Theme parks reduce mask requirements on CDC guidance

Coffinboy, folding the card in half makes it slightly smaller than license/cc size and still thinner, but your method is more fun.

There are plenty of reasons why people might not want to get any of the COVID vaccines just yet. After all, we're supposed to trust the government scientists who give their +approval to this stuff, and they have so far only given conditional +approval to the vaccines now being used in the USA. It's a massive experiment and we're the guinea pigs, and for a lot of people that's just plain uncomfortable. There are people who can't or shouldn't take the vaccine. And I just learned from a long-time friend who happens to be a transplant patient that the immunosuppressive drugs he takes to keep his body from rejecting his pre-owned kidney also have prevented the COVID vaccine he took from producing the necessary antibodies.

As for any of the complication arguments, as I see it there isn't a lot of data to work with. We know how many millions of shots have been given and we have some mostly anecdotal cases of complications that may or may not be linked to the vaccine. The way I look at it, every person who gets one of the vaccines is going to die, but the data we do have suggests that the vaccine drastically reduces the odds of the immunized person actually dying from COVID-19. That, for me, is pretty convincing. I agree that at this time the most logical thing is for anyone who can take the vaccine, take it, and effectively remove yourself from the COVID-19 risk pool. It means you don't have to worry about what other people are doing in terms of COVID-19 risks and behaviors, and it makes the risk pool smaller. In Ohio, the pessimistic odds of encountering in infected person have fallen to about 1:1203, about where they were in early April of 2020. The difference is that now, between immunization and infection, somewhere between 33% and 79% of the population now has some immunity (either through inoculation or infection) which makes for a very tiny risk pool which is causing this virus to die out rapidly.

The thing is, I don't agree with the reasoning behind not wanting to get the vaccine. My own risk calculus told me it was a good idea to get it, and the benefits of immunization exceed both the risks, and the benefits of making it into some kind of ethical or political statement. I will say that from a political perspective, I am very much opposed to vaccination requirements, especially for an experimental vaccine, and I really think the whole 'vaccine passport' idea is going farther than is appropriate or necessary. There's a whole lot of "mind your own business" at work here, and culturally that's something I think we in the USA need to respect. I believe one of the most important freedoms we have is the ability to make our own decisions, even to make illogical, incorrect, or just plain dumb decisions. That makes it that much more important for us all to protect ourselves and to take precautions against our dumb decisions harming others, but I really do think that level of self-determination is vitally important in our society.

--Dave Althoff, Jr.

RideMan said:

It's a massive experiment and we're the guinea pigs, and for a lot of people that's just plain uncomfortable.

No, it's not... the experimentation happened before and during the trials, and really long before that when it comes to the mRNA vaccines. They're not new. Stop saying things like this, because it's not true.

Without emergency use authorization, the vaccines would still be in trials right now. But for the significant problems that Covid causes, the general public would not be receiving vaccines yet. In a cost/benefit analysis, society has determined the unknown risks of the vaccines are worth the benefits. But that doesn't mean the unknown risks don't exist (or at least at this point are unknown). Long term complications of drugs are studied long term. You can't short cut that.

Jeff said:

I was in the studio audience of the short lived Nightly Show with Larry Wilmore several years ago, and Bill Nye was the guest the night of the taping. He talked to the audience between segments and was still mic'd up when the cameras cut off so you could hear his banter with Larry and the other panelists. It was such a cool experience, and my respect for his knowledge and appreciation for his "second act" as a spokesperson for science and facts grew exponentially at that taping.

The show I attended in 60 seconds

I loved Larry's show, though it never really found an audience. I saw Nye a few years ago at DPC (2017 or 2018, I think), where he called Neil deGrasse Tyson on stage to answer a question he couldn't. He ranted quite a bit with the audience about the decline of critical thinking.

GoBucks89 said:

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

That's not necessarily true. The mRNA vaccines already had a robust field of study, both from the messaging bits to the delivery mechanisms, to treat a whole bunch of viruses. If anything, we got lucky that so much research had already been done to treat similar diseases. What would additional trials achieve?

GoBucks89 said:

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

I don't think that's accurate. According to this, EUA simply allows manufacturing to begin during clinical testing. The testing remains the same.

In a public health emergency, manufacturing and approval of vaccines can be streamlined through an Emergency Use Authorization or EUA. An EUA does not affect vaccine safety, because it does not impact development, such as research, clinical studies and the studying of side effects and adverse reactions. Instead, it speeds up manufacturing and administrative processes.

Per the FDA:

An Emergency Use Authorization (EUA) is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and available alternatives. Taking into consideration input from the FDA, manufacturers decide whether and when to submit an EUA request to FDA.

https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use...-explained

Pfizer and Moderna have both applied for full approval (Pfizer in early May and Moderna in late May). Full approval of each is expected to take months.

And even in what you posted:

If the benefits outweigh any possible risks of the vaccine and manufacturing quality can be ensured, the FDA will approve the vaccine for emergency use.

Without Covid being such a significant problem, emergency use would not be approved.

At to what more trials would show, we don't know. Which is the point of the continued trials. Even after full approval, drugs are still reviewed for complications.

