Are vaccines the light at the end of the tunnel?

[John182]

2 minutes ago, Host Jazzbeau said:

I suspect that because of the early foul-up in the AstraZeneca testing procedure, that particular vaccine will always be under a cloud.

Only by those who choose to ignore the empirical evidence arising from its usage which sadly will probably be the majority, it seems to be the modern way to not let facts get in the way of a good argument 😀

[ECCruise]

1 hour ago, Ken the cruiser said:

Thanks! I knew there had to be a loophole. I also noticed they're not requiring folks to be vaccinated before going on one of their little ships. No thanks.

I was really surprised to see that there was no requirement for being vaccinated.  And ships operating at 75% capacity.  

 

I was also surprised to see that there are cabins available for the 3/27 sailing.  Only cabins on wait list are the most expensive (~$14000 for a 7 night sailing) and the least expensive single cabin. 

[D C]

4 minutes ago, ECCruise said:

I was really surprised to see that there was no requirement for being vaccinated.  And ships operating at 75% capacity.  

 

I was also surprised to see that there are cabins available for the 3/27 sailing.  Only cabins on wait list are the most expensive (~$14000 for a 7 night sailing) and the least expensive single cabin. 

This ship doesn't leave US waters or stop in a foreign port, does it? 

 

If not, is it any different than a bus load of tourists as far as the CDC is concerned? It's interstate travel via boat.  Maybe the 'commercial vessel in US waters' mask requirement applies? 

[ECCruise]

1 minute ago, D C said:

This ship doesn't leave US waters or stop in a foreign port, does it? 

 

If not, is it any different than a bus load of tourists as far as the CDC is concerned? It's interstate travel via boat.  Maybe the 'commercial vessel in US waters' mask requirement applies? 

No, no foreign ports.  All FL, GA, SC.  I know they are requiring masks but not sure if that is the US commercial vehicle requirement or simply American Cruise Lines own.

[Host Jazzbeau]

1 hour ago, John182 said:

Only by those who choose to ignore the empirical evidence arising from its usage which sadly will probably be the majority, it seems to be the modern way to not let facts get in the way of a good argument 😀

I am very much a pro-vaxxer [DW and I got Moderna #1 two weeks ago and are eagerly awaiting #2], but the worriers do have a valid point that all these vaccines were developed on an unusually fast time track – which means that field results will be even more important that usual.  That applies double to AstraZeneca, because their phase three results had the foul-up.  So when a field result like this happens with the AstraZeneca, countries are practically compelled to pull it pending investigation.  It's a problem that this represents such a large percentage of the available doses in some countries – but the cautionary principle must be invoked.

[ECCruise]

Just now, Host Jazzbeau said:

 It's just too bad that this represents such a large percentage of the available doses in some countries.

And unfortunately, many of the countries that need the volume the most.

[Tigrou]

1 hour ago, John182 said:

My son has even stronger views on the suspension of its use but he would do as he has worked on the development of the vaccine and is rather fed up with his teams' work being used as a political football by those seeking to explain a slow roll out of vaccination in mainland Europe.

 

When I read of the latest suspensions I couldn't help but think, who has got it in for the Oxford/AZ vaccine and why?  It really does seem that as soon as one unsubstantiated claim against it is proven to have no basis, another one is made.  I wondered if it was a 'dirty tricks campaign' by other pharmaceutical companies wanting a greater share of the market, but for the moment at least surely there's plenty of business to go around.  So a political motive does seem the most likely.

 

Last week I had my first shot of the Oxford/AZ vaccine and was very glad to get it.  Please pass my thanks on to your son and his whole team for their amazing work.  

 

 

[Tigrou]

For anyone wondering how the Oxford/AZ vaccine was developed more quickly than is usual for new vaccines, this BBC article from November 2020 gives a good explanation.

 

https://www.bbc.co.uk/news/health-55041371

 

[SJSULIBRARIAN]

2 hours ago, ECCruise said:

I think it is because of the pax load.

Since the beginning, the restrictions applied to larger ships.  Alaska will have smaller ships sailing soon.

