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FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: p8712
Date: August 11, 2021 04:43PM
Not sure how to prove it

Quote

he US Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing Covid-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.
"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: PeterB
Date: August 11, 2021 05:31PM
Quote
p8712
Not sure how to prove it

Quote

he US Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing Covid-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.
"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."

I personally am in favor of this (having now myself gotten two different vaccines), BUT ... considering that no studies had been done in the immunocompromised population as part of the original trials, yes, it is a bit of stab in the dark.




Freya says, 'Hello from NOLA, baby!' (Laissez bon temps rouler!)
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: Speedy
Date: August 11, 2021 06:01PM
Quote
PeterB
Quote
p8712
Not sure how to prove it

Quote

he US Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing Covid-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.
"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."

I personally am in favor of this (having now myself gotten two different vaccines), BUT ... considering that no studies had been done in the immunocompromised population as part of the original trials, yes, it is a bit of stab in the dark.

Not in the original trials, but studies have been done. For example:

[www.nejm.org]



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: PeterB
Date: August 11, 2021 06:11PM
Quote
Speedy
Quote
PeterB
Quote
p8712
Not sure how to prove it

Quote

he US Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing Covid-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.
"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."

I personally am in favor of this (having now myself gotten two different vaccines), BUT ... considering that no studies had been done in the immunocompromised population as part of the original trials, yes, it is a bit of stab in the dark.

Not in the original trials, but studies have been done. For example:

[www.nejm.org]

Right, but that's only a small portion of the immunocompromised population (solid organ transplant patients), and also not a particularly large N as compared to the original trials. That being said, it is encouraging. I'd like to see the data for those who did what I did, and get a different vaccine rather than a booster of the same one.




Freya says, 'Hello from NOLA, baby!' (Laissez bon temps rouler!)
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: Speedy
Date: August 11, 2021 06:14PM
Quote
PeterB
Quote
Speedy
Quote
PeterB
Quote
p8712
Not sure how to prove it

Quote

he US Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing Covid-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.
"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."

I personally am in favor of this (having now myself gotten two different vaccines), BUT ... considering that no studies had been done in the immunocompromised population as part of the original trials, yes, it is a bit of stab in the dark.

Not in the original trials, but studies have been done. For example:

[www.nejm.org]

Right, but that's only a small portion of the immunocompromised population (solid organ transplant patients), and also not a particularly large N as compared to the original trials. That being said, it is encouraging. I'd like to see the data for those who did what I did, and get a different vaccine rather than a booster of the same one.

The possible permutations means this is not going to happen for years and then it will be a retrospective study.

Also, what holds true for one immunocompromised group is probably indicative of what is true for others.



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: RAMd®d
Date: August 11, 2021 07:09PM
All is know is that if Kaiser Permanente calls and asks if I want a booster, I'd say the same thing I'd say to Diane Sawyer if she ever asked me out on a date — 'Yes, please!'






I am that Masked Man.

All you can do, is all you can do.

There’s trouble — it's time to play the sound of my people.

Your boos mean nothing to me, I've seen what you cheer for.

Insisting on your rights without acknowledging your responsibilities isn’t freedom, it’s adolescence.

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We are a government of laws, not men.

Everybody counts or nobody counts.

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all who would be called good
must suffer with him.

You and I have memories longer than the road that stretches out ahead.

There is no safety for honest men except
by believing all possible evil of evil men.

We don’t do focus groups. They just ensure that you don’t offend anyone, and produce bland inoffensive products. —Sir Jonathan Ive

An armed society is a polite society.
And hope is a lousy defense.

You make me pull, I'll put you down.

I *love* SIGs. It's Glocks I hate.
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: PeterB
Date: August 11, 2021 07:37PM
Quote
Speedy
Quote
PeterB
Quote
Speedy
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PeterB
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p8712
Not sure how to prove it

Quote

he US Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing Covid-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.
"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."

