Are vaccines the light at the end of the tunnel?

[K.T.B.]

On 7/21/2020 at 8:32 AM, TeeRick said:

Thanks!  Good article!  I am optimistic about this vaccine.  But there will be major safety concerns of injecting millions of people with a recombinant adenovirus vector.  I don't see this being used initially in children.  And not sure about immuno-compromised adults.  But it is a new world we live in. 

 

This why I suspect the initial 400 million doses earmarked for the US will not be an issue, especially if 2 doses are require.  I did a quick check the other night, and there are approximately 80 million people under the age  of 20 and under in the US, out of 280 million. I strongly suspect people 50 and older will be among the first to get both doses first, as well as those who work in the health industry and other vital jobs.

[K.T.B.]

17 hours ago, Ken the cruiser said:

I keep hearing folks mention "high risk individuals" when it comes to administering an eventual vaccine. What exactly does this mean? My DW is 66 and I'm 68. Are we considered to be part of that group?

Yes, you would be.  As are people who are diabetic, have COPD, etc. My wife falls under two categories (diabetic and over 70) while I'm diabetic.  So we'd among the first to be able to get the vaccine.  

[TeeRick]

The ModernaTX vaccine will be administered to 30,000 adults 18 and older in phase III starting July 27.

 

https://clinicaltrials.gov/ct2/show/NCT04470427

 

There are multiple age groups (starting from age 5 and through elderly adults over 70) for the Astra Zenica Oxford Vaccine (now known as AZD1222).  There are 10,260 participants in phase II/III.  More to be announced for phase III's.

 

https://clinicaltrials.gov/ct2/show/NCT04400838?term=ChAdOx1+nCoV-19&cond=Covid19&draw=2&rank=2

Edited July 22, 2020 by TeeRick

[LouChamp]

dreaming


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[markeb]

1 hour ago, TeeRick said:

The ModernaTX vaccine will be administered to 30,000 adults 18 and older in phase III starting July 27.

 

https://clinicaltrials.gov/ct2/show/NCT04470427

 

There are multiple age groups (starting from age 5 and through elderly adults over 70) for the Astra Zenica Oxford Vaccine (now known as AZD1222).  There are 10,260 participants in phase II/III.  More to be announced for phase III's.

 

https://clinicaltrials.gov/ct2/show/NCT04400838?term=ChAdOx1+nCoV-19&cond=Covid19&draw=2&rank=2

 

Thanks! The AZ trial is crazy! Definitely spending other people's money on that one to do that much essentially in parallel!!

 

Note the dates on both Phase III's though... This goes to an EUA this year at best if the 2021 and 2022 dates hold. Which doesn't sound like a CVS walkup for the general population anytime soon...

[terrydtx]

From what I have heard and read the first groups to get the vaccine when available will be first responders,  medical technicians and personnel treating sick patients,  and this group will be also include at risk and people over 60. One of the phase 3 trials is being done where I live and they are designating that 40% of the volunteers be over 60. I went online this week to volunteer (I am 70) and the website said they had already filled the over 60 quota.

[travlr21]

We in British Columbia are currently in Phase 3 of our reopening, though we are seeing an increase in cases under this phase. There is an unscheduled news conference just announced by the Health Minister for this afternoon, not sure what they will be saying, new measures or roll-backs?

 

Phase 4 in BC includes 'International Tourism' - whatever that means, and  Phase 4 is meant to start when at least one of 3 things happens - wide vaccination, community immunity or broad successful treatments. I do not see community immunity happening, but would love to hear about broad successful treatments and continued progress on a vaccine. Under this current thinking, not sure when cruising in BC (Canada?) will be possible. 

[terrydtx]

2 minutes ago, travlr21 said:

We in British Columbia are currently in Phase 3 of our reopening, though we are seeing an increase in cases under this phase. There is an unscheduled news conference just announced by the Health Minister for this afternoon, not sure what they will be saying, new measures or roll-backs?

 

Phase 4 in BC includes 'International Tourism' - whatever that means, and  Phase 4 is meant to start when at least one of 3 things happens - wide vaccination, community immunity or broad successful treatments. I do not see community immunity happening, but would love to hear about broad successful treatments and continued progress on a vaccine. Under this current thinking, not sure when cruising in BC (Canada?) will be possible. 

