OT: COVID Science - Pfizer/Moderna vaccines >90% effective; Regeneron antibody cocktail looks very promising in phase II/III trial and more

[WhiteBus]

This really bothers me and I strongly disagree. Fauci isn't some new appointee - he's been there throughout - and if the guy was afraid to make statements before than he's a coward and a zilch. That's the exact opposite of leadership.

You do know he contradicted Trump's false claims all the time. He was banned from the White House and rumors of being fired by Trump numerous times.

 

[tom1944]

This really bothers me and I strongly disagree. Fauci isn't some new appointee - he's been there throughout - and if the guy was afraid to make statements before than he's a coward and a zilch. That's the exact opposite of leadership.

Sometimes leadership means not taking suicidal action. If he spoke out too strongly he would have been removed or put on ice even more than he was.

 

[RobertG]

If you worked at a corporation and the job was to develop and distribute a product into people’s hands (arms) and you left it up to 50 individual distribution centers to develop their own plan and process, you would be summarily fired.

If you were the General in command of a Division and you attempted to plan the battles for each one of your brigade comanders they would court marshal you.

50 state Governors should be smart enough to figure this out.

Some how West Virginia did

 

[WhiteBus]

If you were the General in command of a Division and you attempted to plan the battles for each one of your brigade comanders they would court marshal you.

50 state Governors should be smart enough to figure this out.

Some how West Virginia did

The assumption many are making is that the Federal Government had no control once the vaccine made it to each state. That is completely false. The Federal Government could have had complete control. They elected not to.

 

[pmvon]

If you were the General in command of a Division and you attempted to plan the battles for each one of your brigade comanders they would court marshal you.

50 state Governors should be smart enough to figure this out.

Some how West Virginia did

Umm it’s coordinated from the top and the resources are marshaled and dispersed from the top. Reinforcements, air support etc.

Fail

 

[jerzey devil]

Merck tanks vaccine and gives up. Not a surprise, they are not an innovative vaccine company.
@RU848789

Merck Shuts Down Covid Vaccine Program After Results
By Riley Griffin
January 25, 2021, 6:45 AM EST
Immune response to candidates is inferior to existing shots
Merck to repurpose resources, facilities to Covid-19 therapies

Merck Shuts Down Covid Vaccine Program After Lackluster Data

Merck & Co. is discontinuing development of its two experimental Covid-19 vaccines after early trial data showed they failed to generate immune responses comparable to a natural infection or existing vaccines.

www.bloomberg.com

Not that i had heard this... But had heard suilence on Merck vaccine possibillities months ago

 

[RobertG]

Umm it’s coordinated from the top and the resources are marshaled and dispersed from the top. Reinforcements, air support etc.

Fail

I don't want to clutter this thread up with discussion that have to do with the vaccine and treatments so we can move this to the CE board. I already started a thread there about how a state with a $40 Billion dollar budget is unable to setup a proper distribution network or even set up an an appointment system. We can discuss military planning their also.

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[GSGS]

I can assure you that people are pulling out all the stops on MK-4482 (and MK-7110, which has already shared data) - most people I know barely even took any holiday time off and have been working insane hours. The slow pace was due to slow clinical enrollment, but interim data are expected in the next 1-2 weeks. But like the vaccines, for 4482, nobody knows if there will be efficacy until the data are available.

Sure it's disappointing that the two vaccine candidates failed, but some of that is due to how unexpectedly good the mRNA vaccines are (pretty sure MK would still be pursuing them if the mRNA vaccines didn't work or only showed 50-60% efficacy, which was enough to get approved).

Also, Merck is still the world's #2 vaccine company, by sales and continues to put out new/updated vaccines - and don't forget until COVID, Merck's Ebola vaccine was the fastest ever brought to market and has been a huge success and that was only a couple of years ago.

RU#'s - this might be a stupid question, but if it is, I'm confident that you will answer it respectfully! :-) Does Merck have any vaccine manufacturing capacity that another COVID-19 vaccine manufacturer would be able to rent from them to get more doses of the, say, Pfizer or Moderna vaccines to market? Or, if the mRNA is so different than traditional vaccines, maybe the J&J vaccine if/when it gets approved?

