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Are vaccines the light at the end of the tunnel?


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16 hours ago, BOLOCRUISE said:

No.  Seasonal Flu shots are highly ineffective.  A rushed vaccine for a virus supposedly worse than seasonal flu?  No thanks.  I have never received a flue shot and will not be forced to receive a COVID-19 vaccine.

 

No one is forcing you in either case.  If you decide to risk yourself getting influenza or COVID if vaccines are available that is entirely your business.  But as others have said, if a COVID vaccine is required for cruising or to travel or enter into many countries, then you will have to obviously have to live with that.  Your body, your choice. 

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If you want to take the time to watch this Medscape interview or read the transcript with Dr Paul Offit (also see his Bio link below), he discusses all aspects of COVID vaccine efforts and a few other things too.  It is not too technical.  But it covers many of the issues that we have been discussing on this thread.  A really good interview with great information in my opinion.  Dr Offit is a highly regarded physician, infectious disease expert and vaccine expert from CHOP and UPENN.

 

https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=370300SV&impID=2558382&faf=1#vp_1

 

https://www.chop.edu/doctors/offit-paul-a

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13 hours ago, Arizona Wildcat said:

I would assume NIH can properly staff a multi site phase 3 trial.

The cruise lines had their meeting today with the CDC.  No idea what was said except CLIA will provide a proposal to the CDC on how to resume cruising in about 10 days.

The media article on Cruise Hive seemed mostly concerned with the economic cost to the CLIA members. Hmmmm.

Guess we will see in a few weeks how things will look in the future and probably a good idea of when.

They are using the NIH network.  NIH is not staffing the trial. Using their network means that they are using the clinical sites that NIH uses.  Those sites are largely academic institutions and other locations that run clinical trials (some commercial that do trials for a living, some are normal medical clinics that do trials, etc.) Those locations are not staffed by either NIH or Moderna personnel.  The most that NIH might be doing is to help coordinate between the clinical research locations and potentially help in trial design. NIH is not in the business of preparing regulatory submissions.

 

Moderna is using their own resources, their own personnel (either hired or contracted)  for clinical research and regulatory affairs functions. These are key activities that deal with trial design, data collection and analysis, regulatory communications, submission preparation.  These are critical, time intensive activities.  Actions where experience is important.

 

To give some idea of what we are talking about for a submission, the last NDA (new drug application) that I was involved with, was for a small oncology drug.  Its phase 3 trials was 300 patients.  The paper version of the submission  filled 92 legal size file boxes. 

 

This one will have considerably more data.

 

That is why most small biotechs team with other companies when they take their first product to market.  Especially if it is a large scale product.   Now it is possible that they are outsourcing those functions to contracting organizations.  However, their is no mention of that in any of their releases, and in one of them the CEO referred to their own team dedicated to the trials.

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TeeRick, thank you for posting the above links. LOL about your statement that it is not too technical; the reader will need at least a BS degree level in  biological sciences (including some immunology) to read and understand. However, that is the problem that anyone faces when trying to wrote something for Joe Public (including posts for Cruise Critic).

 

I am always sad when reading comments about FDA and its failure to protect the public health because of political pressure. The FDA of today is not the FDA I started with in 1972 when we knew out mission and did it no matter how unpopular.

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2 hours ago, TeeRick said:

If you want to take the time to watch this Medscape interview or read the transcript with Dr Paul Offit (also see his Bio link below), he discusses all aspects of COVID vaccine efforts and a few other things too.  It is not too technical.  But it covers many of the issues that we have been discussing on this thread.  A really good interview with great information in my opinion.  Dr Offit is a highly regarded physician, infectious disease expert and vaccine expert from CHOP and UPENN.

 

https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=370300SV&impID=2558382&faf=1#vp_1

 

https://www.chop.edu/doctors/offit-paul-a

Very good article.  I believe that it covers the issues quite well.

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29 minutes ago, Homosassa said:

TeeRick, thank you for posting the above links. LOL about your statement that it is not too technical; the reader will need at least a BS degree level in  biological sciences (including some immunology) to read and understand. However, that is the problem that anyone faces when trying to wrote something for Joe Public (including posts for Cruise Critic).

 

I am always sad when reading comments about FDA and its failure to protect the public health because of political pressure. The FDA of today is not the FDA I started with in 1972 when we knew out mission and did it no matter how unpopular.

