Paxlovid on board?

[TeeRick]

23 hours ago, cruisemom42 said:

 

It's not the first time I've seen this question on these boards -- and I read more than just the Celebrity one.

Yes understood.  But you identify yourself as having a medical background.  Many here do not.  So don't you think it is a rather obvious question for people to at least ask their doctors since they want to understand their options if any before traveling and cruising?  So that is why you see it so often on the CC boards.  I am not in support of having a just in case prescription of Paxlovid, as I have stated.  But I do understand why some here are asking the question.  No need to judge them for this IMO.

[cruisemom42]

4 hours ago, Kiran said:

IMHO, hoarding would Only be if my obtaining a prescription just in case prevented someone else from obtaining it when they needed it.

 

This is not actually true. My trusty Merriam-Webster dictionary defines hoarding as "the practice of collecting or accumulating something (such as money or food)."

 

We speak of animal hoarders -- people who keep large numbers of animals in their houses (often cats) due to some beneficial feeling they get from the act. Do you propose they are depriving others of stray cats for adoption?

 

Or people who collect large amounts of "things" and have an inability to throw away what normal people would consider trash or junk....  One assumes they are not depriving others of rusty tools, bags of garbage, rotten food...?

 

 

[Bo1953]

On 5/6/2022 at 11:26 PM, mikewomb said:

Regardless Celebrity is treating their passengers terribly. Cardboard, styrofoam, regardless..this is not the time to be cruising. 

Correct, not the time to be cruising if one has an anxiety or aversion to the current protocols in place aboard OR are very worried of contracting C-19 and having to endure the 'humiliation' of being quarantined not in the style to which we believe we are entitled to be regardless of same... LOL

 

In health and bon voyage

[cruisemom42]

9 minutes ago, TeeRick said:

Yes understood.  But you identify yourself as having a medical background.  Many here do not.  So don't you think it is a rather obvious question for people to at least ask their doctors since they want to understand their options if any before traveling and cruising?  So that is why you see it so often on the CC boards.  I am not in support of having a just in case prescription of Paxlovid, as I have stated.  But I do understand why some here are asking the question.  No need to judge them for this IMO.

 

I think you misunderstand me. I was talking about people asking for paxlovid "just in case". You are talking about asking about paxlovid "just in case". The latter implies a conversation and I'm all for that. But the former is a demand and you might be surprised (or not) at how often such demands are made of those with rights to prescribe....

 

[mikewomb]

1 minute ago, Bo1953 said:

Correct, not the time to be cruising if one has an anxiety or aversion to the current protocols in place aboard OR are very worried of contracting C-19 and having to endure the 'humiliation' of being quarantined not in the style to which we believe we are entitled to be regardless of same... LOL

 

In health and bon voyage

I think there is a real inconsistency in their protocols that makes it difficult. Also due to health reasons which I will not discuss on this board it isn’t safe, additionally my DH had been exposed to covid the day before. 

[Guppy99]

5 hours ago, Kiran said:

IMHO, hoarding would Only be if my obtaining a prescription just in case prevented someone else from obtaining it when they needed it.

 

Paxlovid varying widely in availability

 

If i buy and store a 2 year supply of toilet paper in preparation for Bird Flu or Y2K, that is not hoarding but prepping.

 

Hoarding in its negative connotation is if when toilet paper shortage is announced, i rush to Stop and Shop and clear the shelves leaving others without ability to buy toilet paper.

My supply actually allows me to stop buying toilet paper with usual groceries and leave it in stores for others to purchase.

 

 

I stand by the use of the word hoarding, because that's what it is when you obtain drugs for no purpose other than "what if". This leads to so many issues, among which are:

• drugs being unused and aging to the point where their use would be dangerous or worthless, each in turn being a problem;
• sharing of drugs (this happens all the time, particularly between family members) and it's dangerous because you (the general you) are not capable of diagnosing or knowing when someone is contraindicated from its use;
• drugs being used for something other than what it was immediately prescribed for.

These are just a few issues with drugs being prophylactically prescribed.  I'm not saying there are not specific situations where it is warranted, but they are few and far between. A drug that is not universally approved and given only under tested circumstances with known medical histories should never be in that group.