 

Cruise ship means any commercial, non-cargo, passenger-carrying vessel operating in U.S. waters with the capacity to carry 250 or more individuals (passengers and crew)

 

Yes, American Cruise Lines ships are under 250 passengers which, I believe is where CDC starts limiting the sailing of ships. 

[cgolf1]

I have been away a while from the boards because honestly I never expected to get vaccinated in time for cruising. But now by the end of April when I am clear my wait on the second shot, my wife and I will be ready to go. Now we just have to hope our late 2021 booking on the Apex and early 2022 booking on the constellation stay intact and we can cruise again:) Really excited our jobs qualified us for early vaccination. 

[Fouremco]

56 minutes ago, SJSULIBRARIAN said:

 

Yes, American Cruise Lines ships are under 250 passengers which, I believe is where CDC starts limiting the sailing of ships. 

The 250 ceiling is for combined passengers and crew, not just passengers.

[yorky]

3 hours ago, John182 said:

I too believe that it an overreaction and that there is no causal relationship between that particular vaccine and thrombosis. I have read that in the UK it has been estimated that as many as 1 in a thousand people may be liable to suffer from blood clotting. The Astra Zeneca vaccine is well used here now and there is no evidence of any deviation in clotting cases. My son has even stronger views on the suspension of its use but he would do as he has worked on the development of the vaccine and is rather fed up with his teams' work being used as a political football by those seeking to explain a slow roll out of vaccination in mainland Europe.

Watching the experts over here they seem genuinely baffled as to why some major euro countries have suspended using the vaccine with what appears to be no real evidence of a problem while people continue to die through not getting it.

[nocl]

3 hours ago, Host Jazzbeau said:

I suspect that because of the early foul-up in the AstraZeneca testing procedure, that particular vaccine will always be under a cloud.

Not necessarily.  Unfortunately it was not just one foul up.  AZ did a good job of shooting itself in the foot during their trial execution.

 

1. Demonstrated lack of control in the clinical supply process resulting in under dosing in one trial

2. Lack of establishing proper demographics in clinical trials resulting in insufficient data in the over 65 demographic

3. Running different trials with different protocols and using a meta analysis to get approval in the EU (Note J&J also ran multiple trials in different parts of the world, but all of their trials were the same protocol and appropriate demographics in the trial population.)

 

In addition they did have a potential safety issue that resulted in trial stoppages, the longest in the US.

 

Add to that the South African trial that showed a lack of efficacy in symptomatic illness against the South African strain, resulting in the South African government stopping its use in its vaccination program.

 

The current issue in the EU is that while there is not an unusual number of clotting cases in the vaccinated population, the timing and the relationship to a particular batch has raised concerns.  Normally you might expect a hold of a couple of days while the data is examined.  Kind of surprised that now additional countries are putting it on hold, after they should have had time to do an initial investigation.

 

Couple that in with the lower efficacy numbers resulting in many in Europe avoiding that vaccine, waiting for Pfizer or Moderna and it certainly does put it under a cloud.

 

Lets see what the data shows in their US trial.  Which will have a consistent protocol and appropriate demographics.

[nocl]

2 hours ago, Host Jazzbeau said:

I am very much a pro-vaxxer [DW and I got Moderna #1 two weeks ago and are eagerly awaiting #2], but the worriers do have a valid point that all these vaccines were developed on an unusually fast time track – which means that field results will be even more important that usual.  That applies double to AstraZeneca, because their phase three results had the foul-up.  So when a field result like this happens with the AstraZeneca, countries are practically compelled to pull it pending investigation.  It's a problem that this represents such a large percentage of the available doses in some countries – but the cautionary principle must be invoked.

As far as anything approved in the US.

 

While they were developed quickly, the normal trials designs, standards and protocols were followed.  What you saw is how fast drug development can go when all of the normal bureaucratic are minimized.

During normal drug and vaccine development a company can wait weeks or months between steps. File an investigational new drug application and wait weeks for review, want a discussion with the FDA on trial design and waits weeks or months for the meeting and on and on all the way through the final submission and review which will usually take at least 12 to 18 months.

