Coronavirus and Walt Disney World general discussion

[Disney Experience]

You are correct. When I went back to read the article and not just the quoted blurb... I actually was mostly in agreement with the article. It’s conclusion was very different than the purpose for which it was being cited.

What people need to remember is how limited these studies actually are. When talking about a “20,000 person study” — That sounds huge. Wow... 20,000 people and no deaths just from using the vaccine!!!
But no.. It’s approximately 10,000 people who got a placebo... 10,000 People got the vaccine. Both groups continued to socially distance and mask to the same degree (Since they didn’t know if they got vaccine or placebo).

Then after a couple of months, you compared how many people got infected, hospitalized, etc..
So maybe in the placebo group....200 out of the 10,000 were infected in the 3 months of the study. 20 were hospitalized out of those 200. And 2 out of those 20 died.
In the vaccinated group.... 20 got infected. And thus, it was 90% effective! 20 infections vs 200.
And from there, the same sizes get smaller and smaller. How confident in a conclusion can you be that 0 out of the 20 required hospitalization? Fact that 0 out of 20 didn’t require hospitalization doesn’t give me huge confidence that it would be 0 out of thousands.. 0 out of millions. If you would typically expect 5-10% to require hospitalization — You’d only expect 1-2 of those people to need hospitalization. So the drop from 1-2 shouldn’t inspire massive confidence that there is “100% effectiveness against hospitalization.”
And the fact that there were 0 deaths deals with an even smaller sample size. Ok, 0 out of 20 died.... And the normal IFR of about 0.5% suggests that in a random sample of 20 infections, you’d probably get 0 deaths.

Which is one reason Pfizer is interested in seeing the results in Israel. Larger sample size than study, and in a real world situation (Technically the phase 3 trials are real world, and in Pfizer's case it is about 42,000 subjects in the trial)

Studies site confidence levels, and interim results are usually set to get an acceptable level of confidence. The big trials so far focused on effectiveness against symptomatic disease, so the level of confidence they shot for is based on that primary goal. There were secondary goals. If one reads the interim study results we will see that the effectiveness has a +/- to it, to compensate for the study size and duration to that point.

I too would not give absolute confidence that any vaccine is 100% effective against covid related death given the amount of available data to date. But I think it is good (Like my non-quant, subjective response of "good" )

Pfizer originally was going to create their first interim report when they approached about 50 cases. They expected the end point to be when they got 150 cases . But by the time they submitted for EUA they exceeded the number (and I think was close to 200. They had decided not to report with only 50 cases even though that was their original protocol. Been a while since I read all of the documents, so my numbers may be off by a little bit)

A phase 3 study is never the final say. Nor were Phase 1 and 2. They each have a role in determining safety and efficacy, with an acceptable level of confidence. But nothing is 100% assured.

(Example: Sanofi's Dengue vaccine risks discovered post Phase 3 in the Philippians. https://www.sciencemag.org/news/201...leads-criminal-charges-researcher-philippines)

Or the H1N1 flu vaccine Pandemrix in Sweden:

Pandemrix-induced narcolepsy is associated with genes related to immunity and neuronal survival - PMC

The incidence of narcolepsy rose sharply after the swine influenza A (H1N1) vaccination campaign with Pandemrix. Narcolepsy is an immune-related disorder with excessive daytime sleepiness. The most frequent form is strongly associated with ...

www.ncbi.nlm.nih.gov

Pandemrix - Adjuvanted H1N1 Influenza Vaccine

Pandemrix is an adjuvanted vaccine used in the prevention of the H1N1 (swine flu) virus infection and has been developed…

www.clinicaltrialsarena.com

The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines - PMC

Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the ...

www.ncbi.nlm.nih.gov

 

[Sirwalterraleigh]

You mean voluntarily, though, right? I suppose people could choose to wear a mask the entire flu season instead of getting a flu shot, but I sure wouldn't. Shot takes a few seconds and that's it.

Again...this isn’t an enlightenment political debate while we feed each other grapes in the court of Versailles...

People had the “right” to exercise what their bonehead instincts were for exactly 11.5 months...and it looks like hell in retrospect...across the board.

Gave them the rope and they used it.

The ticker is at 512,398

 

[DCBaker]

"The Food and Drug Administration said Monday that modified Covid-19 vaccines against new, emerging variants may be authorized without the need for lengthy clinical trials.

The new guidance, released in a 24-page document on the FDA’s website, would clear the new vaccines as an amendment to a company’s originally approved emergency use application, according to the FDA. The company would need to submit new data that shows the modified vaccine produces a similar immune response and is safe, similar to the process for annual flu vaccines."