 

Edited May 9, 2022 by Guppy99

[Bo1953]

46 minutes ago, mikewomb said:

I think there is a real inconsistency in their protocols that makes it difficult. Also due to health reasons which I will not discuss on this board it isn’t safe, additionally my DH had been exposed to covid the day before. 

I tend to agree about the protocols and understand your situation, as well.

 

I think what happens, in terms of applying protocols across the fleet is that each Captain and Chief Medical Officer on each ship interprets the protocol for their ship and sailing, which can change daily pending on the situation aboard.

 

As such, many factors will dictate what can and will happen at any given time for this situation.

 

In health and bon voyage

 

 

[TeeRick]

1 hour ago, Guppy99 said:

I stand by the use of the word hoarding, because that's what it is when you obtain drugs for no purpose other than "what if". This leads to so many issues, among which are:

• drugs being unused and aging to the point where their use would be dangerous or worthless, each in turn being a problem;
• sharing of drugs (this happens all the time, particularly between family members) and it's dangerous because you (the general you) are not capable of diagnosing or knowing when someone is contraindicated from its use;
• drugs being used for something other than what it was immediately prescribed for.

These are just a few issues with drugs being prophylactically prescribed.  I'm not saying there are not specific situations where it is warranted, but they are few and far between. A drug that is not universally approved and given only under tested circumstances with known medical histories should never be in that group.

 

Guppy99 has very good points.

[TeeRick]

On 5/9/2022 at 9:07 AM, cruisemom42 said:

 

I think you misunderstand me. I was talking about people asking for paxlovid "just in case". You are talking about asking about paxlovid "just in case". The latter implies a conversation and I'm all for that. But the former is a demand and you might be surprised (or not) at how often such demands are made of those with rights to prescribe....

 

Instead of "Just in case Paxlovid", there is an option for COVID prophylaxis (pre-treatment of uninfected).  For those about to cruise or travel in a high-risk (immunocompromised) category you might want to ask the advice from your doctor about Evusheld.  This is a new drug (injectable) approved by the FDA (EUA status) recently for this purpose.  Personally if I were severely immunocompromised I would check it out- but I would not likely cruise at all.

[Guppy99]

 

 

On 5/9/2022 at 9:07 AM, cruisemom42 said:

 

I think you misunderstand me. I was talking about people asking for paxlovid "just in case". You are talking about asking about paxlovid "just in case". The latter implies a conversation and I'm all for that. But the former is a demand and you might be surprised (or not) at how often such demands are made of those with rights to prescribe....

 

In this case I don't think that is a genuine distinction.

[B x]

1 hour ago, TeeRick said:

Instead of "Just in case Paxlovid", there is an option for COVID prophylaxis (pre-treatment of uninfected).  For those about to cruise or travel in a high-risk (immunocompromised) category you might want to ask the advice from your doctor about Evusheld.  This is a new drug (injectable) approved by the FDA (EUA status) recently for this purpose.  Personally if I were severely immunocompromised I would check it out- but I would not likely cruise at all.

Whilst recently approved in the UK, Evusheld developed by AZ  is aimed for use in adults who are unlikely to mount an immune response from COVID-19 vaccination or for whom vaccination is not recommended. As such those with autoimmune conditions (such as myself, now five timed jabbed) would not be be offered it . 

[B x]

From the CDC guidelines for cruise ship medical facilities for the "Medical Management of suspected or confirmed Covid-19", note the inclusion of antivirals (such as Paxlovid), it's commercially available so why aren't they carrying it for those who should/can have it?

 

Maintaining adequate supplies of antipyretics (e.g., acetaminophen and ibuprofen), antivirals and other therapeutics for COVID-19, if commercially available, other antimicrobial medications, oral and intravenous steroids, and supplemental oxygen is also recommended.

[Homosassa]

I just read an interesting article yesterday about the effectiveness of Paxlovid against Omicron.

