Coronavirus

[bkp_duke]

When the authorized and studied regimen for EACH of these vaccines is two doses, giving one of each is giving two half doses. You dispute that?

Or, when you say two full doses, are you advocating double doses for each vaccine, respectively? Are there studies that show that doing such will actually reduce the spread? Because that seems to take 50% of available vaccine off the table at a time of shortage. I'm trying to understand your logic.

Typical laywer, semantics (I joke, don't come sue me).

The EUA for Moderna is two shots, 100 ug (micrograms) each.
The EUA for Pfizer is two shots, 30 ug (micrograms) each.

Substitute those in for what I said above.


NOW, with that said, we have GOOD data in a recent study (actually data was out before this, but you had to dig) that shows a SINGLE shot of Moderna (100 ug) or Pfizer (30 ug) confers 80% protection. ADDITIONALLY, Moderna in their trial also tested a 50 ug shot dose, and very clearly showed an almost identical antibody response after the first dose, and again after the 2nd dose, to the "full strength" 100 ug dosing regimen. A third, 25 ug dose, was also tested but did not elicit the same level of Antibody production as the 50 and 100 ug doses.

As frequent readers of this thread will remember, I pointed out month ago, that the FASTEST way to get us to herd immunity was to cut the Moderna dose in half (i.e. 50 ug) and get as many shots in as many arms as possible. NOT administering the second dose until after the bulk of the population, or at least the high-risk groups, had that first dose. This was a VERY talked about option at the end of December, with Fauci, etc. mentioning the merits of such, but unwilling to put their weight behind the idea because that is not exactly how the clinical trials were run.


Hopefully that clarifies my medical opinion, as a physician and a molecular biologist, of how I would have run the vaccine roll-out. This would have only applied to the Moderna vaccine, because Pfizer did not do the same dosing comparisons in their Phase 2/3 trials.

 

[bkp_duke]

Are you thinking of bamlanivimab, the monoclonal antibody that does seem to work in patients not sick enough (at that moment) to be hospitalized? Studies suggest it is effective to reduce the severity of COVID in patients who receive it early.

No, it was another small molecule like Remdesivir, but admittedly after the mRNA vaccines came out I cut my reading down drastically, given how well they performed.

 

[rxlawdude]

Typical laywer, semantics (I joke, don't come sue me).

The EUA for Moderna is two shots, 100 ug (micrograms) each.
The EUA for Pfizer is two shots, 30 ug (micrograms) each.

Substitute those in for what I said above.


NOW, with that said, we have GOOD data in a recent study (actually data was out before this, but you had to dig) that shows a SINGLE shot of Moderna (100 ug) or Pfizer (30 ug) confers 80% protection. ADDITIONALLY, Moderna in their trial also tested a 50 ug shot dose, and very clearly showed an almost identical antibody response after the first dose, and again after the 2nd dose, to the "full strength" 100 ug dosing regimen. A third, 25 ug dose, was also tested but did not elicit the same level of Antibody production as the 50 and 100 ug doses.

As frequent readers of this thread will remember, I pointed out month ago, that the FASTEST way to get us to herd immunity was to cut the Moderna dose in half (i.e. 50 ug) and get as many shots in as many arms as possible. NOT administering the second dose until after the bulk of the population, or at least the high-risk groups, had that first dose. This was a VERY talked about option at the end of December, with Fauci, etc. mentioning the merits of such, but unwilling to put their weight behind the idea because that is not exactly how the clinical trials were run.


Hopefully that clarifies my medical opinion, as a physician and a molecular biologist, of how I would have run the vaccine roll-out. This would have only applied to the Moderna vaccine, because Pfizer did not do the same dosing comparisons in their Phase 2/3 trials.

I agree with most of your points here. I will maintain that the definition of the two dose vaccines is "regimen." So perhaps it's more artful to suggest your idea is to give half the authorized regimen of Moderna along with half the authorized regimen of Pfizer. The discussion of using only one administration of the two shot regimens, as you mentioned, never really got off the ground, in part because there are no clinical data to support this. If you can provide any citation to clinical studies in any peer-reviewed source demonstrating your proposal, that would go a long way.