I recall the FDA having its own issues in the 70's and 80's.  A bit different from today, but mistakes or controversies in their own right. I was there during some of them. Today as then, the FDA continues to do it job.  One that is very difficult quite well.

 

SO far there are really  two issues where the FDA has been criticized. Both emergency authorizations. Both were made during a time when there is no effective therapeutic. 

 

In the case of HCQ it was already an approved product, for which there was some reports of efficacy.  It has a known side effect profile and it was already being used off label.  So much so that it was being put on prior auth lists to prevent off label use in a couple of states and medicare regions.  The only real impact of the emergency authorization was that it was no longer an off label use and as such could nolonger be restricted for reimbursement under under medicare rules.  The use did not really go up.  So the risk/benefit considerations were not out of line.  More data was gathered (some of that new data later retracted) and the authorization removed.

 

In the cases of convalescent plasma you have a somewhat similar situation.   While not an approved product, it is a technique that has been used  extensively in the past. The safety profile shows little risk, and while it has not been proven in a fully powered randomized trial, there is some indications that it does have some effect if given early.  Again the risk/benefit profile is not out of line.

 

I suspect that in any other circumstances, in a different political environment, these decisions, that are drawing a lot of publicity and controversy, would have gone forth with a little discussion in medical circles with some debate, but would have not been viewed with the same acrimony that they have drawn today.  

 

In this environment everything is viewed politically as a weapon by one side or the other, even if it is not.

 

When it comes to approvals there is always some debate, not all advisory committee meetings are unanimous.  A majority vote is often the best that one can hope for with a new product.

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7 hours ago, npcl said:

They are using the NIH network.  NIH is not staffing the trial. Using their network means that they are using the clinical sites that NIH uses.  Those sites are largely academic institutions and other locations that run clinical trials (some commercial that do trials for a living, some are normal medical clinics that do trials, etc.) Those locations are not staffed by either NIH or Moderna personnel.  The most that NIH might be doing is to help coordinate between the clinical research locations and potentially help in trial design. NIH is not in the business of preparing regulatory submissions.

 

Moderna is using their own resources, their own personnel (either hired or contracted)  for clinical research and regulatory affairs functions. These are key activities that deal with trial design, data collection and analysis, regulatory communications, submission preparation.  These are critical, time intensive activities.  Actions where experience is important.

 

To give some idea of what we are talking about for a submission, the last NDA (new drug application) that I was involved with, was for a small oncology drug.  Its phase 3 trials was 300 patients.  The paper version of the submission  filled 92 legal size file boxes. 

 

This one will have considerably more data.

 

That is why most small biotechs team with other companies when they take their first product to market.  Especially if it is a large scale product.   Now it is possible that they are outsourcing those functions to contracting organizations.  However, their is no mention of that in any of their releases, and in one of them the CEO referred to their own team dedicated to the trials.

All I can tell you is our local site is indeed at a university hospital managed by Banner.  The lady who greets you has a NIH namebadge.  The others I do not know.

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20 hours ago, Homosassa said:

TeeRick, thank you for posting the above links. LOL about your statement that it is not too technical; the reader will need at least a BS degree level in  biological sciences (including some immunology) to read and understand. However, that is the problem that anyone faces when trying to wrote something for Joe Public (including posts for Cruise Critic).

 

I am always sad when reading comments about FDA and its failure to protect the public health because of political pressure. The FDA of today is not the FDA I started with in 1972 when we knew out mission and did it no matter how unpopular.

I agree (LOL) about the technical reading.  But I think that most members following this thread which is now close to 800 posts will find it at the technical level we have been at here.  So it is for those folks here that want more info from a good source.  Many less technical CC members will just not click the links which is absolutely fine.

 

As for the FDA I totally agree with npcl.  The FDA is always under pressure.  Always has been. From the Public.  From Congress.  From the White House. From the Pharma companies.  From the Media/Press.  They continue to do a fine job and make the right decisions and ask the right questions.  They are always in a difficult position and somebody will always be critical of them.  They will be more flexible (not only now but historically) for compassionate use approvals which sometimes include novel therapeutics or approaches (like convalescent plasma).  I personally have not seen them flexible with vaccine (preventative) approvals in the otherwise healthy population.  But there has never been a deadly pandemic in my lifetime.

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1 hour ago, TeeRick said:

I agree (LOL) about the technical reading.  But I think that most members following this thread which is now close to 800 posts will find it at the technical level we have been at here.  So it is for those folks here that want more info from a good source.  Many less technical CC members will just not click the links which is absolutely fine.

