My family won't get the vaccine because they say it hasn't been "FDA approved"

This week in Pandemic Problems, readers write in regarding families divided on vaccination opinions

By Nicole Karlis

Senior Writer

Published May 13, 2021 7:00AM (EDT)

Two fists with man's and woman's face are collide with each other on coronavirus background (Getty Images)
Two fists with man's and woman's face are collide with each other on coronavirus background (Getty Images)

Dear Pandemic Problems,

There's a growing rift between me and my son-in-law, who says the COVID-19 vaccines are not safe because they have not been "FDA approved." What makes our rift even more difficult? His wife and grown kids with families themselves will also not get the vaccine because of this FDA approval issue. What do I do?


Ruffled by Rifts

Ruffled by Rifts, it does appear that rifts are all around you — or at the very least, you are in the minority of being willing to get vaccinated in your family. I know it's frustrating, and rest assured that you are not alone. I've answered many questions now from people who find themselves in similar predicaments. Plus, it doesn't help that families being divided on whether or not to get vaccinated is adding fuel to perhaps decades of family drama, and at the very least four years of the Trump era tearing families apart.

I have no idea if your family members are staunch anti-vaxxers, or to what extent political allegiances play a role here. But I do know that undermining their concerns won't help if there is any hope of them getting vaccinated. The best approach is to listen to their concerns, and have empathy, which it sounds like you've done a little bit of already.

So, you say that your son-in-law is saying the COVID-19 vaccines are not "safe" because they have not been approved by the United States Food and Drug Administration (FDA). While partly true, this is a classic example of how misinformation spreads. Technically, the COVID-19 vaccines haven't been "approved" by the FDA. However, all three vaccines available in the U.S. have been granted an emergency use authorization, also known as an EUA.

EUAs, by the way, aren't limited to vaccines — they sometimes are issued for medical devices, in vitro diagnostics, and some therapeutics. When it comes to passing an EUA, there are specific conditions that must be considered; they are likely to be granted in situations when "there are no adequate, approved, and available alternatives."

That is certainly that case with COVID-19. The FDA usually takes years to formally approve a vaccine, but in the coronavirus pandemic, the priority was to get a safe vaccine in as many peoples' arms as quickly as possible — hence the emergency use authorization.

But just because there's a bureaucratic difference between an EUA and approval doesn't mean that there isn't a rigor to attaining an EUA. Specific criteria must be met. For example, clinical trials must be done on tens of thousands of study participants to generate at least two months of sufficient scientific data needed for the FDA to determine a vaccine's safety and efficacy. You can read more about this process here.

In order to apply for full FDA approval, a company needs to show at least six months of data. Since Pfizer now has that, recently submitted an application for full approval. The FDA is expected to take at least a few weeks to review it, according to NBC News.

Now, what do you do? Well, I suggest expressing your concerns about their health and safety, and what the consequences are of not getting vaccinated. You could also note that attaining an emergency use authorization is a very rigorous process. And ask: Once the FDA formally approves the Pfizer vaccine, will you get it? While it's not ideal for your family members to wait, it's better than a straight-out refusal of getting vaccinated. Hopefully if they have more understanding into the EUA process, and perhaps speak with their doctors, they can be persuaded to be vaccinated.


Pandemic Problems


Dear Pandemic Problems,

My husband is refusing to get the Covid vaccine. I will be fully vaccinated by the end of the week. Am I wrong to not want to be intimate with him for fear he could infect me?


Hesitant about Intimacy

Dear Hesitant about Intimacy,

Congratulations on being fully vaccinated so soon. As someone who recently joined the fully-vaccinated club, I feel so grateful not having to worry (as much) about getting the coronavirus, potentially dying from it or spreading it to people. It seriously feels so good, and I'm excited for you to feel so good, too.

And yet, you are at a crossroads with your husband not getting vaccinated. I'm curious, why is he refusing the vaccine? The first step to understanding someone's hesitancy is to better understand why they don't want to be vaccinated. It could be due to misinformation they've consumed, a previous trauma or experience.

You ask: "Am I wrong to not want to be intimate with him for fear he could infect me?"

Unfortunately, I cannot answer this question for you. The CDC has not issued guidance on sex between vaccinated and unvaccinated people, and what the risk is. (Hopefully they will soon.) The CDC states that vaccinated people can still possibly get infected and spread the virus to others, but there is still much to be learned from this situation. I'm definitely not a marriage therapist, but here's what I would tell my best friend: do not anything you're uncomfortable with, as that won't be good for your marriage.

I hope you and your spouse can talk about the implications of him not getting vaccinated, and how that might impact the future of your marriage. My hope is that he will listen, and carefully consider your concerns. If not, there's always couple's therapy. If you can't afford to pay out of pocket, check with your insurance or look for free or low-cost counseling options.


Pandemic Problems

"Pandemic Problems" is an advice column that answers readers' pandemic questions — often with help from public health data, philosophy professors and therapists — who weigh in on how to "do the right thing."  Do you have a pandemic problem? Email Nicole Karlis at Peace of mind and collective commiseration awaits.

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By Nicole Karlis

Nicole Karlis is a senior writer at Salon, specializing in health and science. Tweet her @nicolekarlis.

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