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Are vaccines the light at the end of the tunnel?


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I am astonished sometimes by some of these less than enthusiastic comments about these vaccines that are highly likely to save millions of lives.  But I offer the following: 

 

Yes the doses are on order and are being continuously produced by multiple companies and countries. In fact in an unprecedented move the doses were manufactured even before any evidence of efficacy.

Yes storage and distribution is problematic but solvable. 

Yes there are multiple vaccines and more on the way. 

Yes the FDA and other regulatory agencies worldwide are working around the clock on their reviews with a high sense of duty and urgency.

Yes state distribution plans are in place or being finalized in the US.  Other countries as well.

Yes I might be in a group that does not get one of the initial doses. 

Yes the doses have been ordered and paid for by my government.

Yes there are plans to deliver doses of vaccine to poorer countries and individuals for free by the WHO, GAVI and their network of organizations and countries (COVAX).

Yes I might experience side effects for a few days.

Yes I might have to social distance and wear a mask for a while longer.

 

But- We have several COVID vaccines with greater clinical efficacy than anybody would have predicted within less than a year with manufactured doses already being distributed.  And people getting vaccinated already in the UK!

 

What is all the belly-aching about?  Really?

Edited by TeeRick
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57 minutes ago, Ken the cruiser said:

Here's some more good news for those folks first in line to get the first dose of the Pfizer vaccine.

 

The Pfizer vaccine calls for two doses, three weeks apart. In November, Pfizer said early results from its Phase 3 clinical trials appeared to be 95 percent effective in preventing symptomatic Covid-19.

The new information shows it has benefits even after the first dose, with an effectiveness of more than 50 percent about a week later. What's more, the effectiveness seems to be the same across all age groups, racial and ethnic minorities, and people with underlying conditions, such as obesity, diabetes and high blood pressure.

 

FDA: Pfizer's Covid-19 vaccine safe and effective after one dose (nbcnews.com)

Yes this is outstanding news!

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1 hour ago, D C said:

Healthcare workers don't all have an EQUAL chance of interacting with covid patients, and we are not at a point where there is a widespread shortage of healthcare workers due to them being ill with covid.   Thus the prioritization to those most critical to in a first wave.

 

1st goal: Stop people from dying

 

And yes, 50 million is enough for everyone over 65 in the USA.  The acceptance rate won't be 100%.  if we assume a very good 60% acceptance, that's 30 million for 65+ and 20 million doses for others.  Damn good start in my book. 

I realize that this is your opinion, so OK.

 

I am clearly not saying "COVID patients" but rather those infected with COVID, symptomatic, pre-symptomatic, asymptomatic that are interactiving with HC workers.   GPs.. Dentists.  Nurses.  People treating cancer patients. 

But if you think everyone over the age of 65 who wants it is going to receive it in the first wave, good luck with that.  I am well over 65, carry 3+ comorbidities and have zero expectation of being in the first wave.  2nd, maybe, but no way before the end of the year.  Likely not even in the 1st quarter, and that is OK with me.  Would rather have others get the jab first.

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4 minutes ago, ECCruise said:

I realize that this is your opinion, so OK.

 

I am clearly not saying "COVID patients" but rather those infected with COVID, symptomatic, pre-symptomatic, asymptomatic that are interactiving with HC workers.   GPs.. Dentists.  Nurses.  People treating cancer patients. 

But if you think everyone over the age of 65 who wants it is going to receive it in the first wave, good luck with that.  I am well over 65, carry 3+ comorbidities and have zero expectation of being in the first wave.  2nd, maybe, but no way before the end of the year.  Likely not even in the 1st quarter, and that is OK with me.  Would rather have others get the jab first.

THIS IS THE ORDER FOR INJECTIONS BEING USED IN ENGLAND
        They have begun injecting as per this schedule:

1.  Residents in care homes for older adults and their carers
2.  80-year-olds and over and frontline health and social care workers
3.  75-year-olds and over
4.  70-year-olds and over and clinically extremely vulnerable individuals
5.  65-year-olds and over
6.  16 to 64-year-olds with serious underlying health conditions
7.  60-year-olds and over
8.  55-year-olds and over
9.  50-year-olds and over

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31 minutes ago, boscobeans said:

THIS IS THE ORDER FOR INJECTIONS BEING USED IN ENGLAND
        They have begun injecting as per this schedule:

1.  Residents in care homes for older adults and their carers
2.  80-year-olds and over and frontline health and social care workers
3.  75-year-olds and over
4.  70-year-olds and over and clinically extremely vulnerable individuals
5.  65-year-olds and over
6.  16 to 64-year-olds with serious underlying health conditions
7.  60-year-olds and over
8.  55-year-olds and over
9.  50-year-olds and over

Yes.  And in that scenario, I would be in the 4th wave, which is about what I would expect.  

