Are vaccines the light at the end of the tunnel?

[mimbecky]

WOW just now got contacted for the Jassen vaccine trail.  My husband and I have appointments. My only concern is what happens if a viable vaccine comes out in the meantime.  They were pretty vague about if I would be unblinded for that etc. or be able to drop.  Gets complicated.

I even asked about proof of vaccine if wanting to travel.  They said they would issue a "proof of study participant".  I wonder how that would go over.....

I don't want to fill up the board with my personal concerns so...

My email is mimlauff at aol dot com

I would truly appreciate some input from people like TeeRick, markeb, before we make a final decision.  My husband and I would both be in last priority for eventual vaccine.  Trial is 50/50.

 

Thanks....

 

[nocl]

42 minutes ago, mimbecky said:

WOW just now got contacted for the Jassen vaccine trail.  My husband and I have appointments. My only concern is what happens if a viable vaccine comes out in the meantime.  They were pretty vague about if I would be unblinded for that etc. or be able to drop.  Gets complicated.

I even asked about proof of vaccine if wanting to travel.  They said they would issue a "proof of study participant".  I wonder how that would go over.....

I don't want to fill up the board with my personal concerns so...

My email is mimlauff at aol dot com

I would truly appreciate some input from people like TeeRick, markeb, before we make a final decision.  My husband and I would both be in last priority for eventual vaccine.  Trial is 50/50.

 

Thanks....

 

They cannot force you to remain in a clinical trail if you want to drop out.

 

The trial would only be unblinded when the clinical trial reaches the completion milestone.  Which at a minimum would take several months, but depend upon their exact protocol. Totally independent of what is going on with other vaccines and trials.

 

I suspect that proof of trial participant would not meet the requirements of a travel vaccination requirement, but have no information one way or another.  Of course if you are in the study and receive placebo you would not be protected during travel so should probably avoid travel while in the study.

 

I expect that soon you will see vaccine trials changed from being placebo based trials to comparison trials for exactly this reason.  It is one thing to volunteer for a trial when no vaccine exists.  It is far more difficult to recruit a placebo trial when a valid vaccine exists, since basically you be asking half of the volunteers to be unprotected (since they would not which half basically the entire study population would be unsure).

Edited November 24, 2020 by nocl

[mimbecky]

Sorry....BTW it is the one dose study.

M

 

[nocl]

1 hour ago, mimbecky said:

 Yes, seems we would eventually run out of "safe" but "unrecognized" adenoviruses to carry in the spike. ??

Changing the vaccine to use a different adenovirus would basically change it to be a different vaccine and would require new clinical trials.

[TeeRick]

1 hour ago, nocl said:

Changing the vaccine to use a different adenovirus would basically change it to be a different vaccine and would require new clinical trials.

Yes unless the trial was initially designed that way like the Russian Sputnik vaccine (and maybe others) that use different adenovectors in the first and second dose.  But I think this is much harder to keep track of once these vaccines are approved and marketed.

[TeeRick]

4 hours ago, Ken the cruiser said:

Not taking anything away from the progress made by Pfyzer and Moderna, but hearing about AstraZeneca's progress yesterday was definitely very uplifting, especially from a global perspective. One big reason was this:

 

What’s more, the AstraZeneca/Oxford vaccine cuts transmission of the virus by reducing the number of asymptomatic infections, the vaccine developers reported. “That’s critical because we know that a lot of transmission of SARS-CoV-2 is from asymptomatic people,” said Gandhi during a Nov. 23 news briefing of the Infectious Diseases Society of America. It’s unclear whether the vaccines from Pfizer or Moderna reduce transmission.

 

Another reason was this: 

AstraZeneca’s vaccine may be easier to distribute than those from Pfizer and its German collaborator BioNTech and from Moderna because the vaccine doesn’t need to be frozen as the other two do (SN: 11/16/20; SN: 11/18/20; SN: 11/20/20). It can be stored at temperatures found in regular refrigerators, unlike the special freezers needed for the Pfizer vaccine.

AstraZeneca says it has the capacity to produce 3 billion doses of its vaccine in 2021.

 

But, it's all good

 

https://www.sciencenews.org/article/coronavirus-covid-19-oxford-astrazeneca-vaccine-effective

 

 

Just a note of caution here.  The AZ vaccine data needs to be actually released and in particular the data on the transmission of virus, before we get completely excited.  The trial was designed with more frequent nasal swabs so maybe they did enough virus PCR testing to look at transmission particularly in asymptomatic participants.  Waiting to see how it plays out.  But it is good to be hopeful.   Now the leap of faith(or science really) is that if the AZ adenovector vaccine produces an effective enough immune response to reduce infection and transmission, then it is somewhat as likely that the mRNA vaccines will do the same thing since they also have highly effective immune responses against the exact same antigen (SPIKE).  Just because the trials of the two mRNA vaccines did not measure viral swabs frequently this does not mean they are deficient in some way.  That's what I have been saying here as well as others here who have commented.