From what you are saying the approved use of a vaccine is your only hope of opening up BC again.

[travlr21]

14 minutes ago, terrydtx said:

opening up BC again

The latest update to this information was June 24. I assume things can change, as we learn more, or possibly pressure brought on the government. Under the current thinking, it is not until phase 4 that live audience professional sports, conventions and concerts are permitted. Certainly not great for our business and the economy.

[Baron Barracuda]

Whichever vaccine crosses the finish line first it was reassuring to hear HHS secretary Alex Azar on CNBC this morning say US has obtained all the syringes and transport media needed to initially vaccinate the US population.

[Baron Barracuda]

4 hours ago, terrydtx said:

From what I have heard and read the first groups to get the vaccine when available will be first responders,  medical technicians and personnel treating sick patients,  and this group will be also include at risk and people over 60. One of the phase 3 trials is being done where I live and they are designating that 40% of the volunteers be over 60. I went online this week to volunteer (I am 70) and the website said they had already filled the over 60 quota.

 

They can't even decide who gets to make the decision 

 

https://www.statnews.com/2020/07/22/confusion-spreads-over-system-to-determine-priority-access-to-covid-19-vaccines/?utm_source=STAT+Newsletters&utm_campaign=bc1831b774-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-bc1831b774-150117189

[Fouremco]

1 hour ago, Baron Barracuda said:

 

They can't even decide who gets to make the decision 

 

https://www.statnews.com/2020/07/22/confusion-spreads-over-system-to-determine-priority-access-to-covid-19-vaccines/?utm_source=STAT+Newsletters&utm_campaign=bc1831b774-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-bc1831b774-150117189

Great article, thank you. You can only hope that this issue doesn't drag on beyond the availability of the vaccine. It's time for egos to be put away and for everyone to work together towards a common goal.

[TeeRick]

On 7/22/2020 at 4:54 PM, Baron Barracuda said:

 

They can't even decide who gets to make the decision 

 

https://www.statnews.com/2020/07/22/confusion-spreads-over-system-to-determine-priority-access-to-covid-19-vaccines/?utm_source=STAT+Newsletters&utm_campaign=bc1831b774-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-bc1831b774-150117189

I am also trying to volunteer with my dw for one of these Phase III trials.  It might be the best way to actually get vaccinated early ahead of the crowd!

[Ken the cruiser]

On 7/22/2020 at 3:54 PM, Baron Barracuda said:

 

They can't even decide who gets to make the decision 

 

https://www.statnews.com/2020/07/22/confusion-spreads-over-system-to-determine-priority-access-to-covid-19-vaccines/?utm_source=STAT+Newsletters&utm_campaign=bc1831b774-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-bc1831b774-150117189

Thank you for posting this article! From my perspective it highlighted that key US government organizations are starting to seriously focus their attention on the distribution phase of the vaccine dissemination process, which ultimately gets us closer to cruising again. Hopefully, by the time the FDA approves that first vaccine, they will have a clear path on those details.

[chipmaster]

13 minutes ago, Ken the cruiser said:

Thank you for posting this article! From my perspective it highlighted that key US government organizations are starting to seriously focus their attention on the distribution phase of the vaccine dissemination process, which ultimately gets us closer to cruising again. Hopefully, by the time the FDA approves that first vaccine, they will have a clear path on those details.

 

The selection of who is first and how is most certainly going to get politicized,   look at every major press briefing most are soundboards to politicize an action/position.  Even the most respected scientist are trapped and manipulated to a political position.

 

The approval process is also politicized, there is no way the FDA can take what would in a normal situation the necessary process for a vaccine that will be given for hundreds of millions in the US and billions world wide, corners will be cut, data that should be collected won't.

[Ken the cruiser]

1 hour ago, chipmaster said:

 

The selection of who is first and how is most certainly going to get politicized,   look at every major press briefing most are soundboards to politicize an action/position.  Even the most respected scientist are trapped and manipulated to a political position.

 

The approval process is also politicized, there is no way the FDA can take what would in a normal situation the necessary process for a vaccine that will be given for hundreds of millions in the US and billions world wide, corners will be cut, data that should be collected won't.

