Are vaccines the light at the end of the tunnel?

[markeb]

1 hour ago, TeeRick said:

I know this is a vaccine thread but I think the availability of an oral specific anti-viral pill against the SARS-CoV-2 virus is as much of a game changer as a highly efficacious vaccine.  I have posted about this before.  The class of anti-viral drugs called protease inhibitors are being tested in the clinic by several companies.  Pfizer says the one they are testing could be approved later this year.  This will go a long way to getting normal travel and cruising going again.  Vaccines and oral antiviral drugs with high specificity.

 

https://www.cnbc.com/2021/04/27/pfizer-at-home-covid-pill-could-be-available-by-year-end-ceo-albert-bourla-says.html?recirc=taboolainternal

 

 

Have you seen any details on how they're using this? One of the problems with a lot of promising early stage antivirals historically is you couldn't match the therapeutic window with a reasonable trigger to treat. Just curious...

[markeb]

1 hour ago, TeeRick said:

Here is my suspicion:   The discussion of the need for a potential booster (at 1 year?  Why this timing?) is coming from the CEO's and business officials of these companies. 

 

The cynic in me thinks that's the reasoning behind the 6 month dose. That's definitely timed where they could go in for a 0, 21 (or 28) day, and 180 day series. With data to support all three doses from their individual products...

 

When you go to a year or more, I think you're looking at crossover studies between the products to show boosting effectiveness, probably antibody titer only, so not big initial trials.

[harkinmr]

6 minutes ago, K.T.B. said:

 

CDC has no regulatory authority over cruise lines though, which is the frustration.  Their authority is strictly health related.  If cruise lines can prove their ability to sail safely (i.e. foreign port cruises), the CDC should look into it IF they seriously are willing to work with cruise lines.  That doesn't seem to be the case though....

They most certainly do have regulatory authority over cruise lines.  Just look at the Vessel Sanitation Program that the lines are already subject to.  The CDC has very broad authority to regulate interstate and international commerce in order to manage infectious diseases, including the authority to approve methods for the restart of cruises within the context of this pandemic.

 

The CDC will likely take the success (or failure) of cruises taking place in the summer from outside the US into account in their ongoing discussions with the cruise lines.

[Ken the cruiser]

15 minutes ago, K.T.B. said:

 

That JHU link is extremely interesting.  I'm also very disappointed that Illinois only has a quarter of its population fully vaccinated.

Here's the Bloomberg vaccine link. Don't feel too bad. It appears Illinois is doing a lot better than Alabama and a lot of the southern states. NOTE: You have to go about half way down to see the state map.

 

More Than 1.06 Billion Shots Given: Covid-19 Vaccine Tracker (bloomberg.com)

Edited April 28, 2021 by Ken the cruiser

[TeeRick]

24 minutes ago, markeb said:

 

Have you seen any details on how they're using this? One of the problems with a lot of promising early stage antivirals historically is you couldn't match the therapeutic window with a reasonable trigger to treat. Just curious...

No but the details are quite important.  The approved protease inhibitors for HIV and HCV are lengthy protocols and very expensive.  But these are very tough viruses to treat.  And drug resistance becomes a problem too.   Hopefully a simpler and effective oral drug for SARS-CoV-2 will be much less expensive.  Something akin to Tamiflu.  

 

Here is a link to Pfizer's clinical study.

https://clinicaltrials.gov/ct2/show/NCT04756531

Edited April 28, 2021 by TeeRick

[nocl]

1 hour ago, TeeRick said:

OK my rather suspicious view on boosters.   The data from clinical trials on antibodies that has been published by Pfizer and Moderna is excellent at 6 months post second dose.  Presumably same for T-Cells but not a lot of published data.  Maybe 9 month data soon?   Here is my suspicion:   The discussion of the need for a potential booster (at 1 year?  Why this timing?) is coming from the CEO's and business officials of these companies.  They cannot talk about additional inside data even if they had it.  So what better than to keep investors excited and the stock price elevated than throwing around the potential long term need for a booster or yearly boosters?  Get the public thinking that way?  Compare it to yearly influenza vaccines?  Even before anybody knows there is an actual need? 

This all gets more complicated with variant viruses of course.  There might be a need now (not after 1 year) to have a variant vaccine available and tested.   Or a booster (third dose) of the current vaccine to elevate antibodies even higher to make up for weaker binding to the variant SPIKE.   We know that clinical trials have been started with a variant vaccine or extended with a third dose of the current vaccines.   So the data will be interesting but should be the only thing that guides this booster discussion.  Fully vaccinated people are worried needlessly right now that they will come up to a year and will need another shot before travelling.  Based on what?

