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CDC COVID Vaccine in Nov 2020.


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5 hours ago, njhorseman said:

 

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. 

I have stated numerous times that I made no claims that HCQ was effective for the treatment of COVID.  Although even the CDC admits that HCQ is being widely prescribed by physicians for COVID 19 and that studies are underway about it's safety and effectiveness world wide.  My claim has been that HCQ has been the objective of biased attacks.  HCQ is widely and safely used around the world.  Whether it is effective against COVID is irrelevant to whether the drug is safe or not.  The EUA was revoked because it had adverse effects in senior citizens with multiple comorbidities not because it was unsafe for the wider populations.  If the CDC was convinced HCQ was unsafe then they why do they still allow the drug for other uses?

Edited by RocketMan275
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25 minutes ago, RocketMan275 said:

I have stated numerous times that I made no claims that HCQ was effective for the treatment of COVID.  Although even the CDC admits that HCQ is being widely prescribed by physicians for COVID 19 and that studies are underway about it's safety and effectiveness world wide.  My claim has been that HCQ has been the objective of biased attacks.  HCQ is widely and safely used around the world.  Whether it is effective against COVID is irrelevant to whether the drug is safe or not.  The EUA was revoked because it had adverse effects in senior citizens with multiple comorbidities not because it was unsafe for the wider populations.  If the CDC was convinced HCQ was unsafe then they why do they still allow the drug for other uses?

As I explained a while back, a drug can be deemed safe and effective for a particular cohort and particular disease or condition, but that does not mean that drug is safe and effective for others with other conditions of diseases. Try reading the prescribing information for a medication and you'll often see warnings to not use the drug for people of a particular age group or with a certain disease. 

And once again I'll remind you that anecdotal evidence is not accepted as scientific proof.

In the end it's the FDA that makes the decisions about the safety and efficacy of drugs based on accepted scientific methodology, not you based on your personal opinion .

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1 minute ago, njhorseman said:

As I explained a while back, a drug can be deemed safe and effective for a particular cohort and particular disease or condition, but that does not mean that drug is safe and effective for others with other conditions of diseases. Try reading the prescribing information for a medication and you'll often see warnings to not use the drug for people of a particular age group or with a certain disease. 

And once again I'll remind you that anecdotal evidence is not accepted as scientific proof.

In the end it's the FDA that makes the decisions about the safety and efficacy of drugs based on accepted scientific methodology, not you based on your personal opinion .

So do you admit that HCQ might be safe for those who are not senior citizens with multiple comorbidities?

BTW, it's not my personal opinion that HCQ is being widely prescribed for COVID by multiple physicians and around the world.  

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14 minutes ago, RocketMan275 said:

So do you admit that HCQ might be safe for those who are not senior citizens with multiple comorbidities?

BTW, it's not my personal opinion that HCQ is being widely prescribed for COVID by multiple physicians and around the world.  

I admit nothing of the sort. The medications are safe and effective for their FDA approved uses. Anything else is speculative and based on scientifically unacceptable anecdotal evidence. The FDA is accepted as having the highest standards in the world. I could care less what might be acceptable in other countries with lower standards.

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8 hours ago, jotjot said:

HCQ, any drug can be used  "off label", very common. Why would anyone care if a doctor prescribed it.    .https://www.webmd.com/a-to-z-guides/features/off-label-drug-use-what-you-need-to-know#1

Yes any drug can be prescribed off label, but why would you want to take a drug that the FDA has determined is not effective for the disease you're treating and potentially harmful?

Edited by njhorseman
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On 9/9/2020 at 8:04 AM, goldmom said:

 

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.  

 

We are close neighbors !  Bet we have cruised together at one point !!!

 

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41 minutes ago, jaja said:

 

 

41 minutes ago, jaja said:

 

We probably have!  Don't you just love being close to port?  We love the Gem cruises to the Caribbean during January to March.  So nice to get away from North Jersey winter without having to fly.

 

Looking forward to cruising again when it's safe!

