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Updated info on possible vaccine


Dwight1
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13 minutes ago, markeb said:

 

I'm not sure how that's any different from any other approved or licensed drug or biological? Phase IV is post-marketing surveillance and it occurs after approval of a BLA or NDA. It has a better than average chance of being more intense here just because of speed, but I'd consider it a normal process. Maybe we have different understandings and experiences with the terminology?

 

I agree with you, guess I didn’t phase what I was thinking very well ☺️ - however, I would be still on the side of the fence to wait it out 3-6 months and let the first wave of people be vaccinated which will increase the data for safety and efficacy and then I can make a more informed decision.

Given that I’ve practiced social distancing, worked remotely, etc etc etc  since late February - what’s a few more months after a vaccine becomes available? 😉

 

Saying that, if the information regarding same is to my satisfaction, I’m not “fixed” in my decision and will adapt and change as need be.

Edited by hvbaskey
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2 minutes ago, phoenix_dream said:

Agree.  And how safe is "safe"?  What determines that?  Read the literature that comes with any prescription or listen to the commercials on tv that list some of the side affects and no one would ever want to take any medication!  

 

Drugs do get pulled from the market during post-marketing surveillance. It's not common, but it certainly happens. The one that comes to mind off the top of my head was one or more of the non-steroidals that showed cardiac problems once on the market a few years back.

 

In some crazy ways, this process could look like you've just run multiple sprints, and then turn around and do a marathon. The world is trying to not do the marathon first. (Probably a bad analogy...) There's likely going to be a lot to learned once one or more vaccines are actually marketed.

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Just now, markeb said:

 

Drugs do get pulled from the market during post-marketing surveillance. It's not common, but it certainly happens. The one that comes to mind off the top of my head was one or more of the non-steroidals that showed cardiac problems once on the market a few years back.

 

“Vioxx"

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2 minutes ago, hvbaskey said:

 

I agree with you, guess I didn’t phase what I was thinking very well ☺️ - however, I would be still on the side of the fence to wait it out 3-6 months and let the first wave of people be vaccinated which will increase the data for safety and efficacy and then I can make a more informed decision.

Given that I’ve practiced social distancing, worked remotely, etc etc etc  since late February - what’s a few more months after a vaccine becomes available? 😉

 

Saying that, if the information regarding same is to my satisfaction, I’m not “fixed” in my decision and will adapt and change as need be.

I don't mean this to come across harshly, but the answer to the question about what's a few more months is unfortunately that if many people feel the same way it is a few more months the vaccine runs rampant, and for some that will literally mean dying or becoming permanently ill.  I already know people who have died from the virus.  I don't want to know any more (or be one).  

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7 minutes ago, phoenix_dream said:

I don't mean this to come across harshly, but the answer to the question about what's a few more months is unfortunately that if many people feel the same way it is a few more months the vaccine runs rampant, and for some that will literally mean dying or becoming permanently ill.  I already know people who have died from the virus.  I don't want to know any more (or be one).  

 

No worries - everyone is quite passionate of how they feel and I respect how every individual can feel differently.

 

If you read my last sentence in the post reply, my decision is also not “fixed” or set in stone.   I rely heavily on data and information and I cannot change that within myself - it’s my nature.

PS - “a few more months” for me = physical distancing, social circles <10 people, and all the regular protocols to keep myself, my family, and the community safe.  

Edited by hvbaskey
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1 hour ago, markeb said:

 

Drugs do get pulled from the market during post-marketing surveillance. It's not common, but it certainly happens. The one that comes to mind off the top of my head was one or more of the non-steroidals that showed cardiac problems once on the market a few years back.

 

 

 

My favorite was the drug that cured Hepatitis C.  The name may come to me, but it has been about twenty years since the drug hit the market.

 

The drug cured Hep C, however about six months after treatment, patients internal organs dissolved.  Oops!

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Flu vaccine is generally only about 67% effective so this falls within the same range. The difference is that this virus is much more contagious than flu. I think that having a vaccine that is in that 67% effectiveness range, combined with people still using social distancing when possible and wearing masks could put a significant decline on viral spread. And as for those who refuse to take the vaccine (I want to take it but certainly won’t be one of the first and will likely want to wait a couple months to see how it works), well they may find themselves blocked from many public places like cruises, schools, etc. without showing proof of vaccination.
 