 

In this case there were not delays.  The FDA and other regulatory authorities had people lined up waiting for the next step.  That chopped months and even years out of what it would normally take.

 

The pre-clinical, and phase I, II and III clinical trials were done the same as for drugs that might be years in development. 

 

Another matter that can take quite a while is patient recruitment for the clinical trials.  I was once involved with a drug where it took 4 years to do a 6 month trial because it took that long to get the number of patients needed to power the trial (for each patient it only took 6). In this case with Covid the companies were able to staff 30,000+ trials in remarkably short time.

 

Each of the countries has their own version of  VAERS (Vaccine Adverse Event Reporting System). They are pretty similar (for anybody interested there is a group called International Conference for Harmonization, the purpose of which is to work on standardizing drug submission guidelines in the US, Europe and Japan, the working group working on standardizing adverse event report for drugs is called E2b https://ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files. I worked on the data format for that effort, representing the FDA to one of the working groups).

 

In each case when concern is raised the investigation not only involves the specific cases that created the concern, but also an examination of the number of similar instances in the database, the timing of the events, drug batch numbers, manufacturing sites, etc.

 

What is unusual in this case is that some countries have indicated that there seems to be no link to the vaccine, but now a few days later have put a hold on the administration. 

 

As one vaccine developer of note once said (paraphrased since I have not been able to locate the actual quote) I never really relax about the safety of a vaccine until after the billionth dose is given.

Edited March 15, 2021 by nocl

[nocl]

1 hour ago, nocl said:

Not necessarily.  Unfortunately it was not just one foul up.  AZ did a good job of shooting itself in the foot during their trial execution.

 

1. Demonstrated lack of control in the clinical supply process resulting in under dosing in one trial

2. Lack of establishing proper demographics in clinical trials resulting in insufficient data in the over 65 demographic

3. Running different trials with different protocols and using a meta analysis to get approval in the EU (Note J&J also ran multiple trials in different parts of the world, but all of their trials were the same protocol and appropriate demographics in the trial population.)

 

In addition they did have a potential safety issue that resulted in trial stoppages, the longest in the US.

 

Add to that the South African trial that showed a lack of efficacy in symptomatic illness against the South African strain, resulting in the South African government stopping its use in its vaccination program.

 

The current issue in the EU is that while there is not an unusual number of clotting cases in the vaccinated population, the timing and the relationship to a particular batch has raised concerns.  Normally you might expect a hold of a couple of days while the data is examined.  Kind of surprised that now additional countries are putting it on hold, after they should have had time to do an initial investigation.

 

Couple that in with the lower efficacy numbers resulting in many in Europe avoiding that vaccine, waiting for Pfizer or Moderna and it certainly does put it under a cloud.

 

Lets see what the data shows in their US trial.  Which will have a consistent protocol and appropriate demographics.

It appears that the data driving the stoppage is coming out of Norway.

 

https://www.fhi.no/en/news/2021/norwegian-medicines-agency-notified-of-blood-clots-and-bleeding-in-younger-/

 

In the US there was a widely publicized case of  immune thrombocytopenia resulting in death after a person received the Pfizer vaccine. But have not heard of multiples such as Norway is reporting.

[nocl]

6 hours ago, nocl said:

Not necessarily.  Unfortunately it was not just one foul up.  AZ did a good job of shooting itself in the foot during their trial execution.

 

1. Demonstrated lack of control in the clinical supply process resulting in under dosing in one trial

2. Lack of establishing proper demographics in clinical trials resulting in insufficient data in the over 65 demographic

3. Running different trials with different protocols and using a meta analysis to get approval in the EU (Note J&J also ran multiple trials in different parts of the world, but all of their trials were the same protocol and appropriate demographics in the trial population.)

 

In addition they did have a potential safety issue that resulted in trial stoppages, the longest in the US.

 

Add to that the South African trial that showed a lack of efficacy in symptomatic illness against the South African strain, resulting in the South African government stopping its use in its vaccination program.

