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Are vaccines the light at the end of the tunnel?


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On 12/17/2020 at 8:06 AM, TeeRick said:

The US surgeon general just made a comment on his current view in a press interview. That is quite different than some type of official and lawful action.  No matter.  There will be no political will or otherwise for a vaccine to be mandated in the US.  Cannot even get a mask mandate in place.

 

IMO, what the US surgeon general says has no bearing on what private corporations do.   As it stands right now (and I quote from a CC article) "if the ship's medical personnel determine that you're feverish, contagious or otherwise ill, they have the authority to prevent you from boarding."  So they have the right to dictate who gets on board.  If they require people be vaccinated, they can do it.  People can be as pissed as they want and I can see numerous lawsuits over it, but in the end they DO reserve the right to refuse people to board for any reason, especially if impacts passenger and crew safety & health.

 

Personally speaking, and I've said this before, I'll be getting vaccinated as soon as I am able to do so.  Period.  If cruise lines require it, I won't fight it.

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7 minutes ago, VitaminSea53 said:

Question for those ‘in the know’........

what happens if your first vaccination is the Pfizer one and the second vaccination is Moderna (by mistake)?  Do they work the same way and are interchangeable?

 

Shouldn't happen. There's no data on interchangeability, so the first series needs to be the same vaccine. That's probably the primary reason for the card, to show which series you're on. And they're different timetables. Moderna is a day 0 day 28 series and Pfizer is day 0 day 21.

 

Ultimately, if there is a booster requirement (annual or longer), there should be data to support using a different vaccine at that time.

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5 hours ago, TeeRick said:

And they should be ecstatic!  Thank them for us.  These vaccine efforts have been just remarkable and they require an extended team.  All kinds of people and skills and efforts.  And for a small company like Moderna they need to coordinate across a lot of their extended team to make everything happen.  Great for them and for us!

it's fantastic news, & also great that Moderna is stepping up & vaccinating all its placebo recipients immediately....  Pfizer is making us wait until we get sick,  die or hit our 6 month mark, whichever comes first :(    Of course they would prefer one of the first two as that would provide more data points....  can you tell Im feeling a little bitter right now ?   Still glad I did it, & would not go back & change my decision.   

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9 hours ago, cruise kitty said:

it's fantastic news, & also great that Moderna is stepping up & vaccinating all its placebo recipients immediately....  Pfizer is making us wait until we get sick,  die or hit our 6 month mark, whichever comes first 😞    Of course they would prefer one of the first two as that would provide more data points....  can you tell Im feeling a little bitter right now ?   Still glad I did it, & would not go back & change my decision.   

 

How is Pfizer making us wait?  The US government didn't buy enough doses from them.  Whereas with Moderna, they bought quadruple the amount initially and that has recently bee doubled.  Unfortunately, the US put most of their eggs in the AstraZeneca basket and it was a losing proposition, at least in terms of how quickly they got it approved.  (In all fairness, I though they went with the right "horse".)

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13 minutes ago, K.T.B. said:

 

How is Pfizer making us wait?  The US government didn't buy enough doses from them.  Whereas with Moderna, they bought quadruple the amount initially and that has recently bee doubled.  Unfortunately, the US put most of their eggs in the AstraZeneca basket and it was a losing proposition, at least in terms of how quickly they got it approved.  (In all fairness, I though they went with the right "horse".)

Thankful for all of them, but Moderna most of all!

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1 hour ago, K.T.B. said:

 

How is Pfizer making us wait?  The US government didn't buy enough doses from them.  Whereas with Moderna, they bought quadruple the amount initially and that has recently bee doubled.  Unfortunately, the US put most of their eggs in the AstraZeneca basket and it was a losing proposition, at least in terms of how quickly they got it approved.  (In all fairness, I though they went with the right "horse".)

 

My dose is sitting in the trial lab with my trial patient number on it :)    the lab is not allowed to give it to me until Pfizer approves.   

 

Pfizer decided to keep us trial participants waiting until our "real world" number comes up.....Moderna is vaccinating every one of their placebo trial participants by Jan. 21st.  

 

It's a little tough because I have to work (essential worker) & our hospitals are full here (los angeles)  I am literally listening to the news helicopters overhead filming the morgue trailer about a mile from my house. :( 

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1 hour ago, cruise kitty said:

 

My dose is sitting in the trial lab with my trial patient number on it 🙂    the lab is not allowed to give it to me until Pfizer approves.   

 

Pfizer decided to keep us trial participants waiting until our "real world" number comes up.....Moderna is vaccinating every one of their placebo trial participants by Jan. 21st.  

 

It's a little tough because I have to work (essential worker) & our hospitals are full here (los angeles)  I am literally listening to the news helicopters overhead filming the morgue trailer about a mile from my house. 😞

Well done for this reply cruise Kitty. Many of us having been following along with you since you first told us you and yours were in the Pfizer trials.

K.T.B obviously wasn’t aware of your story - it’s a shame that this is the outcome for you with Pfizer, but again you patiently accept the results. 
May your wait not be too long 🤗

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1 hour ago, Porky55 said:

Well done for this reply cruise Kitty. Many of us having been following along with you since you first told us you and yours were in the Pfizer trials.

