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22 minutes ago, Homosassa said:

The "infamous" thalidomide cases in the US were due to pregnant women who either went to Europe or had some one bring the drug back for them.

 

Or, let us not forget, were part of the more than 20,000 people who participated in the US clinical trials run by two pharma companies...

 

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What bothers me is the 'pause' in the use of the J & J vaccine. At present, only about 10 women in the US have had blood clots out of almost 7 million doses dispensed. It is good to be cautious, but think about it. The vaccine is being denied to tens of thousands of people based on a very few reactions. More people will likely get COVID  and die than those 10 reactions to the J & J vaccine. I think it would be wise to go ahead with the vaccinations with a warning about the low probability of blood clots. Let the person receiving the vaccine make up their own minds as to whether or not to take the vaccine.

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8 minutes ago, baldilocks said:

What bothers me is the 'pause' in the use of the J & J vaccine. At present, only about 10 women in the US have had blood clots out of almost 7 million doses dispensed. It is good to be cautious, but think about it. The vaccine is being denied to tens of thousands of people based on a very few reactions. More people will likely get COVID  and die than those 10 reactions to the J & J vaccine. I think it would be wise to go ahead with the vaccinations with a warning about the low probability of blood clots. Let the person receiving the vaccine make up their own minds as to whether or not to take the vaccine.

Honestly I think what you say here will happen.  The J&J vaccine will likely resume soon with some additional warning and instructions to physicians, hospitals and patients on what to look for if you are the 1 in a million unlucky person with this immuno- thrombocytopenia event.  It just takes a bit of time to work out the details and it cannot be rushed or appear rushed.  You correctly point out that the risk of severe COVID and death is much higher than this rare vaccine event.  But also,  the risk of all types of thrombocytopenia is much higher in people infected with the virus with COVID, even mild cases.  Much higher than the vaccine risk in fact.  It seems like a medical slam-dunk to resume the vaccine.  But politics are tricky.

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7501509/

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2 hours ago, baldilocks said:

What bothers me is the 'pause' in the use of the J & J vaccine. At present, only about 10 women in the US have had blood clots out of almost 7 million doses dispensed. It is good to be cautious, but think about it. The vaccine is being denied to tens of thousands of people based on a very few reactions. More people will likely get COVID  and die than those 10 reactions to the J & J vaccine. I think it would be wise to go ahead with the vaccinations with a warning about the low probability of blood clots. Let the person receiving the vaccine make up their own minds as to whether or not to take the vaccine.

Keep in mind that the events were in a specific demographic women between 18 and 48 if I recall correctly.  Considering the timing of the J&J release, when the injections action took place .  The number going to women in that age group was almost certainly less than 1 million.  So now you are talking about more of a 1 in 100,000.  Add to that the reaction has occurred up to 2 weeks after the vaccination.   A large percentage of the J&J vaccinations (almost half) were done in the period within two weeks prior to the stoppage.   So the numbers are probably higher than 1 in 100,000 for that demographic.

 

I expect that it will get a restriction not to be used in that demographic.

 

 

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2 hours ago, TeeRick said:

Honestly I think what you say here will happen.  The J&J vaccine will likely resume soon with some additional warning and instructions to physicians, hospitals and patients on what to look for if you are the 1 in a million unlucky person with this immuno- thrombocytopenia event.  It just takes a bit of time to work out the details and it cannot be rushed or appear rushed.  You correctly point out that the risk of severe COVID and death is much higher than this rare vaccine event.  But also,  the risk of all types of thrombocytopenia is much higher in people infected with the virus with COVID, even mild cases.  Much higher than the vaccine risk in fact.  It seems like a medical slam-dunk to resume the vaccine.  But politics are tricky.

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7501509/

I would not call it politics. Politics did not issue the stop.  Politicians are not working at the FDA reviewing the data.  Politicians are not sitting on the vaccines advisory board that, from what I have heard, will review the data and will make a recommendation to the FDA.

 

With a vaccine, especially with others available, that is put into healthy individuals the FDA will make sure that the vaccine is safe. Otherwise if you think that we have vaccine hesitancy now image it with the FDA not looking at the problem rigorously and people wondering did they approve it with other potential risks.  After all they did this one at one in 100,000 for women between 18 and 48.  Maybe they decided that 1 in 10k was worth it for men over 65.  

