Because of recent emergency use authorizations (EUA) from the FDA, there is trepidation that they will approve a coronavirus vaccine EUA to make a big splash for a desperate Donald Trump. This is unsettling to those of us who are “pro-vaccine,” because it could cause hesitancy towards this vaccine, and frankly, all vaccines, to skyrocket.
Democrats in Congress are trying to make sure that a coronavirus vaccine EUA does not endanger the health of the country or cause Americans to become even more vaccine-hesitant. So, this article will examine what is and is not a part of an emergency use authorization. And what this all means for a potential coronavirus vaccine EUA.
What is the EUA?
The Emergency Use Authorization (EUA) is an authority granted to the US Food and Drug Administration (FDA), under various acts of Congress, specifically the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), in response to an emergency. This type of EUA is specific to the USA, but other parts of the world, including Europe, have similar regulations administered by their drug regulatory bodies.
Because there is a lot of misinformation, pushed by the anti-vaccine zealots usually, I want to be clear what the EUA is and is not.
- It does not constitute a full statutory “approval” of the drug.
- It does not mean that the drug has undergone substantial randomized, double-blinded clinical trials.
- It also does not mean that there haven’t been any clinical studies of the drug, it’s just that the full breadth of the clinical research has not been completed.
- It does not mean that the drug has “permanent approval.”
- It does mean that the FDA is authorized to facilitate the availability of an unapproved drug (or medical device) during a declared state of emergency from one of several Federal agencies including a declaration from the United States President. Of course, the COVID-19 pandemic is one of the emergencies.
- It can mean that the FDA is using the EUA to add indications to a previously approved drug or device.
A drug can be considered for an EUA after it meets a finding that it is “reasonable to believe” that the drug or device “may be effective” to prevent, diagnose or treat serious or life-threatening diseases that are part of a declared emergency. The “may be effective” standard is lower than the standard of effectiveness usually required of all drugs and devices.
The FDA has approved EUAs in the past, including approval of diagnostic tools for the swine flu pandemic of 2009, and approval of a diagnostic test for the Middle East Respiratory Syndrome Coronavirus (MERS-CoV) which is related to SARS-CoV-2, the virus responsible for the current pandemic.
Emergency use authorizations are not employed to speed up the approval of any drug, including every vaccine on the market as of today. Despite some of the memes and tropes pushed by anti-vaxxers, the FDA has never approved EUAs for any vaccine in the past – all of the vaccines on the market underwent robust clinical trials that took years to complete and were all published in peer-reviewed journals.
Through 2020, every vaccine on the market is very safe and very effective. This is settled science.
There have been several EUAs that the FDA has approved in response to the 2020 COVID-19 pandemic. Some have been good, some not so much.
For example, the FDA issued an EUA for remdesivir, a drug that has some potential for treating some cases of COVID-19, but there is not much evidence that it is a “cure” for the disease. However, remdesivir seems to show enough benefits compared to risks during early clinical research that the EUA was probably justified.
The problem with EUAs during this pandemic is that the ineffective response to it by Donald Trump and his pals has been so bad that he is always looking for the magic bullet to claim “victory” over this disease.
Seemingly under pressure from Trump, the FDA issued an EUA for hydroxychloroquine as a treatment of COVID-19. Because of the lack of evidence for its effectiveness as a treatment along with significant side effects, Trump, the FDA, and various quacks were ridiculed for this decision. Eventually, the FDA revoked that EUA.
Like the hydroxychloroquine debacle, a lot of scientists and physicians are troubled by this decision. Dr. Eric Topol, MD, a medical researcher posted a series of Tweets about the therapy, pointing out that it’s not
The Atlantic, in a blistering review of this EUA, wrote:
The limited evidence available suggests that infusing patients with the antibody-rich plasma of survivors is, at best, incrementally effective. One study found that patients who received plasma within three days of a COVID-19 diagnosis had marginally better outcomes than those who received it later. There is no randomized, controlled trial yet comparing patients who were given plasma with those who were not.