“Preliminary reports from clinical trials evaluating COVID-19 vaccine candidates in multiple countries including South Africa have added to concerns that vaccine efficacy against the B.1.351 variant may be lower than against the original virus,” the agency wrote in the document, referring to the strain found in South Africa. “Thus, there is an urgent need to initiate development and evaluation of vaccines against these SARSCoV-2 variants.”

FDA says Covid vaccines that target new variants won't need large clinical trials to win approval

The FDA said Monday that modified Covid-19 vaccines against new, emerging variants may be authorized without the need for lengthy clinical trials.

www.cnbc.com

Direct link to the FDA guidance.

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

FDA Issues Policies Addressing Virus Variants

www.fda.gov

 

[Disney Experience]

"The Food and Drug Administration said Monday that modified Covid-19 vaccines against new, emerging variants may be authorized without the need for lengthy clinical trials.

Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

FDA Issues Policies Addressing Virus Variants

www.fda.gov

Technically they said it would require more discussions. But they seem to be suggesting that they would be open to something less than a full Phase 3 type study.

Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may
be authorized without the need for clinical studies.

 

[ToTBellHop]

The federal level has virtually nothing to do with it. That's why people who hoped Biden was going to issue a national mask mandate or impose other sorts of restrictions have been disappointed. This is entirely managed at the state level. There is very little that the federal government can impose centrally.

In many states, restrictions are already being relaxed. Mine is one of them. For example, permitting larger social gatherings and having schools back for full, in-person, five day per week classes. Less restrictions on restaurants and retail stores. And so forth.

I don't mean this to be rude, but I believe your expectation is not matching the reality that we are seeing throughout the country. States are already starting to relax restrictions and people are already starting to resume things they had stopped because of the drastically lower case numbers we are seeing. When we see vaccination ramp up to the levels they are predicting by May, June, July, etc., you are going to see most of the restrictions drop away. Guaranteed.

Absolutely. My state (Connecticut) announced the final vaccine schedule today. Vaccine will be available to ANYONE over 16 on May 3. There will be little appetite for restrictions within a few weeks of that date, here. I can see holding the line through about Memorial Day to give people a chance to get in, but not much longer than that. And we are a more-restrictive state.

 

[Disney Experience]

Absolutely. My state (Connecticut) announced the final vaccine schedule today. Vaccine will be available to ANYONE over 16 on May 3. There will be little appetite for restrictions within a few weeks of that date, here. I can see holding the line through about Memorial Day to give people a chance to get in, but not much longer than that. And we are a more-restrictive state.

Take a little time for people to get an appointment for a shot, and then we are talking weeks till second shot, and a little longer for peak immunity numbers. So people should (But may not) understand in Connecticut that it will be a little longer after availability(In the sense of getting a reservation for shot if available) to all. I agree people's patience will decrease over time. Ideally they should wait for objective signs of mitigation success. But people are not patient in reality.

The key factor is to see cases, serious cases, and deaths decline enough that mitigation beyond being vaccinated is optional. This will happen as we approach herd immunity or sooner if we are mitigating the virus in other ways.

 

[havoc315]

Which is one reason Pfizer is interested in seeing the results in Israel. Larger sample size than study, and in a real world situation (Technically the phase 3 trials are real world, and in Pfizer's case it is about 42,000 subjects in the trial)

Studies site confidence levels, and interim results are usually set to get an acceptable level of confidence. The big trials so far focused on effectiveness against symptomatic disease, so the level of confidence they shot for is based on that primary goal. There were secondary goals. If one reads the interim study results we will see that the effectiveness has a +/- to it, to compensate for the study size and duration to that point.

I too would not give absolute confidence that any vaccine is 100% effective against covid related death given the amount of available data to date. But I think it is good (Like my non-quant, subjective response of "good" )

Pfizer originally was going to create their first interim report when they approached about 50 cases. They expected the end point to be when they got 150 cases . But by the time they submitted for EUA they exceeded the number (and I think was close to 200. They had decided not to report with only 50 cases even though that was their original protocol. Been a while since I read all of the documents, so my numbers may be off by a little bit)

A phase 3 study is never the final say. Nor were Phase 1 and 2. They each have a role in determining safety and efficacy, with an acceptable level of confidence. But nothing is 100% assured.