I doubt they would go through the expense of a clinical trial looking at a booster at 6 to 12 months if they were not seeing signs of immunity drop off in the initial clinical trial population in that window. The FDA will not ok a booster if there is not data that both shows the medical need (drop off of immunity from the original vaccinations) as well as the benefit of the booster.

 

 

[TeeRick]

2 minutes ago, nocl said:

I doubt they would go through the expense of a clinical trial looking at a booster at 6 to 12 months if they were not seeing signs of immunity drop off in the initial clinical trial population in that window. The FDA will not ok a booster if there is not data that both shows the medical need (drop off of immunity from the original vaccinations) as well as the benefit of the booster.

 

 

Maybe.  But my point is that there is no published data on immunity waning at this point.  And the time frame.

[nocl]

5 minutes ago, TeeRick said:

No but the details are quite important.  The approved protease inhibitors for HIV and HCV are lengthy protocols and very expensive.  But these are very tough viruses to treat.  And drug resistance becomes a problem too.   Hopefully a simpler and effective oral drug for SARS-CoV-2 will be much less expensive.  Something akin to Tamiflu.  

The problem with Covid is recognizing that you need it in time for it to do any good. A lot of the damage is underway in the serious cases before symptoms arise and is caused by inflammatory reaction not continued expansion of the virus.

 

Might be  useful to treat those identified as being in close contact as a preventative. Or to treat others in a facility if an outbreak occurs.

[nocl]

5 minutes ago, TeeRick said:

Maybe.  But my point is that there is no published data on immunity waning at this point.  And the time frame.

Which does not mean that there is no data.

[TrulyBlonde]

21 hours ago, TrulyBlonde said:

The mountain closed this weekend but we still can hike etc. Lots of outdoor activities where I live. Now it will be up to our County to change their rules. Should be interesting. Will keep you posted. 🙂

@Ken the cruiser Read in the local paper today that May1st no masks required outdoors. You however, must socially distance and mask required within 6 ft if in a busy area. Also, expect to have all business fully opened. 

 

 We are expected  to have the busiest Summer season on record. Our real estate has been off the charts.

[nocl]

1 hour ago, markeb said:

 

The cynic in me thinks that's the reasoning behind the 6 month dose. That's definitely timed where they could go in for a 0, 21 (or 28) day, and 180 day series. With data to support all three doses from their individual products...

 

When you go to a year or more, I think you're looking at crossover studies between the products to show boosting effectiveness, probably antibody titer only, so not big initial trials.

Here are the primary and secondary end points for the booster shots.  Looks like using both the original vaccine and a new version

https://clinicaltrials.gov/ct2/show/NCT04368728?term=vaccine+pfizer&cond=Covid19&draw=2&rank=5

 

Primary

1. In participants who receive a third dose of BNT162b2, percentage of participants reporting adverse events [ Time Frame: From the third dose through 1 month after the third dose ]
   As elicited by investigational site staff
2. In participants who receive a third dose of BNT162b2, percentage of participants reporting serious adverse events [ Time Frame: From the third dose through 6 months after the third dose ]
   As elicited by investigational site staff
3. In participants who receive a third dose of BNT162b2, percentage of participants reporting local reactions [ Time Frame: For 7 days after the third dose ]
   Pain at the injection site, redness, and swelling as self-reported on electronic diaries.
4. In participants who receive a third dose of BNT162b2, percentage of participants reporting systemic events [ Time Frame: For 7 days after the third dose ]
   Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.
5. Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after a third dose of BNT162b2 compared to after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ]
   As measured at the central laboratory
6. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after one dose of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ]
   As measured at the central laboratory
7. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ]
   As measured at the central laboratory

 

Secondary

1. Noninferiority of the SARS-CoV-2 SA strain neutralizing titers after a third dose of BNT162b2 compared to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the third dose ]
   As measured at the central laboratory
2. Noninferiority of the SARS-CoV-2 reference strain neutralizing titers after one dose of BNT162b2SA compared to after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the first dose of BNT162b2SA ]
   As measured at the central laboratory
3. Comparison of the SARS-CoV-2 SA strain neutralizing titers after 1 dose of BNT162b2SA to after a third dose of BNT162b2 [ Time Frame: 1 month after the first dose of BNT162b2SA/third dose of BNT162b2 ]
   As measured at the central laboratory
4. Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2, in the same individuals [ Time Frame: 1 month after the second dose of BNT162b2SA ]
   As measured at the central laboratory
5. Comparison of the SARS-CoV-2 SA strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ]
   As measured at the central laboratory
6. Comparison of the SARS-CoV-2 reference strain neutralizing titers after 2 doses of BNT162b2SA to after 2 doses of BNT162b2 [ Time Frame: 1 month after the second dose ]
   As measured at the central laboratory

[nocl]

1 hour ago, markeb said:

 

Have you seen any details on how they're using this? One of the problems with a lot of promising early stage antivirals historically is you couldn't match the therapeutic window with a reasonable trigger to treat. Just curious...

