Theme parks reduce mask requirements on CDC guidance

As far as I can tell, there is effectively no difference other than to reduce bureaucracy. From Advent Health:

EUA was initially established after the September 11, 2001 terrorist attacks to ensure that potentially lifesaving medical products could be made available during an emergency before being approved by the FDA.

In order to issue an EUA, it needs to be proven that the vaccine may be effective in preventing a serious or life-threatening condition, and that the vaccine’s known and potential benefits can outweigh its known and potential risks. The FDA has said that in order for a COVID-19 vaccine to be administered to the public, including healthy people, they will only issue an EUA if a vaccine has demonstrated clear and compelling effectiveness in a large Phase 3 clinical trial.

It may be useful to point out that many drugs do not have phase 3 trials as large as those conducted here. For example, the headlines this week about the trial for the new Alzheimer's drug had less than 3,500 patients. Pfizer had 44,000 for the 18+ trial alone. Granted, what you're really after is statistical significance, not necessarily volume. For a global airborne pathogen, you need pretty big numbers to prove efficacy, though not necessarily safety, which I assume is what the FDA is keyed in on here.

Zero, but that's not the point.

Well it was my point. You can say you don't think is relevant, something is more relevant or it wasn't your point. But to say its not true (necessarily so or otherwise) doesn't make sense when my statement was true.

You're getting hung up on the procedural declarations instead of the effective result of the work of the drug companies.

If stating where the vaccines are at this point in the process is "hung up on the procedural declarations" then so be it.

You can't rationally declare that EUA means it's "experimental."

Don't recall declaring (or even saying) that EUA means its experimental. But given you put it in quotes, it depends on how you are defining experimental.

The experiment was done by December for Moderna and Pfizer.

Not sure if this provides some insight into how you define "experiment" but the trials continued past December. And continue today.

You can argue about long-term effects,

I did mention long term effects. So we are on the same page there.

but the use of mRNA is not that new, and the delivery mechanism (lipids) aren't new at all.

I am not contesting that. Not sure why you bring it up. But whatever.

BTW, "Zero" is wrong. Its not that its not necessarily true. Its just wrong. Factually untrue. Without EUA, the people who would have had the Covid vaccines today are those who are participating in the clinical trials. A number definitely in excess of Zero.

On the difference between EUA and FDA approval, per the FDA:

The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.

https://www.fda.gov/consumers/consumer-updates/understanding-regula...clearance.

GoBucks89 said:

On the difference between EUA and FDA approval, per the FDA:

The EUA process is different than an FDA approval or clearance. Under an EUA, in an emergency, the FDA makes a product available to the public based on the best available evidence, without waiting for all the evidence that would be needed for FDA approval or clearance.

https://www.fda.gov/consumers/consumer-updates/understanding-regula...clearance.

This is an interesting topic as I have often wondered the difference between an Emergency Use Authorization and approval by the FDA.

Per the FDA, an EUA makes a product available "based on the best available evidence" and does so "without waiting for all the evidence that would be needed for FDA approval or clearance"

So it's clear there is a difference in evidentiary requirement for EUA vs FDA approval, it's not just when manufacturing can start. Anyone know or care to look up what the difference is? I think that is what people have been going back and forth on on this thread.

Not sure that chart was very helpful in terms of painting an accurate picture of the timing differences. And as noted above, Pfizer started manufacturing vaccines about 2 months before they even filed their application for EUA. So not only wasn't EUA needed for production, the application for it wasn't needed either. What really drove that is the fact that the US government agreed to pay for vaccines that were produced even if they never were approved. And that decision was the totally the right call.

From what I have seen, the difference is about 4 months of data. EUA requires about 2 months and FDA approval requires 6 months. Looking at what happened, Pfizer submitted its EUA application at the end of November (approved on December 11). They submitted the application for full FDA approval in early May. About 5 months after EUA app. So they had about 5 months of additional data at that point. Could be the case that Pfizer wasn't in the same hurry it otherwise would have been in terms of filing for full approval because they were already going full out under EUA. From what I have seen, Pfizer said they are seeking priority review which I understand would be a 6 month review rather than the normal 10 month review.

From what I understand, EUA has been around for about 10-15 years (first used in 2009 or so). About 500-600 products have been approved under EUA for Covid. There is some discussion that may be too many and there may need to be an adjustment to the approval process.