 

Here is a stripped down summary of the points:

 

1. Paxlovid was approved by the US FDA under an EUA. The drug was developed for and tested against the Delta variant.

 

2. The effectiveness of Paxlovid against the omicron variant  or other new variants is not clear.

 

3. The relapse of patients who have taken Paxlovid  (around 3%) is occurring and there are several theories as to why this is occurring:

     a. Paxlovid knocks the infection back but doesn't completely clear the body of the virus which leaves the virus to multiply and develop symptomatic disease.

      b. Taking the Paxlovid clears the body of the virus so quickly that the body's natural immune process of developing antibodies (including those important T Cells)does not occur and leaves the patient unprotected against new infection.

 

Just food for thought.  Personally, as I have been doubles vacced, double boosted, and had a very mild case of breakthrough covid  (picked up on the Constellation), I will let my body work as designed to add natural immunity against any new strains to supplement the acquired immunity of the vaccination.

[TeeRick]

23 minutes ago, Homosassa said:

I just read an interesting article yesterday about the effectiveness of Paxlovid against Omicron.

 

Here is a stripped down summary of the points:

 

1. Paxlovid was approved by the US FDA under an EUA. The drug was developed for and tested against the Delta variant.

 

2. The effectiveness of Paxlovid against the omicron variant  or other new variants is not clear.

 

3. The relapse of patients who have taken Paxlovid  (around 3%) is occurring and there are several theories as to why this is occurring:

     a. Paxlovid knocks the infection back but doesn't completely clear the body of the virus which leaves the virus to multiply and develop symptomatic disease.

      b. Taking the Paxlovid clears the body of the virus so quickly that the body's natural immune process of developing antibodies (including those important T Cells)does not occur and leaves the patient unprotected against new infection.

 

Just food for thought.  Personally, as I have been doubles vacced, double boosted, and had a very mild case of breakthrough covid  (picked up on the Constellation), I will let my body work as designed to add natural immunity against any new strains to supplement the acquired immunity of the vaccination.

Thanks!  As to your food for thought- I personally agree.  

[Homosassa]

23 minutes ago, TeeRick said:

Thanks!  As to your food for thought- I personally agree.  

I have another cruise planned for the end of June.

 

As I came home with a very mild case of Covid from my last cruise in February, I have developed my own plan to help lessen the chances of becoming ill on my next cruise.

 

In the past, my husband have done all we could do to protect ourselves against becoming ill. We are vaccinated and boosted  (single for the February cruise, now double boosted). We masked and social distanced (even on the cruise).

 

Well, I did finally contract a mild breakthrough case (so mild I though it was an allergy caused by the very high pollen count except my eyes weren't itching) as did my husband.

 

We have now decided to not worry so much about the Covid and hope that both our acquired immunity and limited natural immunity will make future infections mild because of the cross linkage of the already present antibodies with new strains.

 

As we both volunteer at our local state park in an indoor facility, we come into contact weekly with visitors from all over the US and around the world and will probably be exposed to Covid several times.

 

I rather be ill at home than on the cruise ship.  That is assuming that I realize I might have Covid.

 

We will take precautions (masks, etc) starting about three weeks before testing for the next cruise, but until then, I am working on the natural vs acquired immunity part of Covid protection. 

[Guppy99]

4 hours ago, Homosassa said:

I just read an interesting article yesterday about the effectiveness of Paxlovid against Omicron.

 

Here is a stripped down summary of the points:

 

1. Paxlovid was approved by the US FDA under an EUA. The drug was developed for and tested against the Delta variant.

 

2. The effectiveness of Paxlovid against the omicron variant  or other new variants is not clear.

 

3. The relapse of patients who have taken Paxlovid  (around 3%) is occurring and there are several theories as to why this is occurring:

     a. Paxlovid knocks the infection back but doesn't completely clear the body of the virus which leaves the virus to multiply and develop symptomatic disease.

      b. Taking the Paxlovid clears the body of the virus so quickly that the body's natural immune process of developing antibodies (including those important T Cells)does not occur and leaves the patient unprotected against new infection.

 

Just food for thought.  Personally, as I have been doubles vacced, double boosted, and had a very mild case of breakthrough covid  (picked up on the Constellation), I will let my body work as designed to add natural immunity against any new strains to supplement the acquired immunity of the vaccination.

