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Are vaccines the light at the end of the tunnel?


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On 3/3/2021 at 8:37 AM, TeeRick said:

To extend the amount of available vaccine doses, some countries will give only one vaccine shot to people who already had COVID infections.   It potentially does make some sense if one would be considered immunologically "primed" for Covid antigens after being naturally infected.  Then the one dose of vaccine might be the "boost".  But none of this has been tested.  However I think it would be easy and fast to test in the clinic looking at immune responses.  If you are in a country with a lot of ongoing infections and very little vaccine this is an interesting strategy.

 

https://www.medscape.com/viewarticle/946533

Hello,

Canada announced yesterday that they are now advising a 4 month interval between shots to allow more vaccines across all adult populations faster - apparently still very effective this way.  By doing this, I am thinking that the second dose might also be altered to cover for the variants that might pop up over that time?  I was happy to hear this as it will get our entire over 18 population vaccinated by the end of June - or at least that is the prediction.

https://www.cbc.ca/news/politics/naci-interval-advice-change-four-months-1.5934563

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Some news about the CureVac Covid vaccine which is under rolling review right now in Europe.  It is another mRNA vaccine (Like Pfizer and Moderna).  They have been under the radar.  But they will hopefully provide significant doses to Europe.  It is also stable with refrigerator storage so good for the rest-of-world to.   CureVac has partnered with GSK,  and also Novartis has agreed to manufacture doses.  It looks like another vaccine option on the near horizon for EMEA countries.

https://www.ft.com/content/c3159721-6e64-45eb-8935-22ad8cdf3eb5

 

https://www.marketwatch.com/story/novartis-agrees-to-help-make-curevac-covid-19-vaccine-2021-03-04?tesla=y

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12 minutes ago, DebbieActon said:

Hello,

Canada announced yesterday that they are now advising a 4 month interval between shots to allow more vaccines across all adult populations faster - apparently still very effective this way.  By doing this, I am thinking that the second dose might also be altered to cover for the variants that might pop up over that time?  I was happy to hear this as it will get our entire over 18 population vaccinated by the end of June - or at least that is the prediction.

https://www.cbc.ca/news/politics/naci-interval-advice-change-four-months-1.5934563

This is a logical strategy for getting more people vaccinated with limited available doses in Canada and elsewhere.  One dose of the mRNA vaccines seems to be highly effective.  As far as the second dose, it will likely be the same version of the vaccine if it is within the next 4 months.  I think the time line for availability for a new version of the vaccine to match the variant strains like S. Africa (if needed) will be more than 4 months.  

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9 minutes ago, TeeRick said:

This is a logical strategy for getting more people vaccinated with limited available doses in Canada and elsewhere.  One dose of the mRNA vaccines seems to be highly effective.  As far as the second dose, it will likely be the same version of the vaccine if it is within the next 4 months.  I think the time line for availability for a new version of the vaccine to match the variant strains like S. Africa (if needed) will be more than 4 months.  

The next logical question for many people will be why aren't we doing that in the US. PArt of the reason I think, is that FDA is much more conservative in the sense of sticking to the science and data presented in the study. A good reason for that is there is much less virus circulating in Canada, which will make any vaccine strategy more effective. Less virus means reduced risk with or withour vaccine.

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3 minutes ago, TeeRick said:

Enough vaccine doses to cover the US by end of May??  But how long to administer them?

 

https://apnews.com/article/joe-biden-coronavirus-pandemic-25738fbba2ff638be1a1253d96199578

 

 

The infrastructure to do that is building everyday, in the sense that all kinds of different ways of mass vaccination have been tried and many of the kinks worked out. What I hear and see is there isn't enough steady predictable supply to run some of the sites that have been set up around here in an efficient manner. Eventually people to process paperwork and give the shots will be a bottleneck, but right now it is supply. The other step that is creating chaos is front end registration, scheduling piece. There does not seem to be an easy scalable IT solution. Maybe when everyone is eligible and it is only a matter of finding a shot?

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1 hour ago, TeeRick said:

Enough vaccine doses to cover the US by end of May??  But how long to administer them?  I guess this is very good news for cruising overall and some limited start up - possibly Caribbean- in Q4 this year.  We shall see.......

