Are vaccines the light at the end of the tunnel?

[nocl]

14 hours ago, kath00 said:

Yes they have.  They are doing a "rolling" voluntary unblinding that is going in parallel with whom the vaccine is released and currently approved for -- for right now front line doctors/nurses, etc in high risk direct COVID contact positions like ER/ICU.  They encourage people to stay in the trial but each participant can ask to be voluntarily unblinded in this first group.  If you got randomized to the placebo, they bring you in to get the real thing within 1-2 days at the trial site instead of getting it from the hospital.  They really want to see antibody data at this point going out another 18 months to 2 years so you sign a new consent and lab draws continue for a couple more years every few months.  The efficacy has already been established well but how long the AB lasts is not clear.  I am now 2 doses down (late October and November) but husband, who had the placebo, got unblinded last week and got his first "real" shot 2 days ago.  Great feeling to have us both protected finally!

 

Cannot recommend the vaccine enough to anyone who wants to get back to normalcy and especially to travel.  

 

BTW to the person who asked above, yes the recruiter said that when the vaccine was approved, we would be "first in line" to get unblinded and get it.  There really was not a differentiation between what job/position/risk factor you had when they told us this but at the same time, they were actively recruiting in our hospital knowing full well we were all medical staff and very high risk so maybe they figured we would be approved first anyway.

Just one comment - they need to track antibody level in the treated arm, not in the placebo arm.  The only way there will be antibodies in someone in the placebo arm is if they have gotten infected. So having to track antibodies does not create a reason not to treat the placebo arm.

 

The main reason for keeping the placebo arm intact is as a comparator for safety data.  There are other ways to do it now that it is being administered to large numbers.  Main reason to not treat the placebo arm immediately is that is would require a change in study protocol which must be signed off on by regulatory authorities.

[TeeRick]

16 hours ago, cruise kitty said:

 

congrats on getting vaccinated!  & thank you for being in healthcare esp. during this time 🙂    I wonder if we are at the same trial center...  yes, they are unblinding all 1A & vaccinating them...  since CDC guidelines were released yesterday looks like I am 1C & DH is 1B...  relived a phone call this morning asking me to not take the shot in the "real" world when it's offered to me, hopefully in Feb, but to instead call the trial center & they will schedule me asap... this I can get on board with 🙂  Much better than being asked to "respectfully wait until mid-May" 🙂   especially with what is going on here in L.A.   stay safe, & thank you to you & your DH 🙂

Congrats! - it all worked out in a way that is acceptable to you.  Thanks again for volunteering!

[TeeRick]

Here is a pretty balanced and factual article (without the hysterics) on the "mutant" variant virus in the UK.  Most experts at this point agree that it should not be able to evade the current vaccine(s).   There was (is) a similar higher transmission variant in the southwest US a few months ago  discovered in Houston.  Variants of RNA genome viruses like coronaviruses are very common and expected.  The good news is that the current mRNA technology can be pretty easily redesigned to make vaccines for any major variant that escapes the current vaccines in the small chance that happens.  And it is very possible to mix mRNA's of major variants in the same formulation IMO in a broader coverage vaccine if it becomes necessary.  But of course that will take some time.  I hope science plays out here and I'm sure it will.  But anything is possible when dealing with new restrictions and governments.  Hoping this will not further delay cruising in Europe especially from the UK ports.

 

https://www.nytimes.com/2020/12/21/health/new-covid-strain-uk.html

[TeeRick]

Some very early scientific insight (speculation) on what might be causing allergic reactions in some people getting the Pfizer vaccine.  If this hold to be true then expect it to occur with the Moderna vaccine too at about the same frequency.

https://www.sciencemag.org/news/2020/12/suspicions-grow-nanoparticles-pfizer-s-covid-19-vaccine-trigger-rare-allergic-reactions

[UnorigionalName]

21 hours ago, nocl said:

There are other ways to do it now that it is being administered to large numbers.

 

the other ways suck

[nocl]

4 hours ago, UnorigionalName said:

 

the other ways suck

Actually they don't.  When you only have the drug in 15 to 20,000 then an untreated, control arm is the best you can do.   When you have the drug in millions, than the value of a 15 to 20,000 placebo group is less valuable than comparing side effects to normal incidence of events throughout the population.

 

With the number of immunizations that are taking place the value of post approval surveillance will far out weigh the value of the placebo group.

