Older Cruisers Left Out of vaccine Trials

[Mary229]

11 minutes ago, CarelessAndConfused said:

 

Yes, and it seems like you may be one of those reading too many "political sites."  You gave no such examples.  You gave one example without any source cited but your own simple quick interpretation.  BTW, the UK is a "western source."  Most experts seem in agreement that a vaccine will only be 50% effective.  Does that not implicitly tell you that this isn't about people getting sick. 

I gave examples earlier in the thread and I will repeat.  I read FDA, CDC, WHO, NIH as well as the Netherlands and Canadian ministries responsible for health care and public health. I have on occasion read the Indian and Chinese sites but their organization is a bit difficult for me to wade through.    Saying I won't take a vaccine because of the political process is a political statement.  

 

Added.  Why did I choose those.  First I am familiar with the US sites and can easily find the public information.  Canada because they are taking a far more conservative approach, Netherlands because they are taking a slightly more liberal approach.  I read the others for a totally different perspective

Edited October 18, 2020 by Mary229

[Mary229]

12 minutes ago, CarelessAndConfused said:

 

What does any of that have to do with what you stated about the pause related to the clinical trial which is the only thing I was referring to?  It seems like you're hell bent on going off on some tangent and making this a political issue.  You seem all over the place implying that western sources aren't reliable but that is all you seem to cite.  What are these non-western sources that we need to be looking at?  And I never stated I wouldn't take the vaccine.  I'm sure I will once it has proven to be safe and effective in the wider population.

 

The saddest part of all of this is that there's already an effective tool against the virus, the likes of which many in your home state refuse to comply with due to reading too many "political sites."

I am not being political.  I am reading reliable sites from around the globe to see the consensus.The information about the UK trial I read about on the UK government website.There are key elements that there is scientific consensus.  Reading news articles is not reliable and I don't.  I have said numerous things but I will go back to my core issue of the condemnation of the vaccine which may alleviate a lot of human suffering.  I think making declarations that it is not studied properly is fear inducing and a very early conclusion.  The only people who are vaccinating at this point, to my knowledge, are the Chinese and Russians.  Those were not trials those were vaccination programs.  I have not recently read anything about those.    

 

I repeat I am not being political.  I am keeping an open mind and have volunteered for the trials (back in May).  I was not selected, yet, but I have received updates from the NIH.  I am willing to help alleviate human suffering.  

Edited October 18, 2020 by Mary229

[Potstech]

3 hours ago, CarelessAndConfused said:

 

Yes, and it seems like you may be one of those reading too many "political sites."  You gave no such examples.  You gave one example without any source cited but your own simple quick interpretation.  BTW, the UK is a "western source."  Most experts seem in agreement that a vaccine will only be 50% effective.  Does that not implicitly tell you that this isn't about people getting sick. 

Where is your source for your information as you ask it of others?

[Mary229]

1 hour ago, CarelessAndConfused said:

 

Source of information for what exactly?

 

 

Vaccine trials progress and setbacks.   I just think it is awful that people are trying to discourage others from taking a vaccine, just terrible disservice, frightening people needlessly.  There is not yet an offered vaccine, this is all premature speculation 

[Porky55]

11 hours ago, Mary229 said:

First putting things into perspective this is a worldwide issue.  What happens in the US is hardly impactful.  Many of these studies are NOT being conducted on US soil or under the supervision of the FDA.  That is our unfortunate egocentric view.  

 

Oh and, btw, thalidomide is still used outside of the US.  Yep.  Just consider all of the Shriners and St. Jude commercials.  Thalidomide is used off label for morning sickness.  Thalidomide was intended for cancer and leprosy.  

Had read this about Thalidomide - thought it was being used as a cancer treatment?