 

https://apnews.com/article/joe-biden-coronavirus-pandemic-25738fbba2ff638be1a1253d96199578

 

 

Not very long.  Most of the administration issues are due to lack of supply.  The US normally does over 150 million during a normal flu seasons with out major issues, lines or the large immunization venues that have been set up for COVID.  Ramp up all of the pharmacies, keep the COVID large venues open, and with adequate supply the shots will go quickly.

 

Also keep in mind that the stability data for the Pfizer and Moderna vaccine is a shelf life of 6 months at hard frozen temperatures.  As a result once all of this is manufactured it must be used within that time frame.  Not like it can just set on the shelf until needed.  A lot of product will be going to waste once the initial rush is over, unless they can find a way to manage the supply in far more detail than is normally done with some system for moving the product to other countries where it can be used if it is not used quickly.

 

I had to deal with a frozen product with a 12 month shelf life and that was enough of a headache to reduce spoilage, with the 6 month limit in these quantities it is going to be very problematic to keep wastage down at a time when most of the rest of the world will not have adequate supply.

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1 hour ago, cangelmd said:

The next logical question for many people will be why aren't we doing that in the US. PArt of the reason I think, is that FDA is much more conservative in the sense of sticking to the science and data presented in the study. A good reason for that is there is much less virus circulating in Canada, which will make any vaccine strategy more effective. Less virus means reduced risk with or withour vaccine.

The other countries are doing it because there vaccine supply is even more limited.  They are doing so as an unproven, though with some limited data, theory. In the US we will have full supply in a couple of more months. 

 

There are enough issues with people getting second shots, even with the system set up for people to get them on schedule.  Imagine the confusion if the second shots were not scheduled and or prioritized.  How many do you think would just skip the second shot if there was not the sense of urgency that comes with the approved schedule?  

 

The FDA is data driven, they do not guess if they do not have solid data. Especially with an product under EUA.   If these were product with large quantities of actual use data then you might see them make such a change, but a new product with no history - Nope.

 

There is also the question on would the single show approach, with more people vaccinated, but with weaker protection create more opportunity for vaccine resistant traits in new variations?  A trade off with mutations of reducing total number of infections vs allowing more infections in partially protected. Which is more likely to lead to a vaccine resistant strain.

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Just now, nocl said:

The other countries are doing it because there vaccine supply is even more limited.  They are doing so as an unproven, though with some limited data, theory. In the US we will have full supply in a couple of more months. 

 

There are enough issues with people getting second shots, even with the system set up for people to get them on schedule.  Imagine the confusion if the second shots were not scheduled and or prioritized.  How many do you think would just skip the second shot if there was not the sense of urgency that comes with the approved schedule?  

 

The FDA is data driven, they do not guess if they do not have solid data. Especially with an product under EUA.   If these were product with large quantities of actual use data then you might see them make such a change, but a new product with no history - Nope.

 

There is also the question on would the single show approach, with more people vaccinated, but with weaker protection create more opportunity for vaccine resistant traits in new variations?  A trade off with mutations of reducing total number of infections vs allowing more infections in partially protected. Which is more likely to lead to a vaccine resistant strain.

Good point!  The 1st and 2nd order for the Moderna and Pfizer vaccines will probably be fully utilized since production of J&J vaccine is behind its original schedule.  It is the 3rd order of those mRNA vaccines where the doses will have difficulty finding willing recipients in the USA and majority of that order might go to waste or, more likely, diverted to Canada and overseas.

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19 minutes ago, deadzone1003 said:

It is the 3rd order of those mRNA vaccines where the doses will have difficulty finding willing recipients in the USA and majority of that order might go to waste or, more likely, diverted to Canada and overseas.

 

Don't be too sure. I would much rather get the mRNA vaccine and at my age and no qualifying conditions it looks like still a long while until I am eligible in my state. :classic_angry:

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44 minutes ago, cruisemom42 said:

 

Don't be too sure. I would much rather get the mRNA vaccine and at my age and no qualifying conditions it looks like still a long while until I am eligible in my state. :classic_angry:

If the production schedules go as now forecast there should be no problem with anyone getting the vaccine by late May early June.  Then once the rush is done there will be more vaccine coming in, but only limited new patients for it, until the under 18 trials are complete.

