Are vaccines the light at the end of the tunnel?

[markeb]

8 minutes ago, nocl said:

We will also see how long they stick to their various protocols.

 

And the passenger has almost no recourse under the terms in your actual ticket. You can sue them, in Miami, but they'll pull up the various disclaimers. And probably schedule hearings at either 9:00 in the morning or 3:30 pm and demand you be there, even though your attorney could handle everything without you.

 

If they proposed the exact same terms under the CSO, with the details they probably already have, they'd likely get approved with minimal adjustment. But they would have committed to those terms. And would be inspected on those terms. And fined for violating them. And they couldn't just change them.

 

Outrageous analogy time:

 

Let's say the FAA required the airline you're planning to fly to your cruise to ground their fleet and work with the aircraft manufacturer on a major avionics software upgrade following an NTSB investigation that found that software was the root cause of a significant incident. The airline instead decided to make a bunch of public statements about the FAA, bring in a lobbying firm, and ultimately publicly, and maybe even in a letter, propose to instead do mechanical inspections of an unrelated subsystem. Would people be defending the airline against the evil, uncompromising FAA and demanding to fly on those planes? Because that's what I'm hearing here.

 

And now back to vaccines.

 

 

[nocl]

1 minute ago, markeb said:

 

And the passenger has almost no recourse under the terms in your actual ticket. You can sue them, in Miami, but they'll pull up the various disclaimers. And probably schedule hearings at either 9:00 in the morning or 3:30 pm and demand you be there, even though your attorney could handle everything without you.

 

If they proposed the exact same terms under the CSO, with the details they probably already have, they'd likely get approved with minimal adjustment. But they would have committed to those terms. And would be inspected on those terms. And fined for violating them. And they couldn't just change them.

 

Outrageous analogy time:

 

Let's say the FAA required the airline you're planning to fly to your cruise to ground their fleet and work with the aircraft manufacturer on a major avionics software upgrade following an NTSB investigation that found that software was the root cause of a significant incident. The airline instead decided to make a bunch of public statements about the FAA, bring in a lobbying firm, and ultimately publicly, and maybe even in a letter, propose to instead do mechanical inspections of an unrelated subsystem. Would people be defending the airline against the evil, uncompromising FAA and demanding to fly on those planes? Because that's what I'm hearing here.

 

And now back to vaccines.

 

 

Sounds like the 787 Max until the second accident.

[markeb]

1 hour ago, Covepointcruiser said:

My sister is a physician in Pennsylvania.   She said there was no need for a booster as your immunity will be strong for six months.   It would be good if they let us get a different vaccine if a booster is needed, Pfizer since we received Moderna.

 

A couple of things here. Because we're still in the original clinical trial, even though the vaccines are being administered under an EUA, I don't know if the results of adding a third dose, if it adds duration to the immunity, will result in a proposal to change the label for a 3-dose series, a booster beyond the initial series, or no change. That seems like a difference that makes no difference, but it likely will.

 

If it's a label change, then at least initially it's probably going to be for that specific vaccine and manufacturer. If it's a true booster at 6, 12, 24 months or more, there will likely be crossover studies to demonstrate that a different vaccine and manufacturer achieves the the same effect. And if it makes no difference, nothing really changes. Given the effectiveness of the vaccines, other than to add antigens to variants, it's going to be hard to demonstrate a greater effect with a third dose or booster at any kind of statistical power, so I'd expect they'd be looking at duration of immunity.

 

The reality that these products are on EUA, and final BLAs haven't been found means that any of the manufacturers, with data, could propose a label for a 3-dose series (or 2 for J&J), with a booster at some interval. We'll see.

[markeb]

8 minutes ago, nocl said:

Sounds like the 787 Max until the second accident.

 

It was the 737 Max, but I was being nice...

 

BTW, Boeing has a HUGE web page discussing everything they've done and are doing to comply with the FAA and other global regulator's requirements. Didn't click on all the links, but it could be a textbook case of (good) risk communication. And CLIA could be the other example...

[nocl]

11 minutes ago, markeb said:

 

It was the 737 Max, but I was being nice...

 

BTW, Boeing has a HUGE web page discussing everything they've done and are doing to comply with the FAA and other global regulator's requirements. Didn't click on all the links, but it could be a textbook case of (good) risk communication. And CLIA could be the other example...

The really funny thing is that if the cruise lines actually started working on getting back sailing again and publicizing the status their booking would soar.  I guess they consider the long term cost of complying with the CDC (actually having to live up to their state protocols).  Is far more than their losses from not sailing.