 

 

Actually, I appreciate the fact that there is at least one thread on CC where an intelligent discussion is occurring without off the wall posts accusing posters of political agendas (sadly my experience on a another cruise line forum).

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1 hour ago, TeeRick said:

But I think that most members following this thread which is now close to 800 posts will find it at the technical level we have been at here

 

Well, I am not technical by any means but thought the interview was straightforward and very thought provoking. Thank you! 

I am enjoying this thread and expect it to keep flowing until the vaccine itself is flowing. 🥴

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The United Kingdom's Medicines Health Regulatory Authority that it was safe to resume clinical trials after a brief pause. 

  • AstraZeneca paused trials earlier this week due to a potentially unexplained illness. 
  • CEO Pascal Soriot said during a private conference call that the illness occurred in a woman in the U.K. who displayed neurological symptoms consistent with a spinal inflammatory disorder called transverse myelitis.   
  • Illnesses often occur by chance in large trials but are investigated out of an abundance of caution
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4 hours ago, Homosassa said:

Actually, I appreciate the fact that there is at least one thread on CC where an intelligent discussion is occurring without off the wall posts accusing posters of political agendas (sadly my experience on a another cruise line forum).

I agree I dont come here to talk politics.  I am interested in the vaccine and enjoying this thread.

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Dr Fauci finally summarized it all and reaffirmed a lot I've said

- no way we are normal till 2021 at the earliest

- vaccine this year while possible won't have material effect till 2021 at the earliest

- cruising won't be happening any time soon

- sadly he wouldn't be explicit and say a vaccine isn't the cure.. but indirectly pointed to the larger problem in the US.

 

https://www.cnn.com/2020/09/11/health/fauci-normal-life-2021/index.html

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Dr. William Schffner an infectious disease doctor from Vanderbilt University talked about monoclonal antibodies on The Doctor Radio show on Sirius radio the other day. He said that he is hoping for mAbs to be very helpful to combat the virus. Furthermore, he was wondering why there has not been much data coming out so far. But this has been a few days ago.  This is what I have been hoping for since March. INMHO this should be a game changer since it can be both a cure and a prevention.  

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9 hours ago, Arizona Wildcat said:

The United Kingdom's Medicines Health Regulatory Authority that it was safe to resume clinical trials after a brief pause. 

  • AstraZeneca paused trials earlier this week due to a potentially unexplained illness. 
  • CEO Pascal Soriot said during a private conference call that the illness occurred in a woman in the U.K. who displayed neurological symptoms consistent with a spinal inflammatory disorder called transverse myelitis.   
  • Illnesses often occur by chance in large trials but are investigated out of an abundance of caution

let's hope they do not see another

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3 hours ago, Doris&Nereus said:

Dr. William Schffner an infectious disease doctor from Vanderbilt University talked about monoclonal antibodies on The Doctor Radio show on Sirius radio the other day. He said that he is hoping for mAbs to be very helpful to combat the virus. Furthermore, he was wondering why there has not been much data coming out so far. But this has been a few days ago.  This is what I have been hoping for since March. INMHO this should be a game changer since it can be both a cure and a prevention.  

I’ve also been curious about why we haven’t heard more as well.

It could be because the Ab isn’t as effective as hoped. It could be because of the multi billion dollar potential and the security is very tight.

 I worry about the cost of these.

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7 hours ago, cangelmd said:

I’ve also been curious about why we haven’t heard more as well.

It could be because the Ab isn’t as effective as hoped. It could be because of the multi billion dollar potential and the security is very tight.

 I worry about the cost of these.

Yes this is my main concern too with mAb's .  If they work as a therapeutic that would be great but like Remdesivir would be used in a setting with hospitalized COVID patients (presumably with health insurance).  I cannot see any scenario where mAb's would be used longer term for preventing viral infection in healthy people.  They do not take the place of a decent vaccine.

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17 hours ago, chipmaster said:

Dr Fauci finally summarized it all and reaffirmed a lot I've said

- no way we are normal till 2021 at the earliest

- vaccine this year while possible won't have material effect till 2021 at the earliest

- cruising won't be happening any time soon

- sadly he wouldn't be explicit and say a vaccine isn't the cure.. but indirectly pointed to the larger problem in the US.

 

https://www.cnn.com/2020/09/11/health/fauci-normal-life-2021/index.html

Your first two points relate to Fauci's comments but the link is a short read with his actual thoughts.   So thanks for posting it!

