Are vaccines the light at the end of the tunnel?

[nocl]

2 hours ago, cangelmd said:

 

Found an article in NEJM from April 9, concerning the AZ vaccine, but the findings likely apply to J and J as well. Compelling evidence that these rare events may be related to the vaccine. I still think the syndrome is rare enough to allow continued use, but maybe only older people or men? We will see.

While we have been talking about the rate in terms of the total amount of J&J vaccine administered (over 7 million) we really need to look at it in the affected demographic (Women 18-48).  The number used in that demographic is probably much smaller.  Especially since Moderna and Pfizer was used when the priority, non-age related groups were eligible.  I would expect that the number of doses in that age group is almost certainly less then a million  so you might be seeing the reaction in as low as 1 per 100k for that demographic.

 

Of course outside of that demographic you have 0 cases. I expect that there will certainly be some limits added to the label.

[hcat]

2 hours ago, jagoffee said:

True.  Actually the CDC and FDA did not actually phase or pull the J&J vaccine, they just recommended that the states quit administered it.  Of course, some harm has already been done even if they change their recommendation soon,  

Could  you or someone review  the process that went into the initial  approval of using the J and J in U.S. ...and clarify which agency would have authority to revoke approval.?  Is it being used elsewhere?  How is that working out?

 

As to issues of vaccine appts.,  our area in suburban NY  was really short on  convenient sites. Today they increased capacity at our County  Center..now indoor and outdoors in tents.  Hopefully supplies will be available and  people will sign up. 

[hcat]

Recent report on line

 

Pfizer CEO Albert Bourla on raised the possibility of a need for a third dose of the vaccine, possibly at the six- to 12-month mark, as well as a possible need for annual shots against COVID-19. 

 

Wonder if this would be same rec for Moderna? . 

 

We'd need a much better appt and delivery system than  exists now .. drug stores and super market pharmacies seem a good choice fir mass distribution?????

[markeb]

1 hour ago, hcat said:

Could  you or someone review  the process that went into the initial  approval of using the J and J in U.S. ...and clarify which agency would have authority to revoke approval.?  Is it being used elsewhere?  How is that working out?

 

As to issues of vaccine appts.,  our area in suburban NY  was really short on  convenient sites. Today they increased capacity at our County  Center..now indoor and outdoors in tents.  Hopefully supplies will be available and  people will sign up. 

 

This was a pretty good summary from yesterday on the concept of a pause. The FDA approved the Emergency Use Authorization and would be the agency to withdraw that authorization. The CDC typically makes recommendations for specific populations to receive vaccines, and could make recommendations, short of label changes, and may well do so. I'm not sure where else the J&J vaccine is being used; the AZ vaccine has most of the same advantages (other than it's two doses) and concerns, and is being used fairly extensively around the world. I'd have to look for other countries using the J&J vaccine. 

 

The initial approval went through the various agencies of FDA, including their Vaccines and Related Biological Products Advisory Committee. They reviewed all the data submitted up to that point from their Phase III clinical trial which showed effectiveness and safety. What you're seeing now, if it is related to the vaccine, is a rare event that was unlikely to appear even in 30,000 participants. When you hit millions of recipients, and probably hundreds of thousands of women from 18-48, then you'll start seeing rare events.

 

On 4/14/2021 at 1:12 PM, nocl said:

They issued a pause.  That is the regulatory level of action that occurs when there is a safety signal of this kind.  A pause is a recommendation that all use of the product be stopped.  Since the product was not withdrawn a state could continue to use it.  But if they do they face considerably more liability if any body injected during the pause were to develop the problem.

 

For the FDA to force stoppage rather than recommend they would need to withdraw the EUA.  Something that the data does not yet support.  It is a rather rare indication and an investigation is required. I stand behind by comments about showing how closely the FDA look at safety issues. One of the reasons why this was probably triggered is that J&J uses similar technology as AZ.  When one drug in a class has a problem any other drugs in the same class will be scrutinized looking for the same issue.

 

I expect that there will be a label change either restricting the population for which the vaccine is recommended or will result in a warning added to look out for blood clots and not to treat with Hiparin, the normal treatment for clots.  Instead using an alternative therapy.

