Are vaccines the light at the end of the tunnel?

[TeeRick]

16 hours ago, cangelmd said:

Glad you saw that. Until Pfizer can lick the -70 storage issue, usage in the Us is logistically limited to people who can be reached at a central location, whether it’s at work, in a group living situation, or by going to the health department or a mass vaccination site. We are just a much bigger country than Europe or UK. I really don’t think there is going to be a huge drop off in vaccine supply except maybe March/April, when they first open up to general population.

I know you have fretted a lot about this Mimbecky, but I don’t think supply will be the problem at all other than spot shortages and/or a couple of weeks between January and April when the country actually switches from one vaccine to another.

 

If J and J runs into a snafu, we may have a significant delay.

I think I gave a reference a while back in this thread that Pfizer is working on stability studies at different temperatures according to their senior R&D people.  There is little reason per se that their mRNA vaccine formulation should not behave in a similar way to the Moderna mRNA formulation in regards to temperature.  For the clinical trials they had to choose a formulation (from BioNTech) and just go with it.  In normal development process the stability in various formulations would have been tested and optimized long before Phase 3 studies.  Now they have to do it after the fact.  But I am glad they did it this way and at least showed proof-of-concept for the mRNA vaccines and of course EUA approved.  All within a year.  

[Ken the cruiser]

15 minutes ago, TeeRick said:

I think I gave a reference a while back in this thread that Pfizer is working on stability studies at different temperatures according to their senior R&D people.  There is little reason per se that their mRNA vaccine formulation should not behave in a similar way to the Moderna mRNA formulation in regards to temperature.  For the clinical trials they had to choose a formulation (from BioNTech) and just go with it.  In normal development process the stability in various formulations would have been tested and optimized long before Phase 3 studies.  Now they have to do it after the fact.  But I am glad they did it this way and at least showed proof-of-concept for the mRNA vaccines and of course EUA approved.  All within a year.  

It goes without saying, we all hope Pfizer is able to reduce their cold storage stability requirements. But in the interim it's comforting to hear the US just bought another 100m doses of the Moderna vaccine. That's, of course, it gets approved which it sure sounds like it's on track to do so in the next week or so.

 

U.S. government buys another 100M doses of Moderna vaccine (politico.com)

[cangelmd]

7 hours ago, K.T.B. said:

 

Yeah....

 

Glad to know someone got my aside reference!

[cangelmd]

26 minutes ago, TeeRick said:

I think I gave a reference a while back in this thread that Pfizer is working on stability studies at different temperatures according to their senior R&D people.  There is little reason per se that their mRNA vaccine formulation should not behave in a similar way to the Moderna mRNA formulation in regards to temperature.  For the clinical trials they had to choose a formulation (from BioNTech) and just go with it.  In normal development process the stability in various formulations would have been tested and optimized long before Phase 3 studies.  Now they have to do it after the fact.  But I am glad they did it this way and at least showed proof-of-concept for the mRNA vaccines and of course EUA approved.  All within a year.  

I hope that’s the case, it makes sense - I understand how they can’t claim anything that hasn’t been tested AND is in the FDA EUA.

I haven’t expressed myself well, but I think the first 3-6 months of vaccinations are going to be a hodgepodge, depending on where you fall on the risk chart and where you live - urban, suburban, rural. I know it is fashionable to call for a federal response, but from what I’ve read coming from our state health Dept, and what I’ve been asked about at work, the state has a reasonably good plan and has asked for specific input from the people who will be receiving and administering the vaccine. CDC and HHS required the plan be submitted way before they knew for sure which vaccine would ship first, so there are going to be snafus. The emphasis is on not wasting doses and getting as many frontline people to sign up as possible.

