Coronavirus and Walt Disney World general discussion

[mmascari]

Wait to see if there are negative reactions to the vaccine. If there are, vaccine is scrubbed.​

​

Wait to see how much more the vaccinated group is protected compared to the placebo. To be effective, it should be 50% more protected.​

This first point is super important, and one of the reasons that vaccine development is different from other treatments.

For say a cancer drug. You've got something that you think may work, and offers some incremental improvement. It may have some wild side effect. But, the comparison is between "this very sick person where cancer is actively killing them and the side effect isn't as bad as death". Lots of room in there

But, a vaccine is given to someone who is healthy and not sick. There's nothing actively killing them. Which makes "let's give this healthy person something that causes a negative side effect" a much more difficult proposition.

Vaccine's have insanely high safety testing because of this. It's harder to do trials for the same reason. That cancer patient is able to take much more risk, the alternative is death. We're not willing to subject a healthy person to the same level of risk.

Crazy scenario, but let's say one or more vaccines pass Phase 3, and vaccine dosages begin publicly; then a few months later noticeable side effects and long term issues show in those vaccinated....is that "normal"? would they pause and go back to the drawing board, and recall the vaccine?

If the testing is done correctly and not rushed for political reasons, the process is supposed to prevent this. Which is part of why the timeline is so long.

There's steps in the development that risking and spending extra money can accelerate, but there's other steps where it just takes time and there's no way to go faster without sacrificing safety. The easy one is starting spending on the next steps, like manufacturing capacity before the prior step is done. Normally, you would wait until you know something works before spending the money. But, willing to risk the cash, that it's all spent and then it doesn't work so it's all wasted money and the next step never happens. Doing that means you can start those tasks before the prior one is done, so it's ready on the day you move to the next step.

I can't imagine they have pregnant people in the trials, they wait to get the vaccine or take a chance? I'm thinking Thalidomide where the problem didn't show up until some detective work was done

Another reason testing is so hard. There's differences between men and women, and more again to pregnant women. Add in that testing the impact on childbirth is always going to take a longer time with no way to accelerate the timeline.

Worth noting too, the FDA never approved Thalidomide.

Frances O. Kelsey

Women pioneers at FDA

www.fda.gov

 

[MisterPenguin]

This makes me sad but very understandable. Can’t really sing out loud with a mask on. Or enjoy the adult beverages. My favorite place on property and hope it’s open by the beginning of the year.

This is why the BatB Singalong should not be open and why First Time in Forever Singalong shouldn't open. Right now so many churches are going without any congregational singing. Neither should Disney theaters have guests singing.

 

[Miss Bella]

Crazy scenario, but let's say one or more vaccines pass Phase 3, and vaccine dosages begin publicly; then a few months later noticeable side effects and long term issues show in those vaccinated....is that "normal"? would they pause and go back to the drawing board, and recall the vaccine?

I haven't met one healthcare worker that's willing to be a guinea pig when the vaccine comes out. I know I'll be taking a hard pass. I'll let you all test it out for me.

 

[DisneyDebRob]

I hope everything in this article is wrong. Predicting 410 thousand deaths by January IF masks stay at same usage as right now. Also 2/3rds of people won’t get vaccinated right away with 1 in 4 never getting it. https://www.google.com/amp/s/amp.usatoday.com/amp/5712554002

 

[GimpYancIent]

I hope everything in this article is wrong. Predicting 410 thousand deaths by January IF masks stay at same usage as right now. Also 2/3rds of people won’t get vaccinated right away with 1 in 4 never getting it. https://www.google.com/amp/s/amp.usatoday.com/amp/5712554002

Me, myself and I, yes, the three of us will quietly continue to enjoy our extra dose of vitamin C each morning and savor chicken soup every day while carefully, socially distanced, watching this vaccination process unfold. Once actual results are achieved and things like safety are established I will see about getting vaccinated.

 

[mmascari]

I don't know of any other "emergency usage" shortcut. There is no "this is taking too long" route to getting the vaccine out past the recommendation of the regulatory board.

