Are vaccines the light at the end of the tunnel?

[Babr]

3 hours ago, TeeRick said:

Convenient time?  I personally find this pretty funny and no offense meant to you.  But you believe that fast tracking a vaccine for a globally deadly disease was because of political motivation, and in the US only?   Any release time is just fine for a vaccine that is effective.  Would you rather wait to release a vaccine until after an election?  Sorry but in my opinion that is just absurd but I do truly understand that lot of people in our country these days think that just everything has a devious political motive.  But I will trust the vaccine scientists and medical community.  Also it is easy to overlook a US centric position and actually see the vaccines(s) approval and distribution will be worldwide.  I will be happy for an approved vaccine at any date and time.  Period.

Actually, I do know it is a global problem and that scientists in many countries have been working on a solution. I am not so provincial as to think it is only happening here nor are we the only ones involved in the approval process. I just didn’t know the rest of the world was slated to release a vaccine by Nov. 1. Russia is the only country I know of that has stopped trials early and started vaccinating.

 

I, too, trust the scientists and the medical community. That is the point. I want them to be the ones who are making the decisions. We have already seen both the FDA and the CDC make statements/policies that were not fully supported by doctors and public health professionals - the same CDC that is now trying to tell us that most of those 185,000+ dead did not really die of Covid, rather their underlying conditions.
 

I truly hope you are right. God knows we need an end to this madness.

[grandgeezer]

34 minutes ago, Babr said:

Actually, I do know it is a global problem and that scientists in many countries have been working on a solution. I am not so provincial as to think it is only happening here nor are we the only ones involved in the approval process. I just didn’t know the rest of the world was slated to release a vaccine by Nov. 1. Russia is the only country I know of that has stopped trials early and started vaccinating.

 

I, too, trust the scientists and the medical community. That is the point. I want them to be the ones who are making the decisions. We have already seen both the FDA and the CDC make statements/policies that were not fully supported by doctors and public health professionals - the same CDC that is now trying to tell us that most of those 185,000+ dead did not really die of Covid, rather their underlying conditions.
 

I truly hope you are right. God knows we need an end to this madness.

 

The way I understand it is that they died of Covid, their underlying conditions made them more vulnerable to the virus and some of them would still be with us.

[npcl]

1 hour ago, Babr said:

Actually, I do know it is a global problem and that scientists in many countries have been working on a solution. I am not so provincial as to think it is only happening here nor are we the only ones involved in the approval process. I just didn’t know the rest of the world was slated to release a vaccine by Nov. 1. Russia is the only country I know of that has stopped trials early and started vaccinating.

 

I, too, trust the scientists and the medical community. That is the point. I want them to be the ones who are making the decisions. We have already seen both the FDA and the CDC make statements/policies that were not fully supported by doctors and public health professionals - the same CDC that is now trying to tell us that most of those 185,000+ dead did not really die of Covid, rather their underlying conditions.
 

I truly hope you are right. God knows we need an end to this madness.

Like many things social media just loves to take things out of context and make a big deal out of it. 

 

The multiple cause data collection is a standard function of CDC that predates COVID. It provides a valid medical information.

A release of such data is just that a release of statistical medical information. In this case comorbidity data. 

 

I have seen cases of others trying to make claims about COVID from that data, but have not seen any such claims that you are indicating from the CDC. A simple search indicates that it is others trying to use the data to make claims, not the CDC making such claims.

 

A good description of the data is here, in this case from the WONDER database

 

https://wonder.cdc.gov/wonder/help/mcd.html

 

 

There are clearly some cases where the CDC and FDA have made what I consider to be mistakes.  The FDA Commissioners statements about convalescent plasma for example.  The CDC trying issuing a moratorium on evictions is another. 42 CFR 70.2 and 42 U.S.C. 264 are to prevent interstate transmission and prevent entry into the US. Using it to prevent evictions inside of a state is clearly an attempt to extend CDC's authority in a way never done before.  I suspect that you will see court challenges on this one.

Edited September 3, 2020 by npcl

[Babr]

52 minutes ago, npcl said:

Like many things social media just loves to take things out of context and make a big deal out of it. 

 

The multiple cause data collection is a standard function of CDC that predates COVID. It provides a valid medical information.

A release of such data is just that a release of statistical medical information. In this case comorbidity data. 

 

I have seen cases of others trying to make claims about COVID from that data, but have not seen any such claims that you are indicating from the CDC. A simple search indicates that it is others trying to use the data to make claims, not the CDC making such claims.

