Older Cruisers Left Out of vaccine Trials

[donaldsc]

4 hours ago, cruzsnooze said:

The speed of the vaccine is problematic to the epidemiologists that have voiced their opinions on TV. The CDC has voiced concern.  There are some ethical issues as well.  In order to know if the vaccine is effective you must expose the trial participant to the virus you are wanting to test efficacy for.  You must also expose those in the placebo group so you can compare the rate of infection. Of the group who gets the real vaccine (not the placebo) you must make a statistical comparison of how many got infected VS not and thus come to a percent of efficacy. Who in their right mind would deliberately expose themselves to covid with no current approved treatment. If the trial participants wears a mask and practices social distance and does meticulous hand washing you don't know if it  the vaccine worked or the  person used all the mentioned protocol to avoid exposure. 

This is just a small part of what goes into clinical trials. Rushing a vaccine before all the data has been collected and studied is not safe enough for me. I suspect health care workers who understand medicine and vaccines will not want to take the vaccine before all the data is in. 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. Medicine has a lot of trial and error and I wish only the best for those in the trials, they are brave people and deserve a world of thanks. 

  There is a good reason why vaccines take longer then warp speed to develop and test. This particular vaccine is close to developed but not tested . Those who want to take it should with their eyes open for side effects and a plan of action should there be serious side effects. If one person has a major adverse effect I can hear the outcry and imagine the lawsuits. Astra Zeneca said the one person who developed neurological issue's represented a huge number if it was extrapolated to the general population. 

  We are all anxious to get back to our normal routines but we must think of the consequences. We should read all we can about the issues surrounding the vaccine and make INFORMED DECISIONS.

  Civil discussions are welcome as are sharing first hand knowledge from the participants in the trials who've posted.

 

Vaccine Injury Compensation Program

 

For most drugs—actually, every type of drug other than vaccines—the manufacturer can be legally liable for harm that results from a product it sells. Vaccines are produced by privately held pharmaceutical companies, but they have a unique arrangement with the U.S. government: When a person reports harm that could feasibly be related to a vaccine, a government program—not a pharmaceutical company—pays compensation.

 

DON

 

[caribill]

13 hours ago, Potstech said:

And these shortcuts are? Where are they documented by scientist that can be trusted?

 

2 hours ago, Potstech said:

So testing on 10's of thousands of people is rushing a vaccine?

 

The main shortcut is in time.

 

You can speed up development of a vaccine and speed up its manufacture, but there is no way to speed up Phase 3 testing.

 

The Phase three tests are designed to last two to three years to give enough time to determine if the vaccines are truly safe and effective.

 

The vaccine manufacturers are being pressured to produce results with less than two months passing since the participants were given the final dose of a two-dose sequence, In addition, even though wanting to have trials with 30,000 or mroe participants, reports have been saying they have been unable to get that many people to volunteer across the different types of volunteers needed (different age groups, ethnic groups, sexes, health conditions, etc.).

 

I have read reports saying they can reach conclusions once 75 people in a trial come down with Covid-19. I am not a statistician, but I don't see how that is enough to prove/disprove effectiveness across all the age groups, ethnic groups, dosage amounts, etc. in the study including those who did or did not have the placebo in a two month period.

 

In addition. a normal phase 3 trial in the past has the participants doing what they normally would do. But with Covid-19, hardly anyone is doing what they normally would do (traveling, working in offices, attending movies and sporting events, eating in crowded restaurants, being very close to others in a store, etc.). So not getting the virus in two months is not proof of anything if most participants restrict their activities, wear masks when in public, etc.

 

If we were in a trial (and we are not), we would be outside our home for maybe three hours a week for shopping and would be wearing masks and socially distancing when doing that. Whether having had the vaccine or a placebo, we would be unlikely to catch the virus in a two month period.