[Mary229]

2 minutes ago, CarelessAndConfused said:

 

These are Phase 3 clinical trials.  Which means that they are double blinded studies.  The patients, nor the doctors, even know whether they're being dosed with the drug or not.  How can one garner much detail on the progress from that?  The optimism from the drug companies you hear about likely stems from the fact that that they are seeing overall numbers of infections being less than they would have thought.  For all we know, there may be more infections from the treated group than the placebo group.  Further making the analysis a complete mess is that the habits of these individuals (being shuttered in, some wearing masks, others not, etc.) and not living their normal lives makes it even more difficult to distinguish how effective the vaccine is.

 

This is why I have a problem with your post declaring, completely erroneously, that the trial was stopped because someone got sick somehow implying that the vaccine is so infallible and working on those that aren't getting sick.  That is NOT the case.  It's people like you who are "frightening" because you are eager to spread misinformation on something that you clearly do not seem to understand.

I am not disseminating anything.  I am telling people where to seek reliable information rather than biased diatribes. Never once have I said to read a drug companies’ press release or information. Never once have I endorsed a single media outlet.  I continue to promote reading the various national and international health organizations’ websites.    I continue to say decrying vaccines that have not even been released is causing needless fear and panic.   Why do you feels studies are never paused for further investigation, they are.     Saying otherwise is another way of causing panic and distrust, implying the studies are not reliable.   I say wait and see,  nothing is being distributed in the western world.  

[caribill]

13 hours ago, CarelessAndConfused said:

 

  Most experts seem in agreement that a vaccine will only be 50% effective. 

 

I think that the FDA said they will be willing to approve a vaccine that is only 50% effective, not that vaccines might not be better than that.

[LDVinNC]

On 9/30/2020 at 9:27 PM, cruzsnooze said:

High risk seniors with underlying co-morbidity might also shun the vaccine for at least 6 months after it comes out to see what effect it has or hasn't.

 

I am one of those high risk seniors (high blood pressure, cancer in remission) and I will get the vaccine the minute it becomes available!  And I suspect I am not alone.

[Potstech]

15 hours ago, CarelessAndConfused said:

 

Source of information for what exactly?

 

 

The things you post saying others are wrong.

[Reader0108598]

2 hours ago, LDVinNC said:

 

I am one of those high risk seniors (high blood pressure, cancer in remission) and I will get the vaccine the minute it becomes available!  And I suspect I am not alone.

Also high risk and will get it when available! emphysema, Cancer survivor and a few other things I won't bore you with rather die from the vaccine then suffer for days in a hospital trying to breathe I already know how that feels, will take my chances!

 

 

 

 

 

 

Edited October 19, 2020 by Reader0108598

[cruzsnooze]

That's good for me because I will wait to see if and how you react to the vaccine before I commit. Thanks for your bravery.

[HappyInVan]

1 hour ago, Reader0108598 said:

Also high risk and will get it when available! emphysema, Cancer survivor and a few other things I won't bore you with rather die from the vaccine then suffer for days in a hospital trying to breathe I already know how that feels, will take my chances!

 

 

Good luck. After your vaccination, take care. Continue masking and distancing. 

 

From what I have read, a vaccine does not mean that everyone will be immune. Some will develop the disease though the prognosis may be milder than without vaccination.

 

 

[Reader0108598]

1 hour ago, HappyInVan said:

 

Good luck. After your vaccination, take care. Continue masking and distancing. 

 

From what I have read, a vaccine does not mean that everyone will be immune. Some will develop the disease though the prognosis may be milder than without vaccination.

 

 

Agree I wear my mask when I have to go out and  distance, stay home mostly!