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I got an email from the Oxford/Southampton team today, it does not say much but for those interested, this is how it reads:

 

Dear Participant

As part of the ongoing randomised controlled global trials of the coronavirus vaccine, our standard review process triggered a study pause to vaccination to allow review of safety data. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the studies, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. All routine follow-up appointments are continuing during this period and swabs should continue as normal. We are committed to the safety of our participants and the highest standards of conduct in our studies.

 

If you would like more information, please phone the study team on xxxxxxxxxx. 

 

Kind regards

Southampton COVID-19 Study Team

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15 hours ago, ziggyuk said:

I got an email from the Oxford/Southampton team today, it does not say much but for those interested, this is how it reads:

 

Dear Participant

As part of the ongoing randomised controlled global trials of the coronavirus vaccine, our standard review process triggered a study pause to vaccination to allow review of safety data. This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the studies, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully. All routine follow-up appointments are continuing during this period and swabs should continue as normal. We are committed to the safety of our participants and the highest standards of conduct in our studies.

 

If you would like more information, please phone the study team on xxxxxxxxxx. 

 

Kind regards

Southampton COVID-19 Study Team

Thanks for the update!  

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Update for the Oxford vaccine just received, it's back on again, if anyone wishes to read here is the update:

 

Dear participant,

 

Please find below a statement issued Saturday 12/09/2020 regarding the recommencement of vaccination in the Oxford COVID-19 vaccine trials. You will be sent an updated participant information sheet and have the opportunity to discuss further with the study team in due course.

 

University of Oxford resumes vaccine trial

The ongoing randomised controlled clinical trials of the Oxford coronavirus vaccine ChAdOx1 nCoV-19 will resume across all the UK clinical trial sites.

Globally some 18,000 individuals have received study vaccines as part of the trial. In large trials such as this, it is expected that some participants will become unwell and every case has to be carefully evaluated to ensure careful assessment of safety. On Sunday [06/09/2020] our standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee, and the national regulators. All routine follow-up appointments continued as normal during this period.

 

The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, the trials will recommence in the UK.

We cannot disclose medical information about the illness for reasons of participant confidentiality.

 

We are committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.

 

Kind regards,

Professor Saul Faust

On behalf of the Southampton COV002 study team

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  • 2 weeks later...
On 9/9/2020 at 2:40 PM, 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'?

 

Interestingly it has just been announced the UK are to begin challenge testing and already have volunteers willing to be infected by the virus under controlled conditions.

https://www.ft.com/content/b782f666-6847-4487-986c-56d3f5e46c0b

https://www.telegraph.co.uk/news/2020/09/23/challenge-trials-set-infect-volunteers-coronavirus-help-speed/

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6 minutes ago, ziggyuk said:

 

Interestingly it has just been announced the UK are to begin challenge testing and already have volunteers willing to be infected by the virus under controlled conditions.

https://www.ft.com/content/b782f666-6847-4487-986c-56d3f5e46c0b

https://www.telegraph.co.uk/news/2020/09/23/challenge-trials-set-infect-volunteers-coronavirus-help-speed/

Good for you. 

Vaccines could have been ready much quicker had we implemented challenge testing.  

Some say challenge testing, deliberate exposure to the virus, is unethical.

How ethical is the continued exposure of the populace to the virus without the vaccine?

Edited by RocketMan275
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1 minute ago, RocketMan275 said:

Vaccines could have been ready much quicker had we implemented challenge testing.  

Some say challenge testing, deliberate exposure to the virus, is unethical.

How ethical is the continued exposure of the populace to the virus without the vaccine?

I agree,

We already do a lot of challenge testing but normally only for conditions where there is a proven treatment, for example people go to camps to be infected with flu or the common cold.

The big departure here is that there is no known effective treatment for Covid and potentially volunteers can die.

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11 minutes ago, ziggyuk said:

I agree,

We already do a lot of challenge testing but normally only for conditions where there is a proven treatment, for example people go to camps to be infected with flu or the common cold.

The big departure here is that there is no known effective treatment for Covid and potentially volunteers can die.

How many have died from the lack of a vaccine?

There are few situations where there are only good choices. 

There are always trade-offs between less than good choices.

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26 minutes ago, RocketMan275 said:

How many have died from the lack of a vaccine?

There are few situations where there are only good choices. 

