vaccine required?

[azbirdmom]

14 hours ago, kiwimum said:

I am in the AstraZeneca trial in the US and the shots were administered 4 weeks apart.   Don’t know if I got the real think, will find out April 6.

 

My husband and I are in the same trial.  We have our day 180 visit at the clinic today.  Actually it is more like day 206 because we got injected on the first day of the US trial and then the pause happened so we got our second injection almost 8 weeks later after the FDA allowed the trial to resume.  There are almost 900 people in the US in the same boat so they will have data within the US study about longer intervals although it sure wasn't planned.

 

We were going to tell the study folks today that we wished to be unblinded.  However I had an email exchange with someone at the study last week and learned that to do that we would have to make an appointment to get another vaccine then they would unblind us.  Those were the terms of the trial.  I was a little nervous about finding something as our state had opened up vaccines to everyone over the age of 16 on the day I started looking for appointments but I lucked out because the medical group we use was having a vaccine event this past weekend.  I got an appointment for this past Saturday and DH got his for Sunday.  Then we learned the verdict - hubby got the vaccine and I got the placebo.  So I kept my appointment and got injected with Moderna on Saturday.  And DH cancelled his appointment.

 

Interestingly enough they want us both to stay in the study.  I was quite happy that the folks at the study encouraged me to keep my appointment to get a rival's vaccine rather than waiting for AZ to get their EUA from the FDA.  Only then would the study give me the AZ vaccine.  They said at this point it's better to be protected.  I'll find out today what value I will continue to be to the study but I'll keep going as long as it's helpful to them.

[nocl]

1 hour ago, Steelers36 said:

Perhaps, but if the supplies are there, then rationing issue largely goes away.  Not necessarily "far more deaths" - and how do you measure scenario 1 vs 2 without being able to go back in time and have a do-over?  It is also possible that overly delaying doses will partially or largely invalidate the vaccine effect.  Again, we don't know for sure as there have not been trials and tests.  Another poster pointed this out as well. 

 

Various governments have made their choices and will have to live with them as time goes on - or adjust if they stay on to of information and data.

 

Certainly there have not been any efficacy trials of sufficient size and scope.

 

It is possible that some work has been done looking at antibody response and then using that as evidence that it provide adequate protection with the delay.  I will see if I can find anything in the NIH publications  database (Medline)

[memoak]

39 minutes ago, Daniel A said:

Agreed, but last I checked the owners of the cruise ships want us to come on board.  It is the government that says we cannot assemble on their private property.

No the owners of the ship do not want unvaccinated people coming on board and possibly coming down with COVID which could mean the end of that cruise line

[nocl]

25 minutes ago, azbirdmom said:

 

My husband and I are in the same trial.  We have our day 180 visit at the clinic today.  Actually it is more like day 206 because we got injected on the first day of the US trial and then the pause happened so we got our second injection almost 8 weeks later after the FDA allowed the trial to resume.  There are almost 900 people in the US in the same boat so they will have data within the US study about longer intervals although it sure wasn't planned.

 

We were going to tell the study folks today that we wished to be unblinded.  However I had an email exchange with someone at the study last week and learned that to do that we would have to make an appointment to get another vaccine then they would unblind us.  Those were the terms of the trial.  I was a little nervous about finding something as our state had opened up vaccines to everyone over the age of 16 on the day I started looking for appointments but I lucked out because the medical group we use was having a vaccine event this past weekend.  I got an appointment for this past Saturday and DH got his for Sunday.  Then we learned the verdict - hubby got the vaccine and I got the placebo.  So I kept my appointment and got injected with Moderna on Saturday.  And DH cancelled his appointment.

 

Interestingly enough they want us both to stay in the study.  I was quite happy that the folks at the study encouraged me to keep my appointment to get a rival's vaccine rather than waiting for AZ to get their EUA from the FDA.  Only then would the study give me the AZ vaccine.  They said at this point it's better to be protected.  I'll find out today what value I will continue to be to the study but I'll keep going as long as it's helpful to them.

The problem is that while they would have data on antibody response for those that were delayed.  It is not a large enough group to actually generate efficacy data. 

 

The data from that group would not have been available when the governments made their timing decisions.

 

By staying in the study, even though you are unblinded, the company will continue to collect valuable information about duration of response.  I hope you chose to continue.

Edited March 29, 2021 by nocl

[nocl]

42 minutes ago, Daniel A said:

Agreed, but last I checked the owners of the cruise ships want us to come on board.  It is the government that says we cannot assemble on their private property.