We will not see that until they progress beyond phase 1.  Currently no trials listed for  PF-07321332

[4774Papa]

3 hours ago, harkinmr said:

First, it’s a numbers game. Lots more people flying in than driving, and from a larger geographical area.  Second, possible exposure is increased thereby risking larger spread. 

Also, checking those driving into their state is virtually impossible.

[Oville]

Just posted this in the EU thread.  Hope it’s true:

https://thehill.com/policy/healthcare/public-global-health/550701-biontech-chief-executive-predicts-europe-will-reach

 

[K.T.B.]

3 hours ago, harkinmr said:

They most certainly do have regulatory authority over cruise lines.  Just look at the Vessel Sanitation Program that the lines are already subject to.  The CDC has very broad authority to regulate interstate and international commerce in order to manage infectious diseases, including the authority to approve methods for the restart of cruises within the context of this pandemic.

 

The CDC will likely take the success (or failure) of cruises taking place in the summer from outside the US into account in their ongoing discussions with the cruise lines.

 

They have a broad authority?  They have never once prevented people from using airlines, buses, or trains during the past year.  And in terms of "regulating them", the most they've said is what they always say:  wear masks, social distancing, etc.  IMO, planes were far more responsible for the virus being spread in the US than cruise ships.  

 

But thanks for pointing out the Vessel Sanitation Program.  My research failed to bring it up.  Be that as it may, cruise lines have more than managed this disease on recent cruises, far better than any country.

Edited April 28, 2021 by K.T.B.

[markeb]

This is a vaccine thread. There have been plenty of better threads for discussing the CDC.

 

However...

 

Transportation was listed early as an essential business/essential industry. Cities and states did significant restrictions on those industries within their states; the CDC provides guidance and regulates interstate and international health issues, but it wouldn't shut down an industry the federal government had determined essential. The federal government in general recommended against non-essential travel, although little was done to exercise any authority to curtail interstate domestic travel. Some states restricted travel into their state.

 

The oldest and most consistent national health regulations, far predating the CDC, are regulations at ports of entry, and those would have been seagoing passenger vessels at the time. It's included international air travel probably since its advent. That is and has always been a very broad authority.

 

Cruising is not transportation.

[harkinmr]

15 minutes ago, K.T.B. said:

 

They have a broad authority?  They have never once prevented people from using airlines, buses, or trains during the past year.  And in terms of "regulating them", the most they've said is what they always say:  wear masks, social distancing, etc.  IMO, planes were far more responsible for the virus being spread in the US than cruise ships.  

 

But thanks for pointing out the Vessel Sanitation Program.  My research failed to bring it up.  Be that as it may, cruise lines have more than managed this disease on recent cruises, far better than any country.

Busses and trains are largely intrastate in nature and are governed by state and local authorities.  The airline favoritism complaint has been beaten to death.  The airlines, besides being a significantly different environment than a cruise, have an outsized role in commerce in this country, not only for essential business travel but for shipping of all kinds.  They have had a significant role in distributing testing and other medical supplies and equipment, not to mention the transport of medical personnel throughout the pandemic.  Very different circumstances than cruising.  

 

When this pandemic began, I personally felt that non-essential travel on airlines should have been stopped.  Having a husband who had to travel for his job, non-essential air travel put him at more risk.  I still believe that non-essential travel should be discouraged, but that guidance is not being followed obviously.  The economics involved in keeping the airline industry going has been the primary driver.  

[D C]

5 hours ago, TeeRick said:

I know this is a vaccine thread but I think the availability of an oral specific anti-viral pill against the SARS-CoV-2 virus is as much of a game changer as a highly efficacious vaccine.  I have posted about this before.  The class of anti-viral drugs called protease inhibitors are being tested in the clinic by several companies.  Pfizer says the one they are testing could be approved later this year.  This will go a long way to getting normal travel and cruising going again.  Vaccines and oral antiviral drugs with high specificity.

