpa's Medical Spa Insider podcast, has been amazed at the scientific progress achieved in just one year. "I've never seen anything like it, but I think it is the intervention that at this point is going to save us from this virus," she says.

This incredible progress has not come without questions, however, and many are still unclear on how the vaccines work, how effective they are and what they mean for the future of COVID-19. There are many resources available across the wild and unregulated online news sphere, and, unfortunately, with that has come mistrust and misinformation. AmSpa has reviewed these resources to find the expert-proven facts and create a guide with answers to some of the most common questions we'e heard when it comes to COVID-19 and the new vaccines.

Should Everyone Get Vaccinated?

The short answer is yes. As stated by Dr. Patel, "It's a choice between the possibility of getting COVID-19 and getting bad, sick, and maybe dying, depending who you are, or taking a vaccine that's been well studied in clinical trials and looks safe and effective." At the end of the day, there are more risks associated with contracting COVID-19 than there are with the vaccine. Each individual should weigh these risks against each other, not just for themselves, but for anyone to whom they could potentially spread the virus.

But How Can We Know That It's Safe Without Long-term Study?

There is understandable hesitation for some people when it comes to getting the vaccine. Given the rushed timeline of its development, how can we trust its safety? It is important to understand the steps that were taken between creating the vaccine and releasing it to the public, as well as how vaccines work in general.

Many point to the fact that the vaccine is currently being used under an Emergency Use Authorization (EUA) as a reason to distrust its safety. While it is true that an EUA allows a treatment to be used without full FDA approval, there are still strict conditions that need to be met before the EUA is granted. "I can certainly understand that concern, and I've reflected on that as well," says Dr. Patel. "The thing is, any new intervention—be it a vaccine or a drug—has to go through clinical trials, and after it goes through clinical trials, it either gets approved for use or not. Anytime something gets approved and is used for the first time, it's not been used outside of a clinical trial by definition. So, all the data that we have on whatever it is, whether it's a vaccine or a therapeutic, anything really is from those clinical trials. In many ways, this is not unlike any other vaccine or any other drug that we have." Other experts agree that the speed of the vaccine's rollout is not a result of cut corners, but rather of increased efficiency and immense focus on the part of development teams.

What Is an mRNA Vaccine? Is It Risky?

Part of why the Moderna and Pfizer vaccines were able to be developed so quickly is that scientists took advantage of mRNA vaccine technology rather than relying on the slower traditional vaccine processes. Unlike traditional vaccines, mRNA vaccines do not contain a dead or weakened version of the virus, which means they can be developed quickly and in large amounts in the lab, but they require stricter delivery methods (such as isolation in cold temperatures), which has limited their application. Despite this, they have been studied for decades and have even shown promising results in cancer clinical trials. This previous research on mRNA vaccines helps us predict how the COVID-19 vaccine might behave, and because its other ingredients are very typical for vaccines, there is a wealth of data on how they impact the human body as well.

Are You Sure It's Safe for Me to Get the Vaccine?

So far, the only groups that the U.S. Centers for Disease Control and Prevention (CDC) recommends do not get the vaccine are children under 16, those allergic to polyethylene glycol (PEG) and those who are allergic to other vaccines. At last update, out of 2 million vaccinations administered, only 21 have reportedly resulted in anaphylactic shock, and, in each case, there was a full recovery. Essentially, if you have never had an issue with any other vaccine, there is little evidence to suggest that you'll have a significant issue with any of the available COVID-19 vaccines. "Many people have absolutely no effect from the vaccine, or there's some local pain or just feeling unwell for a day or so," says Dr. Patel. "Some maybe have swelling or more localized side effects, but they go away and they're predictable. I wish there [were] absolutely zero side effects of a vaccine, but it is revving up your immune system, so it's not surprising that some people do experience mild side effects, and I think it's completely worth it."

But what about if you belong to another vulnerable group? Here is a breakdown of what we know so far about the interactions between the vaccine and other health issues:

• What if I'm pregnant or planning on becoming pregnant? Much like the flu vaccine, it is highly recommended that pregnant or soon-to-be-pregnant women receive the COVID vaccine, due to the high risk the virus poses. No evidence suggests that the vaccine impacts fertility or the health of the expected child.
• What if I have other serious allergies? Those with allergies to non-vaccine ingredients—even potentially severe ones, such as latex, penicillin, bee venom, peanuts, etc.—should still receive the vaccine. There is no reason to believe that the shot will put them at risk for anaphylactic shock. Unlike some traditional vaccines, the mRNA COVID-19 vaccines (Moderna and Pfizer) do not use egg protein, which means they are more accessible to people with allergies than the flu vaccine.
• What if I'e already had COVID-19? You should still get the vaccine, even if you have already tested positive for COVID-19 in the past. Experts still aren't sure if you are protected from re-contracting the virus after you'e created antibodies, or if there is a time limit to the effectiveness to these antibodies.
• What if I'e had dermal fillers? Earlier this year, there were several cases of facial swelling reported by recipients of the Moderna Vaccine who also had dermal fillers. Each of these cases was fully resolved, and it was determined that this was a rare and non-serious reaction to the vaccine. Furthermore, evidence shows this swelling can result from the COVID-19 virus itself, meaning it's not a risk that can necessarily be avoided by refusing the vaccine.

