Coronavirus and Walt Disney World general discussion

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Heppenheimer

Heppenheimer

Well-Known Member
Dan Deesnee said:
The 10-15 year process is in place for a reason. If their were hardly any issues found with vaccines after the first year or two in development then obviously at some point in the past 50 years the process length would have been shortened.

I don't want to go back and forth in depth on a subject neither of us understands enough about. I'll just state the facts. The Covid vaccines are being rushed through. The standard process is 10-15 x longer than the amount of time the Covid vaccine is being given.

If someone can't see the safety (potentially massive) issues there then I'm not sure what to tell them.

I like you GoofGoof so I don't want to go back and forth all night on this. Don't take any of my replies as attacking you :)
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The "10-15 year" process you keep referring to has more to do with economics and available case numbers than testing protocols. Much of the delay in traditional vaccine development was due to securing additional funding between trial stages and setting up the infrastructure and processes to manufacture the vaccine once it was approved. Governments throughout the world have provided guaranteed funding so now the pharamceutical companies can work on multiple aspects of the vaccine at once, rather than the step-wise approach that needed new funding with each bit of progress.

The other reason why this process can be accelerated is that with a disease with as high an incidence as COVID-19 (in the millions currently), the "n" number for the studies gives them much more power and quicker turn-over than for a disease with lower incidence, like for example, measles, who's annual incidence before vaccination was only in the 10s of thousands.

As for safety, no vaccine has ever failed a trial or needed to be withdrawn because of delayed side effects. Most of the side effects of vaccines appear within days of receiving the dose. The most severe (and fortunately, extremely rare) complication, Guillan-Barre syndrome, arises within days to weeks after the causitive event, not months to years later.

I would think the reasons for the accelerated development during a pandemic would be obvious, given how this virus has disrupted the lives of virtually everyone on the planet. Vaccine development was traditionally slower not due to policy, but due to a lack of urgency.
 
Tink242424

Tink242424

Well-Known Member
Heppenheimer said:
The "10-15 year" process you keep referring to has more to do with economics and available case numbers than testing protocols. Much of the delay in traditional vaccine development was due to securing additional funding between trial stages and setting up the infrastructure and processes to manufacture the vaccine once it was approved. Governments throughout the world have provided guaranteed funding so now the pharamceutical companies can work on multiple aspects of the vaccine at once, rather than the step-wise approach that needed new funding with each bit of progress.

The other reason why this process can be accelerated is that with a disease with as high an incidence as COVID-19 (in the millions currently), the "n" number for the studies gives them much more power and quicker turn-over than for a disease with lower incidence, like for example, measles, who's annual incidence before vaccination was only in the 10s of thousands.

As for safety, no vaccine has ever failed a trial or needed to be withdrawn because of delayed side effects. Most of the side effects of vaccines appear within days of receiving the dose. The most severe (and fortunately, extremely rare) complication, Guillan-Barre syndrome, arises within days to weeks after the causitive event, not months to years later.

I would think the reasons for the accelerated development during a pandemic would be obvious, given how this virus has disrupted the lives of virtually everyone on the planet. Vaccine development was traditionally slower not due to policy, but due to a lack of urgency.
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Umm no. Yes, some of the reason for the 10 year timeline is administrative and has to do with circulating cases but in all reality the entire drug development process for almost every drug and vaccine is a years long process. And having long term data for safety is USUALLY a LARGE requirement for approving new drugs and vaccines. The fact that we are expecting that we will know the full risk profile for a new vaccine is 1 year is mind blowing. Considering they trials will not even have been open for 1 full year before doses are starting to be administered. IF you worked in pharma like me you would understand that that is bonkers.

I have said before many pharma employees have expressed their concern with how fast these vaccines are being developed. Many of them will NOT be taking these vaccines in the next year or 2 until a long term safety has been established.

And god help us if they try to mandate this vaccine (which they will try as they need to make back all the money they invested into these vaccines) as that will incite a large revolt in this country.
 