 

Edited October 19, 2020 by Reader0108598

[Mary229]

I am not going to dig through all of Oxford's press releases to find what you specifically want, nor am I going back through the health services press releases to satisfy you.  You can do the research yourself.  This is a recent release - dig away on all of the press releases if you want.    But perhaps Oxford is not good enough for you, many people consider it a top tier university

 

Oxford Covid Trial Vaccinations Press releases - South Africa

[azbirdmom]

1 hour ago, Mary229 said:

I am not going to dig through all of Oxford's press releases to find what you specifically want, nor am I going back through the health services press releases to satisfy you.  You can do the research yourself.  This is a recent release - dig away on all of the press releases if you want.    But perhaps Oxford is not good enough for you, many people consider it a top tier university

 

Oxford Covid Trial Vaccinations Press releases - South Africa

 

As a participant of that trial (paused in the USA), I've been following news closely about the vaccine's status.  Here is a hopeful note at least for those in the UK https://www.businessinsider.com/coronavirus-mps-told-new-year-covid-19-vaccine-possible-report-2020-10 .  As for me, I will await news from the FDA that this trial can resume in the USA.

[Mary229]

2 minutes ago, azbirdmom said:

 

As a participant of that trial (paused in the USA), I've been following news closely about the vaccine's status.  Here is a hopeful note at least for those in the UK https://www.businessinsider.com/coronavirus-mps-told-new-year-covid-19-vaccine-possible-report-2020-10 .  As for me, I will await news from the FDA that this trial can resume in the USA.

I appreciate that AZ. I was responding to a participant who refuses to believe that studies are paused.  There was a UK study paused and this one I quoted was a South African study paused.  Both were resumed once it was determined the single individuals condition was not caused by the vaccine.  Thanks, just the same

[Potstech]

2 hours ago, CarelessAndConfused said:

 

There is not support precisely because there was no support for making the claims that she made.  These are BLINDED studies once again and there is very little known about them, INCLUDING why they were exactly paused.  I've more than proven than her statement is clearly off the mark.  If you can't interpret that, then that's your own limitations for you to deal with, not me.

 

I realize that we are all going to say things based on opinions, interpretations, and sadly political ideology.  However, to imply something like a vaccine in a clinical trial is perfectly safe and that a Phase 3 clinical trial was stopped because of one person getting sick is so chock full of misinformation that it needs to specifically be addressed.  If you don't see that, one again, limitations can be difficult to deal with.  i'm just glad they're your's and not mine.

Seemed they had a lot of sources to support her claims. You on the other hand ? So specifically address them with facts and references which you just admitted you do not have.

 

And now you result to insults and false innuendos.

Edited October 19, 2020 by Potstech

[caribill]

And a possible problem:

 

https://www.sciencemag.org/news/2020/10/could-certain-covid-19-vaccines-leave-people-more-vulnerable-aids-virus

[LDVinNC]

On 10/18/2020 at 6:58 PM, Porky55 said:

Had read this about Thalidomide - thought it was being used as a cancer treatment?

 

I take lenalidomide - a close cousin, so to speak, of thalidomide - for multiple myeloma.  It was used in my initial treatment and I now take a lower dose as a maintenance drug.  It is also used to treat some other blood cancers.

[capriccio]

According to an article in today's Washington Post entitled Britain to infect healthy volunteers with coronavirus in vaccine challenge trials (https://www.washingtonpost.com/world/europe/covid-challenge-trials-uk/2020/10/20/00a31136-026c-11eb-b92e-029676f9ebec_story.html), the British

 

will launch the world's first human challenge trials for covid-19, in which healthy volunteers will be deliberately infected with the coronavirus in hopes of further speeding the drive to a vaccine.

 

Highlights of the article include:

• Research is funded by the British government and being conducted by Imperial College London
• Potential payoff:  accelerating vaccine development by even three months and saving hundreds of thousands of lives globally
• Volunteers will be quarantined in a hospital for 22 days
• Initial phase will be 100 young adults (18 to 30) with hopes to expand in the spring
• Haven't determined which vaccines to test yet (possible candidates include those vaccines that have proven themselves in large-scale Phase 3 trials, or they may be earlier in their development but potentially more effective).
• Study to be reviewed by and ethics committee of the Britain’s Medicines and Healthcare products Regulatory Agency ( the British equivalent of the FDA)

[Mary229]

CDC just published this new informational concerning the vaccines:

 

CDC: 8 Things to Know about Vaccine Planning

[TNTLAMB]

I hesitate to comment anytime Politics is involved as no matter what is said or by who, its wrong to someone and the fireworks start.  So let me start by saying I have set up, run and designed literally dozens of vaccine trials and reviewed hundreds more protocols.

