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Are vaccines the light at the end of the tunnel?


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10 hours ago, TeeRick said:

I wonder if states will follow the recommended guideline put forth in the US by the National Academy of Sciences?  Or will they go off and do their own thing?  Hopefully not. 

hcat- For example, if NYS is different than FL can you get the vaccine in FL instead?  Will people cross state lines for an earlier vaccine?  This would be unfair to those within a given state.  I hope this does not turn into another state-driven political mess.  But yes we need a vaccine first!

 

https://www.nature.com/articles/d41586-020-02684-9

 

We are legal residents  of NY where we vote and pay state income tax. We consider our status in Florida  as part time.  We do not apply for Fla resident cruise discounts or  homestead  property tax relief  from Fla. We can get regular shots at the CVS ( or other pharmacies) in either state when we are there but the Covid vaccine will no doubt be different at first.

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13 hours ago, nocl said:

I expect since there are 50 states there will probably be 50 different plans followed.

 

California has announced that it will not allow any vaccine to be distributed in the state until it is reviewed and approved by a panel the Governor has established.

I am very disappointed but not really surprised that some individual states are all of a sudden not trusting the FDA and deciding to set up their own mini-FDA's.  Maybe just for a COVID vaccine.  But what about all of the multitude of drugs (including new COVID drugs) and Biologics and Vaccines that the FDA approves?  This has never been taken over by individual states.  There is so much at stake for a COVID vaccine and there will be rigorous review.  The FDA has promised to make all of the data on the vaccine public and have independent reviews.  They will be under serious scrutiny.  And outside the US other regulatory agencies outside the reach of US politics will also review the data. 

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18 hours ago, greykitty said:

Is this after the Brazil report?  Although it seems unclear about what exactly happened?  I saw an article that said never before has vaccine development been parsed daily in the press....no wonder it's hard to keep track of real developments.

 

https://www.forbes.com/sites/rachelsandler/2020/10/21/volunteer-in-astrazeneca-covid-19-vaccine-trial-reportedly-dies-in-brazil/#6b69d5c42516

The news seems to be that a volunteer in the trial died.  But the trial has not been stopped.  It also has been reported that the death was in the non-vaccine control group.  So likely just an unfortunate death but not related.

https://www.bbc.com/news/world-latin-america-54634518

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So when the Oxford/AZ Phase 3 trial restarts in the US, hopefully this extended 6-7 week pause will give them insight into the effects of delaying the second dose for longer than was originally planned, turning the delay into a positive.

 

Since the U.S. trial has been halted for longer than four weeks, it's unclear what will happen to participants who have received the first shot but not the second. AstraZeneca said it expects "minimal impact based on the trial plans for 2nd dose timing."

The second dose of a vaccine is often times "more effective if there’s a longer interval between the first and second dose," Falsey said. But she said it would be up to AstraZeneca to decide how to handle delayed second doses.

 

https://news.yahoo.com/astrazeneca-close-restarting-covid-19-153954783.html

Edited by Ken the cruiser
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5 minutes ago, Ken the cruiser said:

So when the Oxford/AZ Phase 3 trial restarts in the US, hopefully this extended 6-7 week pause will give them insight into the effects of delaying the second dose for longer than was originally planned, turning the delay into a positive.

 

Since the U.S. trial has been halted for longer than four weeks, it's unclear what will happen to participants who have received the first shot but not the second. AstraZeneca said it expects "minimal impact based on the trial plans for 2nd dose timing."

The second dose of a vaccine is often times "more effective if there’s a longer interval between the first and second dose," Falsey said. But she said it would be up to AstraZeneca to decide how to handle delayed second doses.

 

https://news.yahoo.com/astrazeneca-close-restarting-covid-19-153954783.html

Typically once your immune system has been primed the second dose (boost) will be effective as long as the minimum timing is followed between doses.

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14 hours ago, nocl said:

I expect since there are 50 states there will probably be 50 different plans followed.

 

California has announced that it will not allow any vaccine to be distributed in the state until it is reviewed and approved by a panel the Governor has established.

I normally am a big believer in states rights but to me this is yet another example of the chaos that will ensue due to 50 states and 50 different approaches.  Per CC rules, I am not going to get into a debate related to politics, meaning which side of the aisle is right or wrong.  But I think it is ok to state what I personally think about this particular topic, although I know it walks a thin line.  And that is, that it should be beyond the reach of any state government to deny their citizens access to a vaccine that has been approved by the FDA.  The FDA is the federal organization with the right and responsibility to approve/disapprove of vaccines, medications, etc..  Once they approve it, I should have the right to receive it if I see fit.  If they want to have a panel review it further that's fine, but delaying distribution is not fine.  How many more people will die or get seriously ill  should the vaccine be delayed even further.  This concerns me greatly.   