Not quite.  The government is saying that a foreign owned cruise ship is not authorized to enter a US port for the purpose of boarding passengers. As such the ships are not considered to be private property inside the boarders of the US.

 

 People are perfectly free to go to the cruise lines office buildings and assemble all they want.

[nocl]

From recent comments made by Dr Fauci and others it would appear that the CDC is running a study in 12000 young adults looking at how well vaccines prevent transmission and asymptomatic infection. From what I have heard about the timing of that study it should be completed in about 5 months.

 

If it shows what everyone is hoping that it will.  That vaccines do greatly reduce transmission and asymptomatic cases, as well as symptomatic case then we should see the recommendations (masks, distancing, etc ) pretty much go away for vaccinated individuals and would also represent when the CDC would certainly accept vaccinations as an alternative to all of the other protective measures on board ship.

[Daniel A]

8 minutes ago, nocl said:

From recent comments made by Dr Fauci and others it would appear that the CDC is running a study in 12000 young adults looking at how well vaccines prevent transmission and asymptomatic infection. From what I have heard about the timing of that study it should be completed in about 5 months.

 

If it shows what everyone is hoping that it will.  That vaccines do greatly reduce transmission and asymptomatic cases, as well as symptomatic case then we should see the recommendations (masks, distancing, etc ) pretty much go away for vaccinated individuals and would also represent when the CDC would certainly accept vaccinations as an alternative to all of the other protective measures on board ship.

So, that would put the timing of the end of the study at about the end of August/beginning of September.  If you give the government two months to ruminate on the study, that makes it November 1st.  (Where have I heard that date before?)

[azbirdmom]

24 minutes ago, nocl said:

The problem is that while they would have data on antibody response for those that were delayed.  It is not a large enough group to actually generate efficacy data. 

 

The data from that group would not have been available when the governments made their timing decisions.

 

By staying in the study, even though you are unblinded, the company will continue to collect valuable information about duration of response.  I hope you chose to continue.

 

The data on antibody response should be in the data that has recently been shared as the 900 or so folks would have received their second injections in late October / early November.  Given that a third of those folks should have received a placebo means they should have data on 600 people who received the AstraZeneca vaccine.  I haven't seen this referenced yet by the company or in the news reports but at least it's a small sampling.  By the way, they do blood draws 14 and 28 days following each injection along with a "nasal adsorption" test (not the same as the awful brain tickler test).  After that the clinic visits (including blood draws etc.) expressed as days after the initial injection are at 90, 180, 360, and 730 days.  And yes, I am choosing to continue.  I committed to that even before I asked to be unblinded - have to finish what I started!

Edited March 29, 2021 by azbirdmom

[nocl]

1 minute ago, Daniel A said:

So, that would put the timing of the end of the study at about the end of August/beginning of September.  If you give the government two months to ruminate on the study, that makes it November 1st.  (Where have I heard that date before?)

If the study is positive I do not think that they will ruminate on it for two months.

[nocl]

1 minute ago, azbirdmom said:

 

The data on antibody response should be in the what has recently been shared as the 900 or so folks would have received their second injections in late October / early November.  Given that a third of those folks should have received a placebo means they should have data on 600 people who received the AstraZeneca vaccine.  I haven't seen this referenced yet by the company or in the news reports but at least it's a small sampling.  By the way, they do blood draws 14 and 28 days following each injection along with a "nasal adsorption" test (not the same as the awful brain tickler test).  After that the clinic visits (including blood draws etc.) expressed as days after the initial injection are at 90, 180, 360, and 730 days.  And yes, I am choosing to continue.  I committed to that even before I asked to be unblinded - have to finish what I started!

While the company would have had the data, it would have internally blinded.  So while they were collecting data it would not have been available to be released as an analysis on the effectiveness of the vaccine in generating antibodies in November.  The US trial was not unblinded until a couple of weeks ago.  As such the data from the US trial would not have been available to the governments to make their decisions on dosing delay. 

 

Now that the study is unblinded they can use that data to look at doing comparisons to show equivalence of response between the delayed group and those dosed on schedule.  Still not enough people for efficacy, but at large enough to show equivalence of response.

[Daniel A]

26 minutes ago, memoak said:

No the owners of the ship do not want unvaccinated people coming on board and possibly coming down with COVID which could mean the end of that cruise line

 

22 minutes ago, nocl said:

Not quite.  The government is saying that a foreign owned cruise ship is not authorized to enter a US port for the purpose of boarding passengers. As such the ships are not considered to be private property inside the boarders of the US.