From my corner of the peanut gallery, we see the Oxford/AZ team with a substantial lead on the pack, at least a month from my calculations. Once they provide their stage 3 results in early September, and we're all hoping they have great results, we'll all just have to wait and see how the events unfold. However, since the UK has been promised first dibs on a significant number of vials of the Oxford/AZ vaccine once the UK powers that be give their approval, my guess is it will get quite interesting to see how long the FDA takes to grant approval of the Oxford/AZ vaccine.

[Baron Barracuda]

Interesting piece from USA Today on projected timeline for vaccine

 

https://www.usatoday.com/in-depth/news/health/2020/07/23/covid-vaccine-race-early-success-fuels-cautious-optimism-panel-finds/5480173002/

[markeb]

16 minutes ago, Baron Barracuda said:

Interesting piece from USA Today on projected timeline for vaccine

 

https://www.usatoday.com/in-depth/news/health/2020/07/23/covid-vaccine-race-early-success-fuels-cautious-optimism-panel-finds/5480173002/

 

Pretty decent article, actually. There's a lot of "inside baseball" here that gets lost in the reporting. I'm cautiously optimistic, but share many of the concerns.

 

I think it was teerick who posted links to the actual clinical trial information. The Moderna vaccine candidate is scheduled to complete Phase III trials in October 2022, not including data analysis and filing of a Biological License Application (BLA). I believe all vaccine candidates are on "fast track" with the FDA, but that really just means more frequent meetings and the ability to file interim data along the way to expedite review.

 

The AZ product shows completion of Phase III in August of 2021; same caveats on review.

 

The "most likely", IMHO, path is approval of an Emergency Use Authorization, if the trial proceeds as expected, late fall to early winter. There are legal requirements for that; declaration of an emergency by the Secretary of HHS, some (not highly specified) initial safety and efficacy data, etc. And ordinarily a specified population. Not the same as a licensed product, but technically not investigational (or experimental). And potentially lots of caveats on use. That's not general public unrestricted use and return to cruising. And lots of drugs and biologicals fail at this stage. You want to fail earlier, frankly, as this is the expensive stage.

 

Things are looking promising, but a lot can still go wrong. And coronaviruses are really tricky. I'm staying hopeful, but there really needs to be more realism injected into this. I think it was an old Far Side math cartoon that had this huge incomprehensible formula leading to a big arrow "And then a miracle happens" and the solution...

[Ken the cruiser]

19 minutes ago, markeb said:

The AZ product shows completion of Phase III in August of 2021; same caveats on review.

August 2020 or 2021?

[markeb]

2021.

 

https://clinicaltrials.gov/ct2/show/NCT04400838?term=ChAdOx1+nCoV-19&cond=Covid19&draw=2&rank=2

 

Grabbed the Moderna link.

Edited July 24, 2020 by markeb

[cangelmd]

On 7/22/2020 at 10:12 AM, markeb said:

 

Thanks! The AZ trial is crazy! Definitely spending other people's money on that one to do that much essentially in parallel!!

 

Note the dates on both Phase III's though... This goes to an EUA this year at best if the 2021 and 2022 dates hold. Which doesn't sound like a CVS walkup for the general population anytime soon...

From what I have read there is unprecedented collaboration between the different trials, the manufacturers and the FDA. Phases II and Iii running as parallel trials, the FDA has already outlined many of its expectations for safety and efficacy, the trials sharing common goals or endpoints- Teerick would understand that much better than I, but I got the idea that they want all the successful vaccines to be fairly equal in potency if you will, and schedule, so people may acquire immunity by slightly different paths, but equal opportunity. Older folks are definitely being enrolled - we looked at my husband volunteering.

 

Someone asked about follow up testing. We have the capacity to do lots and lots of antibody testing, there’s just not much clinical reason to test. After vaccination, though, that’s when Ab tests may come into their own. Surveillance of the PhaseIi and Iii persons will show short term how long Abs hang around. If Abs are reasonable surrogates for immunity (understanding that much of the immunity may be cellular, not humoral, but Abs could be an easy measure), then Ab levels might be the immunity passport we keep hearing about.