[nocl]

32 minutes ago, TeeRick said:

Just a note of caution here.  The AZ vaccine data needs to be actually released and in particular the data on the transmission of virus, before we get completely excited.  The trial was designed with more frequent nasal swabs so maybe they did enough virus PCR testing to look at transmission particularly in asymptomatic participants.  Waiting to see how it plays out.  But it is good to be hopeful.   Now the leap of faith(or science really) is that if the AZ adenovector vaccine produces an effective enough immune response to reduce infection and transmission, then it is somewhat as likely that the mRNA vaccines will do the same thing since they also have highly effective immune responses against the exact same antigen (SPIKE).  Just because the trials of the two mRNA vaccines did not measure viral swabs frequently this does not mean they are deficient in some way.  That's what I have been saying here as well as others here who have commented.

Will be interesting to see when Moderna has its advisory meeting to see if they discuss any of the serology information that they are collecting during the trial for one of its secondary objectives. That information should identify asymptomatic infection.

[Ken the cruiser]

39 minutes ago, TeeRick said:

Just a note of caution here.  The AZ vaccine data needs to be actually released and in particular the data on the transmission of virus, before we get completely excited.  The trial was designed with more frequent nasal swabs so maybe they did enough virus PCR testing to look at transmission particularly in asymptomatic participants.  Waiting to see how it plays out.  But it is good to be hopeful.   Now the leap of faith(or science really) is that if the AZ adenovector vaccine produces an effective enough immune response to reduce infection and transmission, then it is somewhat as likely that the mRNA vaccines will do the same thing since they also have highly effective immune responses against the exact same antigen (SPIKE).  Just because the trials of the two mRNA vaccines did not measure viral swabs frequently this does not mean they are deficient in some way.  That's what I have been saying here as well as others here who have commented.

So if they didn’t test for asymptotic symptoms in the two mRNA trials, how will they know if they are effective against asymptotic transmissions?

[nocl]

1 hour ago, Ken the cruiser said:

So if they didn’t test for asymptotic symptoms in the two mRNA trials, how will they know if they are effective against asymptotic transmissions?

Moderna did have a secondary objective to test for infection using serology with blood samples taken at various times throughout the trial. 

 

Based upon the efficacy I expect that it have some protection against infection, but that still needed to be proven by appropriate trials

 

Other than that it will take additional research.

 

 

[markeb]

1 hour ago, Ken the cruiser said:

So if they didn’t test for asymptotic symptoms in the two mRNA trials, how will they know if they are effective against asymptotic transmissions?

 

More research, or ultimately you'll be able to infer it from epidemiology; if vaccine rates approach the 60-70% of the population that would stop sustained transmission, and the vaccines stop individuals from transmitting, you'll see decreases in the PCR and serological positive population overall, and obviously the disease prevalence, including in the unvaccinated.

 

That's long term, unfortunately. I'll say again that in pretty much every other case I can think of, you would have had years of basic and applied research on the virus and the disease before ever starting serious vaccine development. So we're likely going to have multiple vaccines that control the disease symptoms and decrease morbidity and mortality (very good), but a lot of uncertainty from gaps in basic research (the tradeoff).

 

I think there's still some uncertainty of whether or not recovered RNA on PCR from previously infected (and now vaccinated) individuals represents competent virus, which concerns me a little bit with a swab and PCR strategy. And there's no reasonable way they're going to do viral cultures to test for viability. Serology for antibodies directed against some "other than SPIKE" component could be a good surrogate for whether or not there was significant infection in the vaccinated population. But a lot of work to prove what we all think will be true.

[UnorigionalName]

19 minutes ago, markeb said:

I think there's still some uncertainty of whether or not recovered RNA on PCR from previously infected (and now vaccinated) individuals represents competent virus, which concerns me a little bit with a swab and PCR strategy. And there's no reasonable way they're going to do viral cultures to test for viability. Serology for antibodies directed against some "other than SPIKE" component could be a good surrogate for whether or not there was significant infection in the vaccinated population. But a lot of work to prove what we all think will be true.

 

I think the roche pcr uses the E and ORF1a/b gene, not S.  I believe most systems are not using S. Just need to make sure you're not looking for S, should be pretty easy to do.  Same with antigen testing, similar to HepB testing, just look for N or anti-N instead of S.

[LGW59]

2 hours ago, UnorigionalName said:

 

I think the roche pcr uses the E and ORF1a/b gene, not S.  I believe most systems are not using S. Just need to make sure you're not looking for S, should be pretty easy to do.  Same with antigen testing, similar to HepB testing, just look for N or anti-N instead of S.

sure sounds easy to me

[mimbecky]

When vaccines become more available, will the general public be able to receive them under the upcoming  EUAs, or will the companies need to submit more data or do something else to have it be approved for general use market?

M

[markeb]

16 minutes ago, mimbecky said:

When vaccines become more available, will the general public be able to receive them under the upcoming  EUAs, or will the companies need to submit more data or do something else to have it be approved for general use market?