 

 People are perfectly free to go to the cruise lines office buildings and assemble all they want.

I'm not sure what is being said here but please allow me to clarify.  My response was to the statement that going on a cruise is a privilege and not a right.  I am completely in favor of the cruise lines only permitting vaccinated crew and passengers onboard.  In that environment, I do not see a demonstrated need to continue masking.  My remark about the Right to Assemble was directly in response to the notion that the ability of people to go on a cruise ship at any time is a privilege granted to us by the government and they can grant the privilege or take it away at will.

[Daniel A]

6 minutes ago, nocl said:

If the study is positive I do not think that they will ruminate on it for two months.

Let's hope so.  🤞 

[nocl]

Just now, Daniel A said:

 

I'm not sure what is being said here but please allow me to clarify.  My response was to the statement that going on a cruise is a privilege and not a right.  I am completely in favor of the cruise lines only permitting vaccinated crew and passengers onboard.  In that environment, I do not see a demonstrated need to continue masking.  My remark about the Right to Assemble was directly in response to the notion that the ability of people to go on a cruise ship at any time is a privilege granted to us by the government and they can grant the privilege or take it away at will.

I was just pointing that your example did not really valid. Foreign Cruise ships, not registered in the US are not considered to be the same as  private property inside the united states. As such the government could choose to ban them at pretty much any time.  As one federal threatened to do with CCL after its rash of environmental violations.  

[capriccio]

Federal study results posted 1 hour ago in the Washington Post (https://www.washingtonpost.com/health/2021/03/29/vaccine-effective-essential-workers-study/ :

 

In a study of about 4,000 health-care personnel, police, firefighters and other essential workers, the Centers for Disease Control and Prevention found that the vaccines [Pfizer and Moderna] reduced the risk of infection by 80 percent after one shot. Protection increased to 90 percent following the second dose.

[ontheweb]

1 hour ago, azbirdmom said:

 

My husband and I are in the same trial.  We have our day 180 visit at the clinic today.  Actually it is more like day 206 because we got injected on the first day of the US trial and then the pause happened so we got our second injection almost 8 weeks later after the FDA allowed the trial to resume.  There are almost 900 people in the US in the same boat so they will have data within the US study about longer intervals although it sure wasn't planned.

 

We were going to the study folks today that we wished to be unblinded.  However I had an email exchange with someone at the study last week and learned that to do that we would have to make an appointment to get another vaccine then they would unblind us.  Those were the terms of the trial.  I was a little nervous about finding something as our state had opened up vaccines to everyone over the age of 16 on the day I started looking for appointments but I lucked out because the medical group we use was having a vaccine event this past weekend.  I got an appointment for this past Saturday and DH got his for Sunday.  Then we learned the verdict - hubby got the vaccine and I got the placebo.  So I kept my appointment and got injected with Moderna on Saturday.  And DH cancelled his appointment.

 

Interestingly enough they want us both to stay in the study.  I was quite happy that the folks at the study encouraged me to keep my appointment to get a rival's vaccine rather than waiting for AZ to get their EUA from the FDA.  Only then would the study give me the AZ vaccine.  They said at this point it's better to be protected.  I'll find out today what value I will continue to be to the study but I'll keep going as long as it's helpful to them.

Thank you both for participating in those trials. I would assume they want to keep following both of you even though one had the placebo as a way of staying able to make comparisons. After all that is the reason for the placebo.

 

And to all who are using as an excuse that these are experimental drugs still, I would say look at these people as they are true heroes.

[wowzz]

2 hours ago, Steelers36 said:

Various governments have made their choices and will have to live with them as time goes on - or adjust if they stay on to of information and data.

Quite happy with the decision made by the UK government to go with a 12 week gap. Over 50% of the population given one vaccination ( and over 95% for the over 75s), death rates down, hospitalisation rates down, intensive care bed occupancy (CV19 related) down. 

Yes, of course, there is alway the "what if" scenario,  but I don't think the figures would have been as positive if the 4 week gap had been adhered to, with millions of people not receiving any form of protection at all.  

[Steelers36]

3 minutes ago, wowzz said:

Quite happy with the decision made by the UK government to go with a 12 week gap. Over 50% of the population given one vaccination ( and over 95% for the over 75s), death rates down, hospitalisation rates down, intensive care bed occupancy (CV19 related) down. 