 I do think 2 shots to start, over a few weeks is more likely than not, and boosters even as often as every 6 months could happen with the first gen vaccines.

Supply should be ok unless only one vaccine actually works - then we could have issues.

 

Finally, we need to consider vaccinating persons in the supply chain, especially for food, some of whom may be undocumented, but will be vital to be safe. I think teachers will be close behind healthcare and first responders

[cangelmd]

29 minutes ago, markeb said:

 

Pretty decent article, actually. There's a lot of "inside baseball" here that gets lost in the reporting. I'm cautiously optimistic, but share many of the concerns.

 

I think it was teerick who posted links to the actual clinical trial information. The Moderna vaccine candidate is scheduled to complete Phase III trials in October 2022, not including data analysis and filing of a Biological License Application (BLA). I believe all vaccine candidates are on "fast track" with the FDA, but that really just means more frequent meetings and the ability to file interim data along the way to expedite review.

 

The AZ product shows completion of Phase III in August of 2021; same caveats on review.

 

The "most likely", IMHO, path is approval of an Emergency Use Authorization, if the trial proceeds as expected, late fall to early winter. There are legal requirements for that; declaration of an emergency by the Secretary of HHS, some (not highly specified) initial safety and efficacy data, etc. And ordinarily a specified population. Not the same as a licensed product, but technically not investigational (or experimental). And potentially lots of caveats on use. That's not general public unrestricted use and return to cruising. And lots of drugs and biologicals fail at this stage. You want to fail earlier, frankly, as this is the expensive stage.

 

Things are looking promising, but a lot can still go wrong. And coronaviruses are really tricky. I'm staying hopeful, but there really needs to be more realism injected into this. I think it was an old Far Side math cartoon that had this huge incomprehensible formula leading to a big arrow "And then a miracle happens" and the solution...

Is this like a drug trial where they can stop the placebo arm early if efficacy is strong enough?

i guess that’s how I thought they would be ready to ship in the winter 2020-21

[markeb]

5 minutes ago, cangelmd said:

Is this like a drug trial where they can stop the placebo arm early if efficacy is strong enough?

i guess that’s how I thought they would be ready to ship in the winter 2020-21

 

My assumption is if they get statistical power in an arm of the study, they'll look to truncate and file the BLA. But if you look at the actual design of the AZ trial, that is an incredibly complicated trial! 

 

The EUA route is probably faster, but has its own risks. And adverse events in one of the arms of the study could really confuse things. Fingers really crossed here. I'm in a population that could really use this thing, if it's deemed safe for me...

[Ken the cruiser]

24 minutes ago, markeb said:

2021.

 

https://clinicaltrials.gov/ct2/show/NCT04400838?term=ChAdOx1+nCoV-19&cond=Covid19&draw=2&rank=2

 

Grabbed the Moderna link.

Interesting. In the article referenced at post #208, Dr Gilbert said "Gilbert has voiced remarkable confidence in her chances, saying the Oxford vaccine has an 80% probability of being effective in stopping people who are exposed to the novel coronavirus from developing Covid-19. She has said she could know by September. Asked by MPs in early July whether the world would have to struggle through the winter without a vaccine, Gilbert said, “I hope we can improve on those timelines and come to your rescue.”

[REEtired]

On 7/22/2020 at 10:02 AM, TeeRick said:

The ModernaTX vaccine will be administered to 30,000 adults 18 and older in phase III starting July 27.

 

https://clinicaltrials.gov/ct2/show/NCT04470427

 

There are multiple age groups (starting from age 5 and through elderly adults over 70) for the Astra Zenica Oxford Vaccine (now known as AZD1222).  There are 10,260 participants in phase II/III.  More to be announced for phase III's.

 

https://clinicaltrials.gov/ct2/show/NCT04400838?term=ChAdOx1+nCoV-19&cond=Covid19&draw=2&rank=2

TeeRick,  maybe it’s too early but any idea if this will be a live vaccine vs not a live vaccine like the flu shot. Shingles vaccine is a live vaccine which my oncologist says I should not get.  We have cancelled three cruises and hoping I can cruise with the covid19 vaccine. Fingers toes eyes and everything else crossed!  Thx.  Marie