 

 

[nocl]

4 hours ago, TeeRick said:

Some very early scientific insight (speculation) on what might be causing allergic reactions in some people getting the Pfizer vaccine.  If this hold to be true then expect it to occur with the Moderna vaccine too at about the same frequency.

https://www.sciencemag.org/news/2020/12/suspicions-grow-nanoparticles-pfizer-s-covid-19-vaccine-trigger-rare-allergic-reactions

 

polyethylene glycol is a pretty common ingredient in a number of drugs.  It is also widely used in vaping fluids and theatrical fog.

[UnorigionalName]

deleted.

 

 

Edited December 23, 2020 by UnorigionalName
I guess I shouldn't be too dogmatic. 

[nocl]

1 minute ago, UnorigionalName said:

 

when your voluntarily unvaccinated population has very VERY significantly different characteristics across multiple axis compared to your voluntarily vaccinated population, there is always a chance of a yet-undetermined confounding factor influencing the results.

 

RCT is much much better in face of such different populations.

Anybody that has been involved in clinical trials as well as involved in post approval surveillance knows, that you analyze the data in terms of the demographic breakdown.  Or put another way you slice the data by age, race, geographic location, etc.  and compare the data to like populations.

 

At this stage the initial safety data from the trial has indicated that there are not common serious side effects that will derail the vaccine.  The safety now switches to looking for rare events, items that require millions, not a few thousand.  Also the safety look now goes to looking for long term effects, which again does not require the placebo group to remain untreated.

 

Take for example the swine flu vaccine that many point to as being a problem because there was  an increase in GBS (Guillain-Barré syndrome).  That increase was about 1 per 100,000 vaccinated.  Normal incidence of GBS in the US is between 1.2 and 3 cases per year per 100,000. So with the Swine Flu in 1976 that incidence would have been between 2.2 and 4 cases per year.  Clearly something you are not going to find in a 30-40,000 clinical trial.

[TeeRick]

It appears today that the US has finalized a new agreement with Pfizer for another 100 million doses of vaccine in the first half of 2021.  The US will use the Defense Production Act to allow the manufacture of some of the raw materials needed to make and formulate the additional vaccine doses.  According to Pfizer as early as Sept 2020 it was routinely notifying the US Operation Warp Speed that it was limited in producing more doses because of critical shortages of some of the raw materials.

 

https://thehill.com/policy/healthcare/531398-government-orders-100-million-more-coronavirus-vaccine-doses-pfizer

[TeeRick]

14 hours ago, nocl said:

 

polyethylene glycol is a pretty common ingredient in a number of drugs.  It is also widely used in vaping fluids and theatrical fog.

Yes agree. And it is normally not an issue and is very safe.   It's use in protein-based biological drugs has been to form complexes that give them greater stability and reduce degradation after administration.  The mRNA vaccines use the PEG-ylated approach for the same reason.  But these PEG -Lipid-mRNA complexes might be the source of the rare allergic reaction in some people.

[Crazy planning mom]

42 minutes ago, TeeRick said:

It appears today that the US has finalized a new agreement with Pfizer for another 100 million doses of vaccine in the first half of 2021.  The US will use the Defense Production Act to allow the manufacture of some of the raw materials needed to make and formulate the additional vaccine doses.  According to Pfizer as early as Sept 2020 it was routinely notifying the US Operation Warp Speed that it was limited in producing more doses because of critical shortages of some of the raw materials.

 

https://thehill.com/policy/healthcare/531398-government-orders-100-million-more-coronavirus-vaccine-doses-pfizer

So, the US now will have enough Pfizer Vaccine for 100 million Americans by July 31st.  Didn't the US purchase additional doses from Moderna so that they can vaccinate 100 million people from Moderna.  Doesn't that leave 130 million Americans without access to the vaccine unless J & J and Astra Zeneca are successful.  Even if they are successful, won't it be the Fall before there is enough vaccine for the rest of us?  I have summer travel plans and am not changing.

Maybe if 200 million Americans are vaccinated by July then it's ok to travel even if I didn't get the vaccine.

Edited December 23, 2020 by Crazy planning mom

[TeeRick]

7 minutes ago, Crazy planning mom said:

So, the US now will have enough Pfizer Vaccine for 100 million Americans by July 31st.  Didn't the US purchase additional doses from Moderna so that they can vaccinate 100 million people from Moderna.  Doesn't that leave 130 million Americans without access to the vaccine unless J & J and Astra Zeneca are successful.  Even if they are successful, won't it be the Fall before there is enough vaccine for the rest of us?  I have summer travel plans and am not changing.

Maybe if 200 million Americans are vaccinated by July then it's ok to travel even if I didn't get the vaccine.

