The U.S. Department of Health and Human Services (DHHS) has revoked emergency use authorization (EUA) for the COVID-19 shots. The federal government had relied on the EUA status to justify release of the COVID-19 biologicals in December 2020 for public distribution without full licensure by the FDA.1 On Aug. 27, 2025, DHHS Secretary Robert F. Kennedy, Jr. proclaimed that EUA status for the COVID shots —which was used by the government in 2021 to mandate COVID shots for all federal workers, health care workers and employees working in companies with more than 100 employees—has been rescinded.2
Secretary Kennedy announced on X:
The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded.3
COVID is no longer considered a public health emergency. According to the FDA commissioner Marty Makary, MD, the decision to revoke the EUA for the COVID biological was made in light of decreased COVID disease transmission and hospitalization rates, as well as increased immunity among Americans combined with improved diagnostic testing and availability of effective treatments.4
The COVID shots were authorized to be publicly distributed under an EUA status by DHHS Secretary Alex Azar in December 2020 on the grounds that there were no approved alternative medical products to treat or prevent COVID disease.5 Unlicensed drugs and vaccines can only be authorized to be distributed to the public under an EUA if there is a public health emergency declared by the DHHS Secretary.
Evidence standards for safety and effectiveness of vaccines authorized by FDA for distribution under EUA status are lower compared to the proof of safety and efficacy standards for full licensure.6 The standard for EUA approval is that the potential benefits outweigh the potential risks and there must not be an alternative product to the non-FDA approved vaccine or drug available.7 This is a much lower standard than the kind of scientific evidence manufacturers must provide to the FDA for full licensure of new drugs and vaccines and there has been controversy since the COVID biological was authorized for distribution under the lower EUA standard, with the Pfizer mRNA COVID shot still not fully licensed for use by children under age five.8
The FDA required manufacturers to follow up COVID shot clinical trial participants for at least one month to receive EUA approval for distribution,9 while clinical trial participants were followed for at least six months to receive full FDA licensure. In addition, the time it takes for an EUA vaccine to be approved is significantly less than the time it takes for a vaccine to get FDA approval. One study showed that it took over eight years for a vaccine to gain FDA approval while it took only six months for the Pfizer/BioNTech COVID shot to gain EUA status.10
Bioterrorism and Medical Countermeasures Legislation Passed After 9-11
After the terrorist attacks on New York City and Washington, DC on Sept. 11, 2001 were followed by rumors that there were hidden bioweapons of mass destruction that could be used against the U.S., Congress passed “bioterrorism” and “medical countermeasures” legislation beginning in 2002.11 Among the laws passed by Congress after 9-11 was the 2005 Pandemic and All-Hazard Preparedness Act (PAHPRA), which created guidance for the FDA to grant manufacturers of “medical countermeasures” an EUA for their medical countermeasure (MCM) products and that law has been reauthorized by Congress over the years.12
Authorizing drugs and vaccines, considered “medical countermeasures” during public health emergencies enables the Secretary of DHHS to allow unlicensed medical products to be used when there are no alternative treatment options available.13 The H1N1, Ebola, avian flu, and MERS vaccines were all approved for distribution under EUA status. However, none of these vaccines were distributed as widely as the COVID biological or mandated by the federal government.14
COVID Shots Available for Those Who Want Them
Even though COVID shot use recommendations by DHHS have changed, COVID shots have not been removed from the market and are available for those who choose to use them, although healthy children and adults under age 65 may need a physician’s note to get a COVID shot at a pharmacy.15 Pfizer’s Comirnaty COVID shot is now recommended for use in adults over the age of 65 and anyone between the ages of five and 64 with at least one pre-existing poor health condition. Moderna’s Spikevax COVID shot is recommended for children at high risk for COVID disease complications, as long as they are at least six months old. Novavax’s Nuvaxovid COVID shot is recommended for high-risk children aged twelve years and older.16
DHHS officials had previously recommended COVID shots for anyone over the age of six months. However, doctors can still prescribe the shots off-label for their patients.17 This change aligns with COVID shot use recommendations in other countries such as Germany and Australia.18
FDA Requires COVID Shot Manufacturers to Provide Clinical Trial Data
Dr. Makary and Vinay Prasad, MD, MPH, head of the FDA’s Center for Biologics Evaluation and Research (CBER) announced in May that the agency is requiring COVID shot manufacturers to produce clinical trial data demonstrating safety and effectiveness in healthy children and adults, although the agency is not requiring that same standard of proof for “high risk” children and adults with one or more chronic health conditions or seniors over age 65.19
In order to authorize the shots for Americans under the age of 65 without at least one risk factor, the FDA is requiring data from randomized, controlled clinical trials that demonstrate the COVID shot prevents symptomatic COVID along with preventing secondary outcomes, including death. The trials will compare the COVID shots to saline placebos in order to ensure that the COVID shot approval is evidence based.20
Dr. Prasad warned:
The FDA can only approve products if it concludes, based on scientific evidence, the benefit-to-harm balance is favorable. And we simply need more data to have that confidence for younger individuals at low-risk of severe disease.
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Click here to view References:1 U.S. Food and Drug Administration. Emergency Use Authorization. Aug. 29, 2025.