 

[hcat]

30 minutes ago, markeb said:

 

This was a pretty good summary from yesterday on the concept of a pause. The FDA approved the Emergency Use Authorization and would be the agency to withdraw that authorization. The CDC typically makes recommendations for specific populations to receive vaccines, and could make recommendations, short of label changes, and may well do so. I'm not sure where else the J&J vaccine is being used; the AZ vaccine has most of the same advantages (other than it's two doses) and concerns, and is being used fairly extensively around the world. I'd have to look for other countries using the J&J vaccine. 

 

The initial approval went through the various agencies of FDA, including their Vaccines and Related Biological Products Advisory Committee. They reviewed all the data submitted up to that point from their Phase III clinical trial which showed effectiveness and safety. What you're seeing now, if it is related to the vaccine, is a rare event that was unlikely to appear even in 30,000 participants. When you hit millions of recipients, and probably hundreds of thousands of women from 18-48, then you'll start seeing rare events.

 

 

Thank you..

Lots of info to digest esp if this is not ones area of knowledge..Qe gad Moderna which is what I hope dtr gets when its her turn

[nocl]

52 minutes ago, hcat said:

Recent report on line

 

Pfizer CEO Albert Bourla on raised the possibility of a need for a third dose of the vaccine, possibly at the six- to 12-month mark, as well as a possible need for annual shots against COVID-19. 

 

Wonder if this would be same rec for Moderna? . 

 

We'd need a much better appt and delivery system than  exists now .. drug stores and super market pharmacies seem a good choice fir mass distribution?????

Once we past the immediate process I expect that it will turn to the normal immunization process which in the US is largely through pharmacies.

[cangelmd]

3 hours ago, nocl said:

While we have been talking about the rate in terms of the total amount of J&J vaccine administered (over 7 million) we really need to look at it in the affected demographic (Women 18-48).  The number used in that demographic is probably much smaller.  Especially since Moderna and Pfizer was used when the priority, non-age related groups were eligible.  I would expect that the number of doses in that age group is almost certainly less then a million  so you might be seeing the reaction in as low as 1 per 100k for that demographic.

 

Of course outside of that demographic you have 0 cases. I expect that there will certainly be some limits added to the label.

The NEJM article was again concerning AZ, but the authors had some very esoteric research that I didn’t 100% follow, that linked this to the adenovirus vector (the patients are exhibiting an autoimmune form of HIT, very severe, which means platelets are activated through PF4, platelet factor 4). 
In terms of the incidence in women, again it is likely that there are other known or unknown risk factors producing the syndrome in women - one of the 9 patients had a known genetic condition that causes thrombosis, so who knows why she had clotting, could be a coincidence.

Still, they will have to weigh and compare the risk of Covid with the risk of this vaccine. I’ve already seen an article in lay press saying you are more likely to get clots from Covid than from the vaccine, but there’s clots and then there’s central venous sinus thrombosis in a 30 year old with no obvious risk factors. Fortunately for all, there are alternative vaccines, and if the initial data holds and the syndrome is even rarer in men and women over 50 (post menopausal is how I interpret that), they will again likely limit the use to those groups as was done in Great Britain.

[UnorigionalName]

18 minutes ago, cangelmd said:

The NEJM article was again concerning AZ, but the authors had some very esoteric research that I didn’t 100% follow, that linked this to the adenovirus vector (the patients are exhibiting an autoimmune form of HIT, very severe, which means platelets are activated through PF4, platelet factor 4). 
In terms of the incidence in women, again it is likely that there are other known or unknown risk factors producing the syndrome in women - one of the 9 patients had a known genetic condition that causes thrombosis, so who knows why she had clotting, could be a coincidence.

Still, they will have to weigh and compare the risk of Covid with the risk of this vaccine. I’ve already seen an article in lay press saying you are more likely to get clots from Covid than from the vaccine, but there’s clots and then there’s central venous sinus thrombosis in a 30 year old with no obvious risk factors. Fortunately for all, there are alternative vaccines, and if the initial data holds and the syndrome is even rarer in men and women over 50 (post menopausal is how I interpret that), they will again likely limit the use to those groups as was done in Great Britain.

 

There's a case report on J&J with same clinical picture, also positive for anti PF4. I think that's what sealed it for the emergency stop.