 

With only 6 month shelf life it is going to be very interesting to see if they can mange the supply chain in those circumstances without vaccine expiring on the shelf.

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3 hours ago, TeeRick said:

Enough vaccine doses to cover the US by end of May??  But how long to administer them?  I guess this is very good news for cruising overall and some limited start up - possibly Caribbean- in Q4 this year.  We shall see.......

 

https://apnews.com/article/joe-biden-coronavirus-pandemic-25738fbba2ff638be1a1253d96199578

 

 

 

In the Chicago area, there are 3 pharmacies who are giving shots:  Walgreens, Osco, and the one located in Mariano's.  By May, I suspect there's not going to be a huge problem in getting vaccinated.  The main issue currently is the lack of vaccine availability.  Hopefully that changes within the new few weeks or so.

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1 hour ago, nocl said:

Not very long.  Most of the administration issues are due to lack of supply.  The US normally does over 150 million during a normal flu seasons with out major issues, lines or the large immunization venues that have been set up for COVID.  Ramp up all of the pharmacies, keep the COVID large venues open, and with adequate supply the shots will go quickly.

 

Also keep in mind that the stability data for the Pfizer and Moderna vaccine is a shelf life of 6 months at hard frozen temperatures.  As a result once all of this is manufactured it must be used within that time frame.  Not like it can just set on the shelf until needed.  A lot of product will be going to waste once the initial rush is over, unless they can find a way to manage the supply in far more detail than is normally done with some system for moving the product to other countries where it can be used if it is not used quickly.

 

I had to deal with a frozen product with a 12 month shelf life and that was enough of a headache to reduce spoilage, with the 6 month limit in these quantities it is going to be very problematic to keep wastage down at a time when most of the rest of the world will not have adequate supply.

A point to consider about the stability data and the 6 month shelf life at ultra-low freezer temperatures.  Both Pfizer/BioNTech and Moderna have stated they are doing additional stability studies.  Pfizer already changed their recommendation recently on diluted vaccine shelf life and the FDA approved it.  So these companies will likely come up with data on longer term storage than 6 months at -60C to -80C.   The manufactured doses undergoing stability studies have mostly not even been around for 6 months yet as these vaccines are so new.  If I had to offer an educated (wild ass?) guess they will be stable at these temperatures for much longer than 6 months.  It is different than doing the typical accelerated stability studies at higher temperatures.  For ultra-low storage you actually need to keep the vials at that temperature over time and keep testing for degradation of components.  In normal times this would have been done over a period of a couple of years while the vaccines were going through the testing and approval process.   So I am betting on extended ultra-low shelf life data coming to the FDA soon.  

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Posted (edited)
1 hour ago, K.T.B. said:

 

In the Chicago area, there are 3 pharmacies who are giving shots:  Walgreens, Osco, and the one located in Mariano's.  By May, I suspect there's not going to be a huge problem in getting vaccinated.  The main issue currently is the lack of vaccine availability.  Hopefully that changes within the new few weeks or so.

Once J&J vaccine becomes more readily available and in sufficient numbers, it could feed the normal flu vaccine distribution apparatus.  

 

Apparently, J&J vaccine are being sent to California.  CVS is offering Moderna or Pfizer if you go through their options.  It appears they will offer J&J vaccine soon if available.  I guess it is getting into one of the most utilized section of the flu distribution apparatus.

Edited by deadzone1003
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3 hours ago, TeeRick said:

A point to consider about the stability data and the 6 month shelf life at ultra-low freezer temperatures.  Both Pfizer/BioNTech and Moderna have stated they are doing additional stability studies.  Pfizer already changed their recommendation recently on diluted vaccine shelf life and the FDA approved it.  So these companies will likely come up with data on longer term storage than 6 months at -60C to -80C.   The manufactured doses undergoing stability studies have mostly not even been around for 6 months yet as these vaccines are so new.  If I had to offer an educated (wild ass?) guess they will be stable at these temperatures for much longer than 6 months.  It is different than doing the typical accelerated stability studies at higher temperatures.  For ultra-low storage you actually need to keep the vials at that temperature over time and keep testing for degradation of components.  In normal times this would have been done over a period of a couple of years while the vaccines were going through the testing and approval process.   So I am betting on extended ultra-low shelf life data coming to the FDA soon.  

