CDC COVID Vaccine in Nov 2020.

[lanceholt]

On 9/2/2020 at 5:36 PM, njhorseman said:

Note the NY Times' version of the story includes this statement that somehow the Post failed to include despite citing the NY Times article. Pay particular attention to the statement "...its plans were still hypothetical".

https://www.nytimes.com/2020/09/02/world/coronavirus-covid-live.html?action=click&module=Top Stories&pgtype=Homepage

 

"The C.D.C. noted in its guidance that “limited Covid-19 vaccine doses may be available by early November 2020.” It also said its plans were still hypothetical, noting, “The Covid-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available.” A C.D.C. spokeswoman confirmed that the documents were sent but declined to comment further."

Earliest would be January, more likely early spring, BUT that means "available" and it will take quite a few months to vaccinate everyone who is willing to be vaccinated.  We won't cruise again without a SAFE and EFFECTIVE vaccine.

 

[lanceholt]

On 9/6/2020 at 9:08 AM, njhorseman said:

Anecdotal evidence is worthless for medical science research purposes.  You're the one making a political statement, not the FDA.

 

Agree completely.  

[zdcatc12]

4 hours ago, ziggyuk said:

 

They sound very similar, I also had to do a daily diary for a week after the first shot and then again for a week after the second shot and recorded exactly the same information as you, after the daily diary it's a weekly one as I mentioned earlier. 

 Mine may have been weekly after the first week, I can't remember now.

 

I had an antibody test right at the beginning which showed I have never had the virus and I guess the biggest difference is that I have to do a weekly home swab test regardless of symptoms..... This is actually the worst part but having done 9 swab tests to date I'm getting used to it 🤢

We had tests also, but are never told us the results of them.

 

I also forgot to mention bloods before, obviously they take bloods but that is only 6 times in total.

Yes, we had blood drawn the first time, but not before the second shot. I go back next month for a draw. We have five blood draws, the start, 1-month, 6-month, 12-month and at 24-month.

 

This is how my time line looks:

 

I have to say though I am a bit worried what to do when the vaccine gets released to the public!

As a diabetic I should be in an earlier group to receive the vaccine but I assume I won't be allowed to take the vaccine while on the trial.

Now that is a problem, if the vaccine becomes available I will be taking it even it it means leaving the trial, I have no way to know if I had the trial vaccine or the placebo and if I had the placebo I'm not happy to walk around unprotected while a vaccine is available to me.

As for if the vaccine is released before the trial is over, they told us that it would not be ethically proper for them not to expect us to get it and withdraw from the study if it is released before the study is over. Also, Pfizer may let us know which group we were in should that happen, that way the ones that received the vaccine would reasonably continue with the trial.

 

 I am thinking the same as you, if a vaccine becomes available, I believe that I would get it and withdraw.

[ziggyuk]

7 hours ago, zdcatc12 said:

As for if the vaccine is released before the trial is over, they told us that it would not be ethically proper for them not to expect us to get it and withdraw from the study if it is released before the study is over. Also, Pfizer may let us know which group we were in should that happen, that way the ones that received the vaccine would reasonably continue with the trial.

 

 I am thinking the same as you, if a vaccine becomes available, I believe that I would get it and withdraw.

 

I hope they do tell us which group we were in when that time comes so I can remain in the trial.

Having a placibo group on this vaccine trial is a bit pointless IMHO, in a normal drug trial they use a placibo group to compare the "mind over matter" effect where some people think they feel better when given candy. In this case they are not treating a pre existing condition and therfore nothing we can imagine we feel better about.
The only benefit of a placibo group I can see is that we won't take unnessary risks that we might if we knew we had the trial vaccine, taking extra risks would obviously be dangerous with a vaccine that may or may not work.

Without a placibo group they would have double the test candidates.

[goldmom]

To those of you participating in the trials, thank you for sharing your information and insights with us.  I have found the whole discussion very interesting.  I have always wondered how they conduct these trials and hearing from people who are actually doing it is fascinating.  Please continue to share any pertinent information with us.