 

The current issue in the EU is that while there is not an unusual number of clotting cases in the vaccinated population, the timing and the relationship to a particular batch has raised concerns.  Normally you might expect a hold of a couple of days while the data is examined.  Kind of surprised that now additional countries are putting it on hold, after they should have had time to do an initial investigation.

 

Couple that in with the lower efficacy numbers resulting in many in Europe avoiding that vaccine, waiting for Pfizer or Moderna and it certainly does put it under a cloud.

 

Lets see what the data shows in their US trial.  Which will have a consistent protocol and appropriate demographics.

While a meta analysis for combining data from different trials is sometimes necessary it is considered to be a more problematic method than a large single protocol trial. That I suspect is one of the reasons the FDA is waiting for the large US trial to complete instead of accepting the meta-analysis results.

 

For those interested the following is a link to an FDA draft guidance document concerning the use of Meta Analysis related to clinical trials. 

 

https://www.fda.gov/media/117976/download

[cangelmd]

7 hours ago, nocl said:

While a meta analysis for combining data from different trials is sometimes necessary it is considered to be a more problematic method than a large single protocol trial. That I suspect is one of the reasons the FDA is waiting for the large US trial to complete instead of accepting the meta-analysis results.

 

For those interested the following is a link to an FDA draft guidance document concerning the use of Meta Analysis related to clinical trials. 

 

https://www.fda.gov/media/117976/download

Other than stopping the trial in the US early on, which IIRC was due to issues in the UK, not here, have there been any reported hiccups with the AZ US trial?

[TrulyBlonde]

8 hours ago, nocl said:

While a meta analysis for combining data from different trials is sometimes necessary it is considered to be a more problematic method than a large single protocol trial. That I suspect is one of the reasons the FDA is waiting for the large US trial to complete instead of accepting the meta-analysis results.

 

For those interested the following is a link to an FDA draft guidance document concerning the use of Meta Analysis related to clinical trials. 

 

https://www.fda.gov/media/117976/download

My daughter calls us "Lab Rats".  After over a year of this, I happily took my 2nd vaccine over a week ago so Grandma Lab Rat can see her Grandson.

But she does have a point 😉

[TeeRick]

18 hours ago, John182 said:

I too believe that it an overreaction and that there is no causal relationship between that particular vaccine and thrombosis. I have read that in the UK it has been estimated that as many as 1 in a thousand people may be liable to suffer from blood clotting. The Astra Zeneca vaccine is well used here now and there is no evidence of any deviation in clotting cases. My son has even stronger views on the suspension of its use but he would do as he has worked on the development of the vaccine and is rather fed up with his teams' work being used as a political football by those seeking to explain a slow roll out of vaccination in mainland Europe.

John182, Here is a nice opinion piece that explains some of the EU situation on the slow vaccine rollout which supports what your son is saying.  Please thank him from many of us for his work on providing life-saving COVID vaccines.

 

https://www.eurointelligence.com/column/vaccines?campaign_id=9&emc=edit_nn_20210316&instance_id=28100&nl=the-morning&regi_id=121450033&segment_id=53490&te=1&user_id=8259b050a84d722b46d85f64ae857bb0

[TeeRick]

17 hours ago, Tigrou said:

 

When I read of the latest suspensions I couldn't help but think, who has got it in for the Oxford/AZ vaccine and why?  It really does seem that as soon as one unsubstantiated claim against it is proven to have no basis, another one is made.  I wondered if it was a 'dirty tricks campaign' by other pharmaceutical companies wanting a greater share of the market, but for the moment at least surely there's plenty of business to go around.  So a political motive does seem the most likely.

 

Last week I had my first shot of the Oxford/AZ vaccine and was very glad to get it.  Please pass my thanks on to your son and his whole team for their amazing work.  

 

 

Here is another opinion piece on the AZ Oxford vaccine and blood clots/DVT's.  They are actually quite common in general.  The casual connection of two unrelated things is also quite common.  One can easily relate one event to another and make a case for it for argument's sake. Anti-vaxxers have been doing this for decades.  Without solid evidence.  And without any easy way to disprove it either.  How do you disprove a negative?  