 

As I just posted in the demographic that is impacted by this issue the odds are quite a bit worse than 1 in a million, around an order of magnitude worse.  That is from data that has made the news.  We do not know what other data the FDA has access to.

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What are the adverse  reactions to the other vaccines?  Moderna , Pfiser

 

I was concerned about Moderna for dh  with his shellfish allergy..They watched him for 30 minutes but it did not give him a neg  reaction. 

 

I assume we should stick with what we had if a booster is required..

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2 hours ago, nocl said:

Keep in mind that the events were in a specific demographic women between 18 and 48 if I recall correctly.  Considering the timing of the J&J release, when the injections action took place .  The number going to women in that age group was almost certainly less than 1 million.  So now you are talking about more of a 1 in 100,000.  Add to that the reaction has occurred up to 2 weeks after the vaccination.   A large percentage of the J&J vaccinations (almost half) were done in the period within two weeks prior to the stoppage.   So the numbers are probably higher than 1 in 100,000 for that demographic.

 

I expect that it will get a restriction not to be used in that demographic.

 

 

You make a good point as usual.  Yes perhaps adult women under 50 will be excluded.  We shall see.

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1 hour ago, nocl said:

I would not call it politics. Politics did not issue the stop.  Politicians are not working at the FDA reviewing the data.  Politicians are not sitting on the vaccines advisory board that, from what I have heard, will review the data and will make a recommendation to the FDA.

 

With a vaccine, especially with others available, that is put into healthy individuals the FDA will make sure that the vaccine is safe. Otherwise if you think that we have vaccine hesitancy now image it with the FDA not looking at the problem rigorously and people wondering did they approve it with other potential risks.  After all they did this one at one in 100,000 for women between 18 and 48.  Maybe they decided that 1 in 10k was worth it for men over 65.  

 

As I just posted in the demographic that is impacted by this issue the odds are quite a bit worse than 1 in a million, around an order of magnitude worse.  That is from data that has made the news.  We do not know what other data the FDA has access to.

Maybe I was not clear or used the wrong term. I know that the safety signal was observed and the FDA system worked as designed.  I really am not referring to politics other than the posturing of certain groups to use a rare event to try and disrupt the resumption of using the J&J vaccine or the AZ vaccine in Europe and Canada for that matter.   Politicians in many countries are not by any means scientists or medical doctors.  But they can make vaccine decisions for their countries based on public perception and not necessarily data.  I have recently seen noise from the Oxford group trying to link the rare events to the mRNA vaccines too.  Not sure if it gets them off the hook if all vaccines have the same issue?  But the mRNA vaccines have been used in 100's of millions of doses so far.

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1 hour ago, TeeRick said:

Maybe I was not clear or used the wrong term. I know that the safety signal was observed and the FDA system worked as designed.  I really am not referring to politics other than the posturing of certain groups to use a rare event to try and disrupt the resumption of using the J&J vaccine or the AZ vaccine in Europe and Canada for that matter.   Politicians in many countries are not by any means scientists or medical doctors.  But they can make vaccine decisions for their countries based on public perception and not necessarily data.  I have recently seen noise from the Oxford group trying to link the rare events to the mRNA vaccines too.  Not sure if it gets them off the hook if all vaccines have the same issue?  But the mRNA vaccines have been used in 100's of millions of doses so far.

That is happening. The Chinese and Russians certainly tried to discredit the US vaccines.  Does not help that the head of the UK Joint Committee on Vaccines and Immunizations) is also the head of the Oxford team that developed the vaccine.

 

The problem with the AZ/Oxford vaccine isn't really the safety issue (though it is an issue) as much as its performance or lack thereof with B.1.351.  I have been watching the data from some of the countries that are primarily using the AZ vaccine looking to see if they have a B.1.351 or similar variant problem develop.

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9 minutes ago, Ride-The-Waves said:

NCL is one of the low mass market lines that could just disappear and no one would miss them...

I don't think you want to say that to a Regent Seven Seas or Oceania Cruises passenger.  They have a very loyal following.

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16 hours ago, nocl said:

Keep in mind that the events were in a specific demographic women between 18 and 48 if I recall correctly.  Considering the timing of the J&J release, when the injections action took place .  The number going to women in that age group was almost certainly less than 1 million.  So now you are talking about more of a 1 in 100,000.  Add to that the reaction has occurred up to 2 weeks after the vaccination.   A large percentage of the J&J vaccinations (almost half) were done in the period within two weeks prior to the stoppage.   So the numbers are probably higher than 1 in 100,000 for that demographic.