I know this is a cruising board, but I guess a vaccine at this point in time is "cruise related".  LOL!

Wishing for a safe and effective outcome from the trials and thank you.

[zdcatc12]

17 hours ago, ziggyuk said:

 

I hope they do tell us which group we were in when that time comes so I can remain in the trial.

Having a placibo group on this vaccine trial is a bit pointless IMHO, in a normal drug trial they use a placibo group to compare the "mind over matter" effect where some people think they feel better when given candy. In this case they are not treating a pre existing condition and therfore nothing we can imagine we feel better about.
The only benefit of a placibo group I can see is that we won't take unnessary risks that we might if we knew we had the trial vaccine, taking extra risks would obviously be dangerous with a vaccine that may or may not work.

Without a placibo group they would have double the test candidates.

 

What we were told is that what they need to see is that a higher percentage of the people on the placebo end up catching the virus than those who actually got the vaccine. That is why we all had to meet the requirement of going into higher risk areas at least three times a week. He basically said that if not enough people on the placebo catch it, they won't really be able to tell the effectiveness of the vaccine. Kind of morbid, but that is what I signed up for, lol. 

 

12 hours ago, goldmom said:

To those of you participating in the trials, thank you for sharing your information and insights with us.  I have found the whole discussion very interesting.  I have always wondered how they conduct these trials and hearing from people who are actually doing it is fascinating.  Please continue to share any pertinent information with us.

I know this is a cruising board, but I guess a vaccine at this point in time is "cruise related".  LOL!

Wishing for a safe and effective outcome from the trials and thank you.

No problem, glad to share. I am really happy that I am getting to participate in it. 

 

What part of NJ are you from? I live in TX, but was doing contract work in ACY until the virus hit, now I am working from home.

[njhorseman]

AstraZeneca has put its vaccine trial on hold due to safety concerns. A participant had a "suspected serious adverse reaction". https://www.nytimes.com/reuters/2020/09/08/world/europe/08reuters-health-coronavirus-astrazeneca.html

[BirdTravels]

Yes. In any clinical trial of a large, diverse population, people will get sick for one reason or another. Sick = just about anything from an allergic reaction to a heart attack. And the Sponsor has to evaluate the cause of the illness to determine if it is caused by the drug being tested or just part of the life of that test subject. 
 

Have you ever taken a flu shot and got the “20 questions” on allergies and previous reaction to the flu vaccine?  Or the request to wait 15 minutes to ensure you don’t have a reaction to the shot? A percentage of the population does not tolerate the flu vaccine. And a percentage of the population will probably not tolerate the first COVID vaccines. 
 

As a former clinical trial test subject, any time I get a new or strange illness, I always wonder if it a long term side affect of the test drug I was taking (or not taking) in my clinical trial. Or just another sign of being old. (I would prefer to blame the test drug than blame my age 🙂). 

Edited September 9, 2020 by BirdTravels

[ziggyuk]

 

5 hours ago, njhorseman said:

AstraZeneca has put its vaccine trial on hold due to safety concerns. A participant had a "suspected serious adverse reaction". https://www.nytimes.com/reuters/2020/09/08/world/europe/08reuters-health-coronavirus-astrazeneca.html

 

2 hours ago, BirdTravels said:

Yes. In any clinical trial of a large, diverse population, people will get sick for one reason or another. Sick = just about anything from an allergic reaction to a heart attack. And the Sponsor has to evaluate the cause of the illness to determine if it is caused by the drug being tested or just part of the life of that test subject. 

 

Agreed, It's amazing that in a few hours an "unexplained illness" has become "suspected serious adverse reaction" with the source being another news source.

 

There was a similar situation a month ago where one subject displayed serious neurological symptoms which was a worry at the time, especially as I was having my second shot that day, but it was later determined to be unrelated to the test vaccine.