But no guarantee that we will do it anything like NHS.

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With the 2 vaccines currently up for EUA in the US and the promised initial doses - that would put many of the under-65 healthy folks in the second quarter of 2021.  But other vaccines might also get approved early next year.

 

I am perfectly fine with front line health care workers getting all of the initial doses.  And the nursing home/assisted living folks.  That would be awesome in my view!

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10 minutes ago, TeeRick said:

With the 2 vaccines currently up for EUA in the US and the promised initial doses - that would put many of the under-65 healthy folks in the second quarter of 2021.  But other vaccines might also get approved early next year.

 

I am perfectly fine with front line health care workers getting all of the initial doses.  And the nursing home/assisted living folks.  That would be awesome in my view!

Remember in THE US the state sets the priorities.  Not the CDC.

 

In Arizona the first 3 groups:

 

#1- frontline medical workers and long term care patients and staff

 

#2 - adults with high-risk medical conditions living in shelters, education and childcare providers, those with protective services, and essential workers.

#3 - adults with underlying medical conditions, those 65 and older, and adults in congregate settings.

 

Group #1 expected this month, #2 January.  #3 February.  General population in March and April.

 
 
 
 
 

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I totally understand that there are many people who will and should get the vaccine before me.  I would be THRILLED to get my vaccine in March or April, even May!  But my understanding is that all of these estimates are/were based on our option to purchase more than our original order (no?) which looks like it isn't happening. At least for Pfizer, they are saying additional orders wouldn't be available for the US until June.  Like I said above, is that probable for Moderna as well?

 

Also, my concern about AstraZeneca is based on something I read from one of the medical professionals on this site.  I will try to find it.

 

As always thanks for everyone's expertise.

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On 11/26/2020 at 8:24 PM, nocl said:

the more I read about the AZ vaccine, the less I like about their reported results. They appear to be using a meta analysis from a number of different trials with different protocols. An approach that can be prone to cherry picking the data. I doubt the FDA would approve an EUA if that is what they are doing.

 

On 11/27/2020 at 5:29 AM, TeeRick said:

Fortunately there are a number of late stage adenovector approaches including J&J running huge trials that will really help determine if this technology will work.  I was always a bit concerned that AZ/Oxford is using a chimpanzee version and all the others are human adeno vectors.  It is more likely to get immune modulation of the chimp version when put into people.

 

Both nocl and TeeRick seemed to have some resevations about AstraZeneca.  I would appreciate clarification and any updates on your thoughts.

Thanks.

M

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3 minutes ago, mimbecky said:

 

 

Both nocl and TeeRick seemed to have some resevations about AstraZeneca.  I would appreciate clarification and any updates on your thoughts.

Thanks.

M

 

The complete results of the trial were published today in Lancet. It appears Lancet is making that content available, and I'll probably download it, but it will be complex to interpret if you don't have a background.

 

The editors of Lancet also published a commentary on the trial, also available to download. It was summarized in the Post today, but here's the link to Lancet https://www.thelancet.com/lancet/article/s0140-6736(20)32623-4

 

You can download the PDF and read. I've started it. The WaPo summary is there's a belief that the product will be useful, and it's less expensive to produce and easier to store and transport. It also doesn't appear to be as effective (efficacy 62%), and the trial doesn't appear to have enough over 55 and over 70 participants to assess efficacy in those age groups.

 

AstraZeneca arguably had the most complex clinical trial protocol of any of the vaccine candidates (maybe the most complex I've ever seen; nocl, TeeRick and a few others around here have more experience with that than I do) and that may now be complicating interpretation of their data. And they had the "goof" of a small number of participants receiving a low dose first vaccine, and that group, too small to really evaluate, had the best response (90% efficacy) and including them in the aggregate pushed the efficacy to 70%. But none of the over 55 or over 70 participants were in that group.

 

Personal opinion is they're not in anywhere near as good of shape as Pfizer and Moderna for a fast track to EUA and licensure, and I can't imagine that they won't have to repeat part of the trial to explain the low/high effect. Most of us suspect that if that effect is real it will ultimately prove to be immune modulation from the Chimp adenovirus vector; other adenovirus vectored candidates are using a human virus and it should be less likely to produce that effect. Different regulatory agencies around the world can have different interpretations, but the FDA is historically a very risk adverse organization, and with two 95% effective products almost certainly now being recommended for emergency use (the FDA staff review confirms Pfizer's interpretation of data), a potentially less effective product with a so far unexplainable dose effect seems much less likely to get emergency use in the US.

 

None of that means it's a bad vaccine or that it won't ultimately be licensed. The storage requirements will make it especially useful in less developed parts of the world. But if the J&J product, for instance, has the same efficacy without the low dose/high dose effect, and is just as easily stored and transported...