From that link:

...efforts to speed vaccine development to address the ongoing COVID-19 pandemic have not sacrificed scientific standards, integrity of the vaccine review process, or safety.

The testing protocol isn't different, it's the manufacturing that is less closely monitored, is my understanding. So these aren't experimental or whatever, we're simply trusting vaccine manufacturers to do a competent job of manufacturing vaccines which have been tested to the same standards as all vaccines.

Seems like something in the UNC flowchart is not quite right. If both paths get to the approval stage at the same time, after the trials, why not apply for the "real" approval since both paths get to the approval stage at the same time? There must be a difference between the two different approval steps.

Because normally production cannot begin prior to approval, so we'd still be waiting on many millions of vaccines. If I recall correctly, Pfizer began manufacturing their vaccine two months prior to approval.

Maybe I have it wrong. But its in the name: Emergency Use Authorization. No emergency and there is no use. No Covid vaccine has been approved as of today for full use. Only can be used in the case of an emergency. If 600 people had died rather than 600k, no one would be getting Covid vaccines outside of ongoing trials.

As for manufacturing, I don't think there is an issue with making drugs before approval. But no one does that because you run the risk of spending millions for something you have to toss away. What was different with Covid vaccines is governments were agreeing to buy vaccines before approval so drug companies were willing to make them. But making them doesn't mean you can sell/use them. And if Pfizer began manufacturing 2 months before approval, EUA isn't necessary for manufacturing.

And yes, we haven't sacrificed standards, integrity, etc. But the process isn't yet complete in terms of full approval. You can rush the process to a great extent (particularly if you start manufacturing before approval). But that only goes so far.

djDaemon said:

Because normally production cannot begin prior to approval, so we'd still be waiting on many millions of vaccines. If I recall correctly, Pfizer began manufacturing their vaccine two months prior to approval.

But the chart shows that shows that production is started even before the request for the EUA. Maybe the request step is out of place on that flow path? Otherwise if the actual request for approval for both paths happens at the same time why hasn't the EUA designation been dropped by now since all of the trials have been completed.

GoBucks89 said:

Only can be used in the case of an emergency. If 600 people had died rather than 600k, no one would be getting Covid vaccines outside of ongoing trials.

In both cases the trials would be concluded, but with EUA we would be two months behind in manufacturing and therefore inoculating people relative to where we are now. Or put another way, somewhere in the vicinity of a 7-day new case average of nearly 70,000 compared to around 15,000.

My basic point is that to my understanding the clinical trials are the same in both scenarios.

A normal trial has thousands of participants, not millions. We know more about these vaccines than we know about others years into their use. If someone is still waiting for approval they just want to sound smart and don’t want the vaccine. IMO…

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

Statement of mine with which you and Jeff took issue. How about if I clarify it: Without emergency use authorization, the vaccines would only be in trials right now. Is that better?

Without EAU, you can only sell/administer drugs/vaccines that have been fully approved by the FDA (in the US). No Covid vaccines has full approval at this point. If 600 people had died, I don't think there would be an emergency use authorization and thus the public would not be getting vaccinated now. If the public is not getting vaccinated the only people with the vaccine are those in trials. Not sure how that is controversial.

Covid vaccine trials are still ongoing. So its not like they stopped in December with EUA. I believe Pfizer plans to conclude their trials in early 2023 and Moderna in late 2022. How long the protection lasts is a big part of that (for booster purposes) though so too is continued safety. Data gathered since approval through May was included in the full approval apps filed by Pfizer and Moderna last month.

Clincal trials are the same for full and EUA. But the length of time before applications for approval are different. Makes sense you would need to see less data for something that is reeking havoc than you would something that isn't. Risk/reward analysis is much different.

The full approval process requires more data. Otherwise there would have been full approval by now (will help incentivize more people to get vaccinated). But from what I understand that is not expected for a couple months.

There is still a lot we don't know about the vaccines. Though having them in hundreds of millions of arms does provide a lot of data. Long term data though can't be had from simply more shots.

Are there risks there will be long term complications? I would say yes. Are the large? I would say no. But presumably there is a reason why more data is required for full approval and the longer time period that requires. Otherwise the Covid vaccines would have gotten full approval in December.

GoBucks89 said:
Statement of mine with which you and Jeff took issue. How about if I clarify it: Without emergency use authorization, the vaccines would only be in trials right now. Is that better?

Not really. The trials wouldn't last longer, they would have ended at the same time.

And to be clear, there is still monitoring going on, and data being collected, but the thing scientists are most trying to understand right now is how long we have to go before we need another shot.

In the US, without EUA, how many people do you think would have been vaccinated as of today? And who would those people be?

Zero, but that's not the point. You're getting hung up on the procedural declarations instead of the effective result of the work of the drug companies. You can't rationally declare that EUA means it's "experimental." The experiment was done by December for Moderna and Pfizer. You can argue about long-term effects, but the use of mRNA is not that new, and the delivery mechanism (lipids) aren't new at all.

I ask out of ignorance because we seem to be dancing around it a bit -

What is the difference in EUA approval versus full approval? There has to be some difference in the testing or length of testing - right?