I personally am in favor of this (having now myself gotten two different vaccines), BUT ... considering that no studies had been done in the immunocompromised population as part of the original trials, yes, it is a bit of stab in the dark.

Not in the original trials, but studies have been done. For example:

[www.nejm.org]

Right, but that's only a small portion of the immunocompromised population (solid organ transplant patients), and also not a particularly large N as compared to the original trials. That being said, it is encouraging. I'd like to see the data for those who did what I did, and get a different vaccine rather than a booster of the same one.

The possible permutations means this is not going to happen for years and then it will be a retrospective study.

Also, what holds true for one immunocompromised group is probably indicative of what is true for others.

That last part of what you wrote I definitely don't agree with, because the sheer variety of immunodeficiencies and diseases that have immune-related symptoms means that one size will not fit all. For example, those patients specifically with T-cell defects are not likely to have the same results with vaccines as those who are compromised across the board.




Freya says, 'Hello from NOLA, baby!' (Laissez bon temps rouler!)
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: Sarcany
Date: August 11, 2021 09:32PM
Quote
PeterB
I'd like to see the data for those who did what I did, and get a different vaccine rather than a booster of the same one.

[www.bbc.co.uk]

A mix-and-match approach to Covid vaccines - using different brands for first and second doses - appears to give good protection against the pandemic virus, a UK study has found.

The Com-Cov trial looked at the efficacy of either two doses of Pfizer, two of AstraZeneca, or one of them followed by the other.

All combinations worked well, priming the immune system...


[But getting the mRNA vaccine after the AstraZeneca worked best.]

The Com-Cov study, which looked at giving the doses four weeks apart in 850 volunteers aged 50 and above, found:

AZ followed by Pfizer induced higher antibodies and T cell responses than Pfizer followed by AZ

Both of these mixes induced higher antibodies than two doses of AZ

The highest antibody response was seen after two doses of Pfizer, and the highest T cell response from AZ followed by Pfizer


Trial home-page:
[comcovstudy.org.uk]

South Korea did a similar trial, mixing vaccines. Claimed to see evidence of much greater resistance to the virus and variants in the initial testing.

List of countries doing mixed vaccine trials:
[news.yahoo.com]

Ongoing trial in the United States:
[thevaccinereaction.org]
[www.niaid.nih.gov]

The evidence (and political pressure to act) is growing rapidly.







Edited 1 time(s). Last edit at 08/11/2021 09:33PM by Sarcany.
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: PeterB
Date: August 11, 2021 09:45PM
Quote
Sarcany
Quote
PeterB
I'd like to see the data for those who did what I did, and get a different vaccine rather than a booster of the same one.

[www.bbc.co.uk]

A mix-and-match approach to Covid vaccines - using different brands for first and second doses - appears to give good protection against the pandemic virus, a UK study has found.

The Com-Cov trial looked at the efficacy of either two doses of Pfizer, two of AstraZeneca, or one of them followed by the other.

All combinations worked well, priming the immune system...


[But getting the mRNA vaccine after the AstraZeneca worked best.]

The Com-Cov study, which looked at giving the doses four weeks apart in 850 volunteers aged 50 and above, found:

AZ followed by Pfizer induced higher antibodies and T cell responses than Pfizer followed by AZ

Both of these mixes induced higher antibodies than two doses of AZ

The highest antibody response was seen after two doses of Pfizer, and the highest T cell response from AZ followed by Pfizer


Trial home-page:
[comcovstudy.org.uk]

South Korea did a similar trial, mixing vaccines. Claimed to see evidence of much greater resistance to the virus and variants in the initial testing.

List of countries doing mixed vaccine trials:
[news.yahoo.com]

Ongoing trial in the United States:
[thevaccinereaction.org]
[www.niaid.nih.gov]

The evidence (and political pressure to act) is growing rapidly.

Interesting, thanks. I was thinking of the U.S. specifically, since we don't have access to AZ here.