 

A little long. I think this glass is half full, but with more caveats than I expected a few months ago.

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3 hours ago, boscobeans said:

THIS IS THE ORDER FOR INJECTIONS BEING USED IN ENGLAND
        They have begun injecting as per this schedule:

1.  Residents in care homes for older adults and their carers
2.  80-year-olds and over and frontline health and social care workers
3.  75-year-olds and over
4.  70-year-olds and over and clinically extremely vulnerable individuals
5.  65-year-olds and over
6.  16 to 64-year-olds with serious underlying health conditions
7.  60-year-olds and over
8.  55-year-olds and over
9.  50-year-olds and over

That seems to be a sensible order (though we could debate the semantics of "frontline" and such ad nauseum).

 

I would expect the first batch of 100m doses/50m people to cover the top 5 if this was the order in the US.

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9 hours ago, D C said:

 

Wasn't the application filed a week or so ago??

The inability of these people to pull-ahead a meeting and schedule something immediately (or near) upon the application isn't very comforting for how the rollout will proceed. 

Before the Vaccines Advisory Board meeting

 

The FDA must

 

1. Receive and analyze all of the raw data and make their own conclusions about the safety and efficacy of the vaccine.

 

2. Must distribute information to the members of the committee giving them time to review the information and prepare presentations prior to the public committee meeting

 

3. Prepare the presentation containing the FDA's opinions and conclusions about the product

 

The fact that they are doing it in about two weeks is quite remarkable.

 

To give you some kind of idea of the volume of information involved the last new drug application I submitted was for an Oncology drug and was tested in 600 individuals.  If printed the complete NDA would have filled a 40 foot semi trailer. 

 

The EUA filing is not as large as full NDA, but the amount of data is not trivial.

 

 

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2 hours ago, markeb said:

 

The complete results of the trial were published today in Lancet. It appears Lancet is making that content available, and I'll probably download it, but it will be complex to interpret if you don't have a background.

 

The editors of Lancet also published a commentary on the trial, also available to download. It was summarized in the Post today, but here's the link to Lancet https://www.thelancet.com/lancet/article/s0140-6736(20)32623-4

 

You can download the PDF and read. I've started it. The WaPo summary is there's a belief that the product will be useful, and it's less expensive to produce and easier to store and transport. It also doesn't appear to be as effective (efficacy 62%), and the trial doesn't appear to have enough over 55 and over 70 participants to assess efficacy in those age groups.

 

AstraZeneca arguably had the most complex clinical trial protocol of any of the vaccine candidates (maybe the most complex I've ever seen; nocl, TeeRick and a few others around here have more experience with that than I do) and that may now be complicating interpretation of their data. And they had the "goof" of a small number of participants receiving a low dose first vaccine, and that group, too small to really evaluate, had the best response (90% efficacy) and including them in the aggregate pushed the efficacy to 70%. But none of the over 55 or over 70 participants were in that group.

 

Personal opinion is they're not in anywhere near as good of shape as Pfizer and Moderna for a fast track to EUA and licensure, and I can't imagine that they won't have to repeat part of the trial to explain the low/high effect. Most of us suspect that if that effect is real it will ultimately prove to be immune modulation from the Chimp adenovirus vector; other adenovirus vectored candidates are using a human virus and it should be less likely to produce that effect. Different regulatory agencies around the world can have different interpretations, but the FDA is historically a very risk adverse organization, and with two 95% effective products almost certainly now being recommended for emergency use (the FDA staff review confirms Pfizer's interpretation of data), a potentially less effective product with a so far unexplainable dose effect seems much less likely to get emergency use in the US.

 

None of that means it's a bad vaccine or that it won't ultimately be licensed. The storage requirements will make it especially useful in less developed parts of the world. But if the J&J product, for instance, has the same efficacy without the low dose/high dose effect, and is just as easily stored and transported...

 

A little long. I think this glass is half full, but with more caveats than I expected a few months ago.

Will be interesting to see when they get the read out on their large trial in the US.  In my opinion that will really tell the story on the vaccine.  

 

The AZ results so far are using the results of multiple studies done in different places (UK and brazil), with different doses, limited demographics all combined in a meta-analysis. Not the best way to do things.

 

I do not see the FDA going forward with the AZ vaccine, until there is data from the large US trial.

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6 hours ago, mimbecky said:

I also read about the US not purchasing more doses of Pfizer when we had the chance- damn shame that is for sure.  I can see the same happening with Moderna as we only purchased 100 million of those as well.  Looks like most of us will be getting AstraZeneca IF it is effective.  Not sure I like the chimpanzee thing but my thoughts aren't based in science.  Just seems a bit wiggy. 