Heppenheimer

Heppenheimer

Well-Known Member
Tink242424 said:
Umm no. Yes, some of the reason for the 10 year timeline is administrative and has to do with circulating cases but in all reality the entire drug development process for almost every drug and vaccine is a years long process. And having long term data for safety is USUALLY a LARGE requirement for approving new drugs and vaccines. The fact that we are expecting that we will know the full risk profile for a new vaccine is 1 year is mind blowing. Considering they trials will not even have been open for 1 full year before doses are starting to be administered. IF you worked in pharma like me you would understand that that is bonkers.

I have said before many pharma employees have expressed their concern with how fast these vaccines are being developed. Many of them will NOT be taking these vaccines in the next year or 2 until a long term safety has been established.

And god help us if they try to mandate this vaccine (which they will try as they need to make back all the money they invested into these vaccines) as that will incite a large revolt in this country.
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Long-term safety data is particularly important for medications that people will take daily or more frequently. However, even here, much of this data is acquired through post-marketing surveys, where the much larger sample population allows the researchers to see effects that were too rare to observe in the pre-marketing studies. The CDC and FDA have decades worth of post-marketing surveys for vaccines, and guess what? In the modern era, we've only had to remove a previously approved vaccine for immediate and short-term side effects, not any long-term problems. In those that were removed, like the previously mentioned H1N1 and the original rotavirus vaccine, the problems manifested themselves, at most, within weeks of receiving the vaccine, and still only affected a very tiny cohort of the people who received it. Also, we release the yearly influenza vaccines with, at most, only a couple of weeks of safety data.

And really, on a biological level, there really isn't any feasible mechanism why a vaccine would cause a problem years later. The actual material injected by the vaccine, which is orders of magnitude less than most people ingest in medications daily, is out of your system or broken down within days. The lasting effect of vaccines is not due to the physical presence of the vaccine particles or dilutents themselves within your body, but due to the recruitment of memory B and T cells waiting to fight the infection they are designed to prevent. If there is an error and these cells provoke an auto-immune response, it generally happens relatively quickly. Minutes to weeks later, not months to years.
 
Miss Bella

Miss Bella

Well-Known Member
Chi84 said:
Be a great incentive for that 50%, especially if a lot of businesses and employers decided to make it a requirement. Right now it’s just interesting speculation.
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I don't know 50% is a big number especially during a bad recession.
 
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sullyinMT

sullyinMT

Well-Known Member
Heppenheimer said:
Long-term safety data is particularly important for medications that people will take daily or more frequently. However, even here, much of this data is acquired through post-marketing surveys, where the much larger sample population allows the researchers to see effects that were too rare to observe in the pre-marketing studies. The CDC and FDA have decades worth of post-marketing surveys for vaccines, and guess what? In the modern era, we've only had to remove a previously approved vaccine for immediate and short-term side effects, not any long-term problems. In those that were removed, like the previously mentioned H1N1 and the original rotavirus vaccine, the problems manifested themselves, at most, within weeks of receiving the vaccine, and still only affected a very tiny cohort of the people who received it. Also, we release the yearly influenza vaccines with, at most, only a couple of weeks of safety data.

And really, on a biological level, there really isn't any feasible mechanism why a vaccine would cause a problem years later. The actual material injected by the vaccine, which is orders of magnitude less than most people ingest in medications daily, is out of your system or broken down within days. The lasting effect of vaccines is not due to the physical presence of the vaccine particles or dilutents themselves within your body, but due to the recruitment of memory B and T cells waiting to fight the infection they are designed to prevent. If there is an error and these cells provoke an auto-immune response, it generally happens relatively quickly. Minutes to weeks later, not months to years.
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Yep. The list of medications pulled after market launch is astonishing. -2 inhibitors, Trasylol, and Reglan all come to mind. I’m sure there are others even more recent, and the historic list is huge.