 

 

 

 

[Potstech]

So you think the country/world should stay in the current state for many more months or even years until a vaccine is developed that all can trust? That advances in science and testing should be ignored and just use decades old methods to test and verify its effectiveness.  That is your opinion.  By the way with the constant changing of statements by the CDC which ones are we supposed to believe? They have even said that masks are more effective than a vaccine so I guess all should just not take a CDC approved vaccine and wear masks for the rest of our lives because this virus will be around for a longtime.

[cruzsnooze]

2 hours ago, Potstech said:

So you think the country/world should stay in the current state for many more months or even years until a vaccine is developed that all can trust? That advances in science and testing should be ignored and just use decades old methods to test and verify its effectiveness.  That is your opinion.  By the way with the constant changing of statements by the CDC which ones are we supposed to believe? They have even said that masks are more effective than a vaccine so I guess all should just not take a CDC approved vaccine and wear masks for the rest of our lives because this virus will be around for a longtime.

The CDC doesn't really doesn't change it mind only it's message as dictated by a particular politician.  I anticipate we'll be using masks most of next year if we want to protect ourselves and others. This should never become political but it has and as a result there will always be distrust of this vaccine. 

[ProfMHC]

Interesting article on CNBC today interviewing some vaccine study participants. Doesn’t sound like minimal side effects !?!? 
https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.

Edited October 1, 2020 by ProfMHC

[Potstech]

4 hours ago, cruzsnooze said:

The CDC doesn't really doesn't change it mind only it's message as dictated by a particular politician.  I anticipate we'll be using masks most of next year if we want to protect ourselves and others. This should never become political but it has and as a result there will always be distrust of this vaccine. 

Again your opinion. The CDC has changed its mind many times and there is no proof it was because of any politician. But of course you know going political on here is in violation of the Terms of Agreement.

[azbirdmom]

23 hours ago, Lucky TGO said:

Hi azbirdmom,

I truly Admire you for volunteering for the COVID vaccine trials!! I just like to say Thank You and God Bless. 
Tony

 

 

 

Why thank you Tony!  I was just getting tired of sitting around not being able to do many things that I love to do (like cruising!) and wanted to do something to hopefully help us get out of the muck we are in a bit sooner.  I am hoping that the FDA finds that the health issues with our study aren't related to the vaccine and it can move forward.  Otherwise my time as a human guinea pig will be short.

[azbirdmom]

8 hours ago, ProfMHC said:

Interesting article on CNBC today interviewing some vaccine study participants. Doesn’t sound like minimal side effects !?!? 
https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.

 

The link isn't functioning but if it mentions things like headaches, high fever, chills, etc., I had those after getting my second Shingrix shot.  The doctor I saw for the Covid study said that was good to hear as it meant I had a good immune response.  It lasted about a day and I've read of some in the Covid studies having similar reactions after their second dose of a Covid vaccine. 

[ProfMHC]

https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html
 

Trying again. The types of side effects described by actual participants are significantly beyond the mild or moderate ones being reported by the vaccine developers. 

[caribill]

40 minutes ago, ProfMHC said:

https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html
 

Trying again. The types of side effects described by actual participants are significantly beyond the mild or moderate ones being reported by the vaccine developers. 

 

At least we can assume anyone who had those symptoms did not get a placebo.

[mina]

10 hours ago, azbirdmom said:

 

The link isn't functioning but if it mentions things like headaches, high fever, chills, etc., I had those after getting my second Shingrix shot.  The doctor I saw for the Covid study said that was good to hear as it meant I had a good immune response.  It lasted about a day and I've read of some in the Covid studies having similar reactions after their second dose of a Covid vaccine. 

Had the same reaction to the shingles vaccine and told the same thing.  We got our second Pfizer vaccine shot yesterday and were told that fever, tiredness and joint pain are common.    I do not see anywhere in the article quoted where it says these were unbearable side effects. I am willing to experience whatever is needed to help find a valid scientific solution quicker.   It is easy to read a bunch of articles and ponder.   That’s not enough for us.   We need to take part in finding a solution, not criticizing those who are from the sidelines. So far we have not had a reaction, so I assume we had the placebo.  When the first vaccine goes public, we will withdraw from the study and then we will be unblinded and can move ahead with the approved vaccine.  