They  may or may not. But the batches being produced now will probably carry the current stability.  I doubt they will get longer than 12 months based upon the nature of the product.  When they come out with lyophilized versions the situation might change, but we are a ways from that and it will not impact when we transition for extreme short supply to excess supply before we get anywhere close to a stable supply chain. Even if they get 12 months on the frozen it is really not very long  when you are managing a supply chain and wanting to minimize waste. If you get past the rush, you are not going to need much product sitting on the shelf until the under trials are completed.  Once beyond that the current product will most likely not used for boosters since new product will be designed for the variants.

 

By the time we get to June there should be enough vaccine in the US for all adults, but if you have 30% or so that refuse to get vaccinated you will have quite a bit of extra that will be use in a couple of months or lose it.  US will not look good if we are throwing away millions of doses while other countries cannot get the vaccine.

 

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8 hours ago, TeeRick said:

Enough vaccine doses to cover the US by end of May??  But how long to administer them?  I guess this is very good news for cruising overall and some limited start up - possibly Caribbean- in Q4 this year.  We shall see.......

 

https://apnews.com/article/joe-biden-coronavirus-pandemic-25738fbba2ff638be1a1253d96199578

 

 

Rick - I can use a mass vaccination campaign that happened some 25 years ago regarding measles.  Over 100,000 people - mostly young people - were vaccinated in 5 days in a metro area of 450K.  Once the J&J vaccine is readily available the various physician groups can distribute and vaccinate patients in their offices.  The number of distribution points expand by many times.  Our state also made it so retired docs and nurses etc can administer shots with email application and approval.

Again, except for a terrible registration web portal, things have gone smoothly.  We could be at 30% vaccinated if there was enough vaccine.  Last week our 24hr sites operated for only a couple hours 

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3 minutes ago, Arizona Wildcat said:

mostly young people - were vaccinated in 5 days in a metro area of 450K.  Once

Texas announced they had a record day last week with 216,000 vaccinated in a single day.   The teams seem to be finding their rhythm 

 

https://dfw.cbslocal.com/2021/03/02/watch-live-texas-governor-greg-abbott-announcement-at-130pm-has-hinted-at-possible-changes-to-states-covid-19-restrictions/

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7 hours ago, nocl said:

The FDA is data driven, they do not guess if they do not have solid data. Especially with an product under EUA

Ummmm I don’t know about that. Isn’t this what is going on now with advice on delayed vaccines? First the CDC said it was ok to get a vaccine 4 days late, then up to 6 weeks from first dose (2 weeks delayed for Moderna), then I heard today up to 7 weeks. To my knowledge there have been no studies/data to substantiate this. A doctor on the news the other day said they really didn’t know - it could be ok months delayed but it is just a guess. As for me, I am still waiting for #2 and I know others who have been rescheduled twice so far. I think they are saying increasing delay is ok because there really is no alternative.

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Posted (edited)
1 hour ago, mimbecky said:

Ummmm I don’t know about that. Isn’t this what is going on now with advice on delayed vaccines? First the CDC said it was ok to get a vaccine 4 days late, then up to 6 weeks from first dose (2 weeks delayed for Moderna), then I heard today up to 7 weeks. To my knowledge there have been no studies/data to substantiate this. A doctor on the news the other day said they really didn’t know - it could be ok months delayed but it is just a guess. As for me, I am still waiting for #2 and I know others who have been rescheduled twice so far. I think they are saying increasing delay is ok because there really is no alternative.

Heard from which source?

 

Here is a quote from the FDA

 

We know that some of these discussions about changing the dosing schedule or dose are based on a belief that changing the dose or dosing schedule can help get more vaccine to the public faster. However, making such changes that are not supported by adequate scientific evidence may ultimately be counterproductive to public health.

 

We have committed time and time again to make decisions based on data and science. Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine. 

 

When others tried to extend the FDA's response was

 

The FDA said slight delays shouldn’t affect the protection offered by the vaccine, after the agency resisted pressure earlier this month to stretch supply by adding time between the two shots.