(Example: Sanofi's Dengue vaccine risks discovered post Phase 3 in the Philippians. https://www.sciencemag.org/news/201...leads-criminal-charges-researcher-philippines)

Or the H1N1 flu vaccine Pandemrix in Sweden:

Pandemrix-induced narcolepsy is associated with genes related to immunity and neuronal survival - PMC

The incidence of narcolepsy rose sharply after the swine influenza A (H1N1) vaccination campaign with Pandemrix. Narcolepsy is an immune-related disorder with excessive daytime sleepiness. The most frequent form is strongly associated with ...

www.ncbi.nlm.nih.gov

Pandemrix - Adjuvanted H1N1 Influenza Vaccine

Pandemrix is an adjuvanted vaccine used in the prevention of the H1N1 (swine flu) virus infection and has been developed…

www.clinicaltrialsarena.com

The complementary roles of Phase 3 trials and post-licensure surveillance in the evaluation of new vaccines - PMC

Vaccines have led to significant reductions in morbidity and saved countless lives from many infectious diseases and are one of the most important public health successes of the modern era. Both vaccines' effectiveness and safety are keys for the ...

www.ncbi.nlm.nih.gov

Absolutely. We are seeing lots of both over-confidence and under-confidence in the vaccines based on the studies, people reading their biases into them.

Really though... Boils down to this:

1 -- The vaccines are very very good
2 -- The vaccines are good enough, that vaccinated people congregating with other vaccinated people should be very very safe
3 -- The vaccines are not perfect and there are A LOT of unknowns: therefore, mitigation measures should still be implemented when congregating in large groups, with unvaccinated individuals, etc..
4 -- The vaccines are good enough that mass vaccination in sufficient numbers can effectively reduce Covid to practically nothing.

Ironically... the people who claim to be vaccine optimists are often the most pessimistic. I keep hearing the line, "we can never get rid of Covid, so we should just go back to normal as soon as vaccines are widely available this Spring."

 

[havoc315]

Absolutely. My state (Connecticut) announced the final vaccine schedule today. Vaccine will be available to ANYONE over 16 on May 3. There will be little appetite for restrictions within a few weeks of that date, here. I can see holding the line through about Memorial Day to give people a chance to get in, but not much longer than that. And we are a more-restrictive state.

You realize that availability May 3 does not mean everyone can get their 2 doses by Memorial day.

There are lots of people who have been eligible for the vaccine since January..... For example my Aunt has been eligible for the last month, she has an appointment for her first dose on April 30th, earliest appointment she could get.

So, becoming eligible on May 3rd.... many of those people will need to wait until June or July just for their first dose.

 

[havoc315]

Take a little time for people to get an appointment for a shot, and then we are talking weeks till second shot, and a little longer for peak immunity numbers. So people should (But may not) understand in Connecticut that it will be a little longer after availability(In the sense of getting a reservation for shot if available) to all. I agree people's patience will decrease over time. Ideally they should wait for objective signs of mitigation success. But people are not patient in reality.

The key factor is to see cases, serious cases, and deaths decline enough that mitigation beyond being vaccinated is optional. This will happen as we approach herd immunity or sooner if we are mitigating the virus in other ways.

Correct.... saying anyone can sign up for a vaccine as of May 3rd... is pretty consistent with the timeline announced by Biden that everyone can get fully vaccinated by the end of July. And even that might be a little too optimistic.

 

[Chi84]

Again...this isn’t an enlightenment political debate while we feed each other grapes in the court of Versailles...

People had the “right” to exercise what their bonehead instincts were for exactly 11.5 months...and it looks like hell in retrospect...across the board.

Gave them the rope and they used it.

The ticker is at 512,398

I was responding to JoeCamel’s suggestion about using masks for the annual flu instead of getting a yearly flu shot. What are you talking about?

 

[danlb_2000]

Absolutely. We are seeing lots of both over-confidence and under-confidence in the vaccines based on the studies, people reading their biases into them.

Really though... Boils down to this:

1 -- The vaccines are very very good
2 -- The vaccines are good enough, that vaccinated people congregating with other vaccinated people should be very very safe
3 -- The vaccines are not perfect and there are A LOT of unknowns: therefore, mitigation measures should still be implemented when congregating in large groups, with unvaccinated individuals, etc..
4 -- The vaccines are good enough that mass vaccination in sufficient numbers can effectively reduce Covid to practically nothing.

Ironically... the people who claim to be vaccine optimists are often the most pessimistic. I keep hearing the line, "we can never get rid of Covid, so we should just go back to normal as soon as vaccines are widely available this Spring."