This is a Hail Mary but I figured that I would ask.

 

[RU848789]

RU#'s - this might be a stupid question, but if it is, I'm confident that you will answer it respectfully! :-) Does Merck have any vaccine manufacturing capacity that another COVID-19 vaccine manufacturer would be able to rent from them to get more doses of the, say, Pfizer or Moderna vaccines to market? Or, if the mRNA is so different than traditional vaccines, maybe the J&J vaccine if/when it gets approved?

This is a Hail Mary but I figured that I would ask.

It's a good question, which was discussed months ago, but I don't recall Merck ever saying anything publicly about it. I would think Merck could supply manufacturing capacity for others, but I don't know that it would come on line fast enough to make much of a difference in the US, where we should have enough vaccine doses for everyone who wants one by this summer (assuming J&J comes through); it could make a difference for the rest of the world, however. Maybe @newell138 knows more, as he's in the vaccine manufacturing area (I'm not). I may also ask around as I've been curious about this one too (although it's possible things are going on I don't know about, as MK is very tight with that kind of info normally, even internally).

 

[pmvon]

I don't want to clutter this thread up with discussion that have to do with the vaccine and treatments so we can move this to the CE board. I already started a thread there about how a state with a $40 Billion dollar budget is unable to setup a proper distribution network or even set up an an appointment system. We can discuss military planning their also.

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Last thing I want to do is waste my time on that board debating facts and fake news when most there cannot even discern between the two.
a states budget is designated for certain things and isn’t a slush fund to use on other things. Covid and vaccines require resources. The federal government is uniquely qualified to provide those resources given its virtual unlimited spending authority as well as its pressure it can bring to bear on private enterprises.

thisisn’t even debatable and should be widely understood.

last thing I will say is that there is no difference between red and blue State roll outs. And please stop saying there is. The datas clear and More importantly it doesn’t matter.

 

[newell138]

It's a good question, which was discussed months ago, but I don't recall Merck ever saying anything publicly about it. I would think Merck could supply manufacturing capacity for others, but I don't know that it would come on line fast enough to make much of a difference in the US, where we should have enough vaccine doses for everyone who wants one by this summer (assuming J&J comes through); it could make a difference for the rest of the world, however. Maybe @newell138 knows more, as he's in the vaccine manufacturing area (I'm not). I may also ask around as I've been curious about this one too (although it's possible things are going on I don't know about, as MK is very tight with that kind of info normally, even internally).

Funny that you ask because there was a rumor floating around yesterday that we may possibly be doing some of the packaging for J&J. If true we will know soon, either the new line we were planning for covid is going up or its not.

BTW, if anyone is looking for an entry level job in supply chain we have a couple openings in our department at Lansdale, PA

 

[e5fdny]

RU#'s - this might be a stupid question, but if it is, I'm confident that you will answer it respectfully! :-) Does Merck have any vaccine manufacturing capacity that another COVID-19 vaccine manufacturer would be able to rent from them to get more doses of the, say, Pfizer or Moderna vaccines to market? Or, if the mRNA is so different than traditional vaccines, maybe the J&J vaccine if/when it gets approved?

This is a Hail Mary but I figured that I would ask.

It's a good question, which was discussed months ago, but I don't recall Merck ever saying anything publicly about it. I would think Merck could supply manufacturing capacity for others, but I don't know that it would come on line fast enough to make much of a difference in the US, where we should have enough vaccine doses for everyone who wants one by this summer (assuming J&J comes through); it could make a difference for the rest of the world, however. Maybe @newell138 knows more, as he's in the vaccine manufacturing area (I'm not). I may also ask around as I've been curious about this one too (although it's possible things are going on I don't know about, as MK is very tight with that kind of info normally, even internally).

Funny that you ask because there was a rumor floating around yesterday that we may possibly be doing some of the packaging for J&J. If true we will know soon, either the new line we were planning for covid is going up or its not.

BTW, if anyone is looking for an entry level job in supply chain we have a couple openings in our department at Lansdale, PA

Another question for both of you...