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1 hour ago, TeeRick said:

I am very disappointed but not really surprised that some individual states are all of a sudden not trusting the FDA and deciding to set up their own mini-FDA's.  Maybe just for a COVID vaccine.  But what about all of the multitude of drugs (including new COVID drugs) and Biologics and Vaccines that the FDA approves?  This has never been taken over by individual states.  There is so much at stake for a COVID vaccine and there will be rigorous review.  The FDA has promised to make all of the data on the vaccine public and have independent reviews.  They will be under serious scrutiny.  And outside the US other regulatory agencies outside the reach of US politics will also review the data. 

Political posturing followed by more political posturing - ?pi**ing contest?

I was also very disappointed to see this. There's nothing wrong with having experts from your state chiming in on an existing vaccine, especially as a part of the campaign to get people vaccinated, but at this point these govs are just trying to make political points - confusing the issue, just as they have lambasted the other side for doing.

I will admit to being a petty person, my first reaction to reading this was "good, more for the rest of us".

 

22 minutes ago, phoenix_dream said:

I normally am a big believer in states rights but to me this is yet another example of the chaos that will ensue due to 50 states and 50 different approaches.  Per CC rules, I am not going to get into a debate related to politics, meaning which side of the aisle is right or wrong.  But I think it is ok to state what I personally think about this particular topic, although I know it walks a thin line.  And that is, that it should be beyond the reach of any state government to deny their citizens access to a vaccine that has been approved by the FDA.  The FDA is the federal organization with the right and responsibility to approve/disapprove of vaccines, medications, etc..  Once they approve it, I should have the right to receive it if I see fit.  If they want to have a panel review it further that's fine, but delaying distribution is not fine.  How many more people will die or get seriously ill  should the vaccine be delayed even further.  This concerns me greatly.   

I would make a distinction between the 50 states - 50 plans for distribution and the assertion by Govs Newman and Cuomo about not trusting the FDA.

 

CDC and NASEM and other bodies have issued or are developing suggested

frameworks for plans of distribution, but the details will have to vary a good bit from state to state, if for no other reason than the public health resources and health infrastructure and state laws vary a good bit from state to state. What needs to be done in Nebraska may be very different than what needs to be done in New York, but what works in upstate New York may be applicable to Nebraska and distribution in NYC may look similar to distribution in Chicago or Seattle. The ordering of the groups to get vaccines should be much the same all across the country - but the details may be different.

 

I agree that governers trying to outthink the FDA is unnecessary posturing.

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1 hour ago, cangelmd said:

Political posturing followed by more political posturing - ?pi**ing contest?

I was also very disappointed to see this. There's nothing wrong with having experts from your state chiming in on an existing vaccine, especially as a part of the campaign to get people vaccinated, but at this point these govs are just trying to make political points - confusing the issue, just as they have lambasted the other side for doing.

I will admit to being a petty person, my first reaction to reading this was "good, more for the rest of us".

 

I would make a distinction between the 50 states - 50 plans for distribution and the assertion by Govs Newman and Cuomo about not trusting the FDA.

 

CDC and NASEM and other bodies have issued or are developing suggested

frameworks for plans of distribution, but the details will have to vary a good bit from state to state, if for no other reason than the public health resources and health infrastructure and state laws vary a good bit from state to state. What needs to be done in Nebraska may be very different than what needs to be done in New York, but what works in upstate New York may be applicable to Nebraska and distribution in NYC may look similar to distribution in Chicago or Seattle. The ordering of the groups to get vaccines should be much the same all across the country - but the details may be different.

 

I agree that governers trying to outthink the FDA is unnecessary posturing.

Again it is hard to be apolitical and not take sides.  But we can try.  Walking a thin line but what I will say is that any state (Red or Blue or in between) adding another review layer beyond the FDA is just asking for trouble with their citizens.  And this could backfire on them.  Imagine the public outcry in these states if their citizens have delayed access to a vaccine approved elsewhere in the US?  Or even worse what if this delay leads to increased hospitalizations and deaths in their states?  At the very least it plants more seeds of mistrust for an approved COVID vaccine and lengthens the pandemic for all of us if people refuse to get vaccinated.  And selfishly longer time to return to normal cruising of course.

Edited by TeeRick
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2 minutes ago, TeeRick said:

And this could backfire on them.  Imagine the public outcry in their states if their citizens have delayed access to a vaccine approved elsewhere in the US?  Or even worse what if this delay leads to increased hospitalizations and deaths in their states?