 

 I have gotten the idea, right or wrong, the the process to produce the RNA vaccines is harder to scale up commercially than a traditional process or is more that there hasn’t been an approved vaccine so no reason to have commercial level production? Plus we have never had to vaccinate the entire world population at the same time

[TeeRick]

3 minutes ago, cangelmd said:

 I have gotten the idea, right or wrong, the the process to produce the RNA vaccines is harder to scale up commercially than a traditional process or is more that there hasn’t been an approved vaccine so no reason to have commercial level production? Plus we have never had to vaccinate the entire world population at the same time

Actually the mRNA low dose (only 25-50 micrograms) is why a lot of doses can be produced and the process has been quite scalable. Not sure about the lipid manufacturing in the final formulation but assume it is a simple(r) chemical process. But the actual approved facilities coming on line for this type of vaccine will be playing catch-up since for quite some time.  The manufacturing of more traditional protein subunit vaccines has proven to be more challenging right now anyway for the higher purified protein doses required plus the manufacture of the amount of adjuvant needed - see GSK/Sanofi news in the past couple of days.  Novavax uses a protein subunit in nanoparticle approach.  It is hard to find the actual amounts of protein used in these formulations which seem to be an industrial proprietary secret at least for now. The difference of course is making the antigen in vivo in the human subject's own cells for the mRNA and vectored vaccines vs. making the antigen and purifying it in the manufacturing process for the subunit vaccines.

[K.T.B.]

3 hours ago, Ken the cruiser said:

It goes without saying, we all hope Pfizer is able to reduce their cold storage stability requirements. But in the interim it's comforting to hear the US just bought another 100m doses of the Moderna vaccine. That's, of course, it gets approved which it sure sounds like it's on track to do so in the next week or so.

 

U.S. government buys another 100M doses of Moderna vaccine (politico.com)

 

So this means 125 million people can get vaccinated in the US (250 million shots when you include the 50M Pfizer and the initial 100M of Moderna.)  Just under 40% of the US population.  According to recent polls, only 47% will get it, though I suspect that may change if airlines, cruise lines, etc., all require vaccination in order to travel, which a real possibility.

 

Regardless, when it's my and my wife's time, we'll get our shots!  Cannot wait.

[cangelmd]

4 hours ago, TeeRick said:

Actually the mRNA low dose (only 25-50 micrograms) is why a lot of doses can be produced and the process has been quite scalable. Not sure about the lipid manufacturing in the final formulation but assume it is a simple(r) chemical process. But the actual approved facilities coming on line for this type of vaccine will be playing catch-up since for quite some time.  The manufacturing of more traditional protein subunit vaccines has proven to be more challenging right now anyway for the higher purified protein doses required plus the manufacture of the amount of adjuvant needed - see GSK/Sanofi news in the past couple of days.  Novavax uses a protein subunit in nanoparticle approach.  It is hard to find the actual amounts of protein used in these formulations which seem to be an industrial proprietary secret at least for now. The difference of course is making the antigen in vivo in the human subject's own cells for the mRNA and vectored vaccines vs. making the antigen and purifying it in the manufacturing process for the subunit vaccines.

I knew you could answer my question! Early on there was some discussion about glass shortages to make the vials, have you heard any of that recently, I haven’t kept up with that?

 

im just getting a little, our freezer is the backup backup, but I really don’t want to go there!

[Crazy planning mom]

I am worried it sounds like they won't haven't ordered enough vaccine and there already seems to manufacturing delays. If J & J reports successful results in early 2021, how soon can they manufacture 100 million doses? What about Astrazeneca?

[Fouremco]

9 minutes ago, Crazy planning mom said:

I am worried it sounds like they won't haven't ordered enough vaccine and there already seems to manufacturing delays. If J & J reports successful results in early 2021, how soon can they manufacture 100 million doses? What about Astrazeneca?

DW and I are both in our 70s and suffer from one or more comorbidities. A few weeks ago, it appeared that we would be among the early recipients, but the priority listings have changed and it seems that we now fall into the "everyone else" grouping at the bottom of the list. So rather than the first quarter of 2021, we may be looking at the third quarter. Or possibly later. But we aren't going to spend any time or energy worrying about the timing, numbers of vaccines ordered, distribution, or any of the many issues surrounding the vaccination process. When our turn comes, it comes, and in the meantime we will simply continue to take all of the necessary preventative measures. We missed holding a family Thanksgiving and will miss our family Christmas, but there's definitely light at the end of the tunnel and for that we are thankful.