This is still all a work in progress really.  The US and most countries around the world will try to get as much vaccine as possible in 2021 from these two companies.  And hopefully from a few other companies too.  Being able to travel and cruise is a nice outcome in the latter half of 2021 but the vaccine doses available are prioritized for much more important reasons right now. I can and do accept that.

[Homosassa]

24 minutes ago, Crazy planning mom said:

So, the US now will have enough Pfizer Vaccine for 100 million Americans by July 31st.  Didn't the US purchase additional doses from Moderna so that they can vaccinate 100 million people from Moderna.  Doesn't that leave 130 million Americans without access to the vaccine unless J & J and Astra Zeneca are successful.  Even if they are successful, won't it be the Fall before there is enough vaccine for the rest of us?  I have summer travel plans and am not changing.

Maybe if 200 million Americans are vaccinated by July then it's ok to travel even if I didn't get the vaccine.

I am taking a guess that the 130 million without access to the vaccine are the part of the population under the age of eighteen.

[Crazy planning mom]

24 minutes ago, TeeRick said:

This is still all a work in progress really.  The US and most countries around the world will try to get as much vaccine as possible in 2021 from these two companies.  And hopefully from a few other companies too.  Being able to travel and cruise is a nice outcome in the latter half of 2021 but the vaccine doses available are prioritized for much more important reasons right now. I can and do accept that.

Yes, I realize not being able to travel is a first world problem and totally understand that the first priorities should be for health care workers, seniors and front line workers.  However, life cant shutdown forever. 

 

[K.T.B.]

1 hour ago, TeeRick said:

It appears today that the US has finalized a new agreement with Pfizer for another 100 million doses of vaccine in the first half of 2021.  The US will use the Defense Production Act to allow the manufacture of some of the raw materials needed to make and formulate the additional vaccine doses.  According to Pfizer as early as Sept 2020 it was routinely notifying the US Operation Warp Speed that it was limited in producing more doses because of critical shortages of some of the raw materials.

 

https://thehill.com/policy/healthcare/531398-government-orders-100-million-more-coronavirus-vaccine-doses-pfizer

 

Good news!  But one thing I'm hoping you can clarify because I'm not finding it anywhere:  When they say "doses", does that mean 2 shots or just 1?  This vaccine requires 2 shots to be effective, so to my way of thinking a "dose" would be the 2 shots 3 weeks apart, though I suspect that may not be the case.

[TeeRick]

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

 

Good news!  But one thing I'm hoping you can clarify because I'm not finding it anywhere:  When they say "doses", does that mean 2 shots or just 1?  This vaccine requires 2 shots to be effective, so to my way of thinking a "dose" would be the 2 shots 3 weeks apart, though I suspect that may not be the case.

Interesting that you say that as I have been thinking very much the same.  I can just go by what the current vaccine distribution plan uses as a definition.  It seems that a dose is a single shot by that criteria.  So 100 million doses would vaccinate 50 million people.  Let's hope that for the J&J vaccine one dose = one shot and 100 million shots covers 100 million people.

 

This is from the NPR article today.  https://www.npr.org/sections/coronavirus-live-updates/2020/12/23/949541001/u-s-reaches-deal-with-pfizer-for-100-million-more-vaccine-doses

"This is the second time the U.S. has moved to increase its vaccine supply in the past two weeks. On Dec. 11, the U.S. said it will buy 100 million more doses from Moderna, which will now supply a total of 200 million doses for $3.2 billion.

Together, the two companies have committed to supply 400 million doses — enough to immunize 200 million people, as both companies' vaccines require two doses. The U.S. population is about 330 million."

Edited December 23, 2020 by TeeRick

[phoenix_dream]

58 minutes ago, Homosassa said:

I am taking a guess that the 130 million without access to the vaccine are the part of the population under the age of eighteen.

As well as the people who will not get a vaccine for whatever reason.

[TeeRick]

46 minutes ago, Crazy planning mom said:

Yes, I realize not being able to travel is a first world problem and totally understand that the first priorities should be for health care workers, seniors and front line workers.  However, life cant shutdown forever. 

 

Yes hopefully in 3-4 months we will have access to the vaccine in my age group (under 65).  

[mimbecky]

1 hour ago, Crazy planning mom said:

Doesn't that leave 130 million Americans without access to the vaccine unless J & J and Astra Zeneca are successful. 

Sounds like J&J hopes to have data end of January.  If they have efficacy, EUA in February.  That is 100M single doses and should cover pretty much everyone else.  Issue is that Pfizer final delivery (by) June, not sure about when additional Modena is promised.  Still an effort to go shelf to arm....even Fauci said that could take months after delivery regardless of how many exist.  I am also hoping to travel in Summer....fingers crossed.