I think I could deal with a cruise if it required vaccines for all passengers, mask wearing in certain ship areas and changes to things like buffet no longer being self-service. My next cruise is scheduled for May and if it actually sails I imagine there will be a number of safety changes that might align with the things I mentioned above. The tough decision for me will be that final payment is at the end of February and I don’t know if a vaccine will be ready by then or if ready have enough time to see how people are responding to it. I’m in a Penthouse for this next cruise and it’s a big chunk of money to outlay with the possibility of it being locked in as a FCC option only if the cruise line decides to sail but I’m still not comfortable going. It’s my anniversary cruise so I really want to go but health and safety have to be the priority (my husband is high risk with diabetes).

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3 hours ago, markeb said:

 

I'm not sure how that's any different from any other approved or licensed drug or biological? Phase IV is post-marketing surveillance and it occurs after approval of a BLA or NDA. It has a better than average chance of being more intense here just because of speed, but I'd consider it a normal process. Maybe we have different understandings and experiences with the terminology?

A little difference  you have post marketing surveillance (usually in the form of adverse event reports) and then you have phase 4 trials (also referred to as post marketing trials).  All drugs will have surveillance, not all will do phase 4 trials. Phase 4 trials are usually conducted to address some issues that arise in phase 3 trials (address questions raised during the review process and by the advisory committee)such as efficacy in a particular group, or to study a particular safety issue.  Phase 4 trials are also done to study in a population that might not have been addressed during phase 3, trials in children, or in pregnant women for example.  You might also run a phase 4 to compare dosing such as to see if a single dose might be as effective as a two dose regimen.

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2 hours ago, Homosassa said:

Markeb, do I know you? 

 

Were you NYK-DO and then CBER?

 

Were you with the FDA? I was at NCTR and then Office of the Commissioner for a number of years from 82 until 97 and then went over to the industry side. Spent a lot of time working with the various centers, as well as ICH.

Edited by npcl
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There is a lot of talk comparing influenza vaccines and SARS-CoV-2 vaccines. Influenza mutates very rapidly and the antigens that are targeted do so as well. SARS-CoV-2, which causes Covid-19, also mutates but importantly the spike protein antigens seem to be fairly stable. This is very important for an effective vaccine for this particular virus. It's impossible to tell if this stability will continue, but for now this is where the hope lies. If things continue to go well I'm very hopeful there will be a vaccine this year. The technology is way ahead of where it was in the past. Obviously, phase 3 trials will need to be both robust and complete to figure this out and also rule out any adverse immune issues, but the initial data looks very promising. BTW, this novel technology in vaccine development may be very promising for other infections as well.      

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Fouremco - I dont see anywhere in the contract where it states you have to have had the COVID vaccination as this is just happening now.  It was just a question on what would happen if someone had a cruise booked before vaccinations were made compulsory??

Edited by Tudorcruisers
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32 minutes ago, Tudorcruisers said:

Fouremco - I dont see anywhere in the contract where it states you have to have had the COVID vaccination as this is just happening now.  It was just a question on what would happen if someone had a cruise booked before vaccinations were made compulsory??

I suspect that if the cruise lines were to make it a requirement they would do so such that people could cancel within a certain time after it was announced.  However, Once it was made a requirement than one would expect that new bookings would not have that option

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5 hours ago, WonderMan3 said:

... those who refuse to take the vaccine (I want to take it but certainly won’t be one of the first and will likely want to wait a couple months to see how it works), well they may find themselves blocked from many public places ...

 

As a practical matter, this is what will drive the compliance rate above the rate of people who otherwise would choose a vaccine.

 

I think cruises will require either vaccinated status within a certain time frame or demonstrated antibody status or both.  This makes the cruise relatively safer in terms of who boards it.  Still unclear is the risks from coming on and off at ports.

 

What a mess.

 

- Joel

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8 hours ago, Tudorcruisers said:

What will happen if you have a cruise booked for say Oct 2021 and they insist on a vaccine and you can’t get it or don’t want to get it.  Will you get a full refund due to the fact when you booked this wasn’t in the terms?  

 

My wife and I have a cruise booked for October of 2021and we both fully intend to be vaccinated. Period. What other people do is on them.