 

I expect that it will get a restriction not to be used in that demographic.

 

 

There were 8 million doses of J&J vaccine administered before the pause. In general women are vaccinated 60/40 to men in the US right now all ages from the CDC and states data.  The percentage of doses given to women 18-55 years is maybe half of these doses? So maybe very high level guess 6-8 cases out of 4 million vaccine doses in this demographic?  Just guessing.  I cannot find the breakout data of doses by vaccine, gender and age group.  I'm sure the FDA has it!  In the USA there are 85 million women ages 18-55 out of 108 million 18+ female population.  

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8 hours ago, K.T.B. said:

NCL isn't going to take the silence from the CDC sitting down:  https://www.cruisehive.com/norwegian-cruise-line-sends-reminder-to-cdc-after-no-response/49771

It isn't really silence.  The response is pretty clear.

 

EDIT: Apologies for the print size.

 

DC Statement on Cruise Meeting: The CDC issued the following statement to Cruise Week this morning: "Experts from the Centers for Disease Control and Prevention (CDC) and White House staff met with cruise industry leaders and executives to discuss the Framework for Conditional Sailing Order (CSO) on Monday, April 12, 2021. Cruise industry leaders were able to provide input into the phases of the CSO, expressed frustration with the requirements, discussed the incorporation of vaccination requirements into restarting passenger voyages, and expressed the need to establish a working group with industry and CDC to work forward to resume cruising as soon as possible. Cruising will always pose some risk of COVID-19 transmission, and COVID-19 vaccines will play a critical role in the safe resumption of passenger operations. Cruise travelers represent a global population, and as more people are fully vaccinated worldwide, the phased approach of the CSO also allows CDC to incorporate these advancements into planning for the safe resumption of cruise ship travel. CDC is committed to working with the cruise industry and seaport partners to resume cruising following a phased approach required by the CSO. CDC and DHS senior leadership will begin meetings with cruise industry leaders starting this week. The objective of the meetings are to mutually review the top priority issues of the cruise industry to work out implementation details of the CSO, including the impact of vaccines and other scientific developments since the CSO was issued in October 2020. This goal aligns with the desire for the resumption of passenger operations in the United States by mid-summer, expressed by many major cruise ship operators and travelers."
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Edited by harkinmr
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11 minutes ago, harkinmr said:

It isn't really silence.  The response is pretty clear.

 

EDIT: Apologies for the print size.

 

DC Statement on Cruise Meeting: The CDC issued the following statement to Cruise Week this morning: "Experts from the Centers for Disease Control and Prevention (CDC) and White House staff met with cruise industry leaders and executives to discuss the Framework for Conditional Sailing Order (CSO) on Monday, April 12, 2021. Cruise industry leaders were able to provide input into the phases of the CSO, expressed frustration with the requirements, discussed the incorporation of vaccination requirements into restarting passenger voyages, and expressed the need to establish a working group with industry and CDC to work forward to resume cruising as soon as possible. Cruising will always pose some risk of COVID-19 transmission, and COVID-19 vaccines will play a critical role in the safe resumption of passenger operations. Cruise travelers represent a global population, and as more people are fully vaccinated worldwide, the phased approach of the CSO also allows CDC to incorporate these advancements into planning for the safe resumption of cruise ship travel. CDC is committed to working with the cruise industry and seaport partners to resume cruising following a phased approach required by the CSO. CDC and DHS senior leadership will begin meetings with cruise industry leaders starting this week. The objective of the meetings are to mutually review the top priority issues of the cruise industry to work out implementation details of the CSO, including the impact of vaccines and other scientific developments since the CSO was issued in October 2020. This goal aligns with the desire for the resumption of passenger operations in the United States by mid-summer, expressed by many major cruise ship operators and travelers."
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The last few lines are interesting.  They will all begin meeting this week.  It still sounds like a long process ahead.

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43 minutes ago, gone2c said:

I don't think you want to say that to a Regent Seven Seas or Oceania Cruises passenger.  They have a very loyal following.

Different from NCLH the parent company of Regent, Oceania, NCL etc.  We are booked on Oceania Fall 2022.  Much different experience than NCL.