[UnorigionalName]

2 hours ago, hcat said:

Recent report on line

 

Pfizer CEO Albert Bourla on raised the possibility of a need for a third dose of the vaccine, possibly at the six- to 12-month mark, as well as a possible need for annual shots against COVID-19. 

 

Wonder if this would be same rec for Moderna? . 

 

We'd need a much better appt and delivery system than  exists now .. drug stores and super market pharmacies seem a good choice fir mass distribution?????

 

That would not bode well for the rest of the world, or for the US's image.

 

Already the entire rest of the world is pretty bitter about the mRNA vaccine allocation.  If it doesn't get better soon people are gonna be real upset.

[Mary229]

There has been much talk about a possible future booster.  OK, for one argument that the disease will be pandemic for many, many years then the booster would simply be added to your annual series of vaccines  and might even, in the future, be able to be combined with the flu shot.

But there is another argument that says the disease, like the 1918 influenza, basically disappears.  Perhaps it will arise to haunt another generation but it could be we will finished with this when we reach herd immunity.  There is strong history to disappearing diseases.  Polio, small pox, Hansen's to name a few.   These diseases are all still in existence but they are no longer pandemic 

Edited April 15, 2021 by Mary229

[nocl]

25 minutes ago, Mary229 said:

There has been much talk about a possible future booster.  OK, for one argument that the disease will be pandemic for many, many years then the booster would simply be added to your annual series of vaccines  and might even, in the future, be able to be combined with the flu shot.

But there is another argument that says the disease, like the 1918 influenza, basically disappears.  Perhaps it will arise to haunt another generation but it could be we will finished with this when we reach herd immunity.  There is strong history to disappearing diseases.  Polio, small pox, Hansen's to name a few.   These diseases are all still in existence but they are no longer pandemic 

The ones you mention Polio and Small pox are largely gone due to vaccines. Hansen's due to the development of a multiple drug therapy.

[hcat]

57 minutes ago, UnorigionalName said:

 

There's a case report on J&J with same clinical picture, also positive for anti PF4. I think that's what sealed it for the emergency stop.

Denmark  announced pause of J&J

[Mary229]

8 minutes ago, nocl said:

The ones you mention Polio and Small pox are largely gone due to vaccines. Hansen's due to the development of a multiple drug therapy.

Yes and we now have therapies and vaccines 

[Fouremco]

5 minutes ago, hcat said:

Denmark  announced pause of J&J

Denmark has put a full stop to AstraZeneca, but I've read nothing about them putting a pause on J&J.

[nocl]

2 minutes ago, Mary229 said:

Yes and we now have therapies and vaccines 

But even after vaccines were developed it took time to get the case numbers down.

 

That is the big question now is even with the vaccines are enough going to take them to get the counts down enough.  Is the rest of the world going to get vaccinated soon enough to avoid even worse variants.

[HskrCrsr]

49 minutes ago, nocl said:

But even after vaccines were developed it took time to get the case numbers down.

 

That is the big question now is even with the vaccines are enough going to take them to get the counts down enough.  Is the rest of the world going to get vaccinated soon enough to avoid even worse variants.

 I understand polio is still around due to vaccines hesitancy. There are medical groups trying to administer the vaccine - just a drop of liquid on the tongue - and groups of people are claiming the vaccine contains various bad things to control your mind, etc. So some people just won't get the vaccine and polio survives. Sound familiar?

[Mary229]

6 minutes ago, HskrCrsr said:

 I understand polio is still around due to vaccines hesitancy. There are medical groups trying to administer the vaccine - just a drop of liquid on the tongue - and groups of people are claiming the vaccine contains various bad things to control your mind, etc. So some people just won't get the vaccine and polio survives. Sound familiar?

The issue is that they are not pandemic.  The purpose of public health is not to prevent a single death, it is to prevent massive outbreaks of disease and overwhelming the healthcare system.  Medicine deals with the individual, public health deals with the society 

[HskrCrsr]

1 minute ago, Mary229 said:

The issue is that they are not pandemic.  The purpose of public health is not to prevent a single death, it is to prevent massive outbreaks of disease and overwhelming the healthcare system.  Medicine deals with the individual, public health deals with the society 

 

That's all well and good. Polio requires a single dose and immunity seems to last forever, so pandemic is not likely. It is also not spread through the air. COVID is another beast entirely. With pockets of people who will not vaccinate for whatever reason, COVID will linger. If we let our guard down, it's pandemic all over again. I recognize you mentioned boosters, and it seems those will be needed. But the polio, etc., discussion is following your other argument when diseases disappear. Polio did not disappear for known reasons. COVID may survive for exactly those same reasons, even if it's a slow burn with occasional outbreaks that could indeed be massive.