 

How Many Covid-19 Vaccine Doses Has The U.S. Secured?

Keep in mind that when the US turned down locking in more than 100 million it was prior to any results from the trials.   At that stage they would have been locking in the doses on faith that it would work out.  Instead they chose to spread the purchases over several companies in case one or more did not work out.

 

Once the EUAis approved I expect them to lock in a substantial amount of their production.

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7 hours ago, D C said:

Healthcare workers don't all have an EQUAL chance of interacting with covid patients, and we are not at a point where there is a widespread shortage of healthcare workers due to them being ill with covid.   Thus the prioritization to those most critical to in a first wave.

 

1st goal: Stop people from dying

 

And yes, 50 million is enough for everyone over 65 in the USA.  The acceptance rate won't be 100%.  if we assume a very good 60% acceptance, that's 30 million for 65+ and 20 million doses for others.  Damn good start in my book. 

 

If Covid really causes that much long term damage as the media proclaims then society would do much better protecting young people first, not seniors who are already near the end of their lifespan.

 

Otherwise you'll have two generations with various underlying conditions such as lung damage in 5-10 years while the generation they're now seeking to protect has died of old age.

Edited by Fly and Sail
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Sounds like the U.S. has already locked in enough doses of the various vaccines to cover everyone.   I am hoping for the Moderna approval as it does not require the super cold storage.    I hope we get ours in the first quarter of CY 21.   If the Pfizer is good enough for our friends in England I don’t know why we are dragging our feet.   I really hope they won’t wait until our Inauguration Day for the approval!   We really don’t care which administration gets the credit, we just want a vaccine.

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2 hours ago, nocl said:

Instead they chose to spread the purchases over several companies in case one or more did not work out.

 

Once the EUAis approved I expect them to lock in a substantial amount of their production.

I don't know about spreading it out.  If you look at the purchase chart, 500M purchased from AZ and only 100M from everyone else (Pfizer, Moderna, J and J, Sanofi, Novovax).  That means at least 50% of what we purchased is from AZ- which most now think will be very delayed in authorization (if at all)

I don't know how they are going to lock in more doses, at least with Pfizer who has already said upcoming production is already reserved for countries who purchased.  All estimates on receipt of more vaccines from Pfizer would be next June for the United States. 

It is what it is, nothing to do but move forward.  Hopefully we can secure more doses of Moderna and J and J if it proves to be a good choice and still start to recover by summer. I don't think Novovax nor Sanofi have even started phase 3 yet.

M

 

Edited by mimbecky
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13 hours ago, Fly and Sail said:

 

If Covid really causes that much long term damage as the media proclaims then society would do much better protecting young people first, not seniors who are already near the end of their lifespan.

 

Otherwise you'll have two generations with various underlying conditions such as lung damage in 5-10 years while the generation they're now seeking to protect has died of old age.

I suppose we could just send all of the old folks to a covid party and refuse them access to medical care to speed things up, right?

 

 

We don't know about long-term damage yet.  We're only about a year in from the emergence of the virus.  Personally, I'd be opting for not letting people die now.

 

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15 hours ago, Fly and Sail said:

 

If Covid really causes that much long term damage as the media proclaims then society would do much better protecting young people first, not seniors who are already near the end of their lifespan.

 

Otherwise you'll have two generations with various underlying conditions such as lung damage in 5-10 years while the generation they're now seeking to protect has died of old age.

 

Gee, aren't you a winner.  I bet you're a laugh riot at parties.  Are you the one to push women and children aside to be first on the lifeboats as well?

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15 hours ago, Fly and Sail said:

f Covid really causes that much long term damage as the media proclaims then society would do much better protecting young people first, not seniors who are already near the end of their lifespan.

Wow, you just proved that you are an idiot for this comment. Good bye fool.

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18 hours ago, mimbecky said:

 

 

Both nocl and TeeRick seemed to have some resevations about AstraZeneca.  I would appreciate clarification and any updates on your thoughts.

Thanks.

M

Not serious reservations but just trying to understand their dose effect after one phase 3 clinical trial.  More like speculation.  Normally there are several phase 3 trials and a lot of information is learned before commercialization.  No time for that this year with the raging pandemic but it can still happen going forward.  The AZ vaccine approach has a lot of manufacturing, cost and distribution advantages globally.  AZ is planning and has announced more clinical studies for their vaccine. Let's see how it plays out. But I do not think they will take very long.  They need to show consistent immune responses with their first phase 3 trial and of course the same or better efficacy.  And figure out the best dose protocol.  My concern was the adeno-chimpanzee vector approach (immune modulation against the vector itself)  vs the adeno-human vector approach used by J&J and several others (Sputnik V, CanSino).  It is possible that J&J wins this particular race in the US anyway.  

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