It's just like the other emergency use authorizations that have been done. It would release use under very specific circumstances, not to the general public.

It's almost like an expanded trial. The emergency use authorization includes tracking and conditions. Most (not all) of the hurdle to this is proving something does no harm and we're in an emergency. We're clearly in the second. That doesn't mean something actually works though, just that it doesn't hurt you. Overuse, sloppy use, treating the authorization as if were an approval are all issues that are watched when one is issued, and can result it in being rescinded.

High risk individuals are a likely target for an emergency use authorization vaccine. Mostly older people in care facilities. But, it's not much of a step above being a trial guinea pig.

If we theorize that on date X a vaccine is released only under an emergency use authorization, then the political spin and public questions will all begin. Some will proclaim it's available and wonderful. Others will correctly report that's it's not widespread available, just restricted conditions. Even more will wonder why they cannot get it. Basically, all the reporting will be a disaster of people yelling at each other.

 

[MisterPenguin]

It's just like the other emergency use authorizations that have been done. It would release use under very specific circumstances, not to the general public.

It's almost like an expanded trial. The emergency use authorization includes tracking and conditions. Most (not all) of the hurdle to this is proving something does no harm and we're in an emergency. We're clearly in the second. That doesn't mean something actually works though, just that it doesn't hurt you. Overuse, sloppy use, treating the authorization as if were an approval are all issues that are watched when one is issued, and can result it in being rescinded.

High risk individuals are a likely target for an emergency use authorization vaccine. Mostly older people in care facilities. But, it's not much of a step above being a trial guinea pig.

If we theorize that on date X a vaccine is released only under an emergency use authorization, then the political spin and public questions will all begin. Some will proclaim it's available and wonderful. Others will correctly report that's it's not widespread available, just restricted conditions. Even more will wonder why they cannot get it. Basically, all the reporting will be a disaster of people yelling at each other.

K, I looked it up, and indeed the FDA can go the emergency use route.

Tho... they'd have to convince the drug company to hand it over first, and who knows what will happen if they refuse to because they don't want to damage their reputation or cause unforeseen harm.

 

[mmascari]

The entire emergency use authorization process is weird when looking at it from the outside. The general reporting on it by political press instead of by scientific reporting makes it worse too. Most of us stop our understanding of the FDA process with "FDA Approved" or "Not FDA Approved". In that light, the emergency use authorization is a view deeper into the process, to see how the agency works. But, clearly not a complete view, and really who would want a complete view if it's not your area of interest.

The easy takeaway is that something available for emergency use has currently been deemed to not cause harm, at least under the restrictions it's approved with, but it's not "FDA Approved" in the generic widespread normal understanding. It's only available under specific conditions, and it's use this way is supposed to include collecting information to help determine if it works or not. Similar to other research.

There's been tons (hundreds?) of emergency use applications for different COVID stuff. Some from doctors that want to use treatments that are approved for other stuff, others by companies that want to market something.

EDIT: For my personal use, based on my health right now, would be to wait not use an emergency thing. Or course, a change in health could impact this thought.

 

[sbunit]

My question to the anti vaccine crowd is the following: with a worldwide epidemic, what’s the alternative viable solution to end it outside of a viable and safe vaccine? I anticipate many will be anti the vaccine and I place no judgement on anyone’s personal believes or views. In fact, although I am not an anti vaccine person and have my kids all Up to date with their vaccines and my own share of mandatory vaccines, I am personally not one who is quick to sign up for pharmaceutical intervention or therapeutics unless absolutely necessary.

But looking at the big picture in terms of worldwide health and global economic implications, if not a vaccine, then what’s the solution here?

 

[Tink242424]

To be noticeable, they'd have to be very noticeable. Something like the same reaction in the same population and to occur outside statistical probability. We already have people connecting vaccines to all sorts of problems where there is zero scientific evidence for it. And it would have to be something that made sense, like an immune overreaction (like that which makes COVID deadly already for those for whom it is fatal). Any such correlation would have to stand in the face of millions of people *not* having a adverse reaction.