[roamerfromtexas]

We had similar reactions to our second Shingles vaccine.  I can remember my arm being so sore I couldn’t lift it when vaccines were given to us in elementary school and having a fever as well.  My age is telling with that memory.

[Potstech]

6 hours ago, ProfMHC said:

https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html
 

Trying again. The types of side effects described by actual participants are significantly beyond the mild or moderate ones being reported by the vaccine developers. 

And they are way milder than side effects on medicine advertised on TV.  Ever actually listen to them. 

[azbirdmom]

4 hours ago, mina said:

Had the same reaction to the shingles vaccine and told the same thing.  We got our second Pfizer vaccine shot yesterday and were told that fever, tiredness and joint pain are common.    I do not see anywhere in the article quoted where it says these were unbearable side effects. I am willing to experience whatever is needed to help find a valid scientific solution quicker.   It is easy to read a bunch of articles and ponder.   That’s not enough for us.   We need to take part in finding a solution, not criticizing those who are from the sidelines. So far we have not had a reaction, so I assume we had the placebo.  When the first vaccine goes public, we will withdraw from the study and then we will be unblinded and can move ahead with the approved vaccine.  

 

We are kindred spirits!  That's what drove us to participate as well.  We were supposed to get shot #2 today but with the AstraZeneca trial paused I am not sure that we will.  The trial documents said that we could get the second shot within +/- 3 days of the targeted 4 weeks after the first shot and that seems unlikely.  So I don't know what the future holds for us in terms of staying in the trial but if it is ultimately deemed worthwhile for us to get the second shot, we will do it.

 

I did have very mild symptoms (headache, rash) after the first Covid shot and my husband had no side effects.  But then he didn't react to the second Shingrix shot like I did so we aren't sure if either one of us got the real thing.

 

We were told that if we got the placebo and wanted the vaccine, we could get it free from the trial clinic after the vaccine was approved.  I do want to stay the course with this trial (if it moves forward with us involved, that is).  So I don't know if we would exit and unblind ourselves if another vaccine becomes available but I guess we will cross that bridge when we come to it!  Best wishes to you.

[azbirdmom]

10 hours ago, ProfMHC said:

https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.html
 

Trying again. The types of side effects described by actual participants are significantly beyond the mild or moderate ones being reported by the vaccine developers. 

 

As a trial participant, we were warned that there could be significant reactions to receiving the vaccine.  This was part of the very lengthy document that we had to read and sign before moving forward with the trial:

 

What could be the side effects of the vaccine?
If you suffer any of these side effects (or any others not listed) or you think you are
experiencing a side effect, during this study, please tell your study doctor
immediately (see ‘Who should you contact with questions?’).
Over 5,000 people have received at least 1 dose of the vaccine to date. Thirty
people have received a second dose.

 

Reactions to the vaccination:
Following vaccination you may feel some discomfort on your arm where you get the
shot. This usually gets better within 5 minutes. Later, you might feel pain when you
move your arm, but this should go away in a few days. Pain and tenderness where
people received the shot were the most common side effects and these were usually
mild.

 

General reactions:
Chills, fevers, headache, feeling tired, nausea and body aches were common overall
side effects. These side effects were usually mild or moderate in nature though a
small number of them were also considered severe. Most of reported side effects
appeared within 24-48 hours after the shot. These usually went away within 1-7
days.
People who have received the vaccine have also had decreases in their blood
counts; in the cells that help fight infections and in the cells that help form blood
clots. These decreases have resolved within a few days and have not been
associated with any other side effects so far.
Any side effects or other health issues that happen to you during the study will be
followed up by the study doctor.