I am very optimistic about the effectiveness of the vaccine, what I am not optimistic about is people's desire to do what needs to be done to get virus down to "practically nothing".

 

[Sirwalterraleigh]

I was responding to JoeCamel’s suggestion about using masks for the annual flu instead of getting a yearly flu shot. What are you talking about?

That...why is that a “non-starter”?

 

[sullyinMT]

If you count indoor shows without live performers then there is Carousel of Progress, Muppets, and Country Bears.

And the indoor mask-free area at Launch Bay (though you aren’t supposed to roam and explore the exhibits sans mask)

 

[ToTBellHop]

You realize that availability May 3 does not mean everyone can get their 2 doses by Memorial day.

There are lots of people who have been eligible for the vaccine since January..... For example my Aunt has been eligible for the last month, she has an appointment for her first dose on April 30th, earliest appointment she could get.

So, becoming eligible on May 3rd.... many of those people will need to wait until June or July just for their first dose.

Yes, I understand that. Here in CT, it is anticipated that we will soon be at 100k new first doses per week. There are about 2.2 million adults who have not initiated vaccination. Trends nationwide show about 2/3 of those eligible for vaccine are trying to get it. That is 1.5 million people. So everyone who is eligible and wants the vaccine would get it (not sign up—get shot 1) by 6/7. Shot 2 by 7/5.

With that said, it is anticipated that we will exceed 100k first shots per week soon (especially when JnJ appreciably appears in April). That will easily pull first dose availability to Memorial Day and 2nd dose by late June for Moderna and Pfizer. Then people will trickle in over the summer along with, at some point, kids.

I can’t speak for how other states are running the show but here, you could sign up today for a shot in March (just signed MIL up)—not months into the future. I do recognize that, for some reason, CT is #3 in vaccine administration in the country—and doing much better than other densely-populated states. Someone is doing something right...

 

[sullyinMT]

That is sad because of the side benefit of crushing the flu. A chart that really highlights what a difference wearing masks can have on a virus. I'm all for wearing them if we ditch the marginal yearly flu shot and keep the bugs to ourselves rather than spreading the wealth of germs.

View attachment 534491

The flu “disappearance,” or darn near it, is due to both the marginal shot AND masks. Knowing Pfizer/BNT are working on mRNA flu shots that can be modified in the season for dominant strain(s) could be a game-changer for future flu seasons. Hopefully within the half-decade.

But, your point is well taken.

 

[Sirwalterraleigh]

And the indoor mask-free area at Launch Bay (though you aren’t supposed to roam and explore the exhibits sans mask)

...I had honestly forgotten that was there...

 

[havoc315]

I am very optimistic about the effectiveness of the vaccine, what I am not optimistic about is people's desire to do what needs to be done to get virus down to "practically nothing".

I'm uncertain. The "good" news is that we have had such wide infection, 30% of the population may already be carrying some partial immunity. That could lower the threshold for herd immunity.

If we need to reach 90% for herd immunity, then I'm very pessimistic.
But say it's 70%...

Then we might be able to get there with 50-60% of the population getting voluntarily vaccinated..

Further, if we are short... we might see compulsory vaccination in some form.

 

[Sirwalterraleigh]

I'm uncertain. The "good" news is that we have had such wide infection, 30% of the population may already be carrying some partial immunity. That could lower the threshold for herd immunity.

If we need to reach 90% for herd immunity, then I'm very pessimistic.
But say it's 70%...

Then we might be able to get there with 50-60% of the population getting voluntarily vaccinated..

Further, if we are short... we might see compulsory vaccination in some form.

Except prior exposure does not appear to provide longterm immunity. The “benchmark” now seems to be 90 days.

That’s nothing

Everyone line up and arms out...save the chatter.


I know that it’s not what people want to hear...either side...but it’s the endgame. Look at the history of the polio vaccine as a good example.

 

[havoc315]

Except prior exposure does not appear to provide longterm immunity. The “benchmark” now seems to be 90 days.

That’s nothing

Everyone line up and arms out...save the chatter.


I know that it’s not what people want to hear...either side...but it’s the endgame. Look at the history of the polio vaccine as a good example.

The duration of long term immunity is a real question mark. The consensus for now, appears to be that one can indeed become reinfected ... BUT.... most of the time, the re-infection will be less severe. Thus, some degree of long term protection.

 

[Sirwalterraleigh]

The duration of long term immunity is a real question mark. The consensus for now, appears to be that one can indeed become reinfected ... BUT.... most of the time, the re-infection will be less severe. Thus, some degree of long term protection.

Good point.