[D C]

3 minutes ago, Fouremco said:

DW and I are both in our 70s and suffer from one or more comorbidities. A few weeks ago, it appeared that we would be among the early recipients, but the priority listings have changed and it seems that we now fall into the "everyone else" grouping at the bottom of the list. So rather than the first quarter of 2021, we may be looking at the third quarter. Or possibly later. But we aren't going to spend any time or energy worrying about the timing, numbers of vaccines ordered, distribution, or any of the many issues surrounding the vaccination process. When our turn comes, it comes, and in the meantime we will simply continue to take all of the necessary preventative measures. We missed holding a family Thanksgiving and will miss our family Christmas, but there's definitely light at the end of the tunnel and for that we are thankful.

Who gets to go first in Canada?

 

Here, it's going to be healthcare workers first.  The 65+ category of "everyone else" is priority #5.  

It looks like deaths will continue unchecked for a while, except now they'll have been preventable. 

[D C]

38 minutes ago, Crazy planning mom said:

I am worried it sounds like they won't haven't ordered enough vaccine and there already seems to manufacturing delays. If J & J reports successful results in early 2021, how soon can they manufacture 100 million doses? What about Astrazeneca?

 

The first 100 million doses would have been enough to treat almost everyone over 65 in the US, but it looks like that age group isn't at the top of the list in at least some states.   We went from being able to end the pandemic with the first tranche of vaccines to prolonging it.  

[LGW59]

3 minutes ago, D C said:

Who gets to go first in Canada?

 

Here, it's going to be healthcare workers first.  The 65+ category of "everyone else" is priority #5.  

It looks like deaths will continue unchecked for a while, except now they'll have been preventable. 

Where I live on east coast, 65+ are in group two.  In Michigan, where it appears you live, I took the liberty of looking at your state website, 1C is phase 3, so if you are 65+, that is where you fall in line, not group 5.  

• Phase 1C includes people at high risk for severe COVID-19 illness due to underlying medical conditions, and people 65 years and older.

[D C]

59 minutes ago, LGW59 said:

Where I live on east coast, 65+ are in group two.  In Michigan, where it appears you live, I took the liberty of looking at your state website, 1C is phase 3, so if you are 65+, that is where you fall in line, not group 5.  

Some sources are showing sub-prioritizations within the phases as well. 

 

https://www.wilx.com/2020/12/12/michigan-details-priority-groups-for-distributing-covid-19-vaccine/

Edited December 13, 2020 by D C

[Fouremco]

2 hours ago, D C said:

Who gets to go first in Canada?

 

Here, it's going to be healthcare workers first.  The 65+ category of "everyone else" is priority #5.  

It looks like deaths will continue unchecked for a while, except now they'll have been preventable. 

Just as US states will set priorities for their residents, Canadian provinces will decide who goes first. Ontario hasn't published a final, definitive priority list, and what information has been provided is subject to ongoing revision.

 

Vaccinations will start under Phase One next week in Toronto and Ottawa. The two locations were selected for the pilot because this will test the travel logistics in two different regions of the province, and both have the necessary cold-temperature storage facilities required for Pfizer's vaccine. Vaccinations will be administered to health care workers in high-risk areas such as long-term care and critical care units.

 

To quote the Province of Ontario website:

 

Phase One will continue with the following key milestones:

• Based on per capita allocations, an expected 90,000 Pfizer-BioNTech doses received from the federal government will be delivered to up to 14 hospital sites in Grey-Lockdown and Red-Control zones in December, to vaccinate health care workers in hospitals, long-term care homes, retirement homes and other congregate settings caring for seniors.
• Deliveries of an expected 35,000 to 85,000 doses of the Moderna vaccine, once approved, will enable vaccinations to be expanded to long-term care homes in the Grey-Lockdown areas.
• In early 2021, expansion of additional hospital sites providing the Pfizer-BioNTech vaccine in Grey-Lockdown and Red-Control zones, with continued vaccination provided to health care workers and, with the appropriate safety protocols, to long-term care home and retirement home residents.
• It is anticipated that by end of January over 20 hospitals across the province will be administering the Pfizer vaccine.
• An expansion of the number of locations to administer the Moderna vaccine would include long-term care homes, retirement homes, public heath units, other congregate care settings for seniors, and adults in First Nations, Métis and Indigenous populations.