Not counting on AZ, Novaxx or Sanofi coming anytime soon.

[K.T.B.]

1 hour ago, TeeRick said:

Interesting that you say that as I have been thinking very much the same.  I can just go by what the current vaccine distribution plan uses as a definition.  It seems that a dose is a single shot by that criteria.  So 100 million doses would vaccinate 50 million people.  Let's hope that for the J&J vaccine one dose = one shot and 100 million shots covers 100 million people.

 

This is from the NPR article today.  https://www.npr.org/sections/coronavirus-live-updates/2020/12/23/949541001/u-s-reaches-deal-with-pfizer-for-100-million-more-vaccine-doses

"This is the second time the U.S. has moved to increase its vaccine supply in the past two weeks. On Dec. 11, the U.S. said it will buy 100 million more doses from Moderna, which will now supply a total of 200 million doses for $3.2 billion.

Together, the two companies have committed to supply 400 million doses — enough to immunize 200 million people, as both companies' vaccines require two doses. The U.S. population is about 330 million."

 

That's my guess as well, but it's never good to assume.

 

Anyway, of that 330 million, approximately 75 million are 18 and younger.  They'll be the very last to be vaccinated.  So that actually leaves about 55 million of those 19 and older needing their shots and not getting them until later in the year.  Though based on those who will refuse to get the shots, I suspect everyone who wants one will get one by mid-summer and there'll be a surplus of available vaccine.

[nocl]

2 hours ago, Crazy planning mom said:

Yes, I realize not being able to travel is a first world problem and totally understand that the first priorities should be for health care workers, seniors and front line workers.  However, life cant shutdown forever. 

 

That is also part of the mind set that has large numbers of people ignoring social distancing, mask use, shutdown orders etc.

 

The first thing they say is life cant shut down forever.

 

Vaccine or no vaccine the incidence rate of the virus will indicate when it is appropriate  to travel

[nocl]

1 hour ago, TeeRick said:

Interesting that you say that as I have been thinking very much the same.  I can just go by what the current vaccine distribution plan uses as a definition.  It seems that a dose is a single shot by that criteria.  So 100 million doses would vaccinate 50 million people.  Let's hope that for the J&J vaccine one dose = one shot and 100 million shots covers 100 million people.

 

This is from the NPR article today.  https://www.npr.org/sections/coronavirus-live-updates/2020/12/23/949541001/u-s-reaches-deal-with-pfizer-for-100-million-more-vaccine-doses

"This is the second time the U.S. has moved to increase its vaccine supply in the past two weeks. On Dec. 11, the U.S. said it will buy 100 million more doses from Moderna, which will now supply a total of 200 million doses for $3.2 billion.

Together, the two companies have committed to supply 400 million doses — enough to immunize 200 million people, as both companies' vaccines require two doses. The U.S. population is about 330 million."

One interesting question that is not really being discussed now is will the vaccine immunity last long enough  for enough to be produced to vaccinate everyone before doses have to start to be used as booster shots for those first dosed.

[markeb]

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

 

Good news!  But one thing I'm hoping you can clarify because I'm not finding it anywhere:  When they say "doses", does that mean 2 shots or just 1?  This vaccine requires 2 shots to be effective, so to my way of thinking a "dose" would be the 2 shots 3 weeks apart, though I suspect that may not be the case.

 

We developed a term in DoD probably 20 years ago (and this time by "we" I do mean me and a couple of coworkers) of Troop Equivalent Dose, or TED, because you had to have a mandatory acronym, to address this very issue. So a TED represented both the number of people requiring vaccinations, and the number of people that could be vaccinated with a given number of doses. So 500K people needing a three-dose series would require 1.5M doses, or 1M doses of a two-dose series. Both cases were 500K TEDs. It kept the focus on the number of people to be protected, which we all though was the most important consideration, and the one we could develop methodologies to identify.

 

Terminology never took off outside of DoD, obviously, but the concept was accepted at BARDA, for instance. But it wouldn't have made much sense to the public without a lot of background (and they're paying by dose, I think, not by people).

 

But for the current vaccines, a dose is a single administration. 1 = 1, but 1 ≠ 1 person's series.

[TeeRick]

2 hours ago, nocl said:

One interesting question that is not really being discussed now is will the vaccine immunity last long enough  for enough to be produced to vaccinate everyone before doses have to start to be used as booster shots for those first dosed.

Yes --- and also will the virus start to mutate around the vaccine-induced immunity as the population becomes more vaccinated?  Then an alternative vaccine will need to be made.  But that should be straight forward with the mRNA technology.