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Are vaccines the light at the end of the tunnel?


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There was a meeting of the vaccine advisory committee on October 22.

 

This link is for the meeting announcement 

https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-october-22-2020-meeting-announcement

 

In the announcement there is the recording  to the entire meeting (8 hours 50 minutes)

 

https://youtu.be/1XTiL9rUpkg

 

There were some concerns raised. Primarily the short duration of the trials for 1. collecting safety data and 2. for determining duration of immune response.  There were also some concerns about demographic participation, and some on study design and the focus on symptoms as measures and not actual infection.

 

With the design of the trials making determining duration of response difficult.  One of the recommendations is to not vaccinate those that received placebo (counter to current plans by the pharmaceutical companies), and to continue the trial to continue to collect safety information and to be able to determine duration of immune response. (Start listening around 7:15 for some really interesting discussion)

 

This video should answer many questions that have been discussed here.

 

This also points out how open the FDA process really is and the proposed actions by some states to block release of the vaccine in their states until approved by their own committees is a bit inane.

Edited by nocl
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2 hours ago, TeeRick said:

I am worried about the states (and now cities) setting a precedent by adding levels of unnecessary regulation and review.  And time.  Will this over reach stop with the COVID vaccine?  Or will we have 50 mini FDA's setting up their own drug approval boards at the whim of their governors?  Yes you can get the new colon cancer drug in Ohio but it is not approved yet by the board in Illinois.  Insurance Nightmare.  Patient Nightmare. 

I doubt that it will come to that, I truly do. Posturing in NY, and California always has to look more “consumer” friendly than the rest of the country. I’m not sure even state law can supersede the FDA, Pure Food and Drug Act, Interstate Commerce, etc.

The thing I would worry about if I lived in one of those states is whether or not a biotech company with a vaccine lagging in the race or stopped, can exert influence on this blue ribbon panel to slow implementation of a more successful rival. But I’m devious as well as being petty.

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OK today's very good news is that the Moderna vaccine phase 3 has completed enrollment of 30,000 subjects!

 

The company released a public short slide show that goes into a lot of detail of the ages, races, health status, etc and a map of US states of those enrolled.  Very informative.

2020-COVE-Study-Enrollment-Completion-10.22.20.pdf

Edited by TeeRick
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18 hours ago, cangelmd said:

All good news about resumed trials. Mode RNA’s looks like it has a hefty number of at risk persons in the trial. Counting down to results!

Yes but of interest nobody under 18 yrs old was enrolled in this Moderna study.  I do think other ongoing studies will include or have included pediatric and adolescent subjects.  But since the hospitalization and mortality rates are so very low in the younger population the number of these subjects would need to be much much higher for statistically significant results.  So there will need to be focused follow up studies.  And a lot more safety data before vaccinating young kids in trials.  On the other hand if these trials produce immunological readouts that are confirmed correlates of a protection readout, then future studies will proceed quickly.

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I am including a video- if it will post. It is a bit lengthy and basically about mask wearing.  I am not posting because of that...we all have our opinions.  However, if you get towards the end, Fauci talks about the top 3 vaccines and says 2 appear currently to have 60 percent efficacy and the other closer to 50.  I was a bit bummed.  Anyone hear anything else from a reputable source? I think this was recorded Oct. 22.

 

 

 

Edited by mimbecky
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"I am including a video- if it will post. It is a bit lengthy and basically about mask wearing.  I am not posting because of that...we all have our opinions.  However, if you get towards the end, Fauci talks about the top 3 vaccines and says 2 appear currently to have 60 percent efficacy and the other closer to 50.  I was a bit bummed.  Anyone hear anything else from a reputable source? Not sure when this was recorded but sounds recent."

 

But keep in mind that even vaccines with an effective rate of 50-60% will still very likely provide some level of immunity to everyone, so that if you do get sick you are much less likely to become seriously ill or die.  That is a huge step in the right direction.  Plus, many people have already had the virus and have some level of immunity for some period of time (still not really known).  Add all this up together and maybe it will help you be less bummed🙂

 

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mimbecky,  Thanks for sharing!

If you are referring to Dr Fauci's answer at around 9 mins in the video, he does not say anything about the actual clinical trial data of the current potential vaccines.  What he says is that the trials are powered to see efficacy at a minimum of 50% and some higher and he would love to see 75% or higher.  He has said this in many of his public presentations.  Nobody has knowledge yet of the efficacy data from these blinded trials including Dr. Fauci.    He is trying to point out that the level of vaccine-acquired herd immunity in a population will depend on the % efficacy of the vaccine and the number of people vaccinated overall plus the number with naturally acquired immunity (from infection).  

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13 minutes ago, TeeRick said:

mimbecky,  Thanks for sharing!