[mayleeman]

57 minutes ago, nocl said:

The really funny thing is that if the cruise lines actually started working on getting back sailing again and publicizing the status their booking would soar.  I guess they consider the long term cost of complying with the CDC (actually having to live up to their state protocols).  Is far more than their losses from not sailing.

 

Another business looking at short term rather than long term. They can't possibly expect to leave US ports permanently. Unless the virus magically disappears, they will likely have to comply eventually with CDC requirements for specific plans and contracts. If any problems occur in their alternate-site cruises, the CDC may be more strict and less cooperative in adjusting their reqs.

[Ken the cruiser]

40 minutes ago, mayleeman said:

 

Another business looking at short term rather than long term. They can't possibly expect to leave US ports permanently. Unless the virus magically disappears, they will likely have to comply eventually with CDC requirements for specific plans and contracts. If any problems occur in their alternate-site cruises, the CDC may be more strict and less cooperative in adjusting their reqs.

But what happens if all goes smoothly at all 3 separate start-up locations, St Maarten, Southampton and Athens? Should CDC give them credit for having their act together? 

[nocl]

2 hours ago, Ken the cruiser said:

But what happens if all goes smoothly at all 3 separate start-up locations, St Maarten, Southampton and Athens? Should CDC give them credit for having their act together? 

Depend upon what one means by giving them credit. If you are saying bypass the CSO nope.

If you are saying that they do the port agreements and submit the protocols and all of the test and health information from those cruises as part of their submission for the test cruise then they should be considered as part of the submission.

[mayleeman]

@Ken the cruiser  I would say that complete success in those cruises would be evidence of adequate screening. But, as @nocl points out, much of the CDC requirements are for procedures that need to be in place to handle numerous contingencies. 

 

The cruise lines seem to want to stop at screening and other things that are designed to reduce exposure. No one should assume screening and excursion limits will not be bypassed, especially once pax start demanding less restrictions. And there are always some anti-vaxxers, and virus hoax adherents, who will present fake credentials, think distancing and masks are a joke, and skirt any rules.

 

Also, the ability of vaccines to prevent variant infections is not yet proven. If an outbreak occurs, the CDC doesn't want another ship wandering around hoping to find refuge. Promising ad hoc reactions won't be enough to meet CDC demands.

Edited April 28, 2021 by mayleeman

[K.T.B.]

11 hours ago, markeb said:

Outrageous analogy time:

 

Let's say the FAA required the airline you're planning to fly to your cruise to ground their fleet and work with the aircraft manufacturer on a major avionics software upgrade following an NTSB investigation that found that software was the root cause of a significant incident. The airline instead decided to make a bunch of public statements about the FAA, bring in a lobbying firm, and ultimately publicly, and maybe even in a letter, propose to instead do mechanical inspections of an unrelated subsystem. Would people be defending the airline against the evil, uncompromising FAA and demanding to fly on those planes? Because that's what I'm hearing here.

 

And now back to vaccines.

 

 

 

Outrageous is right.  The FAA's sole responsibility is to regulate all aspects of civil aviation.  Whereas the CDC's responsibility is a national public health agency.  Technically, they have as much right to regulate cruising as does the governor of Florida.  BUT since this is a pandemic, and the previous administration gave the authority, they can impose restrictions on travel.  So with the number of vaccinations increasing (97 million are fully vaccinated, with 141 million with at least 1 dose, as of April 27th), and the new guidelines that they released yesterday, their regulating the stoppage should come to an end.  At the very least, it's time for the correct agencies to start regulating cruise ships again.

 

It's been proven already that we can cruise safely, if the European/Mediterranean cruises are any indication.  400,000+passengers, only 50 Covid cases.  ALL pre-vaccine.  But because the CDC didn't have a hand in it, it's being ignored.  The FAA wouldn't ignore it if it was affecting the airlines, just because it was happening outside of the US.  It's that simple.

 

People can say all they want about the cruise lines need to do X, Y, & Z to get cruising again.  Well, guess what?  They have.  Just not with ships leaving the US.  Why?  Because they're not being held back by an agency that shouldn't be regulating them, so they sail from foreign ports.  Successfully and with extremely minimal issues.  But, again, it's being ignored.  

 

In a very short amount of time, more than half of the population of the US will be fully vaccinated.  It's time for people to see that this light has finally reached the end of the tunnel and we're close to exiting it, albeit still with the need for masks, but not outside! 

[TeeRick]

11 hours ago, markeb said:

 

A couple of things here. Because we're still in the original clinical trial, even though the vaccines are being administered under an EUA, I don't know if the results of adding a third dose, if it adds duration to the immunity, will result in a proposal to change the label for a 3-dose series, a booster beyond the initial series, or no change. That seems like a difference that makes no difference, but it likely will.