K.T.B obviously wasn’t aware of your story - it’s a shame that this is the outcome for you with Pfizer, but again you patiently accept the results. 
May your wait not be too long 🤗

thank you :)  I sound like such a selfish jerk, don't I ?   I definitely don't want to be vaccinated ahead of people on the front line... but I also don't want to wait 6 months to become a "data point"  I've decided I should just try & zen myself out every time I have to encounter a "mask-hole" in my job ;)   

 

& I still would not change my mind, despite Pfizer's decision 

 

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4 hours ago, cruise kitty said:

thank you 🙂  I sound like such a selfish jerk, don't I ?   I definitely don't want to be vaccinated ahead of people on the front line... but I also don't want to wait 6 months to become a "data point"  I've decided I should just try & zen myself out every time I have to encounter a "mask-hole" in my job 😉   

 

& I still would not change my mind, despite Pfizer's decision 

 

I believe that Pfizer is weighing its options with the FDA and of course they knew that these decisions with current trials would certainly be reviewed after an EUA approval.  Same with Moderna.  And having two vaccines approved now complicates the outcomes of the trials for all of the other much-needed vaccines still in trials.  What about the 10's of thousands in the J&J trials?  The AZ trials? Run them without placebo?  This is a moral and clinical dilemma.  So is the Pfizer decision right now temporary as it evaluates everything?  Will it change so you do not have to wait 6 months?  Will the FDA step in and allow them to change the rest of their trial(s)?  I totally understand your view and worry from a personal perspective.  I would see my situation the same way if I were you.  But success with vaccines is a two-edged sword for the ongoing trials in the US and globally.  

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I am thrilled with the good news that the FDA approved the Moderna EUA and shipments will start happening almost immediately!😀

 

The Johns Hopkins University group that has done an amazing job throughout the pandemic tracking virus cases globally on its website with a great dashboard and daily updates.  They now have put a Vaccine Tracker in place (for now the US) so it is worth checking out what is happening in your state every day going forward with your vaccine shipments.

https://coronavirus.jhu.edu/vaccines

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5 hours ago, cruise kitty said:

I still would not change my mind, despite Pfizer's decision 

 

Do you think you got the real dose? I am sorry that this is their decision.  Played a big role in our not doing the J and J trial as we kept getting different answers for this scenario.  No, you don't sound selfish.

M

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43 minutes ago, TeeRick said:

They now have put a Vaccine Tracker in place (for now the US) so it is worth checking out what is happening in your state every day going forward with your vaccine shipments.

Love this idea but either California (with many others) are not reporting or data is lagging....

Still interesting to watch.

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Just now, mimbecky said:

Love this idea but either California (with many others) are not reporting or data is lagging....

Still interesting to watch.

Yes just give it a few days.  It is new.  The data needs to be reported so there will be a bit of a lag.

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2 hours ago, TeeRick said:

I believe that Pfizer is weighing its options with the FDA and of course they knew that these decisions with current trials would certainly be reviewed after an EUA approval.  Same with Moderna.  And having two vaccines approved now complicates the outcomes of the trials for all of the other much-needed vaccines still in trials.  What about the 10's of thousands in the J&J trials?  The AZ trials? Run them without placebo?  This is a moral and clinical dilemma.  So is the Pfizer decision right now temporary as it evaluates everything?  Will it change so you do not have to wait 6 months?  Will the FDA step in and allow them to change the rest of their trial(s)?  I totally understand your view and worry from a personal perspective.  I would see my situation the same way if I were you.  But success with vaccines is a two-edged sword for the ongoing trials in the US and globally.  

 

Some interesting ethical challenges here. You really need the long term data from the ongoing trials, but the efficacy breakthrough came pretty early. Losing the placebo control could make it much more difficult to see nuances in the data, but not vaccinating the placebo group in the face of what appears to be overwhelming evidence of effect against a potentially fatal or disabling disease would border on unethical...

 

And then going forward with other trials. For a potentially fatal disease with an emerging standard of care but no clear indicator of whether a potential new therapy (vaccine in this case) is equally or more effective, you would normally compare the new vaccine to the standard of care, not placebo. But we've already seen evidence that the AZ product "may not" be as effective as the Pfizer and Moderna products. What if they ultimately are statistically inferior? Of course, the two vaccines in use have EUAs, not approved BLAs, and how much more data do they need for a full BLA?

 

Mind you, I'd much rather have two products useable under emergency use and be asking those questions than none!

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4 hours ago, mimbecky said:

 

Do you think you got the real dose? I am sorry that this is their decision.  Played a big role in our not doing the J and J trial as we kept getting different answers for this scenario.  No, you don't sound selfish.

M

 Hi there, my husband & daughter received the "real" thing, my SIL & I received placebo :)

 

Also edit to add:  I also want to add my sincere thanks & congrats to all the health care heroes who are receiving shots asap, they truly deserve it along with all our thanks 

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15 hours ago, cruise kitty said:

 

My dose is sitting in the trial lab with my trial patient number on it 🙂    the lab is not allowed to give it to me until Pfizer approves.   