It can't be about time, because not all treatments for all problems have the same time constraints. You wouldn't judge a cancer treatment in the same time you would a bandage for a paper cut. It's about the statistical significance of the data that you collect. For Covid vaccines, you won't get materially different results in three months and 40k patients compared to the next three months and 40k patients (simplifying here because you will get different results, given changes in behavior or, in this case, general vaccine distribution).

Both authorization and approval are rigorous processes that look at the safety and efficacy of a vaccine, [Dr. William Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health] said. A key difference between the two is that at least two months of follow-up data from phase 3 clinical trials are considered for authorization, versus at least six months for approval.

https://abcnews.go.com/Health/full-fda-approval-drive-covid-19-vacc...d=78048166

From Pfizer in an April 1, 2021 press release:

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced updated topline results from analysis of 927 confirmed symptomatic cases of COVID-19 observed in their pivotal Phase 3 study through March 13, 2021,

I thought the trials were over with EUA back in December 2020. These Pfizer people must not know what they are talking about.

showing the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, was 91.3% effective against COVID-19, measured seven days through up to six months after the second dose. ..... Safety data from the Phase 3 study has also been collected from more than 12,000 vaccinated participants who have a follow-up time of at least six months after the second dose, demonstrating a favorable safety and tolerability profile.

“These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “The high vaccine efficacy observed through up to six months following a second dose and against the variant prevalent in South Africa provides further confidence in our vaccine’s overall effectiveness.”

https://www.pfizer.com/news/press-release/press-release-detail/pfiz...no-serious

If only the people at Pfizer were readers of this site. Who'd have thunk it?

You keep moving the goalposts, yo...

Without emergency use authorization, the vaccines would still be in trials right now.

then...

(paraphrasing) They're still in trials.

The question was about whether or not wide distribution of the vaccines constitutes an "experiment," and if the efficacy and safety of them could be proven. In both cases, they most certainly were proven, and this is not experimentation on a global scale.

Of course they'll keep studying it, because they want to see what happens now that the variables have changed. New strains, 50%+ vaccination rates, changes in behavior, etc. It still doesn't make it experimental. There are still trials run with acetaminophen now and then to study specific things, and that's been around for 60 years. It's not experimental either.

Yo Adrian. No movement of goalposts. Point of my clarification:

Without emergency use authorization, the vaccines would only be in trials right now.

And you liked Andy's post about semantic arguments (which I think was well played) but want to go down that same rabbit hole again with "experiment." As tempting as that isn't, I will pass.

If this was an in-person debate...

I don't think so. There is still one person awake in that picture. Must have been taken days ago. And way too many people. Like by almost all of them.

Oh, don't get me wrong. I love a good (or even mediocre) semantic argument. That's half the reason I'm here. I just think it's a funny meme, though I guess that depends on your definition of the word, "funny."

This judge isn't interested in the "experimental" argument, and generally argues that businesses in this case should do what they feel is appropriate regarding vaccination.

https://arstechnica.com/science/2021/06/judge-tosses-reprehensible-...trocities/

The judge noted that the claims of the vaccines being experimental and dangerous were irrelevant. So even if those claims were true, the ruling would have been the same. Texas apparently only protects at-will employees from being terminated for refusing to commit an act carrying criminal penalties to the employee. Not a surprise given its Texas (though other states may have similar limited statutory protections).

Discussion of experimental nature/human trials (though again not relevant at all to the decision) was weak. Not human trials because the hospital's employees are not participants in a human trial. Hospital hasn't applied to test Covid vaccines on its employees, hasn't been approved by an institutional review board and has not been certified to proceed with clinical trials. Nothing about EUA or full FDA approval. Again, not binding and really meaningless in terms of whether the vaccines are "experimental." Even if they are, the hospital can still mandate them under Texas law (according to the court's order).

Comparissons to Nazi Germany concentration camps (reprehensible as the court notes) didn't help the plaintiff here.

Court did note that the EEOC issued guidance on May 28, 2021 that federal EEO laws do not prevent employers from requiring vaccines for those working onsite:

Federal EEO laws do not prevent an employer from requiring all employees physically entering the workplace to be vaccinated for COVID-19, so long as employers comply with the reasonable accommodation provisions of the ADA and Title VII of the Civil Rights Act of 1964 and other EEO considerations. Other laws, not in EEOC’s jurisdiction, may place additional restrictions on employers. From an EEO perspective, employers should keep in mind that because some individuals or demographic groups may face greater barriers to receiving a COVID-19 vaccination than others, some employees may be more likely to be negatively impacted by a vaccination requirement.