I am not anti-semantic in the least.

 

[rxlawdude]

You seem to be arguing for two definitions of the word "dose". The J&J regimen is for a single dose while Moderna and Pfizer are for two doses, not two half doses. It appears to be a pointless semantics argument.

You are a chef with a bunch of hungry campers. A carton of eggs is purchased with the intent of making a 12-egg omelette. But you discover the carton contains only six eggs.

Is your omelette going to be complete, or is it HALF of what it is supposed to be? Enough dancing on the head of a pin.

I'm just tired of hearing theoreticals (and I agree with @bkp_duke on the theory of crossing the two dose regimens) that sound good, but fail in clinical practice over the past 13 months. How many of these have been suggested, tried, and ultimately discovered not to provide advantages over authorized regimens?

Maybe some venlafaxine?

 

[madodel]

UPDATE: German cities halt AstraZeneca jabs for under-60s

"The German cities of Berlin and Munich on Tuesday suspended vaccinations with the AstraZeneca jab for under-60s, as further reports emerge of blood clots among people who have received it."

Article says 31 cases of blood clots post AZ but they don't say out of how many, and at least 1 death from blood clots post AZ vaccination. Almost all cases in young to middle aged women. NYT says 12,872,859 doses in Germany, but doesn't say how many are AZ or Pfizer or Moderna. Tracking Coronavirus Vaccinations Around the World Oddly while France has also limited its use to over-55s, Spain only uses it for under-65s.

 

[rxlawdude]

Single dose 80% effective after 2 weeks.

1 dose of Moderna, Pfizer vaccines effective against COVID-19. 'Get the second dose,' experts say.

Experts warn that people shouldn't look at the CDC findings and assume they don’t need a second dose of the COVID-19 vaccine.

www.yahoo.com

But:
Schaffner stresses that people shouldn't look at these findings and assume they don’t need a second dose of the COVID-19 vaccine. "Don't try to slice this salami too thin," he says. "I do think we need that second dose in order to get maximum protection." Schaffner points out that people get "much more antibodies" against SARS-CoV-2 with the second dose, as well as "more complete protection" that can help against variants of the virus.

Dr. Thomas Russo, professor and chief of infectious disease at the University at Buffalo in New York, agrees. "I can't emphasize enough how important it is to get the second dose," he tells Yahoo Life. Russo points out that some people are nervous about getting the second dose after hearing that side effects can be worse afterward, but he says that many stories about the side effects have "a little bit of embellishment."

If the data ultimately supports single doses of either Moderna or Pfizer, I will happily lead the charge to move to that regimen. We're just not yet there.

 

[bkp_duke]

I agree with most of your points here. I will maintain that the definition of the two dose vaccines is "regimen." So perhaps it's more artful to suggest your idea is to give half the authorized regimen of Moderna along with half the authorized regimen of Pfizer. The discussion of using only one administration of the two shot regimens, as you mentioned, never really got off the ground, in part because there are no clinical data to support this. If you can provide any citation to clinical studies in any peer-reviewed source demonstrating your proposal, that would go a long way.

I am not anti-semantic in the least.

I'll let you peruse the thread for the references, I'm pretty sure @AlanSubie4Life initially quoted the well-performed antibody neutralization studies that demonstrated the Pfizer vaccine has different and in many cases better neutralization against SARS-CoV-2 variants than the Moderna vaccine did. And yes, they were well-respected, peer-reviewed journals.

And, to argue against what you said, there is CLINICAL data to support the 50 ug dose of Moderna vaccine. The Phase 2 clinical trial for Moderna was conducted with 50 and 100 ug doses. There is VERY good clinical data to support my recommendation. Again, the 100 ug dose was chosen because it produced SLIGHTLY higher Ab levels in the elderly (70 and up) and since that group had the highest mortality was the main reason for that choice. On the flip side, the 50 ug dose series produced the same antibodies in the under 70 groups, with far less of a side effect profile.