 

My view:  Fauci and most experts have been pointing out for quite some time that a vaccine, even if approved by late 2020, will not be an effective weapon against the virus until enough people are vaccinated (2 doses).  Hopefully by mid to late 2021 that would start to be the case.  That would be my best case scenario guess at this point.  But just getting health care workers and first responders started with a dose of vaccine by end of 2020 would be a huge step forward IMO.

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1 hour ago, TeeRick said:

Yes this is my main concern too with mAb's .  If they work as a therapeutic that would be great but like Remdesivir would be used in a setting with hospitalized COVID patients (presumably with health insurance).  I cannot see any scenario where mAb's would be used longer term for preventing viral infection in healthy people.  They do not take the place of a decent vaccine.

Yes, I agree that they (the companies) are pushing the term "preventative" treatment

since the mAb have a limited half life (weeks/months) depending on the dose and

NO potential memory (T&B cells). They also mention using mAb's that don't

have FC receptors to increase their half life but you are still left with clearing

the virus once the mAb's bind to the virus. They are used effectively to treat

certain disease but are EXPENSIVE to make/use.

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11 hours ago, cangelmd said:

I’ve also been curious about why we haven’t heard more as well.

It could be because the Ab isn’t as effective as hoped. It could be because of the multi billion dollar potential and the security is very tight.

 I worry about the cost of these.

the first trial is expecting to read out late september, others in December. When this started I was hopeful that MAB could make a substantial impact. But my expectations have dropped as more has been discovered about Covid.

 

Too expensive and too difficult to make large volumes to be a widespread preventive. Could be useful in facilities like nursing homes to prevent an out break from spreading or to non infected family members. but not for general

public.

 

 As far as an effective treatment. By the time symptoms show up, and one can get treated, a lot of the damage is being done by the bodies own reaction to the infection and not the virus itself. Reduce mortality probably, reduce not eliminate. Stop or prevent all of the other damage not likely

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Just an FYI for some of the readers of this thread - whenever you see "mab" at the end of any drug name (not the brand name, but the chemical name that is also usually included in the labeling), the drug is a monoclonal antibody.

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The Medscape article was great!  Thanks for the link. The surprise to me is that they are not including test subjects over the age of 65 in the phase 3 trial. Therefore they won’t be recommending  the use of the vaccine in the age group that comprises most of the cruisers. When will they test the senior population?

 

Offit: If we don't have adequate data in the greater-than-65-year-old group, then the greater-than-65-year-old person shouldn't get this vaccine, which would be a shame because they're the ones who are most likely to die from this infection. We have to generate those data.

 

I can't see how anybody — the DSMB or the FDA Vaccine Advisory Committee, or FDA decision-makers — would ever allow a vaccine to be recommended for that group without having adequate data

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2 hours ago, BP99 said:

Yes, I agree that they (the companies) are pushing the term "preventative" treatment

since the mAb have a limited half life (weeks/months) depending on the dose and

NO potential memory (T&B cells). They also mention using mAb's that don't

have FC receptors to increase their half life but you are still left with clearing

the virus once the mAb's bind to the virus. They are used effectively to treat

certain disease but are EXPENSIVE to make/use.

BP99, you say that the mAb will not kill the current infection.  So they just drop off , and the same infection just comes back after the 4 months or so. I thought that the person who got the treatment could get another infection, but not the same one would get back into the cells. That is why I was hoping for mAbs to work on sick people and those at very high risk until we can get the vaccine to work. Also, there are some people who have poor immune response to vaccines, and they could benefit.

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1 hour ago, VitaminSea53 said:

The Medscape article was great!  Thanks for the link. The surprise to me is that they are not including test subjects over the age of 65 in the phase 3 trial. Therefore they won’t be recommending  the use of the vaccine in the age group that comprises most of the cruisers. When will they test the senior population?

 

Offit: If we don't have adequate data in the greater-than-65-year-old group, then the greater-than-65-year-old person shouldn't get this vaccine, which would be a shame because they're the ones who are most likely to die from this infection. We have to generate those data.

 

I can't see how anybody — the DSMB or the FDA Vaccine Advisory Committee, or FDA decision-makers — would ever allow a vaccine to be recommended for that group without having adequate data

the article used the over 65 as an example. The trials are including that age group in the study populations.

 

Pfizer is expanding their trial to include down to age 16, and some additional pre existing conditions.

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