 

If it's a label change, then at least initially it's probably going to be for that specific vaccine and manufacturer. If it's a true booster at 6, 12, 24 months or more, there will likely be crossover studies to demonstrate that a different vaccine and manufacturer achieves the the same effect. And if it makes no difference, nothing really changes. Given the effectiveness of the vaccines, other than to add antigens to variants, it's going to be hard to demonstrate a greater effect with a third dose or booster at any kind of statistical power, so I'd expect they'd be looking at duration of immunity.

 

The reality that these products are on EUA, and final BLAs haven't been found means that any of the manufacturers, with data, could propose a label for a 3-dose series (or 2 for J&J), with a booster at some interval. We'll see.

OK my rather suspicious view on boosters.   The data from clinical trials on antibodies that has been published by Pfizer and Moderna is excellent at 6 months post second dose.  Presumably same for T-Cells but not a lot of published data.  Maybe 9 month data soon?   Here is my suspicion:   The discussion of the need for a potential booster (at 1 year?  Why this timing?) is coming from the CEO's and business officials of these companies.  They cannot talk about additional inside data even if they had it.  So what better than to keep investors excited and the stock price elevated than throwing around the potential long term need for a booster or yearly boosters?  Get the public thinking that way?  Compare it to yearly influenza vaccines?  Even before anybody knows there is an actual need? 

This all gets more complicated with variant viruses of course.  There might be a need now (not after 1 year) to have a variant vaccine available and tested.   Or a booster (third dose) of the current vaccine to elevate antibodies even higher to make up for weaker binding to the variant SPIKE.   We know that clinical trials have been started with a variant vaccine or extended with a third dose of the current vaccines.   So the data will be interesting but should be the only thing that guides this booster discussion.  Fully vaccinated people are worried needlessly right now that they will come up to a year and will need another shot before travelling.  Based on what?

[TeeRick]

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

 

The CDC should now allow the ships to do test cruises as long all the passengers and crew are vaccinated.  That new guideline indicates that, according to the CDC, it would perfectly safe to do so.

 

I wonder how long until the lines request that.

Here is an interesting item.  In Massachusetts the governor announced that on August 1, all sports stadiums will be allowed to operate at full capacity.  So why are cruises on hold until Nov 1 even if fully vaccinated? 

 

https://www.nbcboston.com/news/sports/nbcsports/gov-bakers-covid-19-update-is-good-for-boston-sports-teams/2365691/

[TeeRick]

From a just published study from the UK.  Only 1 dose of Pfizer or AZ vaccine can cut the rate of virus transmission by 50%.  Based on contact tracing.

 

https://www.cnbc.com/2021/04/28/coronavirus-single-dose-of-vaccine-can-almost-halve-transmission.html

[harkinmr]

On 4/26/2021 at 4:32 PM, 4774Papa said:

Some states require a COVID19 test or proof of a vaccine prior to entry by air.   I am flying into Boston in June and Mass. has such a requirement.   Interesting, if I decided to drive, I can go there without either.  I had a friend that drove up through the entire eastern seaboard and into Mass.. Vermont, NH and Maine.  No problem.  Doesn't make a lot of sense.

First, it’s a numbers game. Lots more people flying in than driving, and from a larger geographical area.  Second, possible exposure is increased thereby risking larger spread. 

[TeeRick]

I know this is a vaccine thread but I think the availability of an oral specific anti-viral pill against the SARS-CoV-2 virus is as much of a game changer as a highly efficacious vaccine.  I have posted about this before.  The class of anti-viral drugs called protease inhibitors are being tested in the clinic by several companies.  Pfizer says the one they are testing could be approved later this year.  This will go a long way to getting normal travel and cruising going again.  Vaccines and oral antiviral drugs with high specificity.

 

https://www.cnbc.com/2021/04/27/pfizer-at-home-covid-pill-could-be-available-by-year-end-ceo-albert-bourla-says.html?recirc=taboolainternal

 

[harkinmr]

13 hours ago, nocl said:

We will also see how long they stick to their various protocols.

Not to mention actually enforcing those protocols even if not changed in writing.  All of them.

[harkinmr]

41 minutes ago, TeeRick said:

Here is an interesting item.  In Massachusetts the governor announced that on August 1, all sports stadiums will be allowed to operate at full capacity.  So why are cruises on hold until Nov 1 even if fully vaccinated? 