This is NOT theory, this is cold, hard clinical trial data from the Phase 2 portion of the original Moderna trial.

Quick google version for you (I'm on vacation and not take the time to find the info on a conversation that we hashed out here in Jan - you seem perfectly capable of doing that):

U.S. officials consider half-doses of Moderna’s vaccine to give more people some immunity

A top official of Operation Warp Speed floated a new idea Sunday for stretching the limited number of coronavirus vaccine doses in the United States: halving the dose of each shot of Moderna’s vaccine to potentially double the number of...

www.seattletimes.com

Again - my comments were my professional, medical AND scientific opinion, backed by the facts as they were at the time of the proposal. Obviously I don't run the vaccine recommendations at the CDC, but I firmly believe that by splitting the Moderna vaccine down to 50 ug shots, and giving the population just ONE dose of mRNA vaccine, that would could have saved more lives and hit herd immunity more quickly.

 

[rxlawdude]

UPDATE: German cities halt AstraZeneca jabs for under-60s

"The German cities of Berlin and Munich on Tuesday suspended vaccinations with the AstraZeneca jab for under-60s, as further reports emerge of blood clots among people who have received it."

Article says 31 cases of blood clots post AZ but they don't say out of how many, and at least 1 death from blood clots post AZ vaccination. Almost all cases in young to middle aged women. NYT says 12,872,859 doses in Germany, but doesn't say how many are AZ or Pfizer or Moderna. Tracking Coronavirus Vaccinations Around the World Oddly while France has also limited its use to over-55s, Spain only uses it for under-65s.

It certainly seems that, given very specific and repeated instances of blood clots associated with AZ, that this should be considered a second tier until causality is proven or disproven.

 

[rxlawdude]

I'll let you peruse the thread for the references, I'm pretty sure @AlanSubie4Life initially quoted the well-performed antibody neutralization studies that demonstrated the Pfizer vaccine has different and in many cases better neutralization against SARS-CoV-2 variants than the Moderna vaccine did. And yes, they were well-respected, peer-reviewed journals.

And, to argue against what you said, there is CLINICAL data to support the 50 ug dose of Moderna vaccine. The Phase 2 clinical trial for Moderna was conducted with 50 and 100 ug doses. There is VERY good clinical data to support my recommendation. Again, the 100 ug dose was chosen because it produced SLIGHTLY higher Ab levels in the elderly (70 and up) and since that group had the highest mortality was the main reason for that choice. On the flip side, the 50 ug dose series produced the same antibodies in the under 70 groups, with far less of a side effect profile.

This is NOT theory, this is cold, hard clinical trial data from the Phase 2 portion of the original Moderna trial.

Quick google version for you (I'm on vacation and not take the time to find the info on a conversation that we hashed out here in Jan - you seem perfectly capable of doing that):

U.S. officials consider half-doses of Moderna’s vaccine to give more people some immunity

A top official of Operation Warp Speed floated a new idea Sunday for stretching the limited number of coronavirus vaccine doses in the United States: halving the dose of each shot of Moderna’s vaccine to potentially double the number of...

www.seattletimes.com

Again - my comments were my professional, medical AND scientific opinion, backed by the facts as they were at the time of the proposal. Obviously I don't run the vaccine recommendations at the CDC, but I firmly believe that by splitting the Moderna vaccine down to 50 ug shots, and giving the population just ONE dose of mRNA vaccine, that would could have saved more lives and hit herd immunity more quickly.

And I respect your opinion. I'll agree with your assessment about Moderna. We disagree on the wisdom of a routine recommendation to cross mRNA vaccines in a two dose regimen.

However, the article you linked is not current (late Dec early Jan discussions to increase availability to the largest number of people due to vaccine supply issues). The quotes from a more recent article (see post above) suggest that the experts recognize two doses of the same vaccine are better and continue to be the gold standard. Any additional armamentarium against the virus and COVID is a good thing!