Everyone's bodies are so individual, no single course of action is appropriate for all. Nor will it yield the same results.  Everyone needs to rely on their own physician's advise and then on what they feel comfortable with. Physicians are after all only people, and they are just as influenced by their own prejudices.  Which is why public health officials and cruise lines must be extra cautious and take into consideration the lesser likely scenarios to protect themselves, their passengers and their business.

[Kiran]

On 5/9/2022 at 9:40 AM, Guppy99 said:

 

These are just a few issues with drugs being prophylactically prescribed.  I'm not saying there are not specific situations where it is warranted, but they are few and far between. A drug that is not universally approved and given only under tested circumstances with known medical histories should never be in that group.

 

I agree

 

But when I am are one of those atypical asthma individuals, it is a good idea for me to ask my Pulmonologist what he would recommend for me, prior to me going on my next cruise

[TeeRick]

23 hours ago, Homosassa said:

I just read an interesting article yesterday about the effectiveness of Paxlovid against Omicron.

 

Here is a stripped down summary of the points:

 

1. Paxlovid was approved by the US FDA under an EUA. The drug was developed for and tested against the Delta variant.

 

2. The effectiveness of Paxlovid against the omicron variant  or other new variants is not clear.

 

3. The relapse of patients who have taken Paxlovid  (around 3%) is occurring and there are several theories as to why this is occurring:

     a. Paxlovid knocks the infection back but doesn't completely clear the body of the virus which leaves the virus to multiply and develop symptomatic disease.

      b. Taking the Paxlovid clears the body of the virus so quickly that the body's natural immune process of developing antibodies (including those important T Cells)does not occur and leaves the patient unprotected against new infection.

 

Just food for thought.  Personally, as I have been doubles vacced, double boosted, and had a very mild case of breakthrough covid  (picked up on the Constellation), I will let my body work as designed to add natural immunity against any new strains to supplement the acquired immunity of the vaccination.

Pfizer reported a phase II study about a week ago showing that pre-treatment (prophylaxis) of Paxlovid did not prevent infection in households with another infected person.

[Homosassa]

1 hour ago, TeeRick said:

Pfizer reported a phase II study about a week ago showing that pre-treatment (prophylaxis) of Paxlovid did not prevent infection in households with another infected person.

Interesting. 

 

The Emergency Use Authorization did have the statement that Paxlovid was not for prophylaxis use.  It looks like the Investigational New Drug clinical trials will not support the use when the New Drug Application is bought in for review for marketing approval. 

 

I don't know if I posted the following link for the labeling of Paxlovid under the Emergency Use Authorization.

 

If not, I will post it again for any others reading this thread who do not realized that Paxolvid is not an approved drug for marketing by the US FDA. It is only available for use under the EUA with strict indications for use and many contraindications.

 

https://www.fda.gov/media/155050/download

[Homosassa]

I found the phase two study article on the use of Paxlovid for prophylaxis after infection.

 

Short version: There wasn't a significant difference in the percentage of exposed patients in the lack of development of  Covid  with those given Paxlovid and those given a placebo.

 

For anyone trying to understand why Paxlovid is not available on cruise ships because of the contraindications and indications for use, here is the Pfizer news release.

 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-top-line-results-phase-23-epic-pep-study 

[fsupharm77]

Just a quick comment about just in case rx for Paxlovid.  I highly doubt any Dr is going to write it nor Pharmacy going to dispense since the EUA protocol to dispense requires Symptom onset within 5 days, and positive Covid test and requires dose adjustment made based on kidney function.  Not sure if all states are the same but in Michigan it is also reported through the health department, so there could be sanctions taken against prescriber and pharmacy if dispensed without meeting this criteria.

[drarill]

On 5/12/2022 at 10:45 AM, Homosassa said:

I have another cruise planned for the end of June.

 

As I came home with a very mild case of Covid from my last cruise in February, I have developed my own plan to help lessen the chances of becoming ill on my next cruise.

 

In the past, my husband have done all we could do to protect ourselves against becoming ill. We are vaccinated and boosted  (single for the February cruise, now double boosted). We masked and social distanced (even on the cruise).