 

A good description of the data is here, in this case from the WONDER database

 

https://wonder.cdc.gov/wonder/help/mcd.html

 

 

There are clearly some cases where the CDC and FDA have made what I consider to be mistakes.  The FDA Commissioners statements about convalescent plasma for example.  The CDC trying issuing a moratorium on evictions is another. 42 CFR 70.2 and 42 U.S.C. 264 are to prevent interstate transmission and prevent entry into the US. Using it to prevent evictions inside of a state is clearly an attempt to extend CDC's authority in a way never done before.  I suspect that you will see court challenges on this one.

You are correct. It is others who have misunderstood or misused the information from the CDC. While  Cruise Critic is as close as I come to social media, I must have taken part of a news story or a headline from somewhere else and conflated it with the new Covid advisor who is promoting herd immunity. I do not want to be part of any group that spreads misinformation so thanks for pointing that out.

 

Nevertheless, I think the FDA realizes they have a messaging problem that could impact their credibility. There have been some recent personnel changes to try to combat that.

[terrydtx]

Before I retired earlier this year I worked with several of our country's largest hospital and medical groups, including Baptist Health System, Methodist Health Systems and HCA. One of my contacts with one of the groups told me this week that they have been told by corporate management to be geared up to start administering vaccine immunization by November 1 in mass quantities. I think the light at the end of the tunnel just got brighter.

Edited September 4, 2020 by terrydtx

[terrydtx]

19 hours ago, Babr said:

Actually, I do know it is a global problem and that scientists in many countries have been working on a solution. I am not so provincial as to think it is only happening here nor are we the only ones involved in the approval process. I just didn’t know the rest of the world was slated to release a vaccine by Nov. 1. Russia is the only country I know of that has stopped trials early and started vaccinating.

 

I, too, trust the scientists and the medical community. That is the point. I want them to be the ones who are making the decisions. We have already seen both the FDA and the CDC make statements/policies that were not fully supported by doctors and public health professionals - the same CDC that is now trying to tell us that most of those 185,000+ dead did not really die of Covid, rather their underlying conditions.
 

I truly hope you are right. God knows we need an end to this madness.

I have seen reports that China has a vaccine and also has begun vaccinating. 

[TeeRick]

51 minutes ago, terrydtx said:

Before I retired earlier this year I worked with several of our country's largest hospital and medical groups, including Baptist Health System, Methodist Health Systems and HCA. One of my contacts with one of the groups told me this week that they have been told by corporate management to be geared up to start administering vaccine immunization by November 1 in mass quantities. I think the light at the end of the tunnel just got brighter.

While I truly hope this is true that a vaccine will be soon available this fall,  it is actually quite simple at this point to understand when current phase 3 trials end and data will be available for evaluation and then go through an approval process. Nothing will come sooner.  That is the true US (and EU and UK) timeline anyway.  (China and Russia might be different). But the current confusion is that in the US, the CDC just put all health systems and states on alert to prepare plans for vaccine administration starting in November but of course that is a best case scenario.   This will be very complex and getting approved plans in place will take time and effort and money.  And possibly a minefield of local politics.  

[TeeRick]

20 hours ago, Babr said:

Actually, I do know it is a global problem and that scientists in many countries have been working on a solution. I am not so provincial as to think it is only happening here nor are we the only ones involved in the approval process. I just didn’t know the rest of the world was slated to release a vaccine by Nov. 1. Russia is the only country I know of that has stopped trials early and started vaccinating.

 

I, too, trust the scientists and the medical community. That is the point. I want them to be the ones who are making the decisions. We have already seen both the FDA and the CDC make statements/policies that were not fully supported by doctors and public health professionals - the same CDC that is now trying to tell us that most of those 185,000+ dead did not really die of Covid, rather their underlying conditions.
 

I truly hope you are right. God knows we need an end to this madness.

Babr,

-The FDA, and other worldwide health authorities (like EMEA) will evaluate the data and make approvals based on safety and efficacy in the age groups and special condition groups as studied and powered in the phase 3 trials with sufficient statistical validation.  This data-driven process is not really going to be over-ruled by external or political influence (although it might be present and vocal of course).  The stakes are too high. Everybody will have the data and it will be published.  The only gray area will be in the "effectiveness" of the vaccine (ie, 60%, 75%, 90% etc).  This debate is already ongoing even before the data comes out.  

