Does Disney know more than Celebrity?

[K.T.B.]

3 hours ago, ipeeinthepool said:

 

Sorry but you missed the context of the discussion.  Children will not have a vaccine by the fall.  Nothing will change between the summer to the fall relative to vaccinations for children.

 

Honestly, there is absolutely no way of knowing this.  A lot can change between now and, say, June 1.  

[ipeeinthepool]

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

 

Honestly, there is absolutely no way of knowing this.  A lot can change between now and, say, June 1.  

 

No, children will not have vaccines this year.

[Fouremco]

13 minutes ago, ipeeinthepool said:

 

No, children will not have vaccines this year.

Not according to Dr. Fauci. According to this article in the Los Angeles Times (https://www.latimes.com/science/story/2021-03-10/covid-19-vaccines-for-kids-and-teens-are-coming😞

 

The nation’s top infectious diseases expert says that by fall, he expects to have data showing that children and teens age 12 to 17 can start rolling up their sleeves for COVID-19 shots. Younger children could follow in the first quarter of 2022.

[ipeeinthepool]

1 hour ago, Fouremco said:

Not according to Dr. Fauci. According to this article in the Los Angeles Times (https://www.latimes.com/science/story/2021-03-10/covid-19-vaccines-for-kids-and-teens-are-coming😞

 

The nation’s top infectious diseases expert says that by fall, he expects to have data showing that children and teens age 12 to 17 can start rolling up their sleeves for COVID-19 shots. Younger children could follow in the first quarter of 2022.

 

I was aware about children over 12 maybe getting shots this fall but kids under 12,  really Disney's target market, won't have anything this year.  But who knows, Fauci may change direction again.

[Fouremco]

31 minutes ago, ipeeinthepool said:

 

I was aware about children over 12 maybe getting shots this fall but kids under 12,  really Disney's target market, won't have anything this year.  But who knows, Fauci may change direction again.

Thanks for clarifying that you only meant children under twelve, not all children.

 

Yes, I'm sure that Dr. Fauci will continue to adjust appropriately as additional scientific information comes to the fore.

[markeb]

1 hour ago, Fouremco said:

Thanks for clarifying that you only meant children under twelve, not all children.

 

Yes, I'm sure that Dr. Fauci will continue to adjust appropriately as additional scientific information comes to the fore.

 

Getting approval down to 12 by fall is probably doable, although it would still be under an EUA. Below that I would expect there to be a lot more hoops to jump through, and a VERY cautious approach. And time consuming. And I'd argue understandable. There are a handful of articles out there in the "other than purely scientific press" that talk through that; I hesitate to post one as some of them I don't recognize and even though they have good information, the one I'd pick would randomly be to an extreme of the spectrum!

 

They'll have to look for any unforeseen safety issues, and try to bridge a correlate of protection (antibody titer?) as the disease prevention metrics in adults are probably not going to be as useful in pediatrics, and we've seen different disease manifestations in children. That will likely also slow down the trials for younger age groups. We'll see. 

[Fouremco]

28 minutes ago, markeb said:

 

Getting approval down to 12 by fall is probably doable, although it would still be under an EUA. Below that I would expect there to be a lot more hoops to jump through, and a VERY cautious approach. And time consuming. And I'd argue understandable. There are a handful of articles out there in the "other than purely scientific press" that talk through that; I hesitate to post one as some of them I don't recognize and even though they have good information, the one I'd pick would randomly be to an extreme of the spectrum!

 

They'll have to look for any unforeseen safety issues, and try to bridge a correlate of protection (antibody titer?) as the disease prevention metrics in adults are probably not going to be as useful in pediatrics, and we've seen different disease manifestations in children. That will likely also slow down the trials for younger age groups. We'll see. 

Thanks. I expect that this topic will receive a lot more attention as adult vaccination issues are resolved. 

[TeeRick]

16 hours ago, ipeeinthepool said:

 

I was aware about children over 12 maybe getting shots this fall but kids under 12,  really Disney's target market, won't have anything this year.  But who knows, Fauci may change direction again.

It is not up to Fauci.  It is entirely up to getting clinical safety and efficacy studies done in a careful way and progressing downwards in age.  It is up to the FDA.  Fauci is not part of the FDA.

[NMTraveller]

I suspect that vaccinated adults would sail on Disney if the itinerary was good enough.  But perhaps children are the reason for their delayed view of return to cruising.