 

https://www.nbcboston.com/news/sports/nbcsports/gov-bakers-covid-19-update-is-good-for-boston-sports-teams/2365691/

I am very surprised to hear 100%, but it is August 1.  We'll see if it holds.  No mention of any vaccine or other health protocols.  If the virus is still around and they've got unvaccinated spectators and no masks it could prove to be interesting.  Massachusetts is Baker's decision, not the CDC's, so it may not be a fair comparison.

 

The November 1 date was picked last October.  There was no way to predict how this pandemic was going to go at that time. I believe that the CSO was a slap by Dr. Redfield for the cruise lines bypassing the CDC and going to the White House for relief.  He had been pushed around enough already by the Administration.  So instead of a No Sail Order to be renewed every 90 days, the CDC gets expanded control over the whole restart process.  That certainly didn't work out well for the cruise lines. 

 

All that being said, I think cruising will restart well before November 1 IF the cruise lines do their part as well.

[Ken the cruiser]

8 hours ago, nocl said:

Depend upon what one means by giving them credit. If you are saying bypass the CSO nope.

If you are saying that they do the port agreements and submit the protocols and all of the test and health information from those cruises as part of their submission for the test cruise then they should be considered as part of the submission.

The latter, to include accepting those cruises as Celebrity's Phase 3 "no revenue" test cruises representing all Celebrity ships, not just the Millennium, Apex and Silhouette, as those three ships are examples from each type of ship Celebrity sails.

[paulh84]

2 minutes ago, harkinmr said:

The November 1 date was picked last October.  There was no way to predict how this pandemic was going to go at that time.

 

The Nov 1 date marks the date somewhere about when the busy winter Caribbean season begins. There's all the doom about how lack of cruises destroyed the Florida economy, but there really isn't a lot of cruising happening during summer and hurricane season from US ports, especially in Florida. Last winter was an obvious wash, spring/summer 2021 likely will be too, but the Nov 1 2021 date bought some time to get the virus under control and looks toward the timeframe when US cruises are at their height for the year. 

[mimbecky]

57 minutes ago, TeeRick said:

  Fully vaccinated people are worried needlessly right now that they will come up to a year and will need another shot before travelling.  Based on what?

Based on nothing other than being a worrier. Specifically regarding availability and logistics dovetailing with potential cruise and land tour. 🥴

 

[harkinmr]

6 minutes ago, Ken the cruiser said:

The latter, to include accepting those cruises as Celebrity's Phase 3 "no revenue" test cruises representing all Celebrity ships, not just the Millennium, Apex and Silhouette, as those three ships are examples from each type of ship Celebrity sails.

They likely won't be substituted as the CSO "test" cruises because they are not being completed under the oversight of the CDC, including inspections of the sailings with the protocols in practice.

[Ken the cruiser]

Here's some good news from the CDC director regarding the movement towards flattening the curve. Hopefully it continues.

 

CDC director sees 'a really hopeful decline' as Covid cases in the U.S. fall (msn.com)

 

And here's the JHU link I check out every morning to see how my state (and others) are doing. What's really interesting is when you click on a State and then their State Profile link, how few beds are being taken up by COVID patients. A MUCH smaller percentage than in the past.

 

Have we flattened the curve in the US? - Johns Hopkins (jhu.edu)

[K.T.B.]

2 minutes ago, harkinmr said:

They likely won't be substituted as the CSO "test" cruises because they are not being completed under the oversight of the CDC, including inspections of the sailings with the protocols in practice.

 

CDC has no regulatory authority over cruise lines though, which is the frustration.  Their authority is strictly health related.  If cruise lines can prove their ability to sail safely (i.e. foreign port cruises), the CDC should look into it IF they seriously are willing to work with cruise lines.  That doesn't seem to be the case though....

[Ken the cruiser]

7 minutes ago, harkinmr said:

They likely won't be substituted as the CSO "test" cruises because they are not being completed under the oversight of the CDC, including inspections of the sailings with the protocols in practice.

I know. It's just "selfish" wishful thinking. 🙃

[K.T.B.]

1 minute ago, Ken the cruiser said:

Here's some good news from the CDC director regarding the movement towards flattening the curve. Hopefully it continues.

 

CDC director sees 'a really hopeful decline' as Covid cases in the U.S. fall (msn.com)

 

And here's the JHU link I check out every morning to see how my state (and others) are doing. What's really interesting is when you click on a State and then their State Profile link, how few beds are being taken up by COVID patients. A MUCH smaller percentage than in the past.

 

Have we flattened the curve in the US? - Johns Hopkins (jhu.edu)

 

That JHU link is extremely interesting.  I'm also very disappointed that Illinois only has a quarter of its population fully vaccinated.