Vaccine Trials

[gerntz]

Just saw on the evening news about second thoughts and a special meeting (I believe on Tuesday) on whether nursing home residents should be in the first wave of recipients of the first vaccines. Reason is because of caution about possible side effects for such a fragile population. Maybe should wait and see a bit.

So, what happened to 95% effective and very little side effects?

Regardless, I think nursing home workers should get vaccine before residents. They are more likely spreaders to elderly than the residents are.

But, how does waiting change what the elderly's side effects will be when they get the shots? Non-effective caution imo.

I wouldn't trust/consider evening news on this subject. Stick to the CDC over them.

 

[easysurfer]

Regardless, I think nursing home workers should get vaccine before residents. They are more likely spreaders to elderly than the residents are.

But, how does waiting change what the elderly's side effects will be when they get the shots? Non-effective caution imo.

I wouldn't trust/consider evening news on this subject. Stick to the CDC over them.

The emergency meeting will be by the CDC.

Advisers to the US Centers for Disease Control and Prevention have called an emergency meeting for Tuesday to vote on who they recommend should be the first to get a coronavirus vaccine once one is authorized.

Members of the committee will also discuss clinical considerations. One worry is side effects from the vaccine, and whether vaccinating frail nursing home residents, who may be likely to suffer a number of health events regardless of vaccination, could damage faith in the safety of the immunizations.

https://wsvn.com/news/us-world/cdc-...rgency-meeting-to-vote-on-who-gets-one-first/

 

[Gumby]

Just saw on the evening news about second thoughts and a special meeting (I believe on Tuesday) on whether nursing home residents should be in the first wave of recipients of the first vaccines. Reason is because of caution about possible side effects for such a fragile population. Maybe should wait and see a bit.

So, what happened to 95% effective and very little side effects?

Extremely intelligent and incredibly dedicated people have been working night and day to bring a vaccine to you, and you respond by whining? Nice.

 

[easysurfer]

Extremely intelligent and incredibly dedicated people have been working night and day to bring a vaccine to you, and you respond by whining? Nice.

Don't shoot the messenger. I'm just repeating the news. Found it odd that suddenly the experts are talking about possibly not having the nursing home folks vacinated in the beginning. When story after story them getting shots early was a no brainer.

 

[Ronstar]

I read that United Airlines has just flown a plan load of vaccine from Belgium to Chicago. Appears that the vaccine is ready to rollout when it gets the green light from the FDA.

In the US, some agency (maybe CDC) needs to put together a comprehensive plan to administer the vaccine pronto. Make it a national plan so that all states follow the plan - unlike the testing rollout where different parts of the country had different testing programs.

 

[Aerides]

It makes sense that nursing home residents might not be ideal early candidates, if they were not highly represented in the test trial pool. Just as children weren't. I'd imagine most vaccine trials for anything exclude those most vulnerable, for safety.

Pharma's don't want people dying during trials. It sets things back for everyone even if the vaccine isn't the issue - weeks of extra research at minimum.

So, unfortunately, when you've got a few months to get something out that could stop literally millions of deaths, and time is critical, but you don't yet know for sure that it's really safe and effective, you can't have 3 year olds or 97 year olds in the test group.

I view the 95% effective thing as applying to 95% of us if we're lucky. There are always exceptions, people who can't get every vaccine safely. But every person vaccinated brings the R0 rate down for the rest of us.

 

[RetireBy90]

I read that United Airlines has just flown a plan load of vaccine from Belgium to Chicago. Appears that the vaccine is ready to rollout when it gets the green light from the FDA.

In the US, some agency (maybe CDC) needs to put together a comprehensive plan to administer the vaccine pronto. Make it a national plan so that all states follow the plan - unlike the testing rollout where different parts of the country had different testing programs.

I disagree with a national vaccine plan. Different states and localities have different needs and demographics. The over 65 population in Florida and Phoenix are a larger percentage than in mid-west cities and need to be able to direct available supplies to most vulnerable according to the local demographics. I would agree with a framework that sets say health care workers and those that are being exposed daily as first priority. There can also be other framework guidelines but we need states and local government to be responsible for the last mile distribution and coordination. The constitution, our constitution is based on a core set of responsibilities and authorities being handed to federal government and those not are reserved for the states.

 

[Popeye]

The CDC has a playbook on their website already.

https://www.cdc.gov/vaccines/imz-ma...D-19-Vaccination-Program-Interim_Playbook.pdf

This document serves as an interim playbook for state, territorial (including the US-affiliated Pacific Islands [USAPI] of American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau), tribal, and local public health programs and their partners on how to plan and operationalize a vaccination response to COVID-19 within their jurisdictions.