 

I hope this has nothing to do with the vaccine (not least because I am a trial subject) but at the moment it remains a simple unexplained illness which happens all the time in life and on trials when you have 1000's of subjects.

[ziggyuk]

7 hours ago, zdcatc12 said:

 

What we were told is that what they need to see is that a higher percentage of the people on the placebo end up catching the virus than those who actually got the vaccine. That is why we all had to meet the requirement of going into higher risk areas at least three times a week. He basically said that if not enough people on the placebo catch it, they won't really be able to tell the effectiveness of the vaccine. Kind of morbid, but that is what I signed up for, lol. 

 

That does make sense, we don't have to have any commitment to go to high risk areas on our trial.

You are right, morbid or not they need to see if it works which is why Oxford are also trialling it is Brazil and South Africa where there is much higher transmission.

 

I'm 10 week in and booked for my second bloods on Monday, from then on it's just a weekly diary, weekly swabs and bloods every 90 days.

[RocketMan275]

11 hours ago, zdcatc12 said:

 

What we were told is that what they need to see is that a higher percentage of the people on the placebo end up catching the virus than those who actually got the vaccine. That is why we all had to meet the requirement of going into higher risk areas at least three times a week. He basically said that if not enough people on the placebo catch it, they won't really be able to tell the effectiveness of the vaccine. Kind of morbid, but that is what I signed up for, lol. 

 

 

Interesting.   It's  'unethical' to do challenge testing where participants are purposefully exposed to the virus but it is 'ethical' to send participants into high risk areas?

[goldmom]

11 hours ago, zdcatc12 said:

 

What we were told is that what they need to see is that a higher percentage of the people on the placebo end up catching the virus than those who actually got the vaccine. That is why we all had to meet the requirement of going into higher risk areas at least three times a week. He basically said that if not enough people on the placebo catch it, they won't really be able to tell the effectiveness of the vaccine. Kind of morbid, but that is what I signed up for, lol. 

 

No problem, glad to share. I am really happy that I am getting to participate in it. 

 

What part of NJ are you from? I live in TX, but was doing contract work in ACY until the virus hit, now I am working from home.

 

I'm in northern Jersey about 16 miles west of the George Washington Bridge.  With no traffic we're about 20 minutes from the NYC cruise terminal which was great.  

 

Even though they are asking you to go to high risk areas, please wear your mask and try to stay safe!

[ziggyuk]

11 minutes ago, RocketMan275 said:

Interesting.   It's  'unethical' to do challenge testing where participants are purposefully exposed to the virus but it is 'ethical' to send participants into high risk areas?

 

That is an interesting comparison, I would guess in this case they will say they are not asking people to put themselves at risk but instead selecting candidates that already take those risks.

I my case, my trial does not require me to go into high risk areas and the question was never asked during screening, another small difference in approach.

[Trimone]

The Oxford coronavirus vaccine trial is facing a "challenge", the health secretary has admitted, after it was put on hold due to a suspected serious adverse reaction in one of its volunteers.

Researchers have paused the trial while they investigate the reaction in one of the participants in the UK, it was announced on Tuesday night.

[JAMESCC]

The Oxford coronavirus vaccine trial is facing a "challenge", the health secretary has admitted, after it was put on hold due to a suspected serious adverse reaction in one of its volunteers.
Researchers have paused the trial while they investigate the reaction in one of the participants in the UK, it was announced on Tuesday night.

I'm not gonna go crazy here just yet and freak out. Could just be a small setback and the fact it's just one person might mean it's an isolated incident. Let's wait and see what happens here.

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[RocketMan275]

1 hour ago, ziggyuk said:

 

That is an interesting comparison, I would guess in this case they will say they are not asking people to put themselves at risk but instead selecting candidates that already take those risks.

I my case, my trial does not require me to go into high risk areas and the question was never asked during screening, another small difference in approach.