 

 

So while others are making statements the FDA has not gone beyond slight delays because they do not have the data for anything else.

 

There is also a limit on how early one can get the second dose

 

Both vaccines authorized for emergency use in the U.S. were cleared based on trials of two doses weeks apart. A grace period of four days ahead of schedule would be considered valid for a second dose, but people shouldn’t receive the second dose earlier than that.

 

Another statement from the FDA on the subject

 

“The FDA recognizes that getting as many people as possible across the country fully immunized will help to curtail the spread of the virus that causes COVID-19 and should be a priority,” the FDA said in a statement. “Modest delays in the administration of the second dose, if absolutely necessary, would not be expected to decrease the protection conferred by the 2nd dose and are preferable to not completing the 2-dose series.”

Then-FDA Commissioner Stephen Hahn and Peter Marks, head of the agency’s office that oversees vaccines, signed on to an earlier statement that said extending the time between shots hadn’t been studied and “may ultimately be counterproductive to public health.” 

Edited by nocl
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SC is opening 55+ on March 8  and CVS has opened a whole slew of appointments. Wife, myself, and close friend are going to a CVS about an hour away on March 9, and they have already scheduled us for shot #2 for March 30.. (My 65+ appt is not available until April 9. Looking forward to cancelling that one!) Ourss is Pfizer acc to confirm.

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2 hours ago, mimbecky said:

Ummmm I don’t know about that. Isn’t this what is going on now with advice on delayed vaccines? First the CDC said it was ok to get a vaccine 4 days late, then up to 6 weeks from first dose (2 weeks delayed for Moderna), then I heard today up to 7 weeks. To my knowledge there have been no studies/data to substantiate this. A doctor on the news the other day said they really didn’t know - it could be ok months delayed but it is just a guess. As for me, I am still waiting for #2 and I know others who have been rescheduled twice so far. I think they are saying increasing delay is ok because there really is no alternative.

?????   We had appointments rescheduled 2 weeks ago for a couple days when the state ran out of vaccine.  All cancelled appointments were rescheduled and vaccinated within a week.  Not sure why no alternative as dose numbers up last week and this week again.

Would like to see where CDC said to space doses by another couple weeks.  There was a shortage when FedEx was pretty much shut for 4 days.  Over now with our state open to more groups now.  Almost 1.3M with 2 doses in AZ.  Another 650K with one.  Expect all that want vaccine to have jabs by May.

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3 hours ago, nocl said:

Heard from which source?

As I said...the CDC has given up to 6 weeks.

CDC: Gap Between Vaccine Doses Could Be 6 Weeks (webmd.com)

As far as now 7 weeks, I believe it was GMA this morning.

 

 

2 hours ago, Arizona Wildcat said:

?????   We had appointments rescheduled 2 weeks ago for a couple days when the state ran out of vaccine.  All cancelled appointments were rescheduled and vaccinated within a week. 

Our largest Superstation has been closed for minimum of 2 days 3x in the last month.  Before the storms, we never received promised doses and people were rescheduled, then the storm hit and we were closed 3 days and those people were all rescheduled again...the promised doses still didn't come for another week causing more rescheduling.  Just as those rescheduled were catching up, we had a lightning storm here and they closed again.  All those people have needed to be rescheduled.  I personally know of 4 people who have been rescheduled multiple times and are at the end of the 2 week additional referred to above.  There is plenty of Pfizer here now but a big shortage of Moderna which is the problem in getting the second dose.  Don't know what to tell you....glad your rescheduling went well.  We too are getting more doses so hopefully this will rectify in the next week or so.  Then again the governor just said they are saving 40 percent of our doses for those who work or live in "vunerable zip codes".  That is a whole other story.  Maybe those of us who live and work outside of those zip codes will be rescheduled once again.

Links here...

"It is the third time in as many weeks that the site has had to close due to vaccine shortages".Vaccine in San Diego: Petco Park vaccination super site closing again through Tuesday (fox5sandiego.com)

 

California to earmark 40% of vaccine doses to vulnerable areas, officials say could speed reopening – Daily News

 

 

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