2 Constantino AK. FDA approves new Covid shots with limits on who can get them under RFK, Jr. CNBC Aug. 27, 2025.
3 Stieber Z. FDA Revokes Emergency Authorization for COVID-19 Vaccines. The Epoch Times Aug. 27, 2025.
4 US Newsper. FDA Revokes COVID-19 Vaccine EUA: What It Means for Us. Aug. 27, 2025.
5 FDA. Emergency Use Authorization. Aug. 29, 2025.
6 Soloman L. Emergency Use Authorization vs. Full Approval: What are the Implications? National Center for Health Research June 20, 2021.
7 Fink D. Emergency Use Authorization: Overview and Considerations for COVID-19 Vaccines. FDA Vaccines & Related Biological Products Advisory Committee Dec. 17, .2020.
8 Schnirring L. FDA Oks updated COVID vaccines but places limits for kids, adults. CIDRAP Aug. 27, 2025.
9 Fink D. Emergency Use Authorization: Overview and Considerations for COVID-19 Vaccines. FDA Vaccines & Related Biological Products Advisory Committee Dec. 17, .2020.
10 MacMillan C. Emergency Use Authorization Vs. Full FDA Approval: What’s the Difference? Yale Medicine Mar. 7, 2022.
11 FDA. MCM-Related Countermeasures Legislation. Apr. 29, 2024.
12 FDA. Emergency Use Authorization of Medical Products and Related Authorities: Guidance for Industry and Other Stakeholders. January 2017.
13 FDA. Emergency Use Authorization for Vaccines Explained. Nov. 20, 2020.
14 Ibid.
15 Landi H. CVS Health, Walgreens Shift COVID vaccine policies as providers say new FDA criteria create barriers for patients. Fierce Healthcare Sept,. 2, 2025.
16 Lim D. FDA revokes emergency use of Covid-19 vaccines. Politico Aug. 27, 2025.
17 Stieber Z. FDA Revokes Emergency Authorization for COVID-19 Vaccines. The Epoch Times Aug. 27, 2025.
18 Stieber Z. FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data. The Epoch Times May 20, 2025.
19 Fisher BL, Pebsworth V. Public Comment submitted to FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) on behalf of National Vaccine Information Center (NVIC). References #22-118. May 23, 2025.
20 Stieber Z. FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data. The Epoch Times May 20, 2025.
4 Responses
It’s funny that EUA status was given to the untested poison Covid vaccines, so the Gov’t. could issue mandates to take them, considering that EUA status protects anyone from being forced to take drugs with that status.
This is absolutely wonderful news and should be celebrated BIG!!! And, it is a deception that distracts from the fundamental lie that there is no proof of a corona virus, none, zero, or any virus. Once this truth is known, the lie of vaccines is known.
Quite the news cycle lately. I have not read news this great in perhaps my entire life. The hits keep on coming. Still will never excuse the failures which allowed these events to happen in the first place. Better late than never. The entire event illustrates how unreliable centralized systems really are. Why the bureaucratic state of these proportions does more harm then good. Why corporations should not have as much influence in governance. How within centralized systems there is a complete breakdown of logical and sound process management and logistical planning. Why decentralization is a far better approach. ‘Central planning never works.’
Primarily; this article reminds me of jessie ventura conspiracy theory type content, dark journalist, infowars, the million others. You want to have your mind blown? There were people predicting this event would play out in exactly this manner decades ago. The entire thing was a staged event to install global governance, a new technocracy. They keep bringing the receipts to this day too, the proof is out there. Thankfully the people resisted, for this round at least.
Besides, we never listened to the government bureaucrats in the first place. Nor are we beholden to any corporations planned messaging. We do not respond to sales persons or solicitations. We maintain freedom and independence as much as possible. If we need something from this world, we research, ponder, make informed decisions, delay on purpose, then reach out and find what we need on a strictly voluntary basis.
This is how people can achieve a more natural less complex navigational path. One does not need ‘expertise’ or government guidance on anything, in order to make smart decisions. Simply recognize when the ‘voluntary principal’ is being applied, and when the voluntary principal is being disregarded. Respond accordingly.
An alternative slogan which conveys the same message; ‘Good ideas do not require force.’ If anyone tries to pressure or force you to do anything, they do so because they’re not promoting a good idea, but rather using the mechanisms of power to force your acceptance. That’s the opposite of freedom and liberty. Where as good ideas that are beneficial to the people, tend to be voluntarily accepted without coercion.
In a free society we must only respond to voluntary engagement, and we must never force anyone elses hand either. As long as you’re not hurting anyone else, you should be free to make your own completely independent decisions. Our government is not in place to tell us how we ought to live, what we should believe, how we should direct our own personal wealth. The governments primary responsibility is to protect our liberties. Nothing more, nothing less. This reminds me, is the government really going to shut down for lack of funding this round? Oh please, let it be true, even but for a fleeting instant. Who gave them the ‘rights’ to do any of this in the first place? Ask a different question…
Mythbusters; the ‘right’ to never be offended.
https://www.youtube.com/watch?v=DQwW4DukHlQ
So, can people successfully sue if they are injured by the COVID vaccine? More specifically, is the Prep Act not providing liability immunity any more?