In the midst of this COVID-19 pandemic, a vaccine has come. It’s been out on the market since December 2020 and millions of Americans have received at least one dose (Johnson & Johnson’s Jansen) while others have received at least 2 doses (Pfizer and Moderna patients). There are millions who, even after seeing millions received their doses with no major side effects or health problems, still refuse to take the vaccine.
While a few reasons abound, there is one that stands above them all currently: that is, the COVID-19 vaccines only have Emergency Use Authorization (or EUA), not full official FDA approval. There’s a difference between EUA and full FDA approval, and that difference stands in the way of many who, other reasons aside, would get vaccinated.
Two weeks ago, on ABC News’s “This Week” with George Stephanopoulos, leading infections specialist Dr. Anthony Fauci took to the broadcast to tell all Americans that his response to vaccine hesitancy is the following:
“You know, I think the Governor [of Arkansas, Asa Hutchinson], does have a point there…there are certainly some people who, when you use the terminology “emergency use authorization,” they kinda think it’s tenuous data showing that it works so that it’s safe. That’s not the case. In some emergency use authorization for other products, the data just barely gets to show you that the benefit is definitely worth any risk. When you’re dealing with the data that we have now, you’re talking about hundreds of millions of people who’ve been vaccinated and in every country you go to, you see that the effectiveness and the safety of the vaccines are very high. So, although it’s understandable, quite understandable, that some people might say, ‘Well, we wanna wait for the full approval,’ that’s really only a technical issue. It’s the FDA dotting the i’s and crossing the t’s. But there’s no doubt in my mind that these vaccines are going to get full approval because of the extraordinary amount of positive data.”
There are problems with this statement.
emergency use authorization for the covid-19 vaccine should demonstrate its safety
The COVID-19 vaccine is just that, a vaccine. Vaccines contain medicine and, as we all know, medicines bring side effects. This is true for all pill, tablet, and powder medications on the market. It’s also true for the COVID-19 vaccines and all vaccines in general. When you’re putting medicine in your body, the last thing you want to do is question whether or not it’s safe and effective. Dr. Fauci compares Emergency Use Authorization for the COVID-19 vaccine to other EUAs for other products, but it’s not necessarily the same. Some EUA products are applied to the skin while others are ingested. Vaccines aren’t ingested like pills and tablets, but their entrance into a vein and thus, the blood stream, merit that they are thoroughly tested.
EUA data for the COVID-19 vaccine should show its safety. And if the data says it isn’t safe, then it shouldn’t receive full FDA approval. The reason why foods and medicines are recalled on the market is that there are times when they prove to be harmful for ingestion and use. You don’t want to eat food rushed through the FDA process that you later find out has poison in it, do you? Well then, the same goes for the COVID-19 vaccine. I’m not suggesting here that the vaccine is poison, nor am I suggesting that vaccines are poisonous. What I am saying is that, if you want your food tested before being released on the market, why wouldn’t you want your vaccine even more thoroughly tested?
Full FDA Approval is more than just a “Technical Issue”
I understand Dr. Fauci’s desire to assuage the fears of vaccine-hesitant individuals. But at the same time, by trying to assuage their fears, Dr. Fauci is downplaying the role of the FDA and its protocols for product approval in the process. Contrary to Dr. Fauci, I do not believe that full FDA approval of the COVID-19 vaccines is just a “technical issue.” It’s more than that.
The whole point of having a full FDA approval process is to ensure that Americans are safe using the products and medicines. The full approval can take as long as 3-5 years. In that time, tests are being conducted and clinical trials are being held. Volunteers who seek to participate in groundbreaking research are paid for their time and risk to themselves and their health for taking an experimental drug. As tests are conducted, clinical trials bring out the bad about the product, the need for warning labels about side effects.
The whole point of testing the product is to see the good and bad and to know what to expect when it is released to consumers. No one wants the FDA to rush a product (or in this case, a COVID-19 vaccine) out to market that isn’t up to par, that doesn’t provide any real protection against this lethal virus. So with that said, there’s a time and process in place to ensure that it is safe for Americans.