I think there's no question it would likely lead to increased hospitalizations and deaths.  Whether they would ever be qualified and counted as such is of course another issue.  Perhaps I am being overly cynical and looking at this the wrong way.  Perhaps what they really want to do is to add another voice of reason to the mix to try to reassure their residents so that they will be more willing to take the vaccine. ...............................nah.  wishful thinking

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3 hours ago, TeeRick said:

I am very disappointed but not really surprised that some individual states are all of a sudden not trusting the FDA and deciding to set up their own mini-FDA's.  Maybe just for a COVID vaccine.  But what about all of the multitude of drugs (including new COVID drugs) and Biologics and Vaccines that the FDA approves?  This has never been taken over by individual states.  There is so much at stake for a COVID vaccine and there will be rigorous review.  The FDA has promised to make all of the data on the vaccine public and have independent reviews.  They will be under serious scrutiny.  And outside the US other regulatory agencies outside the reach of US politics will also review the data. 

It is would be rather comical, if it was not so sad.

 

After all the states could send experts to attend the advisory committee meeting, which is public.  For that matter if they actually did pick the experts for their state level committee, some of them are probably on the FDA Vaccine Advisory Committee which is comprised of vaccine experts from academia and the medical industry that are outside of the government and therefore are independent of both political and industry pressure.

 

The only thing the state will accomplish by blocking distribution will be to muddle things even more. After all if one government agency that has been doing this for decades is not trustworthy, why should another government agency that has not had this responsibility be any more trustworthy.

 

 

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1 hour ago, nocl said:

It is would be rather comical, if it was not so sad.

 

After all the states could send experts to attend the advisory committee meeting, which is public.  For that matter if they actually did pick the experts for their state level committee, some of them are probably on the FDA Vaccine Advisory Committee which is comprised of vaccine experts from academia and the medical industry that are outside of the government and therefore are independent of both political and industry pressure.

 

The only thing the state will accomplish by blocking distribution will be to muddle things even more. After all if one government agency that has been doing this for decades is not trustworthy, why should another government agency that has not had this responsibility be any more trustworthy.

 

 

I hope they are wrong, but Barron's published this today:

 

U.S. cruise line sailings likely won’t resume until March, despite the projections of some in the industry, according to Macquarie Research.  Full article below.

 

https://www.barrons.com/articles/dont-expect-cruise-ship-sailings-to-resume-this-year-analysts-say-51603376755

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Barron’s is wrong.   The Bahamas Paradise Cruise Line has received approval from the CDC to start sailing.   Admittedly a small step, but it is the first line to get approval and it’s on a much older ship.   They are scheduled for the first week of December on their largest, but oldest ship.

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19 minutes ago, Covepointcruiser said:

Barron’s is wrong.   The Bahamas Paradise Cruise Line has received approval from the CDC to start sailing.   Admittedly a small step, but it is the first line to get approval and it’s on a much older ship.   They are scheduled for the first week of December on their largest, but oldest ship.

Barron isn't wrong, as it was simply reporting the findings of Macquarie Research.

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5 hours ago, LGW59 said:

I hope they are wrong, but Barron's published this today:

 

U.S. cruise line sailings likely won’t resume until March, despite the projections of some in the industry, according to Macquarie Research.  Full article below.

 

https://www.barrons.com/articles/dont-expect-cruise-ship-sailings-to-resume-this-year-analysts-say-51603376755

Don't have a subscription so can't sign in to read.

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10 hours ago, phoenix_dream said:

I normally am a big believer in states rights but to me this is yet another example of the chaos that will ensue due to 50 states and 50 different approaches.  Per CC rules, I am not going to get into a debate related to politics, meaning which side of the aisle is right or wrong.  But I think it is ok to state what I personally think about this particular topic, although I know it walks a thin line.  And that is, that it should be beyond the reach of any state government to deny their citizens access to a vaccine that has been approved by the FDA.  The FDA is the federal organization with the right and responsibility to approve/disapprove of vaccines, medications, etc..  Once they approve it, I should have the right to receive it if I see fit.  If they want to have a panel review it further that's fine, but delaying distribution is not fine.  How many more people will die or get seriously ill  should the vaccine be delayed even further.  This concerns me greatly.   

Who knows  what will actually take place.  Not just states,  what about cities, County health Depts?

 

 Yesterday NYC Mayor anounced his distribution plan, Governor says   only he has authority..they have an ongoing tension..nothing new.

 

Hoping sanity and fairness will prevail,  if and when we have a vaccine....