Your state probably has something out there already as well. I know there’s a lot online for PA.

 

[CaptTom]

I disagree with a national vaccine plan. Different states and localities have different needs and demographics.

Good point. Decisions made at the lowest possible level are generally best. The federal government's role might be in making resources (distribution, logistics, money) available to state and local authorities who are in the best position to prioritize activities within their communities.

I'm sure in today's polarized society, there will be some level of politics involved. Still, our system is set up to make this work, if everyone puts the needs of the citizens above their petty party bickering. We can hope.

 

[Car-Guy]

I just heard Moderna will request emerge approval today... It was also "reported" that the CDC will respond on December 17th... That's another 2 and 1/2 "more weeks"....I must have heard it wrong or it's being mis-reported. Surely the CDC has been keeping up very closely with the details on Moderna's vaccine and not waiting for the actual filing. I'm sure (or hope) there is a good reason.

Sure they need to fully understand what's being requested but I have a hard time believing they don't already know!

I'm sure someone here that keeps up with this better than I do, knows with some "certainty" why. I can guess too....

 

[Badger]

Still, our system is set up to make this work, if everyone puts the needs of the citizens above their petty party bickering. We can hope.

Good luck with that. It hasn't worked so far. Watch the numbers start rising even faster in a week because people didn't do what you are hoping for during Thanksgiving. Christmas is coming. Are the citizens being naughty or nice?



Cheers!

 

[Go-NoGo]

I just heard Moderna will request emerge approval today... It was also "reported" that the CDC will respond on December 17th... That's another 2 and 1/2 "more weeks"....I must have heard it wrong or it's being mis-reported. Surely the CDC has been keeping up very closely with the details on Moderna's vaccine and not waiting for the actual filing. I'm sure (or hope) there is a good reason.

Sure they need to fully understand what's being requested but I have a hard time believing they don't already know!

I'm sure someone here that keeps up with this better than I do, knows with some "certainty" why. I can guess too....

It's the FDA that will either approve or deny the application, not the CDC.
The FDA does not know what the data looks like as the companies have not submitted it, we only have press releases to go by.

The FDA requires the company to submit _all_ of the raw data from the clinical trial and they will analyze it to confirm safety and efficacy. Note that the EU and UK authorities do not do this - they only review the the reports generated by the Pharma companies and base their decision on it. This is faster, but has its own consequences.

 

[Car-Guy]

It's the FDA that will either approve or deny the application, not the CDC.
The FDA does not know what the data looks like as the companies have not submitted it, we only have press releases to go by.

The FDA requires the company to submit _all_ of the raw data from the clinical trial and they will analyze it to confirm safety and efficacy. Note that the EU and UK authorities do not do this - they only review the the reports generated by the Pharma companies and base their decision on it. This is faster, but has its own consequences.

OK, so the news said CDC and not the FDA.. Assuming that's correct, which sounds right to me, then the same question applies... Why hasn't the FDA been keeping on top of this... Seems "on this one" they (Moderna) should have been submitting the data along the way and they (FDA) should have been analyzing it.

I'm sure 2 and 1/2 more weeks is actually super fast for any approval but in this case "come on man" ..... NNTR

 

[Car-Guy]

It's the FDA that will either approve or deny the application, not the CDC.

Interesting ~2 minutes ago I heard them talking about this again... Guess what, this time they said the FDA and not the CDC.... They must be monitoring this board and corrected their mistake. Or maybe I heard it wrong.

 

[ivinsfan]

OK, so the news said CDC and not the FDA.. Assuming that's correct, which sounds right to me, then the same question applies... Why hasn't the FDA been keeping on top of this... Seems "on this one" they (Moderna) should have been submitting the data along the way and they (FDA) should have been analyzing it.

I'm sure 2 and 1/2 more weeks is actually super fast for any approval but in this case "come on man" ..... NNTR

They do have to report any serious issues with the trials as they are happening, I remember at least one of the trials was halted for several days.

Your other comment don't make sense, that's why they call them "trials: , run it , compile all the data when it's over and submit.

As they are waiting for approval I'm guessing that they and the government with continue working on the logistics of getting the vaccine out to the public, which is a big project.

 

[Car-Guy]

They do have to report any serious issues with the trials as they are happening, I remember at least one of the trials was halted for several days.

Yep, remember that too.

Your other comment don't make sense, that's why they call them "trials: , run it , compile all the data when it's over and submit.

I guess I didn't make my point(s) well enough... that's ok.....

As they are waiting for approval I'm guessing that they and the government with continue working on the logistics of getting the vaccine out to the public, which is a big project.