During Phase Two, vaccinations will be administered to health care workers, as well as to residents, in long-term care homes and retirement homes, to home care patients with chronic conditions and to additional First Nation communities and urban Indigenous populations, including Métis and Inuit adults. Timing for Phase Two will depend upon the speed with which vaccine stocks are received.

 

Phase Three, start date to be determined, opens up vaccination to everyone else in Ontario who wants one. 

 

Vaccine availability, storage facilities and regional COVID-19 levels will all have an impact on how the program rolls out. While there are three broad phases, I believe that further sub-phases will be developed. As currently laid out, the plans to throw things wide open to everyone in Phase Three ignores the reality that this includes the vast majority of residents and ignores previously identified priority groups. We'll see.

 

[Manchester is blue]

21 hours ago, TeeRick said:

Actually the mRNA low dose (only 25-50 micrograms) is why a lot of doses can be produced and the process has been quite scalable. Not sure about the lipid manufacturing in the final formulation but assume it is a simple(r) chemical process. But the actual approved facilities coming on line for this type of vaccine will be playing catch-up since for quite some time.  The manufacturing of more traditional protein subunit vaccines has proven to be more challenging right now anyway for the higher purified protein doses required plus the manufacture of the amount of adjuvant needed - see GSK/Sanofi news in the past couple of days.  Novavax uses a protein subunit in nanoparticle approach.  It is hard to find the actual amounts of protein used in these formulations which seem to be an industrial proprietary secret at least for now. The difference of course is making the antigen in vivo in the human subject's own cells for the mRNA and vectored vaccines vs. making the antigen and purifying it in the manufacturing process for the subunit vaccines.

Just was I was thinking......😀

[TeeRick]

For the US members here, how many of the initial vaccine doses will your state get?  See article.

https://www.nytimes.com/interactive/2020/12/11/us/covid-19-vaccine-doses.html?campaign_id=9&emc=edit_nn_20201213&instance_id=25000&nl=the-morning&regi_id=121450033&segment_id=46784&te=1&user_id=8259b050a84d722b46d85f64ae857bb0

 

[TeeRick]

16 hours ago, cangelmd said:

I knew you could answer my question! Early on there was some discussion about glass shortages to make the vials, have you heard any of that recently, I haven’t kept up with that?

 

im just getting a little, our freezer is the backup backup, but I really don’t want to go there!

As the vaccines started to become more of a reality, it seemed that people were coming from every corner trying to bring up potential issues- some very real ones and others just to get page hits I think on some sources.  I think the glass vials and syringes are well in hand- see link below.  I am glad we just have some hope with over 3000 deaths a day in the US right now.  No need for sources to be purposely negative about these vaccines and discourage their use with those numbers.  

https://www.pharmtech.com/view/readying-glass-vials-for-vaccines

 

[TeeRick]

12 hours ago, D C said:

 

The first 100 million doses would have been enough to treat almost everyone over 65 in the US, but it looks like that age group isn't at the top of the list in at least some states.   We went from being able to end the pandemic with the first tranche of vaccines to prolonging it.  

Prolonging it?  Ending the pandemic is not possible and has never been possible with the initial doses of vaccine even if 100 million.  The Pfizer and Moderna vaccines at the very least protect 95% of exposed people from being sick or worse.  And the other 5% have much milder symptoms.   The initial goal is to protect the groups that have been the most at risk for death and have unfortunately statistically contributed to most of the horrible mortality and morbidity numbers to date.  People like the most vulnerable ones in nursing homes and the front-line health care workers that care for them.   And other front-line health care workers that are dealing day and night with the massive surge in COVID hospitalizations right now.  I will gladly step aside until later next year if we can get these folks all protected from sickness and death.  Cruising to me is way way down as a priority compared to this.