If you are referring to Dr Fauci's answer at around 9 mins in the video, he does not say anything about the actual clinical trial data of the current potential vaccines.  What he says is that the trials are powered to see efficacy at a minimum of 50% and some higher and he would love to see 75% or higher.  He has said this in many of his public presentations.  Nobody has knowledge yet of the efficacy data from these blinded trials including Dr. Fauci.    He is trying to point out that the level of vaccine-acquired herd immunity in a population will depend on the % efficacy of the vaccine and the number of people vaccinated overall plus the number with naturally acquired immunity (from infection).  

 

I went back and listened again....you are right.  Thank goodness as what they are "geared to detect" and where they may end up could be significantly different.  

There is another forum on Princess regarding vaccines that started recently.  I happened across it and let them know about this one.  We may have an influx of new followers. I have been impressed by how informative and respectful this forum has been!

Thanks to all of you....

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50 minutes ago, TeeRick said:

Yes but of interest nobody under 18 yrs old was enrolled in this Moderna study.  I do think other ongoing studies will include or have included pediatric and adolescent subjects.  But since the hospitalization and mortality rates are so very low in the younger population the number of these subjects would need to be much much higher for statistically significant results.  So there will need to be focused follow up studies.  And a lot more safety data before vaccinating young kids in trials.  On the other hand if these trials produce immunological readouts that are confirmed correlates of a protection readout, then future studies will proceed quickly.

Didn’t the Pfizer or JandJ just start adding persons under 18? Looking at the proposed schema for vaccination order, that was the most glaring thing I saw - no approved vaccine for under 18, gotta rearrange that order! Can’t physicians get vaccine for children with serious underlying conditions on a compassionate use basis? Most would be reluctant to do that with NO pediatric data, I would think.

21 minutes ago, phoenix_dream said:

"I am including a video- if it will post. It is a bit lengthy and basically about mask wearing.  I am not posting because of that...we all have our opinions.  However, if you get towards the end, Fauci talks about the top 3 vaccines and says 2 appear currently to have 60 percent efficacy and the other closer to 50.  I was a bit bummed.  Anyone hear anything else from a reputable source? Not sure when this was recorded but sounds recent."

 

But keep in mind that even vaccines with an effective rate of 50-60% will still very likely provide some level of immunity to everyone, so that if you do get sick you are much less likely to become seriously ill or die.  That is a huge step in the right direction.  Plus, many people have already had the virus and have some level of immunity for some period of time (still not really known).  Add all this up together and maybe it will help you be less bummed🙂

 

Also, unlike flu where vaccines are chasing new viruses every year, there is likely some tweaking room to improve the efficacy of the Covid vaccine by changing the dosing or the constituents.

 

moving into the realm of speculation, I think there is emerging evidence that most immunity is cellular, therefore we can’t easily measure it and there is little immunity to reinfection, but more (?a lot) immunity to severe disease. What this may mean is that children and younger adults will gradually become functionally immune, and may not need vaccinations unless an individual has underlying immunocompromise. Then those of us over  say, 50, will need lifelong vaccination. Then, our kids and grandkids in turn, may need vaccines as they age - much like how pneumonia vaccines work now.

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40 minutes ago, cangelmd said:

Didn’t the Pfizer or JandJ just start adding persons under 18? Looking at the proposed schema for vaccination order, that was the most glaring thing I saw - no approved vaccine for under 18, gotta rearrange that order! Can’t physicians get vaccine for children with serious underlying conditions on a compassionate use basis? Most would be reluctant to do that with NO pediatric data, I would think.

Also, unlike flu where vaccines are chasing new viruses every year, there is likely some tweaking room to improve the efficacy of the Covid vaccine by changing the dosing or the constituents.

 

moving into the realm of speculation, I think there is emerging evidence that most immunity is cellular, therefore we can’t easily measure it and there is little immunity to reinfection, but more (?a lot) immunity to severe disease. What this may mean is that children and younger adults will gradually become functionally immune, and may not need vaccinations unless an individual has underlying immunocompromise. Then those of us over  say, 50, will need lifelong vaccination. Then, our kids and grandkids in turn, may need vaccines as they age - much like how pneumonia vaccines work now.

It will take a few years but I would speculate on the most effective COVID vaccine being a prime-boost with different vaccines.  This would have to be done in new clinical trials first.  The prime dose (say mRNA -Moderna vaccine or Ad-vector vaccine -AZ) then followed up with a protein subunit vaccine (like Novavax or GSK).  Maybe primed once to set the T-Cell immunity.  The subunit vaccine might need to be changed yearly or every few years depending on the changes to Spike protein antibody response.  Again just speculating.  

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3 hours ago, mimbecky said:

 

I went back and listened again....you are right.  Thank goodness as what they are "geared to detect" and where they may end up could be significantly different.  

There is another forum on Princess regarding vaccines that started recently.  I happened across it and let them know about this one.  We may have an influx of new followers. I have been impressed by how informative and respectful this forum has been!

Thanks to all of you....

 

There used to be one on the Princess board that started about the same time as this one. I was reading on both of them at the time. Unfortunately, the Princess one got shut down because it suddenly became political. 

☹️  Hopefully, this one can keep from having that happen. It's such a wonderful source of information. Thanks to everyone, especially those of you who have experience with vaccines / drugs in the 'real' world. 