 

Pfizer decided to keep us trial participants waiting until our "real world" number comes up.....Moderna is vaccinating every one of their placebo trial participants by Jan. 21st.  

 

It's a little tough because I have to work (essential worker) & our hospitals are full here (los angeles)  I am literally listening to the news helicopters overhead filming the morgue trailer about a mile from my house. 😞

Have they broken the blind and informed the placebo patients that they are placebo?

 

You can always withdraw from the trial if you can get the vaccine earlier from another source.

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5 hours ago, markeb said:

 

Some interesting ethical challenges here. You really need the long term data from the ongoing trials, but the efficacy breakthrough came pretty early. Losing the placebo control could make it much more difficult to see nuances in the data, but not vaccinating the placebo group in the face of what appears to be overwhelming evidence of effect against a potentially fatal or disabling disease would border on unethical...

 

And then going forward with other trials. For a potentially fatal disease with an emerging standard of care but no clear indicator of whether a potential new therapy (vaccine in this case) is equally or more effective, you would normally compare the new vaccine to the standard of care, not placebo. But we've already seen evidence that the AZ product "may not" be as effective as the Pfizer and Moderna products. What if they ultimately are statistically inferior? Of course, the two vaccines in use have EUAs, not approved BLAs, and how much more data do they need for a full BLA?

 

Mind you, I'd much rather have two products useable under emergency use and be asking those questions than none!

If they have broken the blind and the patients have been informed as to what they have received they no long have a blinded placebo trial.  They still have a placebo group, but that is more for safety info comparison than for any efficacy information.

 

With the number of doses being administered Pfizer would probably be better off treating the placebo group and go to normal incidence for side effect comparison.  

 

Based upon what they are doing I suspect that the 6 months comparison safety data might be something that has come up in discussions with the FDA for their full NDA.

 

I personally would take the Pfizer or Moderna Vaccines.  Probably not the AstraZeneca vaccine. They made a mess of their trials.  Will see what comes out of their large US trial.

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42 minutes ago, nocl said:

I personally would take the Pfizer or Moderna Vaccines.  Probably not the AstraZeneca vaccine. They made a mess of their trials.  Will see what comes out of their large US trial.

I could be wrong, but something tells me as both the DW and myself are over 65, we really won't have the luxury of choosing which vaccine we'll be able to take, especially if we're going to get it when it's first made available to us. Right now my gut is saying we'll either wind up getting the Moderna vaccine in January or the J&J vaccine in February, if it's awarded an EUA.

 

As far as the AZ/OX vaccine goes, I haven't seen any estimates recently as to when they even hope to submit their data to the FDA for an EUA. I'm guessing it will be well after J&J hopes to submit their data in late January. 

 

Are these good assumptions?

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1 hour ago, nocl said:

I personally would take the Pfizer or Moderna Vaccines.  Probably not the AstraZeneca vaccine. They made a mess of their trials.  Will see what comes out of their large US trial.

No argument with your preference, but I'm just wondering about the extent to which one has or will have a choice.  

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20 minutes ago, Ken the cruiser said:

I could be wrong, but something tells me as both the DW and myself are over 65, we really won't have the luxury of choosing which vaccine we'll be able to take, especially if we're going to get it when it's first made available to us. Right now my gut is saying we'll either wind up getting the Moderna vaccine in January or the J&J vaccine in February, if it's awarded an EUA.

 

As far as the AZ/OX vaccine goes, I haven't seen any estimates recently as to when they even hope to submit their data to the FDA for an EUA. I'm guessing it will be well after J&J hopes to submit their data in late January. 

 

Are these good assumptions?

Not sure what is going to happen.  The AZ/Oxford vaccine is trying to complete its major US trial and figure out the 1/2 dose vs full dose effect.  So what will the FDA advisory committee and the FDA do if this vaccine has less efficacy (70%) than the mRNA vaccines?  I am not sure I would want to get it personally.  In particular since the J&J vaccine (one shot, similar adenovector technology) is coming fast and if it has 90%+ efficacy maybe the AZ Oxford vaccine is not used in the US.  Just speculating.

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11 minutes ago, Fouremco said:

No argument with your preference, but I'm just wondering about the extent to which one has or will have a choice.  

I hope Pfizer is trying to extend the storage conditions of the vaccine. Of course it is very early in the process and the state/feds (rightly) are requiring a lot of documentation and a lot of care in administering vaccine, but it is a lengthy process to get a shot. Plus everyone has to social distance. The team at my hospital has planned for about 75 people a day. Each person has to rest 15 minutes under observation after the shot. I think they were able to almost double the number given, but that pretty much maxes out the space and available personnel. They are working on getting vaccine to the night shift - right now they have to come in the middle of their sleep time.

The other thing is trying to not waste a single dose, arranging in groups of 5, then immediately realizing there were 6 shots in a vial and rearranging all the appts. Each day  at the end of the clinic session, they would call on different departments to send down staff, no appt needed, so nothing was wasted.

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