Two things.  One 'challenge' testing has been used in the past, particularly during the Spanish Flu pandemic.

Two, a 'challenge' test can be completed with higher accuracy, sooner, and much cheaper than out current testing protocols.  How many people have/will die that could have been saved had we developed a vaccine sooner using 'challenge' testing?  Which is more 'ethical'?

[Trimone]

Phase three trials of the Oxford vaccine had recently expanded to the US, recruiting up to 30,000 adults.

Trials were also underway in South Africa and Brazil.

Experts believe finding a vaccine is the only way for the world to return to normal in the future and there are currently nine vaccine candidates in larger phase three trials.

But it is not known how well a vaccine will work, and the top US infectious diseases expert Dr Anthony Fauci recently warned the chances of it being almost 100% effective are "not great".

"We don't know yet what the efficacy might be. We don't know if it will be 50% or 60%. I'd like it to be 75% or more," he said

[oteixeira]

55 minutes ago, Trimone said:

 

"We don't know yet what the efficacy might be. We don't know if it will be 50% or 60%. I'd like it to be 75% or more," he said

Expect 50-60% at best, like the flu.  If it doesn't mutate as bad as the flu, then after a few years maybe it can be like polio and basically be wiped out, but if it does mutate a lot, it just becomes another every year virus, and we live as best we can with it.

Edited September 9, 2020 by oteixeira

[njhorseman]

On 9/6/2020 at 11:32 AM, RocketMan275 said:

The mean (SD) age was 62.6 (15.50) years • Sex: 35% male, 23.3% female, 41.7% missing • Baseline severity of illness: 5% mild, 33% moderate, 45% severe, 17% critical • Comorbidities: 6% had cardiovascular disease, 23% had HTN, and 20% had DM.  (HTN is hypertension, DM is diabetes mellitus.) 

 

 https://www.fda.gov/media/138945/download

 

IOW, these were some very sick people.  The original EUA authorized HCQ only in hospitals for the very ill.  While this EUA has been withdrawn, multiple studies are ongoing to gauge the effects in other populations.  Clearly, HCQ might not be advised for those very ill, but it might have utility in these other populations.

 

My point all along has not been that HCQ is effective against COVID but that the media narrative has been overwhelming biased in it's assertions that HCQ is too deadly for widespread use.  Somewhat similar to the emerging media narrative that the vaccines under development are being rushed into distribution because of political reasons.

 

FWIW, if I were diagnosed with COVID, I would certainly ask my primary for a HCQ prescription even though I'm in my mid seventies.  And, I will certainly be in line for the vaccine when it is available.

 

In the sentence I've highlighted above in red you're saying that HCQ and CQ are not effective against COVID-19, but somehow it should be allowed anyway because it isn't as dangerous as media reports claim. Well thank you, because the first part of your statement explains why the FDA withdrew the EUA. In order to be an approved treatment a drug is required to be both safe and effective. Both...not one or the other. Since HCQ and CQ were not effective, the safety issue is moot regardless of the accuracy of media reports. 

 

But, guess what...the FDA says you're wrong about the safety issue too.  Read the second sentence of the first paragraph on page 5 of the document you've cited :

"Based on the above, the Agency has concluded that it is unlikely that CQ and HCQ may be effective in treating COVID-19. Further, in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia in COVID-19 patients, the Agency has concluded that the known and potential benefits of CQ and HCQ do not outweigh the known and potential risks for the authorized uses. "

 

You can request whatever you want for your own treatment, but the FDA has clearly concluded that HCQ and CQ are neither safe nor effective for the treatment of COVID-19. That's the FDA speaking, not some demonic media cartel with a political agenda. 

[sanger727]

1 hour ago, RocketMan275 said:

Two things.  One 'challenge' testing has been used in the past, particularly during the Spanish Flu pandemic.

Two, a 'challenge' test can be completed with higher accuracy, sooner, and much cheaper than out current testing protocols.  How many people have/will die that could have been saved had we developed a vaccine sooner using 'challenge' testing?  Which is more 'ethical'?