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6 hours ago, phoenix_dream said:

"I am including a video- if it will post. It is a bit lengthy and basically about mask wearing.  I am not posting because of that...we all have our opinions.  However, if you get towards the end, Fauci talks about the top 3 vaccines and says 2 appear currently to have 60 percent efficacy and the other closer to 50.  I was a bit bummed.  Anyone hear anything else from a reputable source? Not sure when this was recorded but sounds recent."

 

But keep in mind that even vaccines with an effective rate of 50-60% will still very likely provide some level of immunity to everyone, so that if you do get sick you are much less likely to become seriously ill or die.  That is a huge step in the right direction.  Plus, many people have already had the virus and have some level of immunity for some period of time (still not really known).  Add all this up together and maybe it will help you be less bummed🙂

 

 

 

However, also keep in mind two other issues. 

 

1. the criteria - the studies are using symptoms, a somewhat subjective criteria to determine infection or not, instead of confirmed infection.  This is one of the issues raised by the vaccine advisory committee. They are not including asymptomatic infections at all.  While a vaccine that prevents moderate illness would have some benefit, the criteria might mean less benefit than one might expect.

 

2. Duration of response - One would expect the vaccine to be most effective in time frames right after the period for the second inoculation to be effective.  There is no information of duration of response so 50 or 60% two months after inoculation might fall off and be less than the 50% figure 4 or 5 months out. This was also raised by the Vaccine advisory committee.

 

Not sure where he would be getting that info, if he is not on the Monitoring and Safety Board which is the only group that should have access to any efficacy data at this time .

Edited by nocl
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On 10/19/2020 at 7:48 PM, LGW59 said:

I just want to get back to cruising here, I'm leaving scince to the experts, on here I wish to focus on the CC topic..."sailing takes me away to where I've always heard it could be, just a dream and the wind to carry me"  

Ironic that you quoted that song. Christopher Cross was infected back in March and was paralyzed. He has regained feeling, but still has difficulty walking. I guess he would be considered a “long-hauler”. Fortunately, he can sing again.

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On 10/21/2020 at 9:33 AM, TeeRick said:

Suggest you get the shot in the arm that you use less.  My dw and I just got Shingrix this year and both shots gave us quite a painful local reaction that lasted several days.

Good idea. My Shingrix injections hurt, but I didn’t get the sore arm that I get from the flu vaccine. A minor inconvenience when compared to the health benefit for me (and the flu vaccine also helps protect others).

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9 hours ago, TeeRick said:

Yes but of interest nobody under 18 yrs old was enrolled in this Moderna study.  I do think other ongoing studies will include or have included pediatric and adolescent subjects.  But since the hospitalization and mortality rates are so very low in the younger population the number of these subjects would need to be much much higher for statistically significant results.  So there will need to be focused follow up studies.  And a lot more safety data before vaccinating young kids in trials.  On the other hand if these trials produce immunological readouts that are confirmed correlates of a protection readout, then future studies will proceed quickly.

I do believe from when I read the trial information on clinicaltrials.gov that the enrollment criteria specified 18 and over.

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44 minutes ago, Porky55 said:

I think this is good news perhaps in the return to cruising (and the disappearance of 6” cotton swabs in painful places)

https://www.uts.edu.au/news/health-science/spot-coronavirus-test-within-spitting-distance

 

 

 

 

My state is doing saliva testing. It just started in the last couple of months. They just announced that some counties are eligible to request tests from home that they can mail back. They are being processed in a new facility being built in the state. 

https://www.health.state.mn.us/diseases/coronavirus/testsites/saliva.html

 

 

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6 hours ago, dreaminofcruisin said:

 

My state is doing saliva testing. It just started in the last couple of months. They just announced that some counties are eligible to request tests from home that they can mail back. They are being processed in a new facility being built in the state. 

https://www.health.state.mn.us/diseases/coronavirus/testsites/saliva.html

 

 

This is good news, but these tests have been around for some time and are referred to as ‘drool saliva’ - you spit into a tube. And the results are still taking 48 to 72 hours. This definitely won’t allow us to board a cruise ship.

 

The Australian test will be carried out the same way as a saliva drug test, with a swab of the inside of the mouth / tongue and results within 10 MINUTES.

This test is the type that will get us back cruising.

Edited by Porky55
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19 hours ago, mimbecky said:

I am including a video- if it will post. It is a bit lengthy and basically about mask wearing.  I am not posting because of that...we all have our opinions.  However, if you get towards the end, Fauci talks about the top 3 vaccines and says 2 appear currently to have 60 percent efficacy and the other closer to 50.  I was a bit bummed.  Anyone hear anything else from a reputable source? I think this was recorded Oct. 22.

 

60% is better than expected.  The expected was 50%.  Under the circumstances, it's pretty amazing.

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

 

60% is better than expected.  The expected was 50%.  Under the circumstances, it's pretty amazing.

Kevin- go back to post 1138 if you have not watched the video.  That was not what Fauci said.

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