General Question

flo's avatar

What does for "emergency use" mean regarding COVID 19 vaccines for example?

Asked by flo (13313points) August 6th, 2021

”...the federal government hasn’t yet fully approved Covid-19 vaccines. Rather, the vaccines are currently authorized for “emergency use.”
https://tinyurl.com/45kuddcs
Who are the people approved to be vaccinated if it is only for emergency use?

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16 Answers

Lightlyseared's avatar

The FDA website has a perfectly good explanation of what “emergency use authorisation” means.

The real problem is that people dont actually understand what FDA approved means. The general assumption is that it means safe and effective but what actually means is unlikely to kill you the moment you take and and at least as good as doing nothing (Just to be clear that IS NOT A JOKE you’re free to look it up)

flo's avatar

Interesting.
By the way I’m asking since so many hesitants are looking that as the reason to not get vaccinated.

rebbel's avatar

I haven’t looked it up on the FDA site, but my logic tells me that “emergency” in ”(only for) emergency use” refers to, in this case, the pandemic.
And pandemics are no joke.
Millions upon millions of people die.
The off chance that (unfortunately) some people might die from side effects of said vaccins is of course very sad, but it doesn’t weigh up to the above mentioned millions of deaths (extra) (if we hadn’t massively vaccinated).

seawulf575's avatar

I just got a Covid test and it had the disclaimer that the test was not approved for use by the FDA. It was approved by the FDA under an EUA (Emergency Use Authorization). In other words, it has not been fully vetted, but enough so that they can use it to detect the Covid Virus. Once the emergency is over, it will no longer be a valid test.

Tropical_Willie's avatar

“Once the emergency is over, it will no longer be a valid test.”

Not true just the opposite once the studies have reach a longer test period like half a year to year, it would be fully approved. Look up EUA (Emergency Use Authorization) !

JLeslie's avatar

Emergency use is utilized when risk of using the medication seems worth it.

Classic examples are people who have terminal illnesses and want to try a drug that has not been approved yet. The person is going to die, there is a drug in the works that might save his life, and the patient is willing to risk it.

With the vaccines we had a virus killing hundreds of thousands of people, life in the US was being significantly altered, the phase three trials appeared to not cause any serious harm, and also appeared to be effective against the virus, so they went ahead and gave it emergency use approval to get it out on the market. The most important part of that is not cause harm.

Everyone 12 years and older are approved to get the Pfizer or Moderna, I’m not sure if J&J has under age 18 approval. The only exceptions are if someone has a specific condition that makes the vaccines contraindicated.

Contraindications to Pfizer amd Moderna:

People currently sick with covid can’t get vaccinated.

Someone who had a severe allergic reaction to a first dose should not get a second.

Someone with severe allergic reaction to Polyethylene glycol (PEG), which is found in some medications, such as laxatives and preparations for colonoscopy procedures.

Severe allergy to Polysorbate, which is found in some vaccines, film coated tablets, and intravenous steroids

Previous severe reaction to another vaccination. This does not necessarily preclude you, but should be considered when evaluating the risks of the vaccination.

Disclaimer: I’m not a doctor.

seawulf575's avatar

@Tropical_Willie What is your source of information? Because it is 100% NOT what is being put out by the lab doing the test. Here is EXACTLY what they stated on my official test results:
“This test has not been FDA cleared or approved. This test has been authorized by FDA under and EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of SARS-CoV-2 viral RNA, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Sction 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner”

Now I know that medical professionals that are bound by law to give such warnings aren’t as reliable as yourself, but I really would love to know where you get your information that it would automatically be approved after a certain length of time.

Tropical_Willie's avatar

“EUAs are in effect until the emergency declaration ends but can be revised or revoked as we evaluate the needs during the emergency and new data on the product’s safety and effectiveness, or as products meet the criteria to become approved, cleared, or licensed by the FDA.” – - FDA Frequently Asked Questions.

Why are you so antivaccination ?

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Tropical_Willie's avatar

Your statement was ” In other words, it has not been fully vetted, but enough so that they can use it to detect the Covid Virus. Once the emergency is over . . . . . . . . . . . . . . . . . . . . . it will no longer be a valid test.

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