Is it all being made here? The reason I ask is that I got a memo the other day at work referencing a fire in an assembly plant in India that is making the vaccine.

 

[rutgersdave]

Another question for both of you...

Is it all being made here? The reason I ask is that I got a memo the other day at work referencing a fire in an assembly plant in India that is making the vaccine.

Oxford/AstraZeneca vaccine which is mostly manufactured for the rest of the world for right now.

 

[newell138]

Another question for both of you...

Is it all being made here? The reason I ask is that I got a memo the other day at work referencing a fire in an assembly plant in India that is making the vaccine.

The fire in India is not J&J or any other American co. to my understanding its an Indian pharma co. IDK if you want any of what they are making anyway. I am hearing the Chinese and Indian version of the covid vaccine have less immune response than the 2 Merck just scrapped.

We are continuing work on the new packaging line so the J&J rumor may be true

 

[WhiteBus]

The fire in India is not J&J or any other American co. to my understanding its an Indian pharma co. IDK if you want any of what they are making anyway. I am hearing the Chinese and Indian version of the covid vaccine have less immune response than the 2 Merck just scrapped.

We are continuing work on the new packaging line so the J&J rumor may be true

Americans seem to ignore what the rest of the world is doing some times. This is one of those cases. Currently there are a total of 9 vaccines approved and being used worldwide.

 

[RobertG]

Last thing I want to do is waste my time on that board debating facts and fake news when most there cannot even discern between the two.
a states budget is designated for certain things and isn’t a slush fund to use on other things. Covid and vaccines require resources. The federal government is uniquely qualified to provide those resources given its virtual unlimited spending authority as well as its pressure it can bring to bear on private enterprises.

thisisn’t even debatable and should be widely understood.

last thing I will say is that there is no difference between red and blue State roll outs. And please stop saying there is. The datas clear and More importantly it doesn’t matter.

You make assumptions , I said nothing of red state and blue state. I pointed out West Virginia having success because of smart management and a knowledge of their state make up.

The remainder of my comments here (no more replies here).

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[rutgersdave]

You make assumptions , I said nothing of red state and blue state. I pointed out West Virginia having success because of smart management and a knowledge of their state make up.

The remainder of my comments here (no more replies here).

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The definitive source for all Rivals news.

rutgers.forums.rivals.com

The state also opted out of a federal partnership to administer vaccines to long-term care residents and staff, working instead with local pharmacies. West Virginia decided to not use CVS and Walgreens, a Warp speed federal program, for their LTC vaccines. NJ should have opted out of that program.

Why West Virginia's Winning The Race To Get COVID-19 Vaccine Into Arms

To get vaccines into long-term care facilities, West Virginia was the only state to opt out of a federal partnership with CVS and Walgreens. Instead, a network of smaller pharmacies got a jump-start.

www.npr.org

For one thing, West Virginia has been charting its own path to vaccine distribution. All 49 other states signed on with a federal program partnering with CVS and Walgreens to vaccinate long-term care and assisted living facilities. But those chain stores are less common in West Virginia, so the state instead took charge of delivering its vaccine supply to 250 pharmacies — most of them small, independent stores.

 

[Joey Bags]

Israel has closed its airspace as a result of the new strains and now Angela Merkel says Germany will follow suit. This seems pretty drastic considering current vaccines do have an effect against the new strains and there still isn't irrefutable peer-reviewed proof these new strains are more transmissible (last I checked, at least).

 

[ArminRU]

A lot of good news on the mABs the last couple days. They work very well as a prophylactic. And the Regeneron one can be administered via subcutaneous injection, so no need for an IV or anything.

Too bad supply is scarce and it’s so expensive to make.

Regeneron Reports Positive Interim Data with REGEN-COV™ Antibody Cocktail used as Passive Vaccine to Prevent COVID-19 | Regeneron Pharmaceuticals Inc.

TARRYTOWN, N.Y. , Jan. 26, 2021 /PRNewswire/ -- Reduction in overall infections seen within first week, with 100% prevention of symptomatic infections Markedly decreased levels and duration of viral shedding in asymptomatic infections that still occurred in REGEN-COV group Confirmatory Phase 3

investor.regeneron.com

Lilly had similar results in their mAB combo cocktail, but don’t think it can be as easy administered.