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3 hours ago, Tudorcruisers said:

Fouremco - I dont see anywhere in the contract where it states you have to have had the COVID vaccination as this is just happening now.  It was just a question on what would happen if someone had a cruise booked before vaccinations were made compulsory??

The contract requires you to follow Celebrities rules and policies at the time of the cruise. Period. Nothing in the contract that says that the policy only applies to the rules and policies in force on the date you booked. For example, the policy currently say that you can bring a couple of bottles of wine per stateroom aboard, but if they reduce that to one bottle after you book, you will be limited to one. Let's face it, the contract is written totally in Celebrity's favour, with no attempt made to make it fair. If they decide to skip a port, for example, or to change the itinerary in its entirety, they are allowed to under the contract. So if providing proof of a vaccination becomes a policy requirement, the contract says you follow the policy or risk being denied boarding. 

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47 minutes ago, Fouremco said:

The contract requires you to follow Celebrities rules and policies at the time of the cruise. Period. Nothing in the contract that says that the policy only applies to the rules and policies in force on the date you booked. For example, the policy currently say that you can bring a couple of bottles of wine per stateroom aboard, but if they reduce that to one bottle after you book, you will be limited to one. Let's face it, the contract is written totally in Celebrity's favour, with no attempt made to make it fair. If they decide to skip a port, for example, or to change the itinerary in its entirety, they are allowed to under the contract. So if providing proof of a vaccination becomes a policy requirement, the contract says you follow the policy or risk being denied boarding. 

 

To follow up what up what you just mentioned:  Celebrity and the other cruise lines that operate out the of US have all stated they'll follow the guidelines set forth by the CDC to ensure safe cruising for the passengers and crew.  As of right now, we do not know what those guidelines might be, but it's reasonable to expect that passengers being vaccinated and masks being used as a requirement to sail.

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5 hours ago, Fouremco said:

The contract requires you to follow Celebrities rules and policies at the time of the cruise. Period. Nothing in the contract that says that the policy only applies to the rules and policies in force on the date you booked. For example, the policy currently say that you can bring a couple of bottles of wine per stateroom aboard, but if they reduce that to one bottle after you book, you will be limited to one. Let's face it, the contract is written totally in Celebrity's favour, with no attempt made to make it fair. If they decide to skip a port, for example, or to change the itinerary in its entirety, they are allowed to under the contract. So if providing proof of a vaccination becomes a policy requirement, the contract says you follow the policy or risk being denied boarding. 

Thank you.   I just wasn’t sure what way it would work and this has helped explain it.

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13 hours ago, cl.klink said:

 

As a practical matter, this is what will drive the compliance rate above the rate of people who otherwise would choose a vaccine.

 

I think cruises will require either vaccinated status within a certain time frame or demonstrated antibody status or both.  This makes the cruise relatively safer in terms of who boards it.  Still unclear is the risks from coming on and off at ports.

 

What a mess.

 

- Joel


If everyone onboard the ship was vaccinated then I don’t think getting on and off at ports would make any difference. If the vaccine is only up to 75% effective there is still a risk of course but that risk would apply from the moment passengers got onboard depending on where they were coming from, how they traveled there, etc. So there would be risk the entire length of the cruise but it would be a much lower risk than as things stand now. That’s why, for some time initially, masks and social distancing will still need to be employed in conjunction with the vaccine until the numbers have diminished significantly worldwide.

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19 hours ago, markeb said:


No. DoD.  Had to learn the system to explain the system...

 

You have learned it well.

 

I thought you might have been a fellow FDAer that started in New York District  and then went to the headquarters unit for biologics.

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17 hours ago, npcl said:

Were you with the FDA? I was at NCTR and then Office of the Commissioner for a number of years from 82 until 97 and then went over to the industry side. Spent a lot of time working with the various centers, as well as ICH.

Guilty.

 

Project Hire (1972)  New York District. Then Medical Devices (1977) and over to drugs in 1992.

 

I was at the first GLP training for field investigators at NCTR in 1976 (or was it 1975?).

 

If you ever call over to drugs to obtain information on human subject protection, you probably spoke to me.

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22 hours ago, markeb said:

 

That was it. Could have hit Google. My mom was on it when they pulled it.

Vioxx and Celebrex, allow they finally allowed Celebrex back. Z-packs have been curtailed in the US as well (Covid aside) and Levoquin has lost a lot of luster.

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