When Dr. Fauci downplays the process because it’s just a “technical issue,” it makes Americans question the concept of the procedure itself. Why have Emergency Use Authorization or “Full FDA approval” if both are just mere technicalities? Why even have a process in place at all if it’s nothing more than mere formality? Dr. Fauci knows that the vaccines aren’t being tested for testing’s sake. They are being tested because the best scientific minds aren’t aware of all the side effects and possible risks of these vaccines. If the medical and scientific experts knew all there was to know about them in December when Pfizer released its vaccine, there’d have been no need for scientific data.
What “positive data”? American citizens and the EUA experimental data
For those who may not know it, Dr. Fauci gives something in his statement to Stephanopoulos that’s worth listening to. What it is? The positive data from the Emergency Use Authorization process.
He’s very confident that the Pfizer and Moderna vaccines will receive full FDA approval (remember, it’s just a “technical issue”) because of one reason: positive data gathered so far. Where does this data come from? all Americans so far who have received at least one dose of the COVID-19 vaccine. If you’ve received at least one dose, congratulations: you have been part of the COVID-19 vaccine experiment.
You are the experiment. Your willingness to undergo the vaccines to protect yourself against the pandemic have provided the data for Pfizer and Moderna and the Federal Government to ensure that these vaccines are safe and effective. But your participation in this brings out a few things you may not think about.
First, you were told these vaccines were safe and effective and may have decided to get your two doses (or one, for J&J patients). And yet, if they were safe from the start, why have Fauci, Pfizer, and Moderna been collecting data on American patients who undergo them? You don’t determine the safety of a vaccine before you get the data. You don’t tell people the vaccine is safe before you receive the data. You wait until the data is received to make that determination. So back in January when it was said the vaccines were safe and effective (after they’d been out for a few weeks), you decided to get yours. Except, there’s no way the safety and effectiveness could have been known back in January.
Next, look at what the Emergency Use Authorization data-gathering has uncovered: side effects of blood clots, strokes, liver malfunction. It’s been said that taking certain immune-suppressing drugs can undo the effects of the vaccines. We’ve seen that those with compromised immune systems may need to take a third dose (before the upcoming booster shot, that is) in order to produce antibodies because the first two doses didn’t produce any for them. We’ve also seen that Johnson & Johnson’s Jansen vaccine isn’t the only one that has serious side effects.
Just recently, the FDA has placed a warning label on Pfizer and Moderna’s COVID-19 vaccines because they’ve been found to produce myocarditis and pericarditis (heart inflammation) in young teenage males ages 16 and 17. The myocarditis find is new. We didn’t know this side effect of the vaccines back in January. We’ve also learned the hard truth that these COVID-19 vaccines do not prevent vaccinated individuals from being infected with COVID-19. Some fully vaccinated individuals still get COVID, still show symptoms, and still spread it to others. In one of the latest cases, seven fully vaccinated Stanford University students have come down with COVID-19, and all seven are displaying symptoms.
These few examples show that the past 6 months of study and testing on the COVID-19 vaccines have not been in vain: rather, they’ve helped highlight how important the testing process is. Who knows what the next 6 months will uncover before they could receive full FDA approval.
Summing it all up
Dr. Fauci has a job to do. His job is to encourage everyone to get vaccinated because it is believed that vaccinations are the only way to end the current COVID-19 pandemic and get everyone back to normal.
And yet, at the end of the day, it doesn’t make sense to downplay the full FDA approval and rigorous testing process in order to encourage Americans to undergo what is essentially tantamount to an experimental drug. True, we’re in a pandemic. True, this virus is lethal and killing Americans every day. Something must be done to try to put an end to this disaster on American lives (and that of world citizens).
And yet, in our haste to “do something,” we must always remember that nothing is done well unless it is done right.
Nothing is done well unless it is done right.
What this means is that, as my mother always said, two wrongs don’t make a right. To be sure, this pandemic is wrong, wrong, wrong. It’s evil.
But we don’t commit evil by bypassing rigorous testing protocols in order to end another evil (that is, the pandemic). Two evils don’t bring about good but rather, more evil.
With that being said, there’s a set of procedures in place designed to protect life. After all, without human lives, America would be an empty place to live.
Dr. Fauci, to you I say this: respect the procedures that are in place for full FDA approval. And also, please respect the views of Americans who choose to wait until these vaccines are fully-approved products, not experimental ones with “FDA-approving, Emergency Use Authorization-gathering data.”
And by waiting and allowing these vaccines to undergo the rigorous procedures in place, these COVID-19 vaccines, and American citizens, will come out all the better for it.