Edited March 13, 2021 by NMTraveller

[DirtyDawg]

Does Disney know more than Celebrity?

Of course they do.

I little talking mouse told them.😉 

 

[nocl]

16 hours ago, markeb said:

 

Getting approval down to 12 by fall is probably doable, although it would still be under an EUA. Below that I would expect there to be a lot more hoops to jump through, and a VERY cautious approach. And time consuming. And I'd argue understandable. There are a handful of articles out there in the "other than purely scientific press" that talk through that; I hesitate to post one as some of them I don't recognize and even though they have good information, the one I'd pick would randomly be to an extreme of the spectrum!

 

They'll have to look for any unforeseen safety issues, and try to bridge a correlate of protection (antibody titer?) as the disease prevention metrics in adults are probably not going to be as useful in pediatrics, and we've seen different disease manifestations in children. That will likely also slow down the trials for younger age groups. We'll see. 

Its all perfectly clear in the FDA guidance document for vaccine development  section 4 C  Basically immune response and safety studies should be sufficient.

😉

 

https://www.fda.gov/files/vaccines, blood & biologics/published/Guidance-for-Industry--General-Principles-for-the-Development-of-Vaccines-to-Protect-Against-Global-Infectious-Diseases.pdf

 

Vaccine development generally takes place in a stepwise fashion from adults to children. However, for many global diseases (e.g., malaria), the pediatric population may face greater mortality or morbidity than the adult population because adults may already be immune. Therefore, it may be appropriate or necessary to start development in infants or children. For pediatric studies in the U.S., institutional review boards must ensure research is compliant with 21 CFR Part 50, Subpart D. The Pediatric Research Equity Act of 2003 (PREA), (Public Law 108-155) as reauthorized in Title IV of FDAAA, addresses product development for pediatric uses. PREA requires pediatric assessments to be included in all applications submitted under section 505 of the FD&C Act or under section 351 of the PHS Act, unless the sponsor has obtained a waiver or deferral from FDA. If the course of the disease and the effects of the drug are sufficiently similar in adults and pediatric patients, FDA may conclude that pediatric effectiveness can be extrapolated from adequate and well-controlled studies in adults, usually supplemented with other information obtained in pediatric subjects, such as immune response studies (section 505B(a)(2)(B) of the FD&C Act). Sponsors must also submit adequate safety information to support use in the pediatric population (section 505B(a)(2)(A)(ii) of the FD&C Act).

Edited March 13, 2021 by nocl

[TeeRick]

21 hours ago, nocl said:

Its all perfectly clear in the FDA guidance document for vaccine development  section 4 C  Basically immune response and safety studies should be sufficient.

😉

 

https://www.fda.gov/files/vaccines, blood & biologics/published/Guidance-for-Industry--General-Principles-for-the-Development-of-Vaccines-to-Protect-Against-Global-Infectious-Diseases.pdf

 

Vaccine development generally takes place in a stepwise fashion from adults to children. However, for many global diseases (e.g., malaria), the pediatric population may face greater mortality or morbidity than the adult population because adults may already be immune. Therefore, it may be appropriate or necessary to start development in infants or children. For pediatric studies in the U.S., institutional review boards must ensure research is compliant with 21 CFR Part 50, Subpart D. The Pediatric Research Equity Act of 2003 (PREA), (Public Law 108-155) as reauthorized in Title IV of FDAAA, addresses product development for pediatric uses. PREA requires pediatric assessments to be included in all applications submitted under section 505 of the FD&C Act or under section 351 of the PHS Act, unless the sponsor has obtained a waiver or deferral from FDA. If the course of the disease and the effects of the drug are sufficiently similar in adults and pediatric patients, FDA may conclude that pediatric effectiveness can be extrapolated from adequate and well-controlled studies in adults, usually supplemented with other information obtained in pediatric subjects, such as immune response studies (section 505B(a)(2)(B) of the FD&C Act). Sponsors must also submit adequate safety information to support use in the pediatric population (section 505B(a)(2)(A)(ii) of the FD&C Act).

Thanks for posting this!  The interesting question for children is whether the risk vs. reward equation will come into play here.  Covid deaths have not been a major factor in children (thank goodness).  Very different from a lot of other infectious diseases world wide.  Will the FDA wait until a lot of safety studies in these age groups are in place to approve the vaccine?  Particularly since the vaccines are still in the EUA status?  Are young children at great enough risk from COVID to justify speeding up vaccines to them?  Regardless of what Disney knows or wants.