 

Basic protocols never change based on a particular set of circumstances In the cases of vaccines those protocols are not only determined by local (national) regulatory boards but also by an International board overseen by the WHO. Once a medication is ready for human trials The first step is to define your cohort. This is a statistical process in order to get large sample results from a a smaller sample which in effect gives better results. This is called a container certain age groups may be left out,  gender may be adjusted (n need to test a birth control pill on men)  The container is large enough and defined enough  to eliminate sample bias. the subjects are define in a  the same way.

 

There are essentially 3 phases to every study each phase increasing the numbers of subjects in each. The studies are NOT conducted by a regulatory agency OR the drug manufacturer (Though both track) Studies are done by CRO (contract research Organizations, and always by several different groups (though all may be contracted by the same CRO.) Gawd help any trial that has a difference in results by different testers. There is some Serious explaining to do. More than one study has been terminated or started over with new cohort definitions

 

When phase 3 studies are completed that data verfies and tested by and yet another independent group, the drug is submitted to the FDA for approval YET anothr independent group of Physician specialists in the area reviews the data and votes yea or Nay and submits their recommendations to the FDA. The drug then receives market approval based on the cohort. The FDA also has the option to grant compassionate approval or early access (based on the data and review committee) to folks outside the initial container. (you will see on TV Commercials :for patients 12 to 65 for example. That doesn't mean only folks 12 to 65 can take the drug)

 

Once the Drug is taken to market a whole new series of studies kick in. I'll spare you that detail

 

A word about Phase 3 trials. The proctor of the study recieves an update on every patient enrolled on a set schedule (that time may vary) EVERY adverse event is reported immediatly an adverse event may range from a sudden ingrown toe nail to death. The proctor then has options note it or act on it. If they don't know exactly what to do the study is halted until they do know. I have NEVER seen a trial EVER that at somepoint has NOT been halted. The Covid study is no exception. The only difference is The press is intrested in this one.

 

So what does this have to do with Covid and Warp speed?  The differenc between this study and a normal stdy is this study has gone to the top of the waiting list. The study protocol (including the contianers) was considered and approve before any other waiting trial. This save anywher efrom 1  year to 3 years.  When the competed studies are turned over for approval, againthe waiting period is waived and IMMEDIATE action will be taken. In 1992, the U.S. passed the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from companies to expedite the drug-approval process. Even that has been waived. The approval committees are evaluating data as it comes. Mostly put the Red tape along the way is being eliminated but nothing else is.

 

The protocol for a vaccine BTW is 889 pages long so compressing it into one post is difficult forgive me for leaving some stuff out. There are two difference though It is entirely possible that at least 2 of the vaccines could have fallen into the Abbreviated New Drug Application (ANDA) for approval requiring NO clinical trials or at most additional efficacy data, meaning we could have had them months ago as all they were was a variation of existing vaccines. (no testing of this years flu jab has happen for example)  Of course the Public wouldn't have stood for that as the antivaxers have been very active and the politicians even more so. 

 

The other difference is the FDA ADDED a step. trump an and others, including industry were pissed (excuse my  French) but of course we were unable to explain it in light of all the new Social media Qualified Immunologist. They clamped on a 2 month waiting period after the Phase 3 trials were completed before the approval process can start. They are going to explain that on the 22nd. Who know maybe its something that should have been done all along.

 

Yes most age groups have been considered (portionally on users) NO, at risk groups have not been purposely excluded for any reason other than defining a consistent cohort. That's not to say they haven't been evaluated for suitability for vaccines. this one isn't that special.

Anyway, hope this is helpful. (Excuse any sarcasm you come across I really try to avoid it lol)