 

[nocl]

21 minutes ago, HskrCrsr said:

 I understand polio is still around due to vaccines hesitancy. There are medical groups trying to administer the vaccine - just a drop of liquid on the tongue - and groups of people are claiming the vaccine contains various bad things to control your mind, etc. So some people just won't get the vaccine and polio survives. Sound familiar?

However we are far better off today than when polio was considered to be a scourge.  Fortunately enough take vaccines that its incidence is almost non-existent in the US.  Those against vaccines get protected by those that take them.

 

Even before the vaccine it paralyzed maybe 15,000 per year.  People celebrated in the streets with the vaccine became available.

 

Today with 550,000 dead in a little over a year in the US we get its just the flu.

[Oville]

8 hours ago, Mary229 said:

Thanks for posting this.  I do want to remind people that the states can only administer what is delivered to them.  The real measure is how many vaccines for the week are not delivered by week's end.  Texas looks awful on this chart but they have a history of delivering every single vaccine provided.  

I’m sure Texas is doing a great job but no state is at the 100% mark, it’s just not feasible.  Some shots have to be held back for second doses and in some rural areas it is not easy to get people vaccinated and then there are those who are reluctant.  I live in Florida and it too is not at the top of the chart but the state is doing so much better than when we got our pokes in March.  

[Mary229]

12 minutes ago, Oville said:

I’m sure Texas is doing a great job but no state is at the 100% mark, it’s just not feasible.  Some shots have to be held back for second doses and in some rural areas it is not easy to get people vaccinated and then there are those who are reluctant.  I live in Florida and it too is not at the top of the chart but the state is doing so much better than when we got our pokes in March.  

If you look at the state dashboards at weeks’ end they are about as close to 100% as feasible.  There are always going to be handling errors.  I watch Texas but have looked at other states and most are doing an excellent job 

[Mary229]

40 minutes ago, HskrCrsr said:

 

That's all well and good. Polio requires a single dose and immunity seems to last forever, so pandemic is not likely. It is also not spread through the air. COVID is another beast entirely. With pockets of people who will not vaccinate for whatever reason, COVID will linger. If we let our guard down, it's pandemic all over again. I recognize you mentioned boosters, and it seems those will be needed. But the polio, etc., discussion is following your other argument when diseases disappear. Polio did not disappear for known reasons. COVID may survive for exactly those same reasons, even if it's a slow burn with occasional outbreaks that could indeed be massive.

 

We don’t know, that is the key point to my argument.  We don’t know and fear mongering does nothing but disturb people.  It is fairly easy to have a lively discussion with the facts without having to project the future from limited data

[UnorigionalName]

1 hour ago, nocl said:

But even after vaccines were developed it took time to get the case numbers down.

 

That is the big question now is even with the vaccines are enough going to take them to get the counts down enough.  Is the rest of the world going to get vaccinated soon enough to avoid even worse variants.

 

I am getting more and more pessimistic.  Looks like in Israel, 60% still is not good enough, as math expected.

[HskrCrsr]

4 minutes ago, Mary229 said:

We don’t know, that is the key point to my argument.  We don’t know and fear mongering does nothing but disturb people.  It is fairly easy to have a lively discussion with the facts without having to project the future from limited data

 

I guess you're having a different discussion than I am. Fearmongering? Project the future? Isn't this you: "Perhaps it will arise to haunt another generation but it could be we will finished with this when we reach herd immunity. "

 

I was just looking at why polio's not gone and noting a similarity. 

[mayleeman]

And we simply cannot get herd immunity if 30 to 50% of thepopulation refuses to get vaccinated or thinks they can wait for herd immunity to protect them. Some Game Theorists need to figure out how to get people over the hesitation. If a lot of people wait for everyone else, it ain't happenin'.