No medical procedure is without risk. A 'simple' surgical procedure can kill someone if a blood clot loosens during it. Introducing foreign bodies into human beings has a non-zero risk. But we take that risk to eradicate deadly diseases, like with did with small pox, but not so much with minor illnesses as with colds.

This isn't really true the way you have it laid out. You don't have to have proof of correlation for it to be related to the drug. Any side effect that is observed in more than 2% of clinical trial participants is considered a side effect of the drug whether related to the drug or not.

Now, we don't really follow adverse events as well when a drug or vaccine goes into the general population. This is why it is very difficult to determine what is going on. So while I generally agree that we need it to be something serious the vaccine (or any vaccine) could be harming people at a level that isn't death and we may not ever be told about it because of the set-up of our reporting systems and the lack of reporting by physcians.

 

[MisterPenguin]

This isn't really true the way you have it laid out. You don't have to have proof of correlation for it to be related to the drug. Any side effect that is observed in more than 2% of clinical trial participants is considered a side effect of the drug whether related to the drug or not.

That's in clinical trials.

We were talking about what happens if there are purported side effects after trials. And for a side effect sever enough which would then cause the vaccine to be pulled.

 

[Tink242424]

My question to the anti vaccine crowd is the following: with a worldwide epidemic, what’s the alternative viable solution to end it outside of a viable and safe vaccine? I anticipate many will be anti the vaccine and I place no judgement on anyone’s personal believes or views. In fact, although I am not an anti vaccine person and have my kids all Up to date with their vaccines and my own share of mandatory vaccines, I am personally not one who is quick to sign up for pharmaceutical intervention or therapeutics unless absolutely necessary.

But looking at the big picture in terms of worldwide health and global economic implications, if not a vaccine, then what’s the solution here?

How about treatment solutions? Then you are only treating the people who have contracted the virus. There are a lot of reasons that people don't want to and shouldn't be forced to take vaccines. The fact is that some people die from vaccines. If you think even 1 COVID death is too much then do you feel the same about possibly a few otherwise healthy people dying from the vaccine?

There are several ways out of this and herd immunity is one and viable treatment options is another. There are plenty of other bacteria and viruses that we don't have vaccines for that we are able to treat. That is my hope to move forward as no one should be forced to have a vaccine. If you want to take it voluntarily then good for you...

 

[Tink242424]

That's in clinical trials.

We were talking about what happens if there are purported side effects after trials. And for a side effect sever enough which would then cause the vaccine to be pulled.

Yes, and there are problems with after market reporting as it generally isn't done. So it could still cause major issues and no one would be able to prove it. I would not take the vaccine for at least 6mos if not a year of it being out. I'm not going to be a guinea pig.

 

[GoofGoof]

It is my understanding that full FDA approval of a vaccine won’t happen until the second half of 2021. If a vaccine proves safe and effective by the end of the year it could get emergency authorization but full approval would not happen until safety data is monitored for at least a year on the patients from the initial trial. It is possible that enough people get vaccinated under emergency approval to snuff out the virus before full approval ever occurs.

Below is from an article on the requirements:

Here is how a fast approval might play out, if all goes well — and some warning signs that a science-based process is not being followed.

The FDA has laid out clear criteria for the full approval of a vaccine: It should reduce the rate of symptomatic Covid-19 disease by 50%. Equally important is that the data should suggest it’s highly unlikely that the vaccine could possibly be less than 30% effective. Any vaccine less effective than that would be useless.

The agency also said that there should be safety data of a year or more for at least 3,000 patients. There’s no way to shorten that timeframe, and it is one of the reasons experts believe the FDA could grant a Covid-19 vaccine an emergency use authorization, rather than full approval.

 

[oceanbreeze77]

I will NOT be getting the nov vaccine for obvious reasons we dont need to go into....but It will also be interesting to see what happens to people who already had it this past year in 2021. We still dont know all of the long term effects. Will the vaccine impact their "long haul" symptoms? Will it be ineffective for them? It is a very complex virus that has me asking millions of questions.