Filter got me. *** is for a drug class that includes Celebrex and Vioxx
 
Miss Bella

Miss Bella

Well-Known Member
Tink242424 said:
Umm no. Yes, some of the reason for the 10 year timeline is administrative and has to do with circulating cases but in all reality the entire drug development process for almost every drug and vaccine is a years long process. And having long term data for safety is USUALLY a LARGE requirement for approving new drugs and vaccines. The fact that we are expecting that we will know the full risk profile for a new vaccine is 1 year is mind blowing. Considering they trials will not even have been open for 1 full year before doses are starting to be administered. IF you worked in pharma like me you would understand that that is bonkers.

I have said before many pharma employees have expressed their concern with how fast these vaccines are being developed. Many of them will NOT be taking these vaccines in the next year or 2 until a long term safety has been established.

And god help us if they try to mandate this vaccine (which they will try as they need to make back all the money they invested into these vaccines) as that will incite a large revolt in this country.
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No one I work with wants it. There is also the fact that about 30% of my co-workers have already had the virus and recovered just fine. The rest of us wonder if we already had it or if we just aren't going to get it. The people were admitting with Covid aren't as sick as they were a couple of months ago. Could the virus be less virulent? There are just so many unknowns.

It's hard to believe we've only been in this for 7 months. It feels like 7 years. By the time they come out with a safe vaccine this virus could be a thing of the past.
 
Dan Deesnee

Dan Deesnee

Well-Known Member
If a vaccine works to protect someone from Covid, why would everyone have to get it? Wouldn't it simply be optional for those who are fearful or have medical issues that put them at risk? How would anyone unvaccinated put anyone vaccinated at risk?

If the answer is "the vaccine might not provide full immunity" then the vaccine is not going to be the magic bullet to get us past this virus many people seem to think it will be.

In the above scenario Covid likely becomes something we simply have to take precautions on similar to the flu every year. Until a cure or more effective treatments are developed.
 
sullyinMT

sullyinMT

Well-Known Member
pocketlint said:
this reminds me..is reglan road still open at DS?
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Dunno. We were planning on visiting for the first time during our cancelled Memorial Day trip. But if they are, I’d assume no entertainment. And I can get pub food without entertainment most anywhere so we haven’t checked and are doing Homecomin’ instead.
Raglan Road does look fun in “normal” times, though!
 
seabreezept813

seabreezept813

Well-Known Member
GoofGoof said:
I could see it for certain jobs for sure. Like working at a nursing home or some other professions where it would be critical to keep people free from Covid. Cruise ships have a lot to lose with a Covid outbreak. It’s a tough call.
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Ya I view being vaccinated like mask wearing. You are doing it for others as well as yourself. When kids who can’t be vaccinated, like cancer patients, get sick from those who won’t vaccinate by choice it seems wrong to me.
 
pocketlint

pocketlint

Member
sullivan.kscott said:
Dunno. We were planning on visiting for the first time during our cancelled Memorial Day trip. But if they are, I’d assume no entertainment. And I can get pub food without entertainment most anywhere so we haven’t checked and are doing Homecomin’ instead.
Raglan Road does look fun in “normal” times, though!
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it is a fun place to visit..i miss it for the wonderful people and the live music..
 
D

DisneyCane

Well-Known Member
Dan Deesnee said:
If a vaccine works to protect someone from Covid, why would everyone have to get it? Wouldn't it simply be optional for those who are fearful or have medical issues that put them at risk? How would anyone unvaccinated put anyone vaccinated at risk?

If the answer is "the vaccine might not provide full immunity" then the vaccine is not going to be the magic bullet to get us past this virus many people seem to think it will be.

In the above scenario Covid likely becomes something we simply have to take precautions on similar to the flu every year. Until a cure or more effective treatments are developed.
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The answer is that the vaccine will not provide immunity in 100% of people. Since it doesn't, the "herd immunity" level via the vaccine must be reached in order to stop the spread. It is unknown what the herd immunity level is for this virus but let's assume 60%. If the vaccine is 70% effective and only 70% of the population takes it, only 49% of the population will be immune which will not reach the "herd immunity" level.

If the vaccine was over 90% effective, then it wouldn't matter if a large percentage of the population opted not to take it.
 
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