[TeeRick]

13 hours ago, Fouremco said:

But we aren't going to spend any time or energy worrying about the timing, numbers of vaccines ordered, distribution, or any of the many issues surrounding the vaccination process. When our turn comes, it comes, and in the meantime we will simply continue to take all of the necessary preventative measures. We missed holding a family Thanksgiving and will miss our family Christmas, but there's definitely light at the end of the tunnel and for that we are thankful.

Fouremco- This is exactly my attitude as well.  Thank you for expressing it.  Well said.

Edited December 13, 2020 by TeeRick

[SJSULIBRARIAN]

As an example of number of doses in the first round.

 

In AZ, the state will get a total of 58,500 and the state has decided only the two largest counties, Maricopa (Phoenix) and Pima (Tucson) will be allocated these doses. The rest of the state will get the Moderna vaccine later.

 

I live in Tucson so my county will get 11,700 does - divide this by 2 and that means 5850 people can receive the vaccine. First in line are  health care workers  working directly with patients, then home health aides, nursing and medical assistants.  After that residents of skilled nursing and independent and assisted living facilities. 

 

This was reported in the AZ Daily Star on December 10th. Population of Pima County is just over 1 million people.  I doubt these first doses allocated to my county will barely, if at all, cover the health care workers. There was no mention in the article when the second batch would arrive.  At 76 years , I think I will be waiting for several months. This process is going to take some time, IMO.

 

 

[D C]

1 hour ago, TeeRick said:

Prolonging it?  Ending the pandemic is not possible and has never been possible with the initial doses of vaccine even if 100 million.  The Pfizer and Moderna vaccines at the very least protect 95% of exposed people from being sick or worse.  And the other 5% have much milder symptoms.   The initial goal is to protect the groups that have been the most at risk for death and have unfortunately statistically contributed to most of the horrible mortality and morbidity numbers to date.  People like the most vulnerable ones in nursing homes and the front-line health care workers that care for them.   And other front-line health care workers that are dealing day and night with the massive surge in COVID hospitalizations right now.  I will gladly step aside until later next year if we can get these folks all protected from sickness and death.  Cruising to me is way way down as a priority compared to this.

~90% of deaths could be prevented if everyone over 65 was vaccinated.  

In my mind, that ends the pandemic (epidemic really on a national scale), although there admittedly doesn't seem to be established criteria for when epidemic transitions to endemic.  

 

Vaccinating the 65+ first also has an immediate effect on lowering hospital admissions.   

[TeeRick]

Just now, D C said:

~90% of deaths could be prevented if everyone over 65 was vaccinated.  

In my mind, that ends the pandemic (epidemic really on a national scale), although there admittedly doesn't seem to be established criteria for when epidemic transitions to endemic.  

 

Vaccinating the 65+ first also has an immediate effect on lowering hospital admissions.   

Dave I agree with you but it is not possible with initial doses anyway to vaccinate everybody over 65 with the initial doses and some will be reluctant for whatever reason to get the vaccine too.

[Pinboy]

14 minutes ago, TeeRick said:

Dave I agree with you but it is not possible with initial doses anyway to vaccinate everybody over 65 with the initial doses and some will be reluctant for whatever reason to get the vaccine too.

Your posts are excellent !! 

Off topic question :

How do so many people know the " real " name of people on CC ?

I understood CC keeps it confidential. 

 

[Ken the cruiser]

26 minutes ago, Pinboy said:

Your posts are excellent !! 

Off topic question :

How do so many people know the " real " name of people on CC ?

I understood CC keeps it confidential. 

 

Some folks like Dave put their name at the end of some of their posts. For me, well, I think you know where they get my first name. 🙂

Edited December 13, 2020 by Ken the cruiser

[Fouremco]

29 minutes ago, Pinboy said:

Your posts are excellent !! 

Off topic question :

How do so many people know the " real " name of people on CC ?

I understood CC keeps it confidential. 

 

Roll calls are filled with spread sheets listing CC members' names, all volunteered. Usually just given names, but often last names too.