Some of the user comments on that thevaccinereaction.org page are really disturbing...




Freya says, 'Hello from NOLA, baby!' (Laissez bon temps rouler!)
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: cbelt3
Date: August 12, 2021 07:39AM
FWIW, my older sister volunteered for a trial of the J&J. She's gotten TWO J&J vaccinations. She works with the public and is super healthy and fit.
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: Speedy
Date: August 12, 2021 08:39AM
Quote
PeterB
Quote
Speedy
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PeterB
Quote
Speedy
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PeterB
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p8712
Not sure how to prove it

Quote

he US Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing Covid-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.
"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."

I personally am in favor of this (having now myself gotten two different vaccines), BUT ... considering that no studies had been done in the immunocompromised population as part of the original trials, yes, it is a bit of stab in the dark.

Not in the original trials, but studies have been done. For example:

[www.nejm.org]

Right, but that's only a small portion of the immunocompromised population (solid organ transplant patients), and also not a particularly large N as compared to the original trials. That being said, it is encouraging. I'd like to see the data for those who did what I did, and get a different vaccine rather than a booster of the same one.

The possible permutations means this is not going to happen for years and then it will be a retrospective study.

Also, what holds true for one immunocompromised group is probably indicative of what is true for others.

That last part of what you wrote I definitely don't agree with, because the sheer variety of immunodeficiencies and diseases that have immune-related symptoms means that one size will not fit all. For example, those patients specifically with T-cell defects are not likely to have the same results with vaccines as those who are compromised across the board.

Perhaps we can agree that getting a booster is better than not getting one.



Saint Cloud, Minnesota, where the weather is wonderful even when it isn't.
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Re: FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours
Posted by: PeterB
Date: August 12, 2021 09:05AM
Quote
Speedy
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PeterB
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Speedy
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PeterB
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Speedy
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PeterB
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p8712
Not sure how to prove it

Quote

he US Food and Drug Administration is expected to announce within the next 48 hours that it is authorizing Covid-19 vaccine booster shots for some people who are immunocompromised, according to a source familiar with the discussions.
This would be a third shot of the current two-dose Pfizer and Moderna vaccines. That announcement could slide, the source cautioned, but this is the current timing.
"The FDA is closely monitoring data as it becomes available from studies administering an additional dose of the authorized COVID-19 vaccines to immunocompromised individuals," an FDA spokesperson told CNN. "The agency, along with the CDC, is evaluating potential options on this issue, and will share information in the near future."

I personally am in favor of this (having now myself gotten two different vaccines), BUT ... considering that no studies had been done in the immunocompromised population as part of the original trials, yes, it is a bit of stab in the dark.

Not in the original trials, but studies have been done. For example:

[www.nejm.org]

Right, but that's only a small portion of the immunocompromised population (solid organ transplant patients), and also not a particularly large N as compared to the original trials. That being said, it is encouraging. I'd like to see the data for those who did what I did, and get a different vaccine rather than a booster of the same one.

The possible permutations means this is not going to happen for years and then it will be a retrospective study.

Also, what holds true for one immunocompromised group is probably indicative of what is true for others.

That last part of what you wrote I definitely don't agree with, because the sheer variety of immunodeficiencies and diseases that have immune-related symptoms means that one size will not fit all. For example, those patients specifically with T-cell defects are not likely to have the same results with vaccines as those who are compromised across the board.

Perhaps we can agree that getting a booster is better than not getting one.

Oh, absolutely. I think it will turn out that getting the boosters will be entirely safe, I'm just wondering / thinking if it may be even more advantageous to switch vaccines, rather than getting a booster of the same one. Furthermore, it might be yet more advantageous if the different vaccines target different components of the virus, for example one vaccine targeting the spike protein, another targeting the nucleocapsid protein or some other essential component of the virus.




Freya says, 'Hello from NOLA, baby!' (Laissez bon temps rouler!)
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