The FDA commissioner, Stephen Hahn, boasted that plasma could save 35 out of 100 treated COVID-19 patients – it was a claim so grossly misleading that Hahn ended up recanting it:
I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.
— Dr. Stephen M. Hahn (@SteveFDA) August 25, 2020
It appears that, at best, convalescent plasma therapy may reduce mortality risks by around 3%. Except, we don’t have any robust clinical trial data to support that claim. And because of this EUA, it’s difficult to actually perform randomized, placebo-controlled, double-blind clinical trials since few patients will agree to be in a trial where there’s a 50% chance of getting the placebo.
Bad move, FDA.
What’s also tragic is that it appears that Trump just pressured the FDA to do this by claiming that the “deep state” is controlling the FDA, keeping coronavirus treatments from being approved. Curiously, after he tweeted that, the FDA drops the convalescent plasma therapy EUA right before the Republican convention.
Coincidence? Only if you believe in magic. It appears that the FDA has no guts to stand up to the loud and unscientific rants of Donald Trump. What next? An emergency use authorization of oleander extract?
Of course, Trump and his lackeys are considering using a coronavirus vaccine EUA to fast-track a COVID-19 vaccine right before the November election. With Vladimir Putin pushing the Sputnik-5 vaccine without substantial clinical trials, we can expect that Trump will follow his handler in the
Soviet Union Russia.
Jesse Goodman, a former chief scientist at the FDA now at Georgetown, stated:
It just seems to be a pattern now. I’m very worried that this might happen with vaccines.
So am I.
Trump has pushed vaccine development through “Operation Warp Speed,” which is trying to rush a new vaccine to market. Most vaccines take 5-10 years to develop, so it’s amazing how many coronavirus vaccines are in clinical trials. But I am deeply concerned about a rushed coronavirus vaccine EUA.
And I’m not alone. There is a new bill introduced in the US Senate, the SAVE Act, ‘‘Safe Authorization for Vaccines during Emergencies Act’’, that will require the FDA Commissioner to seek the approval of the Vaccines and Related Biological Products Advisory Committee for the “purpose of reviewing and providing recommendations with respect to emergency use of the product.”
According to the FDA, this is what this committee does:
The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA’s research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
Furthermore, the Committee itself is not a bunch of political hacks, but they are experts in the field of vaccines. Again, according to the FDA,
The Committee shall consist of a core of 15 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology; bacteriology, epidemiology or biostatistics, vaccine policy, vaccine safety science, federal immunization activities, vaccine development including translational and clinical evaluation programs, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry.
These are THE experts in the field of vaccinology, and they are the most capable individuals to decide whether there is enough evidence of safety and effectiveness to justify a coronavirus vaccine EUA.
Professor Dorit Rubinstein Reiss wrote (reviewed here) a powerful article about the rush to a coronavirus vaccine. It’s more than a concern about just a coronavirus vaccine EUA, it’s how that might affect all vaccines.
If this vaccine is rushed to market without substantial studies about its safety and effectiveness, it may give us a potentially worthless vaccine. But Donald Trump and his sycophants don’t care about science – they just want a vaccine to “prove” to the nation that he, alone, helped stop the pandemic.
I am so troubled about this process, especially if a coronavirus vaccine EUA is issued, that I might become skeptical of the vaccine. I need robust, published scientific evidence, along with FDA approval, to be convinced of a vaccine’s safety and effectiveness – this is what we have with EVERY SINGLE VACCINE ON THE MARKET (just in case anti-vaxxers think that I’ve come over to their side).
But right now, the FDA Commissioner has no credibility. None. If he pushes out a coronavirus vaccine EUA, many of us, maybe most of the scientific community, will be outraged if there isn’t a boatload of evidence of the new vaccine’s safety and effectiveness.
And if we’re not on board, think about vaccine-hesitant parents – maybe half or more of the population might refuse the vaccine. And then we have nothing.
Let’s hope that the SAVE Act is passed by Congress to make sure that we get a safe and effective coronavirus vaccine.
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