- Russia, has not really stopped vaccine trials.  It is semantics. They did a very small number of people in initial trials.  They are in reality vaccinating their population on the chance that their vaccine will work- so it is more like a very large phase 3 trial elsewhere.

https://www.cnbc.com/2020/09/04/russian-coronavirus-vaccine-shows-no-serious-side-effects-lancet-says.html

-The CDC and FDA does their very best IMO.  Yes there are occasional mis-steps but nothing unusual for medical professionals trying to deal with rapidly changing data and the normal scientific process.

Edited September 4, 2020 by TeeRick

[TeeRick]

Here is an update in an NPR interview with Dr. Moncef Slaoui the chief advisor in the US to Operation Warp Speed. This is a very interesting set of comments by an expert in the know.  He spent years at GSK developing various vaccines and is very well respected.  He does not expect that a vaccine will be available in sufficient quantities for the entire US population until mid-2021.  Hard to argue with that IMO.

 

https://www.npr.org/2020/09/03/909312697/operation-warp-speed-top-adviser-on-the-status-of-a-coronavirus-vaccine

[cangelmd]

Could it be that each of those answers is correct, and that each person is answering the question asked of them? Some vaccine early, exhaust that manufacturing capacity, don’t get completely caught up until mid-2021?

 

For example, it’s likely healthcare workers will get vaccinated first. Hospitals and health systems large and small vaccinate their employees all the time. The pharmacy dept is set up to vaccinate patients as needed also. All but the smallest institutions should be able to store and administer the vaccine as well as do the necessary paperwork and reporting back to health dept and CDC. Remember, 2 doses will be needed, someone has to keep up with all of that. Wouldn’t it make the most sense for health depts to turn much of that over to hospitals and concentrate on SNFs and prisons that don’t have the processes and systems to do this.?

It just seems to me that first doses might be ready in Nov, but go to the military and large hospital systems, large and well organized public health depts - organizations that can relatively quickly get the vaccine out.

This may exhaust the first doses, but could have a number good outcomes- work the kinks out of the system (and there will be issues and snafus). Allow more data collection on larger and larger numbers of people of various ethnicities and ages, oh, and get high Risk people vaccinated.

 

[npcl]

On 9/3/2020 at 9:22 AM, Babr said:

Actually, I do know it is a global problem and that scientists in many countries have been working on a solution. I am not so provincial as to think it is only happening here nor are we the only ones involved in the approval process. I just didn’t know the rest of the world was slated to release a vaccine by Nov. 1. Russia is the only country I know of that has stopped trials early and started vaccinating.

 

I, too, trust the scientists and the medical community. That is the point. I want them to be the ones who are making the decisions. We have already seen both the FDA and the CDC make statements/policies that were not fully supported by doctors and public health professionals - the same CDC that is now trying to tell us that most of those 185,000+ dead did not really die of Covid, rather their underlying conditions.
 

I truly hope you are right. God knows we need an end to this madness.

China has started to vaccinate their military prior to phase 3 trial completion

[npcl]

5 hours ago, cangelmd said:

Could it be that each of those answers is correct, and that each person is answering the question asked of them? Some vaccine early, exhaust that manufacturing capacity, don’t get completely caught up until mid-2021?

 

For example, it’s likely healthcare workers will get vaccinated first. Hospitals and health systems large and small vaccinate their employees all the time. The pharmacy dept is set up to vaccinate patients as needed also. All but the smallest institutions should be able to store and administer the vaccine as well as do the necessary paperwork and reporting back to health dept and CDC. Remember, 2 doses will be needed, someone has to keep up with all of that. Wouldn’t it make the most sense for health depts to turn much of that over to hospitals and concentrate on SNFs and prisons that don’t have the processes and systems to do this.?

It just seems to me that first doses might be ready in Nov, but go to the military and large hospital systems, large and well organized public health depts - organizations that can relatively quickly get the vaccine out.

This may exhaust the first doses, but could have a number good outcomes- work the kinks out of the system (and there will be issues and snafus). Allow more data collection on larger and larger numbers of people of various ethnicities and ages, oh, and get high Risk people vaccinated.

 

I would put it more in terms of:

 

If the Data and Safety Monitoring Boards for any of the trials find that the results are exceptionally good during one of their reviews. Good enough to trigger a trial primary  end point, early termination.  Then you might have a vaccine being released in November.

 

A possible, but not highly probable event.  But one that needs to be prepared for.  Thus the CDC notice about preparation.

 

If that does not occur the next time frame would late December/January when some of the trials are scheduled for their primary end point evaluation.

