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CDC COVID Vaccine in Nov 2020.


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On 9/3/2020 at 8:55 AM, ziggyuk said:

I am on the Oxford trial, the results are excellent, I recently had a second shot as they have determined it requires two shots for maximum antibody levels, we were all offered an optional second shot.

Of course 50% of us have a placebo of the meningitis vaccine.

 

 Must be nice to get at least something out of the placebo. I'm on the Pfizer trial in the states and our placebo is saline!!!

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26 minutes ago, zdcatc12 said:

 

 Must be nice to get at least something out of the placebo. I'm on the Pfizer trial in the states and our placebo is saline!!!

 

The mind is a powerful vaccine 😉

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2 hours ago, zdcatc12 said:

 

 Must be nice to get at least something out of the placebo. I'm on the Pfizer trial in the states and our placebo is saline!!!

 

Yes I agree, I initially thought I would get saline too, the meningitis vaccine is given too all teens now but was not in my day so it's nice to get something useful if it turns out I'm not helping by testing the real vaccine.

Apparently they are using meningitis as a placebo so they can compare the side effects side by side with a vaccine with known side effects.

Whatever vaccine I had, there were no side effects at all, slights ache at the injection site but to swelling, redness or pain all all, just like I always experience with a flu jab.

 

Out of interest @zdcatc12, what do you have to do, I am required to fill out a weekly diary saying where I have been (shops, gym, cinema, pub restaurant, public transport), who I have spent time with and if anyone in the household has symptoms, I also have to do a home Covid-19 test once a week, this test is carried out along side regular tests (ie the testers don't know I'm on the trial).

***I'm not under any confidentiality clause so I'm allowed to talk freely about it***

 

What I think is especially good with the Oxford Vaccine is, they have promised “free global access” and to "operate on a not-for-profit basis during the pandemic", some might argue that after receiving tens of millions in government funding they should but it's still admirable.

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If it were available in the fall, there would be a maximum of suppose 6-7 months of data from those in Phase 1 to see how safe it is- there won't be any long term data. One of the trials wont have everyone enrolled until November- in which case full data wouldn't be available until after the second treatment is given.

 

For a vaccine to be released, it would have to be done before Phase III trials are complete- even then we won't have any long term evidence of safety or effectiveness., nor how it interacts with the flu vaccine.

 

However, we all can't continue like this- is it worth the risk to release the vaccine early? It might be.

Until then no cruises, sporting events, concerts, etc.- which I realized is my whole existence.

 

Today I found out my pre cruise hotel is closing for good. If this continues then we will have cruise lines shutting down as well.

 

 

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5 hours ago, gizfish said:

No I am not conflating safe and effective.  HCQ was indeed found to be dangerous in this situation, when used on covid patients.  It was also not found to be effective.  What was found was that the safety issues using HCQ in THIS situation was not worth it due to its not being effective at treating the situation.  With covid patients, due to everything else that is going on with their bodies, it is reasonable in that situation to say HCQ needs to be given in the hospital or under direct MD supervision.  HCQ is indeed a wonder drug, safe and effective for the vast majority, but not for covid patients who are by no means as healthy as the vast majority.  This is not a political thing.  This is a science thing. 

Some anecdotal information for you to peruse.  A friend is a nurse in a hospital.  Upon diagnosis of Covid-19, they are given HCQ, zinc and z-pak.  He said usually they get to go home to convalesce.  That is being done as we speak.  Don't know how they're getting by the FDA but it's working!  I've heard ER doctors that swear by it's use with Covid treatment.  It's depending on where in their sickness they are given the drug and their preexisting illnesses.  It's not as cut and dried as you want to say it and as has been ruled.  It's not a science thing!  It has been made into a political thing!  Just MHO.

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5 hours ago, HowardK said:

If it were available in the fall, there would be a maximum of suppose 6-7 months of data from those in Phase 1 to see how safe it is- there won't be any long term data. One of the trials wont have everyone enrolled until November- in which case full data wouldn't be available until after the second treatment is given.