 

https://www.cnbc.com/2021/04/27/pfizer-at-home-covid-pill-could-be-available-by-year-end-ceo-albert-bourla-says.html?recirc=taboolainternal

 

Will the anti-vaxx crowd take an anti-viral developed by the same company as the vaccine?  🤔

[nocl]

1 hour ago, K.T.B. said:

 

They have a broad authority?  They have never once prevented people from using airlines, buses, or trains during the past year.  And in terms of "regulating them", the most they've said is what they always say:  wear masks, social distancing, etc.  IMO, planes were far more responsible for the virus being spread in the US than cruise ships.  

 

But thanks for pointing out the Vessel Sanitation Program.  My research failed to bring it up.  Be that as it may, cruise lines have more than managed this disease on recent cruises, far better than any country.

Since COVID is considered to be a SARS virus it is considered to be a quarantinable illness by Presidential order since 2003.

 

https://www.govinfo.gov/content/pkg/FR-2003-04-09/pdf/03-8832.pdf

 

The CDC has a brief history on Quarantine and how their role came about

 

https://www.cdc.gov/quarantine/historyquarantine.html

 

The Public Health Service Act of 1944 clearly established the federal government’s quarantine authority for the first time. The act gave the U.S. Public Health Service (PHS) responsibility for preventing the introduction, transmission, and spread of communicable diseases from foreign countries into the United States.

[Roger88]

Well, before first vaccines were introduced - population of Europe was like 100 times less than now. So yeah, vaccines may help the population to grow and fight all the modern diseses 

[nocl]

2 hours ago, Oville said:

Just posted this in the EU thread.  Hope it’s true:

https://thehill.com/policy/healthcare/public-global-health/550701-biontech-chief-executive-predicts-europe-will-reach

 

Note one paragraph from the article.

 

Sahin added that for adults a third "booster" shot might be required, citing data that the immune response to the vaccine will get weaker over time. He suggested that the third shot should be administered within 9-12 months, according to the AP.

[TeeRick]

2 minutes ago, nocl said:

Note one paragraph from the article.

 

Sahin added that for adults a third "booster" shot might be required, citing data that the immune response to the vaccine will get weaker over time. He suggested that the third shot should be administered within 9-12 months, according to the AP.

Again coming from the CEO of a company wanting to push the idea of yearly boosters of his vaccine.  Big profits involved if that happens.   He said "might be" required.  Not "will be" required.   I would like to see the data that he was citing.   That really is all I am saying here.  Will a booster eventually be required.  Probably yes.  But at exactly one year or every year?  Show us the data.

[nocl]

7 minutes ago, TeeRick said:

Again coming from the CEO of a company wanting to push the idea of yearly boosters of his vaccine.  Big profits involved if that happens.   He said "might be" required.  Not "will be" required.   I would like to see the data that he was citing.   That really is all I am saying here.  Will a booster eventually be required.  Probably yes.  But at exactly one year or every year?  Show us the data.

Considering that they are narrowing in on a period and that period is in line with their clinical trial I doubt that they are just doing it for marketing purposes.  I would expect that they are seeing indications of the immune response weakening.  

 

Also keep in mind that the data they are seeing would be from patients in their clinical trial and one only releases specific data at specific times from a clinical trial.  Especially if the data they are seeing is showing a trend that they are projecting the need from.

 

You will also note that the change in their statements from might to in the case of the Pfizer CEO probably coincided with their decision to start and recruit members from their first clinical trial to participate in the booster trial.

 

It certainly sounds like you are questioning the industry's motives.

 

Does the company you work for publish preliminary immunity duration data mid-trial?  I do not recall any others releasing that information prior to having a complete understanding of the duration and completion of the trial end point analysis and certainly not without discussions with the FDA.

 

 

[4774Papa]

2 hours ago, Oville said:

Just posted this in the EU thread.  Hope it’s true:

https://thehill.com/policy/healthcare/public-global-health/550701-biontech-chief-executive-predicts-europe-will-reach

 

Yes, with this notable comment:

"Sahin said he is expecting a “new normal” soon where people can move freely with good immune protection against the virus."

 

The higher the vaccination rate the closer to something like herd immunity.   Vaccination may be a condition precedent to a European vacation later this year and/or cruising.

[Ken the cruiser]

Looks like vaccines were definitely the light at the end of the tunnel for P&O as they get ready for their first start-up cruise in the UK sailing May 17th. You go P&O and thank you England for developing reasonable protocols and having some trust in the various cruise lines performing limited itineraries, some cruises to no where, out of your ports starting in the next several weeks! The world will definitely be watching!

 

There are now protocols for UK operators that mean all cruise passengers will need to take a test before they embark, as well as guidelines on social distancing, bubbles and how to monitor passengers' health.

 

Demand high as cruise ships get ready to set sail (msn.com)

Edited April 28, 2021 by Ken the cruiser