M

It depends on the limitations of the EUA. I think some of us discussed that a couple of pages up. The FDA could expand the EUA once granted, and I’m pretty sure it will be granted. Or it could expedite the Biological License Application or BLA to full licensure. The BLA would require a complete data package.
 

No universal answer.  

[TeeRick]

18 hours ago, nocl said:

Will be interesting to see when Moderna has its advisory meeting to see if they discuss any of the serology information that they are collecting during the trial for one of its secondary objectives. That information should identify asymptomatic infection.

Yes agree.  But that hopefully also includes a look at T-Cells as well as Antibodies.

[TeeRick]

11 hours ago, mimbecky said:

When vaccines become more available, will the general public be able to receive them under the upcoming  EUAs, or will the companies need to submit more data or do something else to have it be approved for general use market?

M

I am thinking that if EUA's get approved for any or all of these vaccines, they will be distributed in the US and the individual states will start vaccinating according to their pre-determined priorities as quick as they can.  If you mean general public - as in those of us not in group 1 or group A or whatever they call it, then that really is the question.  What will the EUA say about this? When can I qualify?  Can I sign up if there are excess doses available beyond these initial groups after two shots?  I guess we will know soon enough.  So no need to speculate.  Just leads to confusion.

[TeeRick]

13 hours ago, LGW59 said:

sure sounds easy to me

Yes some of us continue to speak another language and please call us out on that whenever possible.😀

[mimbecky]

18 minutes ago, TeeRick said:

I am thinking that if EUA's get approved for any or all of these vaccines, they will be distributed in the US and the individual states will start vaccinating according to their pre-determined priorities as quick as they can.  If you mean general public - as in those of us not in group 1 or group A or whatever they call it, then that really is the question.  What will the EUA say about this? When can I qualify?  Can I sign up if there are excess doses available beyond these initial groups after two shots?  I guess we will know soon enough.  So no need to speculate.  Just leads to confusion.

No not speculating about priority distribution, just wondering at what point an EUA would no longer be considered "emergency", and if more work would need to be done to get out of the status or if being that status would effect or slow down distribution at all.

[TeeRick]

1 minute ago, mimbecky said:

No not speculating about priority distribution, just wondering at what point an EUA would no longer be considered "emergency", and if more work would need to be done to get out of the status or if being that status would effect or slow down distribution at all.

Yes I was referring to me speculating on this. Sorry.  The EUA will eventually be replaced with a full approval (hopefully).  It might specify in the EUA what is needed to get that- see I am speculating again!

[mimbecky]

On 11/8/2020 at 5:41 AM, TeeRick said:

Thank you Liz.  The question is whether this viral shedding in feces can be studied and validated as a reliable clinical outcome. 

 

Now what if this method is possible to validate and use on entire cruise ships and test their waste stream perhaps a few times a day?  If it is negative than the ship will be safe for cruise passengers and crew on board.  If positive they know COVID on board and further testing required.  Interesting!

I received an email yesterday and remembered these postings.  Thought you might be interested ...

 

"UC San Diego alerted students, faculty and staff that the university’s wastewater monitoring system detected coronavirus in multiple sites and urged those potentially exposed to get tested."

UCSD Monitoring Detects Coronavirus in 5 Areas, Urges Students to Get Tested - Times of San Diego

 

[TeeRick]

2 hours ago, mimbecky said:

I received an email yesterday and remembered these postings.  Thought you might be interested ...

 

"UC San Diego alerted students, faculty and staff that the university’s wastewater monitoring system detected coronavirus in multiple sites and urged those potentially exposed to get tested."

UCSD Monitoring Detects Coronavirus in 5 Areas, Urges Students to Get Tested - Times of San Diego

 

Thanks.  Yes I think the waste stream is a good first screen for pooling large areas.  Thanks!

[TeeRick]

AZ/Oxford vaccine - the lower 1/2 dose was due to manufacturing error.  Not such good news for an EUA in the US in my opinion.  

 

https://www.usatoday.com/story/news/health/2020/11/26/astrazeneca-covid-19-vaccine-candidate-dose-error-raises-questions/6431858002/

[TeeRick]

HAPPY THANKSGIVING to those of you in the USA that follow this thread!

[Ken the cruiser]

19 minutes ago, TeeRick said:

HAPPY THANKSGIVING to those of you in the USA that follow this thread!

Happy Thanksgiving to you and your family as well!!

[Homosassa]

17 minutes ago, TeeRick said:

AZ/Oxford vaccine - the lower 1/2 dose was due to manufacturing error.  Not such good news for an EUA in the US in my opinion.  

 

https://www.usatoday.com/story/news/health/2020/11/26/astrazeneca-covid-19-vaccine-candidate-dose-error-raises-questions/6431858002/

In the long run, that error may prove to be a good thing for response to the vaccine.  However, until there is enough data from a larger number of test subjects, a request for a EUA based upon the lower dose first shot will be delayed.