 

For a vaccine to be released, it would have to be done before Phase III trials are complete- even then we won't have any long term evidence of safety or effectiveness., nor how it interacts with the flu vaccine.

 

However, we all can't continue like this- is it worth the risk to release the vaccine early? It might be.

Until then no cruises, sporting events, concerts, etc.- which I realized is my whole existence.

 

Today I found out my pre cruise hotel is closing for good. If this continues then we will have cruise lines shutting down as well.

 

 

 

A proper phase 3 trial for a vaccine should last at least 2 years.  6 months of data is not enough to determine efficacy in vaccines.  6 months is an important data point for them but it is the start of reviewing long term efficacy and for vaccines that is everything.

 

We are getting close to the point where people will just accept the risk and want to return to normality.  

 

On a side note, the second attempt for a herpes simplex vaccine is on its way.  It's still too early to say much.  The phase 2 trial just started this year.  The first attempt failed at phase 3 trials.  That vaccine candidate had good results at 5 months but by 12 months, immunity had waned.  

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With all the politicizing going on at the CDC, I wouldn't touch these vaccines for at least one year to be sure its safe. By the way, I get a flu shot every year, including this year, so I'm not against vaccines.
Same here, exactly my point as well.

Sent from my Pixel 4 XL using Tapatalk

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13 hours ago, sargemrs said:

Some anecdotal information for you to peruse.  A friend is a nurse in a hospital.  Upon diagnosis of Covid-19, they are given HCQ, zinc and z-pak.  He said usually they get to go home to convalesce.  That is being done as we speak.  Don't know how they're getting by the FDA but it's working!  I've heard ER doctors that swear by it's use with Covid treatment.  It's depending on where in their sickness they are given the drug and their preexisting illnesses.  It's not as cut and dried as you want to say it and as has been ruled.  It's not a science thing!  It has been made into a political thing!  Just MHO.

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

 

Edited by njhorseman
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All of the people who say that they rather risk getting COVID than getting a vaccination is why the US will continue to have a COVID epidemic and we will continue to destroy our economy. It is self-inflicted with no one to blame except ourselves. 

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10 minutes ago, njhorseman said:

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

 

It's only worthless when one disagrees with the anecdotal evidence.

Edited by RocketMan275
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2 minutes ago, RocketMan275 said:

It's only worthless when one disagrees with the anecdotal evidence.

No it's worthless unless it's later proven to be accurate by accepted scientific standards, and in this case HCQ has been shown to not meet the accepted standards for safety and efficacy to be approved for use in the treatment of COVID-19.

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Just now, njhorseman said:

No it's worthless unless it's later proven to be accurate by accepted scientific standards, and in this case HCQ has been shown to not meet the accepted standards for safety and efficacy to be approved for use in the treatment of COVID-19.

So, you're saying that because HCQ may have adverse effects in the elderly, it should not be prescribed for others?

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1 hour ago, RocketMan275 said:

So, you're saying that because HCQ may have adverse effects in the elderly, it should not be prescribed for others?

I don't have the data that the FDA evaluated when they made the decision to withdraw the Emergency Use Authorization. All I can say is that the drugs must not have met FDA standards for safety and efficacy.  The fact is that the FDA granted the EUA, so it's not as if they just shut the door on the possibility those drugs might be safe and effective. They withdrew the EUA only after the medications apparently did not meet standards.

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30 minutes ago, njhorseman said:

I don't have the data that the FDA evaluated when they made the decision to withdraw the Emergency Use Authorization. All I can say is that the drugs must not have met FDA standards for safety and efficacy.  The fact is that the FDA granted the EUA, so it's not as if they just shut the door on the possibility those drugs might be safe and effective. They withdrew the EUA only after the medications apparently did not meet standards.

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.

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On 9/2/2020 at 7:09 PM, Sand and Seas said:

Leaving politics out of it.....I'm just happy to hear there are several companies working on vaccines.   