 

Well, I did finally contract a mild breakthrough case (so mild I though it was an allergy caused by the very high pollen count except my eyes weren't itching) as did my husband.

 

We have now decided to not worry so much about the Covid and hope that both our acquired immunity and limited natural immunity will make future infections mild because of the cross linkage of the already present antibodies with new strains.

 

As we both volunteer at our local state park in an indoor facility, we come into contact weekly with visitors from all over the US and around the world and will probably be exposed to Covid several times.

 

I rather be ill at home than on the cruise ship.  That is assuming that I realize I might have Covid.

 

We will take precautions (masks, etc) starting about three weeks before testing for the next cruise, but until then, I am working on the natural vs acquired immunity part of Covid protection. 

Please don't count on the natural immunity,  you can find good information on this Twitter thread https://twitter.com/g0ingmad/status/1525063913896812547?s=20&t=lsRMraXWetWi-9TggKYYFw

[drarill]

On 5/13/2022 at 11:32 AM, Homosassa said:

I found the phase two study article on the use of Paxlovid for prophylaxis after infection.

 

Short version: There wasn't a significant difference in the percentage of exposed patients in the lack of development of  Covid  with those given Paxlovid and those given a placebo.

 

For anyone trying to understand why Paxlovid is not available on cruise ships because of the contraindications and indications for use, here is the Pfizer news release.

 

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-shares-top-line-results-phase-23-epic-pep-study 

this is a study about prophylactic use of Paxlovid after exposure, not infection.  Which means giving the drug to someone that was exposed to the virus but we don't know if this person is going to develop the disease. Does it make a difference? it doesn't.

 There are prophylactic protocols for accidental exposure to other virus like HIV, and keep in mind that one of the drugs in Paxlovid was developed for HIV patients. Paxlovid is really good keeping people out of the hospital and IMHO will be an excellent tool on a cruise.  I turned positive three days after my Edge cruise and the same day started to take Paxlovid, seven doses later (4 days) I was already negative. 

 

[Homosassa]

1 hour ago, drarill said:

this is a study about prophylactic use of Paxlovid after exposure, not infection.  Which means giving the drug to someone that was exposed to the virus but we don't know if this person is going to develop the disease. Does it make a difference? it doesn't.

 There are prophylactic protocols for accidental exposure to other virus like HIV, and keep in mind that one of the drugs in Paxlovid was developed for HIV patients. Paxlovid is really good keeping people out of the hospital and IMHO will be an excellent tool on a cruise.  I turned positive three days after my Edge cruise and the same day started to take Paxlovid, seven doses later (4 days) I was already negative. 

 

Yes, I said that in a post in response to someone who totally misunderstood the the Pfizer study for prophylactic use.

 

I posted the information for anyone interested in the status of clinical trials that are being done to expand the use of Paxlovid in the general population and to support the request for UD FDA approval for the drug.

 

Here is that post:

 

The article is about a phase 2 study under an Investigational New Drug application that Pfizer was conducting to expand the use of Paxlovid in the general population.

 

This study arm  was specifically studying if Paxolvid could prevent the development of disease  in someone that was exposed to Covid by a household contact. The study subjects had not yet tested positive or  developed any symptoms.

 

Understand? NO positive test, NO symptoms, ONLY exposure to someone in the household who is sick.

 

It was found that Paxlovid was NOT  significantly better in preventing the subjects  becoming ill than subjects given a placebo.

 

Therefore, the IND phase two study was stopped and this particular indication for use (prophylaxis) will not progress to Phase 3 (more study subjects and possibly refinement of dosing) and will not be submitted in a New Drug Application for marketing approval.

 

And yes, it is aimed at scientists and doctors? Who do you think does the reviews at the US FDA or keeps track of this type of thing outside the Agency?

Edited May 14, 2022 by Homosassa

[Homosassa]

1 hour ago, drarill said:

Please don't count on the natural immunity,  you can find good information on this Twitter thread https://twitter.com/g0ingmad/status/1525063913896812547?s=20&t=lsRMraXWetWi-9TggKYYFw

If you read my post, you would see that I have worked diligently on acquired immunity (double vacced, doubled boosted).  Natural immunity is just supplemental and just needs to last for my next cruise in June.