 

[ArminRU]

More good news. Pfizer getting us 200M doses by end of April. They pushed their timeline up by 2 months somehow.

Global Cases Top 100 Million; N.J. May Relax Curbs: Virus Update

Global coronavirus cases surpassed 100 million, according to data compiled by Johns Hopkins University, marking another grim milestone in the pandemic.

www.bloomberg.com

If J&J works we’ll have enough doses to vaccinate anyone who wants it by April. We’ll be close to that even without J&J!

 

[e5fdny]

More good news. Pfizer getting us 200M doses by end of April. They pushed their timeline up by 2 months somehow.

Global Cases Top 100 Million; N.J. May Relax Curbs: Virus Update

Global coronavirus cases surpassed 100 million, according to data compiled by Johns Hopkins University, marking another grim milestone in the pandemic.

www.bloomberg.com

If J&J works we’ll have enough doses to vaccinate anyone who wants it by April. We’ll be close to that even without J&J!

Tell me more about the J&J one.

@RU848789
@newell138

and anyone else who knows about it.

 

[WhiteBus]

More good news. Pfizer getting us 200M doses by end of April. They pushed their timeline up by 2 months somehow.

Global Cases Top 100 Million; N.J. May Relax Curbs: Virus Update

Global coronavirus cases surpassed 100 million, according to data compiled by Johns Hopkins University, marking another grim milestone in the pandemic.

www.bloomberg.com

If J&J works we’ll have enough doses to vaccinate anyone who wants it by April. We’ll be close to that even without J&J!

I'll believe it when I see it. They have made many false promises about production from the beginning. 200 million doses is vaccinating 100 million people twice. No way that gets done by the end of April.

 

[mdh2003]

More good news. Pfizer getting us 200M doses by end of April. They pushed their timeline up by 2 months somehow.

Global Cases Top 100 Million; N.J. May Relax Curbs: Virus Update

Global coronavirus cases surpassed 100 million, according to data compiled by Johns Hopkins University, marking another grim milestone in the pandemic.

www.bloomberg.com

If J&J works we’ll have enough doses to vaccinate anyone who wants it by April. We’ll be close to that even without J&J!

Please oh Pointy God Vaccus, patron of the vaccine arts, make this be true.

 

[newell138]

Tell me more about the J&J one.

@RU848789
@newell138

and anyone else who knows about it.

The only thing I know about it is its a 1 shot deal instead of the 2 like what we currently have

 

[RU848789]

Lots of vaccine questions and Derek Lowe came out with a very good blog entry on the vaccine landscape for the major players; it's so good, the entire entry is below. I agree with him that while the Pfizer/BioNTech and Moderna mRNA vaccines are off to a slow vaccination start, hopefully the CDC is right that we'll see vaccination numbers rise quickly. We do this every year for the flu and it shouldn't be that much harder for these vaccines, even with cryo conditions required for the Pfizer vaccine - this is a distribution issue, not a supply issue.

With regard to other vaccines, the most concerning issue is that many experts are now starting to believe that that UK variant may well be more infectious than previous strains and that is likely part of the reason why the UK gave an earlier approval to the Astra-Zeneca/Oxford vaccine in the UK, especially for a potential single shot, where, with a more transmissible variant, one shot of a pretty good vaccine for twice as many people is better than two shots of a better vaccine for half as many people. Hopefully, we don't have to make a decision like that here if we can get the mRNA vaccination rates up and if we don't get high rates of the UK variant. Lots of questions still on how they ran their trial, which Lowe details below.

The other thing people need to keep in mind is that the J&J vaccine has a lot of similarities to the AZ vaccine, as both are adenovirus vector vaccines, with the AZ one using a chimp adenovirus to carry the genetic info on it for the spike protein to prime people's immune systems to make antibodies to SARS-CoV-2, while the J&J one uses a fairly rare human adenovirus vector - that means it's possible that the issues with dosing seen for AZ might apply here, although we'll see pretty soon what their first phase III trial using a single dose shows. If it shows even modest efficacy (like ~70%) and good safety from a single shot, we're likely to see it still used a lot.