 

[AlanSubie4Life]

Dr. Thomas Russo, professor and chief of infectious disease at the University at Buffalo in New York, agrees. "I can't emphasize enough how important it is to get the second dose," he tells Yahoo Life. Russo points out that some people are nervous about getting the second dose after hearing that side effects can be worse afterward, but he says that many stories about the side effects have "a little bit of embellishment."

I agree with this. All the data we do have shows a huge improvement in antibody titers after the second dose. It's not double, it's more like 10x-100x the protection (leading to a 80% -> ~95%+ efficacy improvement (or higher depending on how you read the Israel data and what you're measuring), as you would expect from that). There's a huge difference there. However, it does seem possible we could have saved lives by spacing out the doses a bit more. Eventually someone will analyze it.

But I'm definitely on board with the half-dose of Moderna as well - unless there is some reason Moderna knows about other than the immune response in the elderly which indicates they shouldn't do that (I have no idea whether the µg of active ingredients in the dose of Pfizer and Moderna convert 1:1 into strands of RNA - I've got no idea. Seems like it probably does but it doesn't necessarily follow as it would depend on the size of the LNPs, the molecular weight of the LNP constituents (presumably nearly identical for both but the size of the droplet and RNA molecules therein seems like it could change), etc.). But in any case the 50µg dose seemed to generate plenty of antibodies so it is probably fine. Halving the dose would have saved lives, and it's not clear that there's any downside.

Re: embellishment - Can't remember if I already mentioned this, but my wife had an exceedingly painful lymph node swelling under her arm for about 4-5 days after the second dose of Pfizer, and her words were: "I never want to have to get another dose of this again." Fever of 101.7 but that started 18 hours post injection and only lasted about 18 hours. It was not great!

 

[TEG]

So, this evening, I went to my neighboring city’s downtown to drop off my kid’s library books. Today was their school district’s first day of Spring Break. I honestly could not tell we ever had a pandemic. Restaurants are packed. The outside seating areas are as close as they can be without bumping into each other. People without masks strolling on the streets. I assume many think they don’t need masks if they’re outside regardless of their situation or surrounding.

These days it is hard to know how many of those people you see "partying like it's 1999" have been vaccinated and/or already had COVID.
Opening things back up is making sense for that demographic. The problem is when everyone else thinks it is time to join in (maskless and not distanced.)
We are in this awkward transition period as we start to see the pandemic wind down.

 

[TespaceX]

These days it is hard to know how many of those people you see "partying like it's 1999" have been vaccinated and/or already had COVID.
Opening things back up is making sense for that demographic. The problem is when everyone else thinks it is time to join in (maskless and not distanced.)
We are in this awkward transition period as we start to see the pandemic wind down.

That is true. But, at this point, I'd say few of those people I saw probably were. Our county just went to a less restrictive tier last week. So, that's the most likely cause.

Given that about 16% of the population had a vaccine shot, and mostly in a high priority group, I don't think many of them were vaccinated. Most of the people I saw out there were probably in their 40's and 50's and most likely high-income demographics working from home given the population makeup around where I live. Not the typical crowd to likely have priority for a vaccine working as servers, grocery store employees, factory workers, or having significant chronic health issues.

 

[rxlawdude]

These days it is hard to know how many of those people you see "partying like it's 1999" have been vaccinated and/or already had COVID.
Opening things back up is making sense for that demographic. The problem is when everyone else thinks it is time to join in (maskless and not distanced.)
We are in this awkward transition period as we start to see the pandemic wind down.

I think we should have our thumbs dyed once we are vaccinated and sufficient time has passed since the last shot. Show your purple thumb with pride!

 

[NikolaACDC]

UPDATE: German cities halt AstraZeneca jabs for under-60s

"The German cities of Berlin and Munich on Tuesday suspended vaccinations with the AstraZeneca jab for under-60s, as further reports emerge of blood clots among people who have received it."