 

How many people will get seriously ill/die during the vaccine trial using a challenge test? Two sides of the same coin. It's generally always more ethical to not intervene than to cause harm due to an intervention. Covid is happening and that is not the fault of any of the researchers. But intentionally exposing vaccination participants to a potentially serious/deadly disease would be. The other big challenge is I don't think they would pass any ethics board with this method if they included high risk participants.  However, that is who needs to be in the trial to be sure it works on them. It doesn't do the 70+ crowd much good if we develop a vaccine that works great in 20 year olds but not in them.

[sanger727]

On 9/8/2020 at 3:39 AM, ziggyuk said:

 

I hope they do tell us which group we were in when that time comes so I can remain in the trial.

Having a placibo group on this vaccine trial is a bit pointless IMHO, in a normal drug trial they use a placibo group to compare the "mind over matter" effect where some people think they feel better when given candy. In this case they are not treating a pre existing condition and therfore nothing we can imagine we feel better about.
The only benefit of a placibo group I can see is that we won't take unnessary risks that we might if we knew we had the trial vaccine, taking extra risks would obviously be dangerous with a vaccine that may or may not work.

Without a placibo group they would have double the test candidates.

 

This is exactly why they need the placebo group. The placebo group is simply the control group for comparison.  If we do nothing then we have X rate of individuals get infected and if we give this vaccine we have Y rate of individuals get infected. If Y is statistically significantly better than X, we have a positive result. Those groups need to be balanced and very similar - so similiar demographics, similar risk factors, similar amount of exposure. If the "vaccine" group felt like they could take extra risks then they might have an artificially higher rate of infection than if they didn't since felt it was "safe". This could make the vaccine appear less effective. 

[JAMESCC]

Listen I'm all for vaccines, I'm not an anti vaccer in the least. I've been saying got months I'll trade this the minute it comes out but when the government announces "get ready for the vaccine November 2nd", just two days before the election I get very skeptical. I have to say very, very skeptical.

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[RocketMan275]

56 minutes ago, sanger727 said:

 

How many people will get seriously ill/die during the vaccine trial using a challenge test? Two sides of the same coin. It's generally always more ethical to not intervene than to cause harm due to an intervention. Covid is happening and that is not the fault of any of the researchers. But intentionally exposing vaccination participants to a potentially serious/deadly disease would be. The other big challenge is I don't think they would pass any ethics board with this method if they included high risk participants.  However, that is who needs to be in the trial to be sure it works on them. It doesn't do the 70+ crowd much good if we develop a vaccine that works great in 20 year olds but not in them.

The higher risk could participate in a following trial once the safety and effectiveness is established in the challenge trial.

[crewsweeper]

45 minutes ago, JAMESCC said:

Listen I'm all for vaccines, I'm not an anti vaccer in the least. I've been saying got months I'll trade this the minute it comes out but when the government announces "get ready for the vaccine November 2nd", just two days before the election I get very skeptical. I have to say very, very skeptical.

Sent from my Pixel 4 XL using Tapatalk
 

I think that was more of a hope than a prediction. Pfizer and Biotech are only in the monkey testing stages. AstraZeneca study is on hold in UK , while they study one of the trial subjects getting an unexplained illness.

 

Just get your flu shot, wash your hands (and face), wear a mask and don't let anyone breath on you inside 2 meters.

 

[JAMESCC]

I think that was more of a hope than a prediction. Pfizer and Biotech are only in the monkey testing stages. AstraZeneca study is on hold in UK , while they study one of the trial subjects getting an unexplained illness.
 
Just get your flu shot, wash your hands (and face), wear a mask and don't let anyone breath on you inside 2 meters.
 

Oh yeah I will be getting the flu shot. Will never go again without one. Got the flu so bad in 2019 it knocked me on my butt for over a week.

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