[nocl]

3 hours ago, TeeRick said:

Thanks for posting this!  The interesting question for children is whether the risk vs. reward equation will come into play here.  Covid deaths have not been a major factor in children (thank goodness).  Very different from a lot of other infectious diseases world wide.  Will the FDA wait until a lot of safety studies in these age groups are in place to approve the vaccine?  Particularly since the vaccines are still in the EUA status?  Are young children at great enough risk from COVID to justify speeding up vaccines to them?  Regardless of what Disney knows or wants.

considering that any infection is a potential source for mutation, it is not just the risk level within the age group that will drive the decision. Though the inflammatory syndrome cases also need to be considered.

 

The FDA will move on this as soon as they have data.

[ipeeinthepool]

4 hours ago, TeeRick said:

Thanks for posting this!  The interesting question for children is whether the risk vs. reward equation will come into play here.  Covid deaths have not been a major factor in children (thank goodness).  Very different from a lot of other infectious diseases world wide.  Will the FDA wait until a lot of safety studies in these age groups are in place to approve the vaccine?  Particularly since the vaccines are still in the EUA status?  Are young children at great enough risk from COVID to justify speeding up vaccines to them?  Regardless of what Disney knows or wants.

 

I tend to agree.  The risk vs reward for children is a far different situation than for adults.   I suspect that the FDA decision will based solely on the benefit for children and will not consider any other factors.

[hcat]

Might also depend down the road if school districts  REQUIRE  vaccination of students. Cruising is voluntary..school is not, generally.

 

 

[markeb]

11 minutes ago, hcat said:

Might also depend down the road if school districts  REQUIRE  vaccination of students. Cruising is voluntary..school is not, generally.

 

 

 

School districts won't require vaccination unless it's approved for the age group. I'm having a hard time imagining many school districts (and the approval authority may well be at the state level, BTW) requiring immunization of school age children without a fully licensed vaccine. They theoretically can with an EUA, but I doubt the political will is there to do it.

 

With the amount of concurrent work going on, I certainly can see pushing the clinical trials on down to lower age groups, and that data could even go in with their initial BLA, but it's almost certainly going to be voluntary vaccination of school age children for the foreseeable future.

[TeeRick]

Here is a summary of current required vaccines for children attending public schools in most US states.  There is an exemption form for religious and non-medical reasons.  I am not sure how a COVID vaccine could be added to this required list under an EUA.  I imagine state health departments and education departments are trying to understand what to do.  But of course we are a long way off from collecting the data from safety and immunogenicity studies in school age children.  Then an FDA decision.  Given the low risk of COVID in kids this will be a very controversial public issue and an emotional one at that.  

https://www.healthline.com/health-news/all-your-back-to-school-vaccination-questions-answered

 

 

[K.T.B.]

On 3/13/2021 at 10:59 AM, DirtyDawg said:

Does Disney know more than Celebrity?

Of course they do.

I little talking mouse told them.😉 

 

 

A Minnie Mouse..?

[cangelmd]

On 3/12/2021 at 9:44 AM, TeeRick said:

Yes I know it is a big stretch for this to happen.  But a state like FL might perhaps designate workers supporting tourism to be essential which is a big part of their economy.  Anyway my point is that getting the crew vaccinated will be the big hurdle to resuming cruising.

Had not considered this until you mentioned it. I have wondered if some smaller countries, certain island nations in particular that have a number of young people working on cruise ships might declare them “essential” because of the hard currency they might send home. But if a state like Florida or Alaska, even, ended up with an excess supply of vaccine... Another thing is, at least in the panhandle, there used to be large numbers of workers “brought” in from Eastern Europe to do housekeeping in all the condos and hotels, perhaps they will be made essential, although that part of travel is going great guns.

[cgolf1]

I spend a fair amount of time on a DCL board, and while this person said those words, there is still frustration, because like all other lines they haven't cancelled that far out yet and are forcing people to decide to pay or not pay at final payment time. So he may have muttered the words but the cruise line itself is ignoring them lol. That said everyone over there expects DCL to be one of the last to go and I agree. They are very careful to protect their image, so I think they would wait and see how other lines do before they set sail.

[ipeeinthepool]

Looks like the answer is no.  Apparently Celebrity knows more than Disney and will restart soon.