Yes, of course, there is alway the "what if" scenario,  but I don't think the figures would have been as positive if the 4 week gap had been adhered to, with millions of people not receiving any form of protection at all.  

You were writing about AstraZeneca above, I believe.  Different than Pfizer.

[wowzz]

10 minutes ago, Steelers36 said:

You were writing about AstraZeneca above, I believe.  Different than Pfizer.

12 weeks gap for both vaccines in the UK

[Daniel A]

45 minutes ago, nocl said:

I was just pointing that your example did not really valid. Foreign Cruise ships, not registered in the US are not considered to be the same as  private property inside the united states. As such the government could choose to ban them at pretty much any time.  As one federal threatened to do with CCL after its rash of environmental violations.  

At the risk of belaboring this issue, I am writing in response to the statement "cruising is not right it's a privilege."  You are referencing the ability of a foreign ship entering a port.  I am saying that under normal circumstances, no government issued license is required for a person to board a cruise ship.  There are US flagged cruise ships that are currently operating.  None of those passengers on those ships had to ask the government for permission to cruise, it was already their right to do so.

 

Privilege:  "a special right, advantage, or immunity granted or available only to a particular person or group"

 

I hope this response makes clear that cruising is not a privilege granted by the government.

[Ride-The-Waves]

57 minutes ago, Daniel A said:

At the risk of belaboring this issue, I am writing in response to the statement "cruising is not right it's a privilege."  You are referencing the ability of a foreign ship entering a port.  I am saying that under normal circumstances, no government issued license is required for a person to board a cruise ship.  There are US flagged cruise ships that are currently operating.  None of those passengers on those ships had to ask the government for permission to cruise, it was already their right to do so.

 

Privilege:  "a special right, advantage, or immunity granted or available only to a particular person or group"

 

I hope this response makes clear that cruising is not a privilege granted by the government.

Okay - really really weird.  The "government" is responsible for protecting its citizens.  The cruise example is the same as stopping a person from entering building on fire or one in danger of collapsing.  No different.  And that doesn't include the protocols required for a foreign conveyance to do business in the US.

[NMCruiser55]

10 hours ago, caribill said:

 

A virus evolves to be vaccine resistant when the variations that survive the vaccine can replicate.

 

Although a significant portion of the benefit comes from a first dose and the full benefit of protection can come at four weeks or instead at 12 weeks, the delay of 8 more weeks to get the second dose means the virus has 8 more weeks to possibly evolve in a partially potected body.

A vaccine is not an antibiotic. The vaccine is to give your body a "fire drill" so that it is ready to quickly attack the virus should it appear.

[nocl]

1 hour ago, Daniel A said:

At the risk of belaboring this issue, I am writing in response to the statement "cruising is not right it's a privilege."  You are referencing the ability of a foreign ship entering a port.  I am saying that under normal circumstances, no government issued license is required for a person to board a cruise ship.  There are US flagged cruise ships that are currently operating.  None of those passengers on those ships had to ask the government for permission to cruise, it was already their right to do so.

 

Privilege:  "a special right, advantage, or immunity granted or available only to a particular person or group"

 

I hope this response makes clear that cruising is not a privilege granted by the government.

OK I get it.  Took a while but I get it.

[caribill]

39 minutes ago, NMCruiser55 said:

A vaccine is not an antibiotic. The vaccine is to give your body a "fire drill" so that it is ready to quickly attack the virus should it appear.

 

Correct.

 

But a delayed second shot means more a higher percentage of people are not effectively protected and can still catch and transmit the virus for a longer period of time. This extended period of time allows for variants to develop and be passed on to others.

[caribill]

6 hours ago, Daniel A said:

So going outside the recommendations of the companies that developed the vaccines is all about rationing.

 

It is not as much being a recommendation as it is that the official studies they performed had the three or four week interval between doses.

 

12 weeks may or may not be better or worse for providing immunity. Nobody knows because that interval between doses was not studied.

[beg3yrs]

1 hour ago, caribill said:

 

Correct.

 

But a delayed second shot means more a higher percentage of people are not effectively protected and can still catch and transmit the virus for a longer period of time. This extended period of time allows for variants to develop and be passed on to others.

New study came out today that confirms what earlier but smaller studies have seen. Even after the first shot, after the two-week period, the Pfizer and Moderna vaccines are at about 80% efficacy with the second booster bringing them up to the 95% level.

 

Variants are going to happen with or without the vaccine.