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23 hours ago, cruisemom42 said:

 

Or, let us not forget, were part of the more than 20,000 people who participated in the US clinical trials run by two pharma companies...

 

Tried Dr Google, did we?

 

Dr Frances Kelsey was my direct supervisor for six years (1990-96).  She was the reviewer in charge of the investigational drug trials and later the marketing application. She would talk about the history of the drug if asked.

 

The two clinical trials were for use as a sedative and pregnancy or plans of pregnancy were exclusion factors for the trial. 

 

No cases of birth defects were reported in the IND (because no pregnant women were in the trial).  The NDA was still under review and the drug not available for use in the US when the reports started arriving from Europe where the drug had been approved earlier that there was a  link made between the drug and birth defects.

 

Of the seventeen reported cases of birth defects in the US, the majority of the women obtained the pills from Europe. The rest somehow obtained the pills in the US, probably from someone who had leftover pills from the clinical trial.

 

 

 

 

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2 hours ago, gone2c said:

I don't think you want to say that to a Regent Seven Seas or Oceania Cruises passenger.  They have a very loyal following.

Do you think a letter reminding the CDC they did not respond to the NCL letter is going to elicit a positive response?  The CDC is looking to reduce spread of disease.  Cannot in the current Worldwide Covid situation see how they would support any activity that moves people about the World.

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3 hours ago, Arizona Wildcat said:

Do you think a letter reminding the CDC they did not respond to the NCL letter is going to elicit a positive response?  The CDC is looking to reduce spread of disease.  Cannot in the current Worldwide Covid situation see how they would support any activity that moves people about the World.

Not just "moves people about the world."  But also moves them to areas where COVID-19 is far from under control, moves them into regions and countries where vaccinations lag, and encourages people from those countries to mingle with people which have enjoyed less exposure.

 

I still don't get who so many are set against what the CDC's responsibilities include and denigrate the CDC for keep American's safe.  Most no sense to me...  I don't think I could find pleasure in watching or even knowing that others are suffering.

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50 minutes ago, Ride-The-Waves said:

Not just "moves people about the world."  But also moves them to areas where COVID-19 is far from under control, moves them into regions and countries where vaccinations lag, and encourages people from those countries to mingle with people which have enjoyed less exposure.

 

I still don't get who so many are set against what the CDC's responsibilities include and denigrate the CDC for keep American's safe.  Most no sense to me...  I don't think I could find pleasure in watching or even knowing that others are suffering.

The CDC has NO real authority, they just advise.

I had four flights last weekend and on three of the flights EVERY seat was filled and snacks were served. Only requirement was to remain masked. Amtrak is running with similar rule, sporting events are not shut down nor are most restaurants and other venues. There is no requirement to show proof of vaccination, which does NOT keep one from contracting and exposing others to COVID. How long does the vaccination provide any protection - no one knows. If the vaccination causes you harm, manufacturer and government cannot be held responsible. Are there any long term effects from the vaccine, no one knows.

It would seem that the cruise lines have gone up to and beyond what other forms of transportation have taken but are still being held back with more hoops to jump through. I have had both Moderna vaccinations, with an understanding of it's possible limited coverage, and I'm ready to cruise with all the ship requirements in place. 

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11 hours ago, TeeRick said:

There were 8 million doses of J&J vaccine administered before the pause. In general women are vaccinated 60/40 to men in the US right now all ages from the CDC and states data.  The percentage of doses given to women 18-55 years is maybe half of these doses? So maybe very high level guess 6-8 cases out of 4 million vaccine doses in this demographic?  Just guessing.  I cannot find the breakout data of doses by vaccine, gender and age group.  I'm sure the FDA has it!  In the USA there are 85 million women ages 18-55 out of 108 million 18+ female population.  

A couple of points.

 

First timing you need to drop those given in the last week out of the equation until 13 days has passed. Since we do not know for certain what cases might occur in that group.

 

Second the timing of the window combined with the age group.  During the period in question many stated still had age restrictions meaning that many of the women injected during the window would have been older. Many states were still 55 and over. Many of the  women in the demographic that have been vaccinated were in priority groups that were vaccinated prior to the availability of J&J.  For example my niece fits into that age group, but is also an MD and got Pfizer.