EEOC noted:

he EEOC has received many inquiries from employers and employees about the type of authorization granted by the U.S. Department of Health and Human Services (HHS) Food and Drug Administration (FDA) for the administration of three COVID-19 vaccines. These three vaccines were granted Emergency Use Authorizations (EUA) by the FDA. It is beyond the EEOC’s jurisdiction to discuss the legal implications of EUA or the FDA approach. Individuals seeking more information about the legal implications of EUA or the FDA approach to vaccines can visit the FDA’s EUA page. The EEOC’s jurisdiction is limited to the federal EEO laws as noted above.

https://www.eeoc.gov/newsroom/eeoc-issues-updated-covid-19-technical-assistance

Still have to look at other laws. Many employers are waiting for full FDA approval before mandating vaccines (are encouraging employees to get vaccinated but not requiring them). Others, having to deal with other back to work issues, are not looking to tackle the issue of mandating vaccines right now.

But the ruling sends a pretty clear signal that employers may require vaccination. It also hasn't stopped hundreds of colleges and universities from requiring it. There's literally nothing novel about this, other than the FDA distinction, which the judge rejected. I've had to have vaccines and a TB test to work in schools, and that was 20 years ago. It should hardly be surprising that this is necessary and legally permissible for a hospital, in a global pandemic.

GoBucks89 said:
...Court did note that the EEOC issued guidance on May 28, 2021 that federal EEO laws do not prevent employers from requiring vaccines for those working onsite:

Federal EEO laws do not prevent an employer from requiring all employees physically entering the workplace to be vaccinated for COVID-19, so long as employers comply with the reasonable accommodation provisions of the ADA and Title VII of the Civil Rights Act of 1964 and other EEO considerations. Other laws, not in EEOC’s jurisdiction, may place additional restrictions on employers. From an EEO perspective, employers should keep in mind that because some individuals or demographic groups may face greater barriers to receiving a COVID-19 vaccination than others, some employees may be more likely to be negatively impacted by a vaccination requirement.

...Which is why some employers have partnered with health departments and vaccine providers to operate 'closed' vaccination clinics just as the schools do. By making the vaccine available in the workplace they can remove some of those access excuses. Don't know about other states, but that was definitely encouraged in Ohio. I'm surprised my employer hasn't done it.

--Dave Althoff, Jr.

The cruise lines have been doing it for weeks as a matter of policy. As they (literally) onboard people from all over the world, they get vaccinated an quarantine in guest rooms. By the time they sail, the crews will be fully vaccinated.

Given the state of employment law in Texas as cited by the judge, the order doesn't advance anything meaningful. As long as it wasn't requiring employees to do something illegal, the hospital can terminate anyone refusing to comply. Status of the approval of the vaccines isn't relevant to that analysis.

Last I saw numbers, hundreds of colleges are requiring vaccines. For students. Many fewer for employees though. Most are private schools. And thousands of schools aren't requiring them.

From this list, 4 colleges in Ohio and only University of Miami in Florida are requiring them. Several states have no colleges requiring them.

https://www.bestcolleges.com/blog/list-of-colleges-that-require-cov...9-vaccine/

Court noted that the statute the plaintiffs cited didn't apply to private employers and didn't create a cause of action against the goverment or employer. That isn't a rejection of the status of the vaccine approval having significance. I understand this is the first time we have had a vaccine approved for general use under EUA. Not clear at this point what significance it has, if any.

After spending the evening at Epcot yesterday, I made a few observations:

• Mask wearing among guests is minimal, even among those under-12, which can't be vaccinated yet. This means that among adults, at least 1 in 3 statistically are lying about their vaccination status. Science says it's probably no big deal outside, but things get cramped indoors in places like The Land.
• I do wonder if the "Disney demographic" is more likely to have vaccinated compared to the aggregate public.
• I was not comfortable having my kid mask-free indoors, so he wore it.
• Cast members can go without masks, at least outdoors, but only about 1 in 4 were doing so. This implies their behaviors are better than the guest population, perhaps erring on the side of caution.
• The "wait here" floor markings are largely gone from attractions, but still common in restaurants. Plexiglass barriers are still everywhere.
• Pre-shows are back on some attractions.
• There was live music in the American Gardens Theater, which brings a sense of normalcy that's exciting.
• Many of the stands for Food & Wine are already out, in addition to those currently being used for Flower & Garden. This will clearly not be a scaled back version this year.