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8 hours ago, TeeRick said:

Again it is hard to be apolitical and not take sides.  But we can try.  Walking a thin line but what I will say is that any state (Red or Blue or in between) adding another review layer beyond the FDA is just asking for trouble with their citizens.  And this could backfire on them.  Imagine the public outcry in these states if their citizens have delayed access to a vaccine approved elsewhere in the US?  Or even worse what if this delay leads to increased hospitalizations and deaths in their states?  At the very least it plants more seeds of mistrust for an approved COVID vaccine and lengthens the pandemic for all of us if people refuse to get vaccinated.  And selfishly longer time to return to normal cruising of course.

One thing that I learned in my old military days (Air Force and Air National Guard) a long time ago)was that even if you disagree with those above you in the chain of command you do not criticize them publicly, least the people that report to you start doing the same thing to you.

 

The same applies to Goverment agencies. Public criticism of other government agencies not only creates lack of confidence in those, but also creates lack of confidence in yours..

Edited by nocl
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8 minutes ago, hcat said:

Who knows  what will actually take place.  Not just states,  what about cities, County health Depts?

 

 Yesterday NYC Mayor anounced his distribution plan, Governor says   only he has authority..they have an ongoing tension..nothing new.

 

Hoping sanity and fairness will prevail,  if and when we have a vaccine....

 Hcat I agree. I stream nyc local news daily (I’m in DE) but 93 yr old mom in central NJ so I need to be current on developments in the area, especially vaccine distribution.  Yes, hoping for sanity and fairness for all of us. 

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12 hours ago, hcat said:

Who knows  what will actually take place.  Not just states,  what about cities, County health Depts?

 

 Yesterday NYC Mayor anounced his distribution plan, Governor says   only he has authority..they have an ongoing tension..nothing new.

 

Hoping sanity and fairness will prevail,  if and when we have a vaccine....

Trying to hit get too political, but this is the blue state version of “who the heck needs a mask”. If the election tilts toward the Dems, watch how fast the rhetoric changes.

Even if the election outcome is different, there are many ways to have a “state panel” review the FDA recommendations rapidly. Remember a Stanford, USCLAC, University of San Fran, Montefiore, NYU, Sloan Ket - lots of prestigious unis in those states. I wouldn’t be surprised if there’s a fair amount of overlap in membership of the bodies all ready slated to review the FDA decisions and any state based committee.

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13 hours ago, nocl said:

One thing that I learned in my old military days (Air Force and Air National Guard) a long time ago)was that even if you disagree with those above you in the chain of command you do not criticize them publicly, least the people that report to you start doing the same thing to you.

 

The same applies to Goverment agencies. Public criticism of other government agencies not only creates lack of confidence in those, but also creates lack of confidence in yours..

or another way to say it - Those that live in glass political mansions should not throw stones.

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1 hour ago, cangelmd said:

Trying to hit get too political, but this is the blue state version of “who the heck needs a mask”. If the election tilts toward the Dems, watch how fast the rhetoric changes.

Even if the election outcome is different, there are many ways to have a “state panel” review the FDA recommendations rapidly. Remember a Stanford, USCLAC, University of San Fran, Montefiore, NYU, Sloan Ket - lots of prestigious unis in those states. I wouldn’t be surprised if there’s a fair amount of overlap in membership of the bodies all ready slated to review the FDA decisions and any state based committee.

I am worried about the states (and now cities) setting a precedent by adding levels of unnecessary regulation and review.  And time.  Will this over reach stop with the COVID vaccine?  Or will we have 50 mini FDA's setting up their own drug approval boards at the whim of their governors?  Yes you can get the new colon cancer drug in Ohio but it is not approved yet by the board in Illinois.  Insurance Nightmare.  Patient Nightmare. 

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15 hours ago, Fouremco said:

Barron isn't wrong, as it was simply reporting the findings of Macquarie Research.

Exactly.  One business research firm of thousands out there all generating almost daily market reports.  Mostly for those who want to invest in or short the cruise industry.  Not really newsworthy IMO.

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7 minutes ago, TeeRick said:

I am worried about the states (and now cities) setting a precedent by adding levels of unnecessary regulation and review.  And time.  Will this over reach stop with the COVID vaccine?  Or will we have 50 mini FDA's setting up their own drug approval boards at the whim of their governors?  Yes you can get the new colon cancer drug in Ohio but it is not approved yet by the board in Illinois.  Insurance Nightmare.  Patient Nightmare. 

I do not think it would stand up to a court challenge under the commerce clause. But it would delay things since it would take time for it to go through the system. 

Edited by nocl
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