He also covers the vaccines from Russia and the three from China, with lots of skepticism on these, although they are being deployed in some countries, as well as the Novavax recombinant protein vaccine, which is an exciting entry and which just started phase III trials.

https://blogs.sciencemag.org/pipeline/archives/2020/12/30/vaccine-roundup-late-december



Vaccine Roundup, Late December
By Derek Lowe 30 December, 2020

There’s been a lot of news, so it’s time to survey the vaccine landscape. For this post, I’m only going to cover the big players that are either deep into human trials or have actually been rolling out vaccines to the general population – another post to come will go further down the list. But that still leaves us with plenty to talk about. The situation is. . .well, I’m going with “chaotic”, overused though it is.

I don’t have separate categories for the Pfizer/BioNTech and Moderna vaccines this time, since they’re already under EUA here in the US and people are being vaccinated as we speak. That rollout is worth a longer discussion, but it’s as much politics as it is medicine. Vice President Pence’s statement earlier this month of having 20 million people vaccinated by the end of the year is totally out of reach, though, and I believe that he has now altered that to having 20 million doses shipped (and I’m not even sure about that). The CDC says that vaccinated numbers should start rising steeply, and I certainly hope that’s the case.

Oxford/AstraZeneca: As the world knows, this adenovirus vector vaccine has been a messy one. I think that both partners need to take responsibility for some real mistakes in the trial execution and further mistakes in their announcements since the data became available. But I haven’t seen any sign of that (although I would be even happier than usual to be corrected on that point).

Last night, the UK authorities approved this vaccine for distribution there. Of special interest is the intent to give as many people as possible a first shot, without holding back supplies for the second round. I think that this is simultaneously the correct decision for them to make and also very bad news. It appears that the coronavirus variant first reported there is indeed more contagious: Trevor Bedford is convinced, and we have early data that would seem to only make sense if the R for this form is indeed higher. One mechanism for that may be higher viral load developing in patients more quickly, making them presumably more infectious (via shedding more viral particles). That said, it also appears (so far) that the course of disease with this variant is not actually worse than the other strains, but it’s not any better, either. And with higher transmission, that’s bad enough. (Note that the WHO believes that the South Africa variant is spreading quickly as well).

That situation in the UK appears to be one of the biggest factors driving the approval and rollout, and I see their point: this vaccine is indeed better than nothing, one shot for more people is likely to be better than two-shots-for-some, and it looks like they’re going to need all the help they can get. But “better than nothing” is a rough place to be. So what do we know about the efficacy of a single shot of the Oxford/AZ vaccine, and about the effect of waiting for a second one?

All I can say is that attempts to answer those questions land you immediately in a confusing mess. It’s a mess made worse by AstraZeneca, whose CEO has made statements about the vaccine’s efficacy that are not (so far) backed up by actual numbers. If you’d like me to name a major drug company that’s going to come out of this pandemic looking worse, it’s them. Anyway, as you’ll recall, initially there was a hint that a lower first dose followed by a standard second dose might be more protective overall (although I don’t think the evidence for that is very strong at all, considering the statistical spread in the data). But now there’s a report that increased efficacy might be driven by an even longer wait between the two doses. I don’t find that evidence very compelling, either (we’re getting into some pretty small subgroups by this point, and that is always a dangerous area to draw conclusions from). And if you’re going to leave people walking around with a half dose at first, or a full dose but with a longer wait for the second one, it makes the question above even more crucial: how protective is one dose?

We do not know. We don’t know for this vaccine, nor for the Pfizer/BioNTech one, nor for Moderna’s. No studies have been designed to find that out, so all we can do is guess based on what we’ve seen with the interval between doses in the two-dose studies. That’s been encouraging with the two mRNA vaccines, but remember: we don’t know how they are over a longer period, because no one was left without a second dose for that long. It’s certainly possible that without the second booster that the protection seen after one shot starts to wane. We do not know. And we know even less about the Oxford/AZ vaccine’s behavior under these conditions. Giving as many people in the UK as possible a single dose of that vaccine with a longer wait until the booster is a gamble, and you wouldn’t want to do it that way if the alternatives weren’t even worse. It’s the right move, unfortunately, and it’s a damned shame it’s come to this.