 

That is why the number in the age group is lower.  I had put together a spread sheet that looked at the time J&J started the reported information on shipments, state rules on age restrictions. Based upon the age restrictions some states were eliminated almost entirely.  Now I ran that going up to the period two weeks before the pause.   That is how I came up with the million estimate.

 

We do not know if there have been any additional cases pop up in the data.  Should get that next Friday with the VAC meeting.

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11 hours ago, nocl said:

A couple of points.

 

First timing you need to drop those given in the last week out of the equation until 13 days has passed. Since we do not know for certain what cases might occur in that group.

 

Second the timing of the window combined with the age group.  During the period in question many stated still had age restrictions meaning that many of the women injected during the window would have been older. Many states were still 55 and over. Many of the  women in the demographic that have been vaccinated were in priority groups that were vaccinated prior to the availability of J&J.  For example my niece fits into that age group, but is also an MD and got Pfizer.

 

That is why the number in the age group is lower.  I had put together a spread sheet that looked at the time J&J started the reported information on shipments, state rules on age restrictions. Based upon the age restrictions some states were eliminated almost entirely.  Now I ran that going up to the period two weeks before the pause.   That is how I came up with the million estimate.

 

We do not know if there have been any additional cases pop up in the data.  Should get that next Friday with the VAC meeting.

I was doing a back of the envelope calculation in the absence of real data.  Your points add a bit more to the equations.  It will be very interesting to see the published notes from the FDA meeting.  I assume there will be.

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20 hours ago, Ride-The-Waves said:

Not just "moves people about the world."  But also moves them to areas where COVID-19 is far from under control, moves them into regions and countries where vaccinations lag, and encourages people from those countries to mingle with people which have enjoyed less exposure.

 

I still don't get who so many are set against what the CDC's responsibilities include and denigrate the CDC for keep American's safe.  Most no sense to me...  I don't think I could find pleasure in watching or even knowing that others are suffering.

In all honesty, what in your first paragraph is unique in any sense to cruising?

We have areas in the US that are far from under control and places where vaccinations lag.  Nothing prevents domestic mingling.

 

A ship of vaccinated people presents a miniscule risk in comparison to what's going on within the US. 

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On 4/18/2021 at 6:48 AM, Homosassa said:

Tried Dr Google, did we?

 

Dr Frances Kelsey was my direct supervisor for six years (1990-96).  She was the reviewer in charge of the investigational drug trials and later the marketing application. She would talk about the history of the drug if asked.

 

The two clinical trials were for use as a sedative and pregnancy or plans of pregnancy were exclusion factors for the trial. 

 

No cases of birth defects were reported in the IND (because no pregnant women were in the trial).  The NDA was still under review and the drug not available for use in the US when the reports started arriving from Europe where the drug had been approved earlier that there was a  link made between the drug and birth defects.

 

Of the seventeen reported cases of birth defects in the US, the majority of the women obtained the pills from Europe. The rest somehow obtained the pills in the US, probably from someone who had leftover pills from the clinical trial.

 

 

 

 

Considering that the trials of that day did not require FDA approval and oversight, protocols were very lax if they existed at all.  There is clear documentation that at some pregnant women did receive the drug.  The upper limit of how many did for sure is not documented but the lower limit certainly is known.

 

https://embryo.asu.edu/pages/us-regulatory-response-thalidomide-1950-2000

 

 Prior to discovering thalidomide's teratogenic effects in the early 1960s, the US Food and Drug Administration (FDA) did not place regulations on drug approval or monitoring as it later did. By 1962, approximately 20,000 patients in the US had taken thalidomide as part of an unregulated clinical trial before any actions were taken to stop thalidomide's distribution


 

https://helix.northwestern.edu/article/thalidomide-tragedy-lessons-drug-safety-and-regulation

 

Kelsey felt the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness. Among her concerns was the lack of data indicating whether the drug could cross the placenta, which provides nourishment to a developing fetus.

She was also concerned that there were not yet any results available from U.S. clinical trials of the drug. Even if these data where available, however, they may not have been entirely reliable. At the time, clinical trials did not require FDA approval, nor were they subject to oversight. The “clinical trials” of thalidomide involved distributing more than two and a half million tablets of thalidomide to approximately 20,000 patients across the nation—approximately 3,760 women of childbearing age, at least 207 of whom were pregnant. More than one thousand physicians participated in these trials, but few tracked their patients after dispensing the drug.

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