 

I went to the donut shop yesterday morning and bought a jelly donut.  This morning I was in a car accident.  Two weeks ago my neighbor across town also bought a jelly donut.  The next day he was in a car accident.  Yes- jelly donuts cause car accidents within 24 hours.

 

 https://www.theguardian.com/commentisfree/2021/mar/15/evidence-oxford-vaccine-blood-clots-data-causal-links?campaign_id=9&emc=edit_nn_20210316&instance_id=28100&nl=the-morning&regi_id=121450033&segment_id=53490&te=1&user_id=8259b050a84d722b46d85f64ae857bb0

 

 

[TeeRick]

30 minutes ago, cangelmd said:

Other than stopping the trial in the US early on, which IIRC was due to issues in the UK, not here, have there been any reported hiccups with the AZ US trial?

The US phase 3 trial is proceeding and there have been no reports of any unusual adverse events.  I would assume that if DVT's were discovered in this trial at this point the FDA would have put the trial on pause.

[TeeRick]

13 hours ago, Texed said:

There are a lot of very smart folks on this board.  I wonder what are the thoughts if you Google:

 

Dr. Hotze on the dangers of the Covid-19 vaccine.

Not sure why you would give this any publicity here at all.

[TeeRick]

15 hours ago, yorky said:

Watching the experts over here they seem genuinely baffled as to why some major euro countries have suspended using the vaccine with what appears to be no real evidence of a problem while people continue to die through not getting it.

It seems that the UK has taken control of their own situation and is rapidly trampling down COVID.  With the AZ/Oxford vaccine and all of the others.  Not sure if that would have happened so quickly if still part of the EU.  

 

For those here thinking about cruises in the next 6-12 months in the EU countries, the vaccine situation there is disheartening.  There is some anti-vaccine sentiment in the US, but some of the EU countries have very strong and vocal anti-vaccine sentiment.  So any type of event with these vaccines will feed the beast there and governments are in the cross-hairs.

[Fouremco]

Some further thoughts on the situation in Europe:

 

https://messaging-custom-newsletters.nytimes.com/template/oakv2?abVariantId=0&campaign_id=9&emc=edit_nn_20210316&instance_id=28100&nl=the-morning&productCode=NN&regi_id=76537048&segment_id=53490&te=1&uri=nyt%3A%2F%2Fnewsletter%2F5d4445f2-e78d-5bf1-93a2-9d2b2e0a3ac0&user_id=241f8588b53e2154ccd27c09adff2933

[John182]

17 hours ago, Tigrou said:

 

When I read of the latest suspensions I couldn't help but think, who has got it in for the Oxford/AZ vaccine and why?  It really does seem that as soon as one unsubstantiated claim against it is proven to have no basis, another one is made.  I wondered if it was a 'dirty tricks campaign' by other pharmaceutical companies wanting a greater share of the market, but for the moment at least surely there's plenty of business to go around.  So a political motive does seem the most likely.

 

Last week I had my first shot of the Oxford/AZ vaccine and was very glad to get it.  Please pass my thanks on to your son and his whole team for their amazing work.  

 

 

 

29 minutes ago, TeeRick said:

John182, Here is a nice opinion piece that explains some of the EU situation on the slow vaccine rollout which supports what your son is saying.  Please thank him from many of us for his work on providing life-saving COVID vaccines.

 

https://www.eurointelligence.com/column/vaccines?campaign_id=9&emc=edit_nn_20210316&instance_id=28100&nl=the-morning&regi_id=121450033&segment_id=53490&te=1&user_id=8259b050a84d722b46d85f64ae857bb0

I will pass on your thanks. Everybody around the world who has worked on a vaccine response in such short timescales deserves our thanks. It is amazing what has been achieved when sufficient funding and prioritisation has been given to the scientists. Let's hope that continues now that they are moving on to try to protect us in future years against variants of this virus and those that will inevitably follow as the world's population continues to grow.