No doubt... And I would think that (distribution) would be a big part of operation warp speed.

 

[Chuckanut]

Found it odd that suddenly the experts are talking about possibly not having the nursing home folks vacinated in the beginning. When story after story them getting shots early was a no brainer.

Emphasis added.....

Ah... There's the problem. I will guess you are depending upon the stories you hear in our news media. The media tends to gloss over the details (that place where the Devil hangs out). Most being ignorant of the subject they are reporting on, literally don't know what they don't know. And they often don't seem to care, IMHO.

IOW, while these vaccines are very good news, there are still things they have to learn about them. A lot of things. Such as how long the immunity lasts, which vaccine may be better for this group and not as effective for that group, etc. etc. etc. My guess is that all this is known to the scientific community that is working on the vaccines, but the news media glosses over it at best.

May I suggest Dr. Osterholm's weekly podcast for a better (not perfect) source of information. About 30 minutes into #32 he tells an interesting story about how the media messed up something he said, the lack of any attempt to corroborate the inaccurate story, and how the one 'retraction' was messed up. FWIW, the good Dr. is on the President Elect's advisory team.

https://podcasts.apple.com/us/podcast/the-osterholm-update-covid-19/id1504360345

In this episode, Dr. Osterholm and host Chris Dall discuss the exponential growth of cases in the US and elsewhere, more promising news regarding vaccines and the obstacles that remain, the impact of surging cases on healthcare workers, and an opportunity to help out with the Frontline Families Fund.

 

[ivinsfan]

Yep, remember that too.



I guess I didn't make my point(s) well enough... that's ok.....



No doubt... And I would think that (distribution) would be a big part of operation warp speed.

I guess I didn't get my main point across either which is that the time is takes to approve the trial is not idle time and that data from an ongoing trial won't necessarily be the same as the final data.

I actually remember a thread back in Spring where some of us here, (me included) we saying no way in H would they have a vaccine in 18 months. I'm thrilled to be wrong.

 

[SecondCor521]

And some states and people are not as enthused about the vaccine and even if they're ahead of me in line they may defer for a while, which just moves those of us who prefer to get vaccinated earlier in the calendar.

CNBC reported yesterday that 42% of people don't want to be vaccinated even when a vaccine becomes available to them. That seems like a pretty significant accelerant to me, but it would of course depend on how those 42% are distributed across whatever priority scheme we end up with.

 

[ivinsfan]

CNBC reported yesterday that 42% of people don't want to be vaccinated even when a vaccine becomes available to them. That seems like a pretty significant accelerant to me, but it would of course depend on how those 42% are distributed across whatever priority scheme we end up with.

42%... well it kind of depends on how they worded the question. There are ways to phrase it that leans towards people saying No. Of course, not like the media would ever try to slant things.

That kind of news is just clickbait and doesn't help with anything but ratings.

 

[SecondCor521]

42%... well it kind of depends on how they worded the question. There are ways to phrase it that leans towards people saying No. Of course, not like the media would ever try to slant things.

That kind of news is just clickbait and doesn't help with anything but ratings.

I hear where you're coming from. But the stat was not a headline or the central point of the news story; it was just part of a general discussion of the rollout of the vaccine. And my main thought in providing it here was that the true number is possibly significant enough to accelerate the progress for those who do want the vaccine.

 

[harllee]

I think it is likely that a significant portion of the U.S. population will not get the Covid vaccine. After all less than 50% of adults in the U.S. typically get the flu vaccine. I think we will be lucky in the U.S. if 60% get the Covid vaccine. In other countries probably there will be a much higher vaccine rate. As for me I plan to get the Covid vaccine the first day I am permitted to do so.

 

[ivinsfan]

I hear where you're coming from. But the stat was not a headline or the central point of the news story; it was just part of a general discussion of the rollout of the vaccine. And my main thought in providing it here was that the true number is possibly significant enough to accelerate the progress for those who do want the vaccine.

One can hope for that...because doing even half the country is a huge undertaking.

 

[Amethyst]

We want it, too. We have just started getting flu vaccinations in the last couple of years, because we did not use to be terribly scared of the flu. We're scared less of COVID-19.

I think it is likely that a significant portion of the U.S. population will not get the Covid vaccine. After all less than 50% of adults in the U.S. typically get the flu vaccine. I think we will be lucky in the U.S. if 60% get the Covid vaccine. In other countries probably there will be a much higher vaccine rate. As for me I plan to get the Covid vaccine the first day I am permitted to do so.

 

[Alan]

Th Pfizer vaccine has passed regulatory approval in the UK. Once the manufacturing sites have been inspected vaccinations will begin, probably next week, starting with healthcare workers and care homes.