What Do the Effectiveness Rates Even Mean?

Vaccine efficacy is calculated by the vaccine companies using data from their clinical trial. Researchers look at the total number of people in the trial who contracted COVID-19 and then compare how many of these people were in the placebo group vs. the vaccinated group. For example, roughly 95% of the people who got sick in Moderna's clinical trial were unvaccinated, while only 5% of those who got sick had received the vaccine. The lower efficacy rate of the Johnson & Johnson vaccine does not necessarily mean it is less likely to protect you from COVID-19; it means that the difference between the number of people in the placebo group and vaccine group who got sick is lower than the difference between these two groups in Moderna and Pfizer's clinical trials.

While the efficacy rates for each vaccine are very promising, the data is still evolving, meaning we could see these numbers change over time. As such, we will have to wait and see whether the COVID-19 vaccines will be as effective as polio vaccines, which are more than 99% effective at preventing polio infection, or are more like annual flu shots, which range from 40 to 60% effective. At this point in time, experts like Dr. Patel recommend people get whichever vaccine they can. Unfortunately, the limited availability of doses means not having the luxury of being able to choose between them.

Why Has There Been a Drop in the Death Rate?

It is difficult to point to any one reason for the recent drop of COVID-19 deaths in the U.S. Expanded access to vaccinations is, of course, one factor that may be contributing to this drop, but some experts maintain that social behaviors are more likely to be the cause. Interestingly, a third possibility is that there may be a seasonality to the spread of COVID-19. Dr. Patel believes, "There could be seasonality effects, even though we don't believe that it's a fully seasonal virus. There may be some effect of, say humidity, for example. There's so much we don't understand about infectious diseases and why they happen when they do." This view is supported by other researchers, such as those at the University of Washington's Institute for Health Metrics and Evaluation, whose data suggests that the virus spreads more easily in cold weather. Regardless of the reason for the drop, experts agree that we are not out of the woods yet—not even with the ever-growing vaccine options.

Should I Get One Dose or Two?

Even for those lucky enough to secure an appointment for the Moderna or Pfizer vaccine, getting the required follow-up dose is not guaranteed. The obstacles some have faced in trying to receive the "booster" have started a debate about the best method for fighting COVID-19. Is it better to fully inoculate those who have received a first dose, or is it better to ensure that more people have at least one dose before offering boosters? It is a question without an obvious answer. The United Kingdom has decided to focus on getting more people just one dose, with seemingly good results. Health experts in the U.S. argue the possibility that missing the booster will create more opportunity for mutations in the virus. Dr. Patel's advice, for now, regardless of what health officials decide in the future, is to "take the vaccine the way that it is offered to you, because that's what's been studied."

What Is the Protocol Following the First of Two Doses?

Following your first dose of the Moderna or Pfizer vaccine, you should continue to behave as you did before vaccination and follow social guidelines. While some studies show just one dose to be 92% effective, protection is not guaranteed. You should wait approximately 21 days to get your booster for the Pfizer vaccine and one month for the Moderna vaccine, although two days earlier or later than those dates is also acceptable.

Does the Vaccine Prevent You from Transmitting Infection, or Only from Getting Infected Yourself?

This still has not been proven definitively. It is still possible, but much less likely, for a person to contract COVID-19 after receiving the vaccine, which means you could still be contagious. Until a significant portion of the U.S. population is vaccinated, triggering "herd immunity," social distancing guidelines are still indispensable.

How Long Is the Vaccine Effective?

Unfortunately, it is still too soon to tell. Data that has been collected since vaccines were first administered suggests it is effective for at least four months.

What About Variations?

Some of the most worrying news surrounding COVID-19 has been the emergence of variants in different parts of the globe. Of particular concern to Americans is the newly discovered variant in California known as B.1.427. But how worried should we really be about these new mutations? Dr. Patel and others preach against panic. Mutations are natural occurrences in any RNA virus, and there is evidence that the mRNA vaccines we have already developed will work to protect against most variants. It is worth noting that the more COVID-19 circulates through a population, the greater the chance that it will mutate. That means that right now, our best tool for fighting variants is to stop any spread of the virus, whether that be through vaccination or social distancing.

Listen to Dr. Patel's episode of Medical Spa Insider below.