Mark52479
Well-Known Member
agree. One of the reasons I think Disney will never require 2 masks
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Coronavirus and Walt Disney World general discussion
- Thread starter Parker in NYC
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Disney Experience
Well-Known Member
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
Premium Member
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
"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.”
www.cnbc.com
Direct link to the FDA guidance.
www.fda.gov
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
Disney Experience
Well-Known Member
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."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
ToTBellHop
Well-Known Member
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
Well-Known Member
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.
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 ...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…
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 ...
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."
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.
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
Premium Member
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
Premium Member
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
Premium Member
That...why is that a “non-starter”?
sullyinMT
Well-Known Member
And the indoor mask-free area at Launch Bay (though you aren’t supposed to roam and explore the exhibits sans mask)
ToTBellHop
Well-Known Member
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
Well-Known Member
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
Premium Member
...I had honestly forgotten that was there...
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
Premium Member
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.
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