The US trial of this vaccine was paused for weeks, of course, while adverse events were investigated. It’s basically fully enrolled now, and the data will include many more elderly patients than have been investigated to date. I would assume that our current terrible infection rates will allow this trial to move along rather quickly, but I have no estimate of when we might see it report.

J&J: data on the one-dose clinical trial of this adenovirus vector candidate should be coming very soon indeed. It’s going to be of great interest, given the results from the Oxford/AZ effort, and given the deliberate one-dose protocol. The company has a two-dose trial underway as well, but we won’t be seeing data on that one until later.

CanSino: this adenovirus vector vaccine (Ad5) is said to be submitting data to Mexico shortly, presumably for regulatory approval. Trials have been underway there, as well as in Pakistan, Chile, and other countries. No efficacy or safety data have been reported publicly, however.

Gamaleya Research Institute: this two-adenovirus-vector two-dose vaccine has made some news as well. Earlier this month, a press release from the GRI said that the vaccine was 91% effective, based on a trial with over 17,000 vaccinated patients and over 5600 controls. The release also says that a full paper is in the works, to be published in a leading journal, and I very much look forward to that. It appears that the vaccine is now being shipped to Belarus, Argentina and Hungary, but Reuters reports that the Argentina shipment is for only the first dose, which is the easier of the two different adenovirus vectors to manufacture. Nothing on the other countries as yet, but the Hungarian shipment was quite small (6,000 doses), which tells you that it’s more in press-release territory anyway. It’s unclear what’s going on – Reuters had a source saying that the Argentine shipment was excess production from the manufacture of the first shot, and that they’re still catching up on the second. I have seen no reliable figures on the protection offered by just that first shot – the director of the GRI has said, though, that immunity from the first shot lasts only 3 to 4 months.

Meanwhile, the earlier reported collaboration between GRI and AstraZeneca seems to be real – a clinical trial has been registered. I’m quite curious to see how this is going to go, and whether it will produce results in time to make any sort of impact.

Sinovac: Word has just come in the last couple of days from a trial in Turkey of this inactivated virus vaccine. Turkish officials said that it was 91% effective, but we have no numbers to back that up yet. What we do know is that this was based on a rather small trial (752 people vaccinated, 570 in the control group), so the confidence interval on that number is surely going to be large. Sinovac, for its part, seems to have said nothing yet. I’m glad to see that this vaccine seems to be working, but you would really want to see a lot more data on both efficacy and safety.

SinoPharm/Beijing Institute: this inactivated-virus vaccine candidate has just reported data in The Lancet from its Phase 1/2 trials (safety and immunogenicity). And they have now announced that interim analysis of Phase 3 data show 79% efficacy, but with no actual numbers yet. Note that this is the same one that UAE officials announced an 86% efficacy for, but (as far as I can see) SinoPharm has still made no comment on that. Everyone would very much like to have a more complete look at the data, but there is no word on when that will be forthcoming. We don’t know how many people were in these trials, the inclusion or diagnostic criteria used, nor do we have any safety data at all. So this could be encouraging, but I myself would rather stay home and wait for something with more numbers behind it, rather than take a vaccine on this basis. More on this as more data appear.

Novavax: this should be the next trial we hear about after J&J reports, and a lot of people are waiting to see how this recombinant-protein candidate works out. These will be results from a trial in the UK – a US Phase 3 just launched this week. This one has much less rigorous storage requirements and is generally easier to manufacture, and it could be a big contributor if things work out.