*Adding I'm VERY pro vaccine, the circumstances surrounding the November drop are....suspect.

 

[mmascari]

My question to the anti vaccine crowd is the following: with a worldwide epidemic, what’s the alternative viable solution to end it outside of a viable and safe vaccine?

Is there really a large anti vaccine crowd commenting here? (Or, any there were not already anti vaccine in general?)

Most of the posts above aren't really "anti vaccine", they're just defining what a vaccine is more completely including all of the unstated but assumed vaccine attributes we're used to. An FDA approved and fully tested vaccine with all of the science, trials, data, and analysis over time that we assume is part of a vaccine. That's something that's impossible to rush faster than those steps take to accomplish.

That's very different from a politically motivated and pressured or emergency under specific conditions vaccine. They're not really the same thing. Millions of vaccines are taken every year with complete confidence that they are safe and effective. People want that same level of confidence in a new one. The post from @GoofGoof beat me to it.

As far as other viable solutions, it's the same as it's always been. We need to identify infected people, quarantine infected, contact trace, test contacts to identify, in a loop faster than the virus spreads. This is the basic way any infections disease is contained. In the US we do it just fine for TB. There's a TB vaccine, but it's not really used in the US, yet there's not endemic TB circulating around the country. Whenever a case is identified, it's quarantined, contact traced, tested, quarantined faster than the infection is able to spread.

 

[Disney Analyst]

Widespread COVID-19 vaccinations not expected until mid-2021, WHO says

https://www.cbc.ca/news/world/coronavirus-covid19-world-sept4-1.5712020

 

[MisterPenguin]

The fact is that some people die from vaccines.

Source?

 

[Disney Analyst]

Source?

I found this:

ncbi.nlm.nih.gov/pmc/articles/PMC4599698/

5. Conclusion

Vaccines are rigorously tested and monitored and are among the safest medical products in use. Millions of vaccinations are administered to children and adults in the United States each year. Serious adverse reactions are uncommon and deaths caused by vaccines are very rare. Healthcare providers can take specific actions to help prevent adverse reactions, including proper screening for contraindications and precautions and observing a 15-minute waiting period after vaccinating to prevent fall-related injuries from syncope. CDC and FDA continuously monitor the safety of US licensed vaccines. All serious VAERS reports, including reports of death, are reviewed. A report is considered serious if at least one of the following is reported: death, life-threatening illness, hospitalization or prolongation of hospitalization, or permanent disability [68]. In addition, CDC and FDA scientists use statistical techniques to check for disproportional reporting in the VAERS database for deaths and other adverse events for individual types and brands of vaccines [69]. If CDC or FDA were to detect a potential new safety problem with MMR or any other US licensed vaccine, this “signal” would be further assessed and regulatory and/or public health action would be taken, if necessary.

With respect to the recent claims of deaths caused by MMR vaccine [5–7], drawing broad cause and effect conclusions between vaccination and deaths based on spontaneous reports to VAERS, some of which might be anecdotal or second hand, is not a scientifically valid practice. In fact, a review of the VAERS data reveals that many of the death reports for MMR vaccine involved children with serious preexisting medical conditions or were likely unrelated to vaccination (e.g., accidents). These complete VAERS reports and any accompanying medical records, autopsy reports and death certificates have been reviewed in depth by FDA and CDC physicians and no concerning patterns have emerged that would suggest a causal relationship with the MMR vaccine and death.

The evidence for the safety and effectiveness of vaccines routinely given to children and adults in the Unites States is overwhelmingly favorable. In the case of MMR vaccine, this includes preventing hundreds of potential measles-related deaths each year [34]. Any discussion of the true risks of vaccination should be balanced by acknowledgment of the well-established benefits of vaccines in preventing disease, disability and deaths from infectious diseases.

 

[oceanbreeze77]

There are several ways out of this and herd immunity is one and viable treatment options is another.

So many epidemiologists and doctors around the world have come out and stated herd immunity will not work.