There are always trade-offs between less than good choices.

 

As I said before, I totally agree and am in full favour, you're preaching to the converted 🙂

 

Edited by ziggyuk
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7 minutes ago, RocketMan275 said:

I wasn't criticizing you.

BTW, there are some on CC who are very much against challenge testing.

I'd offer it to prisoners on death row with the option of having their sentence converted to life.

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2 hours ago, ziggyuk said:

I agree,

We already do a lot of challenge testing but normally only for conditions where there is a proven treatment, for example people go to camps to be infected with flu or the common cold.

The big departure here is that there is no known effective treatment for Covid and potentially volunteers can die.

with a young healthy test population that has no comorbidities the risk of death is VERY low. i am 40, i caught covid19 early and it was like a light cold. a large percentage of my coworkers have caught it too. 

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with a young healthy test population that has no comorbidities the risk of death is VERY low. i am 40, i caught covid19 early and it was like a light cold. a large percentage of my coworkers have caught it too. 
And I have a co-worker that is 32 and it kicked his @ss. Was out of work 6 weeks.

Sent from my Pixel 4 XL using Tapatalk

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20 hours ago, RocketMan275 said:

I wasn't criticizing you.

BTW, there are some on CC who are very much against challenge testing.

 

I wouldn't say I'm "against" a challenge test. I don't think it's the best method for determining efficacy and has the potential to create more harm than prevent. Because of that I would not volunteer for one and I wouldn't let a friend or family member volunteer for one. But if they do recruit volunteers and explain the risks and it gets approved by an ethics board, go ahead.

 

People in the challenge test are going to get sick. Not all of them, and hopefully not badly. But it's not as simple as saying we are giving 100 people what we think is the "vaccine" and then the virus and we expect no one to get sick if the vaccine works. According to an article in Science magazine "Making the challenge virus will likely take at least until September, Turner says. At that point, according to the WHO proposal, trials should recruit volunteers to test three different doses to find one that causes mild respiratory illness in 70% of people. WHO estimates it will take 2 months after viral strains are made and characterized to launch a challenge study." 

 

So people who participate will get sick. Will any of them get very sick? Maybe, we don't know. 

 

But because of this they will only use people who are young and healthy. Those people are relatively safe now, so using this to push out a vaccine faster doesn't help them.  They won't be able to use elderly or sick people. Those are the people who need the protection from this virus. But this study won't show that it helps them.

I personally don't see the point, but maybe I'm missing something. You really want to get your grandmother a vaccine that works well on a 20 year old but we don't have good data yet on a proper dose for someone with a less active immune system?

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2 minutes ago, sanger727 said:

 

I wouldn't say I'm "against" a challenge test. I don't think it's the best method for determining efficacy and has the potential to create more harm than prevent. Because of that I would not volunteer for one and I wouldn't let a friend or family member volunteer for one. But if they do recruit volunteers and explain the risks and it gets approved by an ethics board, go ahead.

 

People in the challenge test are going to get sick. Not all of them, and hopefully not badly. But it's not as simple as saying we are giving 100 people what we think is the "vaccine" and then the virus and we expect no one to get sick if the vaccine works. According to an article in Science magazine "Making the challenge virus will likely take at least until September, Turner says. At that point, according to the WHO proposal, trials should recruit volunteers to test three different doses to find one that causes mild respiratory illness in 70% of people. WHO estimates it will take 2 months after viral strains are made and characterized to launch a challenge study." 

 

So people who participate will get sick. Will any of them get very sick? Maybe, we don't know. 

 

But because of this they will only use people who are young and healthy. Those people are relatively safe now, so using this to push out a vaccine faster doesn't help them.  They won't be able to use elderly or sick people. Those are the people who need the protection from this virus. But this study won't show that it helps them.

I personally don't see the point, but maybe I'm missing something. You really want to get your grandmother a vaccine that works well on a 20 year old but we don't have good data yet on a proper dose for someone with a less active immune system?

People are going to get sick regardless of whether we do challenge testing or not.

If the reason younger people needed to mask and do social distancing was to prevent them from catching the virus and infecting their grandmothers, wouldn't it be a good idea to vaccinate the younger people?

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