Another excellent survey of the vaccine landscape by Derek Lowe in his In The Pipeline blog for ScienceMag. He hits all the categories and all the major players. Talks about the Merck vaccine failure (but has a nugget that Merck IAVI are still going to try a different route of administration, as they suspect the intra-muscular route may have been a problem) and has updates on J&J (phase III data any day now on the one dose protocol), Astra-Zeneca, and Novavax, as well as reports on how well the mRNA vaccines from Pfizer and Moderna are doing (medically, not distribution). He also highlights lesser known efforts from about a dozen other outfits. Worth a read.

https://blogs.sciencemag.org/pipeline/archives/2021/01/25/vaccine-roundup-merck-wipes-out-and-more

 

[RobertG]

More good news. Pfizer getting us 200M doses by end of April. They pushed their timeline up by 2 months somehow.

Global Cases Top 100 Million; N.J. May Relax Curbs: Virus Update

Global coronavirus cases surpassed 100 million, according to data compiled by Johns Hopkins University, marking another grim milestone in the pandemic.

www.bloomberg.com

If J&J works we’ll have enough doses to vaccinate anyone who wants it by April. We’ll be close to that even without J&J!

A little more on Pfizer getting more doses. They did this by changing the label.

Chief Executive Officer Albert Bourla said Tuesday that the drugmaker and its partner, BioNTech SE, will be able to deliver more doses to the U.S. and European Union before the end of the second quarter due to a change in the vaccine’s label that allows health-care providers to extract an additional dose from each vial.

 

[RU848789]

The NY Times vaccine tracker is fantastic with overviews of every vaccine, along with links to more detailed scientific explanations of how each one works. Worth bookmarking. The overview and the J&J details are linked below. Briefly, the adenovirus vector vaccines (J&J and Astra-Zeneca being the big ones) work by encoding the DNA of the viral spike protein into a non-replicating adenovirus (a human one for J&J and a chimp one for AZ), which can enter cells and deliver the gene/DNA, prompting the body's immune system to respond to the pathogen by creating the relevant antibodies and other elements of the immune response (T cells and memory B cells), this providing a ready response should one become infected by SARS-CoV-2.

https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html#jnj

https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html

Tell me more about the J&J one.

@RU848789
@newell138

and anyone else who knows about it.

Here you go. The site's search functionality is decent - took 5 seconds to find my post above - phase III data on the single shot protocol are expected any day now and if good (immune responses in healthy volunteers were pretty good, so it's likely to be good, although maybe not quite as effective as the mRNA vaccines), we should expect an EUA (emergency use authorization) by late February.

 

[ArminRU]

A little more on Pfizer getting more doses. They did this by changing the label.

Chief Executive Officer Albert Bourla said Tuesday that the drugmaker and its partner, BioNTech SE, will be able to deliver more doses to the U.S. and European Union before the end of the second quarter due to a change in the vaccine’s label that allows health-care providers to extract an additional dose from each vial.

Not sure if that’s the sole reason. I guess the question is, can they actually get 6 doses or not? If that’s true, than the label change is justified and 6 doses is 6 doses.

 

[RU848789]

More good news from the monoclonal antibody cocktails. Eli Lilly reported results from a large phase III trial (1035 patients) in recently infected high risk patients using their combo of 2 mAbs (they've mostly been using just one of them so far) showing a 70% reduction in hospitalizations and deaths in these high risk patients. Every reason to believe that the Regeneron cocktail would be similarly effective (data pending soon).

https://medicalxpress.com/news/2021-01-lilly-covid-antibodies-hospitalizations-deaths.html

Also, Regeneron announced that their cocktail was effective as a "passive vaccine" with a 50% reduction (400 patient trial) in preventing infections and 100% effectiveness in lessening severity of infection in those who become infected.

https://www.nbcnews.com/health/heal...ive-preventing-covid-19-company-says-n1255667

 

[RobertG]

Not sure if that’s the sole reason. I guess the question is, can they actually get 6 doses or not? If that’s true, than the label change is justified and 6 doses is 6 doses.

It's from the article you linked. Didn't mention anything else.

 

[e5fdny]

Here you go. The site's search functionality is decent - took 5 seconds to find my post above - phase III data on the single shot protocol are expected any day now and if good (immune responses in healthy volunteers were pretty good, so it's likely to be good,
* although maybe not quite as effective as the mRNA vaccines), we should expect an EUA (emergency use authorization) by late February.