 

Serious Reactions:
With any vaccination there is a risk of rare serious side effects, such as an allergic
reaction.
The vaccine is not familiar to your body. Your body’s immune system may react to
this. Strong allergic reactions to vaccines (anaphylaxis) are rare and require
treatment right away but can result in death. These reactions can happen hours or
days after the injection. Symptoms may include:
 swelling of the lips,
 difficulty breathing,
 fainting,
 dizziness,
 wheezing when you breathe,
 fast pulse,
 sweating,
 hives or rash
 low blood pressure
 diarrhea
If this happens, medication for treating allergic reactions will be available. The
research team is trained to treat allergic reactions.
Another reaction that is also very rare can cause an illness called Guillain-Barré
syndrome (GBS). This illness causes muscle weakness that can range from being
mild to being very severe (can cause paralysis and can be fatal). Most of adults who
become sick recover after their illness. Symptoms of GBS are:
 Weakness
 Tingling in the legs or arms and upper body.
There is also a possible risk that if you get the vaccine in the study and then become
ill with COVID-19 that your illness could be worse than if you had not received the
vaccine.
In the past, experimental vaccines were studied against another coronavirus (called
SARS), which also infects the lungs. In some cases, animals that received certain
types of SARS vaccines appeared to develop more severe lung inflammation when
they were later infected with SARS compared with animals that had not been
vaccinated.
An experimental vaccine tested in the 1960s for a different respiratory virus (RSV)
resulted in some infants developing more severe lung inflammation when they were

later infected with the virus. Two of the infants died. Other versions of RSV vaccines
have not caused these severe reactions.
In other studies, animals that received two shots of this vaccine (AZD1222) and then
were infected with COVID-19 had the virus in the intestinal tract but were not sicker
than animals that received one shot. It is possible that people who get two shots of
this vaccine could also have the COVID-19 virus present in their intestinal tract if
they get infected for a longer period of time than people who get infected but didn’t
get the vaccine. As a result, you should practice good hygiene like hand washing, to
avoid spreading the virus to other people.
You should get medical help and contact the study

[mina]

2 hours ago, azbirdmom said:

 

We are kindred spirits!  That's what drove us to participate as well.  We were supposed to get shot #2 today but with the AstraZeneca trial paused I am not sure that we will.  The trial documents said that we could get the second shot within +/- 3 days of the targeted 4 weeks after the first shot and that seems unlikely.  So I don't know what the future holds for us in terms of staying in the trial but if it is ultimately deemed worthwhile for us to get the second shot, we will do it.

 

I did have very mild symptoms (headache, rash) after the first Covid shot and my husband had no side effects.  But then he didn't react to the second Shingrix shot like I did so we aren't sure if either one of us got the real thing.

 

We were told that if we got the placebo and wanted the vaccine, we could get it free from the trial clinic after the vaccine was approved.  I do want to stay the course with this trial (if it moves forward with us involved, that is).  So I don't know if we would exit and unblind ourselves if another vaccine becomes available but I guess we will cross that bridge when we come to it!  Best wishes to you.

Sure sounds like we are a lot alike.   Hubby today has no reaction.  I have a fever of 99.8 to 100.8.  So, good sign.  Hubby never had a reaction to shingles either so, not sure for if he really got the placebo.   I am impressed the Astro Zeneca indicated they will give trial participants the approved shot.  Pfizer just says they have not decided yet about those in the trial that got the placebo.  So we wait.   I hope you are able to get the second shot.  I have been following the oxford research and I do think astra Zeneca will be the overall best once the trials are done.    Very interesting!  Good luck to you both.

[Ombud]

On 9/30/2020 at 10:02 AM, pcur said:

Kaiser is participating in vaccine trials, and they are including members up to 85 years old.  

 

The information I've been reading says that vaccines will be offered initially to first responders and medical personnel, AND to higher risk people.  Included in the higher risk category are older Americans.  So, senior cruisers will probably be in the "sooner" rather than "later" group of recipients.

Yes, my sister (over 65, lynch syndrome, + Addison Disease so very high risk) is in that study

[hobbyfarmer2]

On 9/30/2020 at 12:17 PM, cruzsnooze said:

It's being fast tracked by taking short cuts that undermine it's efficacy and safety.  It's stated the vaccine will be given to those most vulnerable, health care workers and seniors and those with underlying conditions so why wouldn't you want to use those participants in an equal representation in the trial. 