 

 

[cruise kitty]

On 9/2/2020 at 8:45 AM, Fouremco said:

From a CNN article https://www.cnn.com/2020/09/01/health/coronavirus-vaccine-allocation-nas/index.html on the National Academies of Sciences, Engineering, and Medicine committee's draft framework:

 

The 115-page report recommends allocation in four phases. 

 

In the first phase, vaccines would go to first responders, high-risk workers in health care facilities as well as people of all ages with conditions that put them at significantly higher risk of bad outcomes and older adults living in dense settings.

 

In the second phase the vaccine would be distributed to critical risk workers — workers who are both in industries essential to the functioning of society and at substantially high risk of exposure as well as teachers and school staff.

 

The second phase would also include people of all ages with conditions that put them at moderately higher risk; all older adults not included in Phase 1; people in homeless shelters or group homes for individuals with physical or mental disabilities or in recovery; and people in prisons, jails, detention centers, and similar facilities, and staff who work there.

 

Phase one and two combined would cover approximately 45% to 50% of the US population, the report notes.

 

So, in your opinion only, would household members of first responders be included i the first phase?  Asking for a friend lol ;)

[Fouremco]

3 minutes ago, cruise kitty said:

 

So, in your opinion only, would household members of first responders be included i the first phase?  Asking for a friend lol ;)

An interesting question. I suspect not, though, as after having been vaccinated, the first responders should no longer be high risk for catching and spreading the virus to anyone, including household members. No guarantees, of course, and we are a long way off from knowing the efficacy of whatever vaccine(s) will be approved.

 

My opinion only!  😷

[cruise kitty]

Just now, Fouremco said:

An interesting question. I suspect not, though, as after having been vaccinated, the first responders should no longer be high risk for catching and spreading the virus to anyone, including household members. No guarantees, of course, and we are a long way off from knowing the efficacy of whatever vaccine(s) will be approved.

 

My opinion only!  😷

 

thank you :)   I listened to the NPR interview yesterday & was a bit disheartened to hear that if there is a vaccine available in the U.S., I probably won't be able to get it until mid 2021, don't get me wrong, I'm grateful to be fit in my my mid fifties.... it does appear though, that my SIL (police officer) & DH will be able to get it earlier if all goes well.  

[Fouremco]

4 minutes ago, cruise kitty said:

 

thank you :)   I listened to the NPR interview yesterday & was a bit disheartened to hear that if there is a vaccine available in the U.S., I probably won't be able to get it until mid 2021, don't get me wrong, I'm grateful to be fit in my my mid fifties.... it does appear though, that my SIL (police officer) & DH will be able to get it earlier if all goes well.  

DW and I are in our 70s and both of us have underlying conditions putting us at increased risk of severe illness from COVID-19 should be catch it. I imagine that we would be included in one of the earlier phases, but Canadian health authorities haven't released a priority listing so far. I expect that it will be quite similar to the US model, but one never knows. I wish you and your family the best of luck getting early vaccinations!

 

[mimbecky]

2 hours ago, cruise kitty said:

 

thank you 🙂   I listened to the NPR interview yesterday & was a bit disheartened to hear that if there is a vaccine available in the U.S., I probably won't be able to get it until mid 2021, don't get me wrong, I'm grateful to be fit in my my mid fifties.... it does appear though, that my SIL (police officer) & DH will be able to get it earlier if all goes well.  

Cruise Kiitty, I am with you.  I am 63 just short of 65. Retired and healthy. I do volunteer at Navy/Marine Relief and USO but for the most part am not front line or essential by any means.  I think I am in the last phase- apparently even after children!!!

I have a cruise scheduled end of May.  I have my hopes up but won't travel without a vaccine.  I need to have final payment by mid February so may end up ditching it unless they have a definitely time line out which appears unlikely.

M

[cruise kitty]

4 minutes ago, mimbecky said:

Cruise Kiitty, I am with you.  I am 63 just short of 65. Retired and healthy. I do volunteer at Navy/Marine Relief and USO but for the most part am not front line or essential by any means.  I think I am in the last phase- apparently even after children!!!

I have a cruise scheduled end of May.  I have my hopes up but won't travel without a vaccine.  I need to have final payment by mid February so may end up ditching it unless they have a definitely time line out which appears unlikely.