Article says 31 cases of blood clots post AZ but they don't say out of how many, and at least 1 death from blood clots post AZ vaccination. Almost all cases in young to middle aged women. NYT says 12,872,859 doses in Germany, but doesn't say how many are AZ or Pfizer or Moderna. Tracking Coronavirus Vaccinations Around the World Oddly while France has also limited its use to over-55s, Spain only uses it for under-65s.

Germany so far has injected 2.7 Million first doses and 767 second doses of AZ.

31 cases of CVST (Cerebral venous sinus thrombosis) have been reported. 9 of the 31 died.
In 19 of these patients additonally a Thrombocytopenia was reported.

2 cases were men aged 36 and 57. All others were women aged between 20 and 63.

Symptoms appeared or people were diagnosed (article wasn't clear) 4 to 16 days after injection.
Time is so far the only connection to the vaccine.

A lot of countries apparently already had or now have limited the administration of AZ to older population groups.

 

[rxlawdude]

Germany so far has injected 2.7 Million first doses and 767 second doses of AZ.

31 cases of CVST (Cerebral venous sinus thrombosis) have been reported. 9 of the 31 died.
In 19 of these patients additonally a Thrombocytopenia was reported.

2 cases were men aged 36 and 57. All others were women aged between 20 and 63.

Symptoms appeared or people were diagnosed (article wasn't clear) 4 to 16 days after injection.
Time is so far the only connection to the vaccine.

A lot of countries apparently already had or now have limited the administration of AZ to older population groups.

I'm betting it will not get EUA status in the US. There's something unique to that vaccine related to clotting mechanisms that does not seem to happen with the mRNA vaccines.

 

[NikolaACDC]

As one would expect more breakthrough cases reported, this time out of Washington state

Washington confirms 'breakthrough' COVID-19 cases after vaccination

"The state is investigating 102 potential cases of people becoming ill with COVID-19 more than two weeks after being fully vaccinated, the Washington State Department of Health reported Tuesday.

According to the state, the majority of those in Washington with confirmed vaccine breakthrough experienced only mild symptoms or no symptoms. However, eight people were hospitalized with COVID-19, and the state is investigating two "potential" breakthrough cases where patients died.

Both of those patients were more than 80 years old and suffered underlying health issues, according to the state.

The state said that the breakthrough cases are 0.01% of the 1.2 million fully vaccinated people in Washington state, which health officials say falls within the results of the clinical studies of the vaccines."

 

[Jeff N]

But:
Schaffner stresses that people shouldn't look at these findings and assume they don’t need a second dose of the COVID-19 vaccine. "Don't try to slice this salami too thin," he says. "I do think we need that second dose in order to get maximum protection." Schaffner points out that people get "much more antibodies" against SARS-CoV-2 with the second dose, as well as "more complete protection" that can help against variants of the virus.

And yet, somehow a single dose of J&J is all you need. Seems incongruous.

 

[JRP3]

This Dr. doesn't want to take the vaccine because he's tested positive for antibodies, claims no vaccine will provide more immunity than antibodies from an infection, and is concerned about a hyper immune response if given the vaccine. Does he have any valid points? Everyone in the comment section seems to be anti-vaxxers and this is giving them more ammunition.

 

[bkp_duke]

This Dr. doesn't want to take the vaccine because he's tested positive for antibodies, claims no vaccine will provide more immunity than antibodies from an infection, and is concerned about a hyper immune response if given the vaccine. Does he have any valid points? Everyone in the comment section seems to be anti-vaxxers and this is giving them more ammunition.

No, he's half-baked in his "analysis".

 

[Jeff N]

So it wasn’t a hoax?

Covid-19 was third leading cause of death last year, CDC confirms in early data | CNN

Covid-19 was the third leading cause of death in the United States last year, after heart disease and cancer, according to provisional data released on Wednesday by the US Centers for Disease Control and Prevention.

www.cnn.com