Exactly, it is being fast tracked.  What normally takes years is being compressed into months for over 50+ vaccines.  We will not even know which of the vaccines are the best ones, if any, for more than three years after the data for millions has been collated.  I really do not understand what you are expecting when we do not really know enough about the virus and our immune system's reaction tonite.

[caribill]

18 hours ago, mina said:

 When the first vaccine goes public, we will withdraw from the study and then we will be unblinded and can move ahead with the approved vaccine.  

 

And if many people do that with the other vaccines in Phase 3, then there may not be enough participants remaining to ever get a second vaccine validated as safe and effective.

[mina]

4 hours ago, caribill said:

 

And if many people do that with the other vaccines in Phase 3, then there may not be enough participants remaining to ever get a second vaccine validated as safe and effective.

Well bless your heart.   Perhaps you could sign up to help make sure those other vaccines get tested.     Actually, in most cases, as the scientists explained in our trial, they will automatically unblind the study so that those who had the placebo can get vaccinated.    It’s an ethically consideration.   Those who had the experimental vaccine remain in the trial for three years to follow efficacy.  

[cruzsnooze]

Another reason I'm sceptical of the safety of this vaccine

https://www.msn.com/en-us/news/us/white-house-objects-to-fda-plans-on-authorizing-covid-19-vaccine/ar-BB19EiYW?li=BBnb7Kz

[caribill]

4 hours ago, mina said:

 Actually, in most cases, as the scientists explained in our trial, they will automatically unblind the study so that those who had the placebo can get vaccinated.    It’s an ethically consideration.   Those who had the experimental vaccine remain in the trial for three years to follow efficacy.  

 

When the vaccine testing that one is participating in proves that vaccine is safe and effective, of course those in that study who had received the placebo should get the vaccine ASAP.

 

However, your original comment was that when a different vaccine in a test you were not part of was approved, you would stop participating in the test you are in and then receive the other vaccine.

[mina]

9 minutes ago, caribill said:

 

When the vaccine testing that one is participating in proves that vaccine is safe and effective, of course those in that study who had received the placebo should get the vaccine ASAP.

 

However, your original comment was that when a different vaccine in a test you were not part of was approved, you would stop participating in the test you are in and then receive the other vaccine.

Again, bless your heart for knowing what I intended .  I do not think the word different was in my statement. But,  thank you for explaining my intention to me.    Perhaps, again, you should step up instead of criticizing others who are trying to do some good.  For your information, the scientists running our study  indicated that when a vaccine is approved, theirs or not, they typically unblind the study, allowing people who had the placebo to withdraw.  

[caribill]

Proposed order for people to receive vaccines:

 

A tiered approach

The US National Academies of Sciences, Engineering and Medicine has proposed a five-phase plan to fairly allocate a coronavirus vaccine to US residents.

Phase 1	Health-care workers and first responders (5%)
Phase 2	People with underlying conditions that put them at high risk of severe COVID-19 disease or death, and older adults in densely populated settings (10%)
Phase 3	Essential service workers at high risk of exposure, teachers and school staff, people in homeless shelters and prisons, older adults who have not already been treated and people with underlying conditions that put them at moderate risk (30–35%)
Phase 4	Young adults, children and essential service workers at increased risk of exposure (40–45%)
Phase 5	All remaining residents (5–15%)

Note: Phases 1 and 2 might occur in tandem. Per cent is the percentage of the US population to receive a vaccine. Source: NASEM

[Porky55]

On 10/2/2020 at 2:44 AM, ProfMHC said:

Interesting article on CNBC today interviewing some vaccine study participants. Doesn’t sound like minimal side effects !?!? 
https://www.cnbc.com/2020/10/01/coronavirus-vaccine-trial-participants-exhaustion-fever-headaches.

Would not be of any interest to the public or CNBC if they DIDN'T have side effects. And ...... how do they know they haven’t had the placebo? 🧐
Now that would be News 😂