M

 

We are in the same boat, so to speak :)   We have a cruise scheduled for May 4th, but we'd want to fly out at least a week before for pre cruise land travel.  If DH is vaccinated I'd be willing to take a chance as I don't have any co-morbidities...  however, I don't know if vaccines will be required for travel abroad, or if the countries involved will be accepting  people from the U.S. by then.  Fingers crossed for both of us to get to go :)  & more important, for us to stay healthy :)

[REEtired]

Hey gang, I hear you all. First I want to thank so many of our members who have  background in vaccine research and so many related fields. I have been following this thread hourly!  In our case, DH is a lung cancer survivor now with COPD but doing well. Uses an inhaler when necessary.  As for me,  I am under treatment (2 years now) for stage 4 metastatic breast cancer, and am doing Aok. We were on the Eclipse in March for Carnival in Rio.  Catching Covid19 is scary for us. We take all necessary precautions. Hopefully we will win the battle soon. 
 

[REEtired]

1 minute ago, REEtired said:

Hey gang, I hear you all. First I want to thank so many of our members who have  background in vaccine research and so many related fields. I have been following this thread hourly!  In our case, DH is a lung cancer survivor now with COPD but doing well. Uses an inhaler when necessary.  As for me,  I am under treatment (2 years now) for stage 4 metastatic breast cancer, and am doing Aok. We were on the Eclipse in March for Carnival in Rio.  Catching Covid19 is scary for us. We take all necessary precautions. Hopefully we will win the battle soon. 
 

Forgot to mention we are both early 70s.  And boy oh boy do we miss cruising!  But oncologist says no go w/o a vaccine. So we wait. 

[Arizona Wildcat]

2 hours ago, REEtired said:

Forgot to mention we are both early 70s.  And boy oh boy do we miss cruising!  But oncologist says no go w/o a vaccine. So we wait. 

DW in much the same situation. The good news is Glaxo and Sanofi said they expect to be able to deliver hundreds of millions of dose in the first 3 months.  Once approved there should be availability within months to the general public.  CDC estimated could have 8 billion doses by year end 2021.  That suggested to me that a booster might be needed.

[npcl]

22 minutes ago, Arizona Wildcat said:

DW in much the same situation. The good news is Glaxo and Sanofi said they expect to be able to deliver hundreds of millions of dose in the first 3 months.  Once approved there should be availability within months to the general public.  CDC estimated could have 8 billion doses by year end 2021.  That suggested to me that a booster might be needed.

If all of the different vaccines are found to be similarly effective.  If not then the number of available doses could be significantly smaller.

[TeeRick]

As a possible suggestion, to those folks who are otherwise healthy and not in a priority group,  perhaps volunteer for a phase 3 trial in your area.  If the vaccine works you will not need to wait until mid 2021.

[TeeRick]

10 hours ago, Arizona Wildcat said:

DW in much the same situation. The good news is Glaxo and Sanofi said they expect to be able to deliver hundreds of millions of dose in the first 3 months.  Once approved there should be availability within months to the general public.  CDC estimated could have 8 billion doses by year end 2021.  That suggested to me that a booster might be needed.

The Sanofi/GSK vaccine uses the most advanced traditional vaccine technology well proven in humans.  From that standpoint it is the most hopeful (to me anyway) along with Novavax.  Purified protein in adjuvant.  It might be a couple of months behind the mRNA vaccines (Moderna & Pfizer) and the adenovector vaccines (AZ/Oxford, Russian vaccine, China vaccine).  But it has major advantages going forward if it works.  The Novavax vaccine which is also traditional protein in adjuvant is a bit ahead and has produced good levels of neutralizing antibodies in early clinical studies.  All good news really.

 

https://www.barrons.com/articles/glaxosmithkline-and-sanofi-just-launched-the-first-human-trial-of-their-covid-19-vaccine-51599109200

 

https://www.gsk.com/en-gb/media/press-releases/sanofi-and-gsk-selected-for-operation-warp-speed-to-supply-united-states-government-with-100-million-doses-of-covid-19-vaccine/

 

https://www.barrons.com/articles/novavax-stock-is-jumping-again-on-positive-new-data-on-its-covid-19-vaccine-51599139151

[Arizona Wildcat]

22 hours ago, npcl said:

If all of the different vaccines are found to be similarly effective.  If not then the number of available doses could be significantly smaller.

There are numerous facilities FDA approved that can produce millions of does every month.  Availability in the US and Canada will not be an issue - no idea about elsewhere - as plenty contracted and US has small population and Canada smaller.

The issues with a vaccine are vaccines for viruses are usually are 60% of less effective along with the older the person the smaller the number of antibodies they produce.