* Which in your (or anyone else who would know) opinion means?

 

[e5fdny]

Please oh Pointy God Vaccus, patron of the vaccine arts, make this be true.

I read this in Elwood Blues voice. LOL

 

[CERU00]

If you worked at a corporation and the job was to develop and distribute a product into people’s hands (arms) and you left it up to 50 individual distribution centers to develop their own plan and process, you would be summarily fired.

The analogy is just stupid. We understand you hate allowing state's rights and all but planning done locally is almost always better. A top down blanket roll out probably wouldn't have worked any better.

 

[CERU00]

If you were the General in command of a Division and you attempted to plan the battles for each one of your brigade comanders they would court marshal you.

50 state Governors should be smart enough to figure this out.

Some how West Virginia did

Perfect response!

 

[bac2therac]

The analogy is just stupid. We understand you hate allowing state's rights and all but planning done locally is almost always better. A top down blanket roll out probably wouldn't have worked any better.

all that would have done was make it easier for the states to blame the feds for all failures which adds to the polarized country as the msm would create more hysteria. There was plenty of time for states to work and put plans in place. You see some states are accomplishing this and others are not.

 

[pmvon]

You make assumptions , I said nothing of red state and blue state. I pointed out West Virginia having success because of smart management and a knowledge of their state make up.

The remainder of my comments here (no more replies here).

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What about CT or VT or even Puerto Rico? NJ is toward the upper end of states administering what they have. As others have pointed out WV did not follow the senior pop guidelines so an easier early administration.

 

[pmvon]

The analogy is just stupid. We understand you hate allowing state's rights and all but planning done locally is almost always better. A top down blanket roll out probably wouldn't have worked any better.

Umm no. I just don’t think things should be left up to them when it comes to things that require national policy like defense and a global pandemic. You know the virus doesn’t see state borders.

 

[RU848789]

The analogy is just stupid. We understand you hate allowing state's rights and all but planning done locally is almost always better. A top down blanket roll out probably wouldn't have worked any better.

We need both and both the Federal and State efforts have been weak so far, especially on the Fed side, particularly with regard to knowing vaccine doses vs. time and where they're going, plus there was very little funding for the states to put the local programs together that are needed to do the day-to-day work. I also think there's no doubt a very motivated/integrated Federal program, utlizing the military and modern health care data systems would be best - that's what they have in Israel (posted on this a few days ago), where over 30% have been vaccinated already - of course part of that is them successfully procuring a higher % of doses than others have, but they've also been able to deliver almost all of their doses.

 

[RobertG]

We need both and both the Federal and State efforts have been weak so far, especially on the Fed side, particularly with regard to knowing vaccine doses vs. time and where they're going, plus there was very little funding for the states to put the local programs together that are needed to do the day-to-day work. I also think there's no doubt a very motivated/integrated Federal program, utlizing the military and modern health care data systems would be best - that's what they have in Israel (posted on this a few days ago), where over 30% have been vaccinated already - of course part of that is them successfully procuring a higher % of doses than others have, but they've also been able to deliver almost all of their doses.

The last round of stimulus provided $9 Billion in vaccine distribution funding

Covid relief bill includes about $8 billion for vaccine distribution

The Covid-19 relief package agreed to by lawmakers provides for more funding for coronavirus vaccine distribution than did earlier proposals.

www.cnbc.com

The funding appears to exceed the $6 billion target set by the Trump administration and may meet the demand made by national organizations representing local public health officials, who have said that at least $8.4 billion was required to carry out the massive vaccination campaign.

 

[RU848789]

* Which in your (or anyone else who would know) opinion means?

Hard to say without the data. Need to know prevention of symptoms and prevention of severe disease/deaths (as well as any side effects, which are not expected to be an issue) for the comparison with the two mRNA vaccines, which are nearly identical. If it's 80% or more effective in preventing symptoms, with no severe cases, I think it might become the vaccine of choice, given the single shot and milder storage conditions (refrigeration only). If it's only 70% effective and there are even a few severe cases, my guess is it might become a secondary vaccine, at least in the US, where the other two will likely be available in high numbers by late spring.