 

The first approved vaccines need to go to health care providers, the elderly, and those with serious underlying conditions first.

After that, maybe the rest of us can get back to some sort of regular life.

 

 

Thank you, YES, leave out the politics.  We are on these boards for TRAVEL and CRUISING.

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6 hours ago, deliver42 said:

With all the politicizing going on at the CDC, I wouldn't touch these vaccines for at least one year to be sure its safe. By the way, I get a flu shot every year, including this year, so I'm not against vaccines.

 

I wouldn't worry its going to take at least 6-12 months before anyone not in a critical role receives the vaccine. There simply won't be enough in the first few months. Doctors, Nurses, emergency services, teachers etc will all get first access.

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28 minutes ago, 4774Papa said:

Thank you, YES, leave out the politics.  We are on these boards for TRAVEL and CRUISING.

 I agree with you and Sand and Seas that this thread is very political. So many experts...I don't care if a vaccine comes out Nov. 2 as long as it helps get things back to normal. Cruises are already resuming without a vaccine, so it isn't the sole deciding factor.

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On 9/5/2020 at 1:20 PM, ziggyuk said:

Out of interest @zdcatc12, what do you have to do, I am required to fill out a weekly diary saying where I have been (shops, gym, cinema, pub restaurant, public transport), who I have spent time with and if anyone in the household has symptoms, I also have to do a home Covid-19 test once a week, this test is carried out along side regular tests (ie the testers don't know I'm on the trial).

***I'm not under any confidentiality clause so I'm allowed to talk freely about it***

I have a diary app on my phone. I had to fill it out daily for a week after my first shot. That one asked things like highest body temp that day, any chills, muscle aches, etc. Any redness or swelling at the injection site, etc. I also have to do that for a week on the second one that I got last Friday. After the daily ones the first week up until my second shot, I only had to answer each day if I felt ok. That is what I will go back to after Friday for the rest of the trial. I believe then the follow-ups are at two months, six months, 12 months and 24 months and then it is over. We can also end participation at any time for any reason. We also have a swab kit, if we show symptoms, we need to swab ourself and send the swab to the lab. They only consider fevers higher than 102 (39C) as the cutoff for the symptoms, not 100.4 (38C) like businesses that take your temp before you can go in.

 

  They do not track where we go during the study. However, to qualify, you needed to go to high traffic places at least three times a week, e.g. grocery store, restuarants, etc.

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56 minutes ago, zdcatc12 said:

I have a diary app on my phone. I had to fill it out daily for a week after my first shot. That one asked things like highest body temp that day, any chills, muscle aches, etc. Any redness or swelling at the injection site, etc. I also have to do that for a week on the second one that I got last Friday. After the daily ones the first week up until my second shot, I only had to answer each day if I felt ok. That is what I will go back to after Friday for the rest of the trial. I believe then the follow-ups are at two months, six months, 12 months and 24 months and then it is over. We can also end participation at any time for any reason. We also have a swab kit, if we show symptoms, we need to swab ourself and send the swab to the lab. They only consider fevers higher than 102 (39C) as the cutoff for the symptoms, not 100.4 (38C) like businesses that take your temp before you can go in.

 

  They do not track where we go during the study. However, to qualify, you needed to go to high traffic places at least three times a week, e.g. grocery store, restuarants, etc.

 

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.

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 🤢

 

Your trial is very long, ours is 12 months, mine is longer now as the 12 months started again after the optional second shot (this was not part of the original plan), also like you, I can withdraw at any time.

 

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

 

This is how my time line looks:

image.png.41ac241823d5cb3ececbe1f69b1c649f.png

 

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.

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On 9/6/2020 at 5:43 AM, deliver42 said:

With all the politicizing going on at the CDC, I wouldn't touch these vaccines for at least one year to be sure its safe. By the way, I get a flu shot every year, including this year, so I'm not against vaccines.

One thing I am curious about is how the flu vaccine would interact with the covid vaccine. 

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