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Potential hope for Coronavirus treatment...

arkieb1

Ideal_Rock
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May 11, 2012
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@missy - they haven't written up the trials yet, they are sharing information as they go. I'd guess they are still working out when it works and who it works for. The people that have died here are mostly 70 and over and have often had other underlying health conditions. Another theory that is possible, is that the drugs don't work on older patients or anyone with underlying health conditions (they have been stating the latter in our media) so lets say the majority of critical cases are the people with underlying health conditions in the US, I'd assume that is another reason why it seems like the drugs are not working there.

I think they work, but lets assume that the patient has to have a set range of specific parameters like being treated really early, being under a certain age and having no other health conditions or health conditions not greatly impacted by the virus for the drugs to do what they claim they can do.

The one good thing reading statistics is that for the amount of cases you have much lower death rate % wise than China and Italy did, we know the US has better health resources and places like NY are really gearing up for this far faster than Italy did in response to the crisis.

Being better prepared means you will save more lives. But yes, the sad thing is, if the disease was slowed when it was first entering the US and as many cases as possible were traced and tracked then it wouldn't have been spreading as fast as it is now and that would have potentially saved more people.

The only way to stop it now is a complete shut down and social isolation as demonstrated in countries that did that and really slowed the rate of infection.

@chemgirl - I agree, if the drugs are not working in the US and they are needed for other patients they should not be using them, most of the people overseas using them are not part of the actual trials. I think all they are doing is panicking and attempting to use the medications on severe patients grasping at straws trying to help them, when the sad reality is that it's too late to help them. There is no magic "bullet" or "cure" for severe cases, other than what they are already doing... they have read this stuff works, but the simple truth is they do not understand yet whom it works for.... and that means they do not have a full understanding of when they should and should not be using it.

Australia has a vaccine they have developed (different lab to the Malaria and HIV people) that works and the US has a vaccine that also works but again the reality is that for full testing of that and then full scale production it takes time, they are saying 18 months maybe 12 cutting corners.

People want a solution now. Medically so far there isn't one.... Shutting down the global economy (shutting society down to very basic resources) is a horrible prospect for anyone in politics but it's a matter of doing it for the greater good of everyone.

@missy - we have the same shortages you do, the test kits we were getting were manufactured overseas not here initially so yes we have shortages, we ordered them far far sooner than you did and on our news tonight another researcher has developed a quick pin prick test kits (made overseas) our government has ordered half a million of them;


We have no better resources than you do, we simply have a government that has understood what this disease does and reacted to it far earlier and far better than yours.
 
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Arcadian

Ideal_Rock
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This is unbelievable. How can that be legal??? This has got to be some sort of human rights violation. This is immoral.

:(
@missy it shouldn't be, and even worse what some Dr's are doing (writing scripts for themselves and family members). I'm thankful for the Pharmacists out there putting a stop to it


I'm very angered by this. So many people use this med to function and not have their own bodies attack itself, they should not have to do without.
 

Smith3

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Nov 20, 2012
Messages
133
I’m worried, I didn’t know this till now, I try to stay away from the news since it gives me anxiety. This is the medicine I take to control my lupus, which has helped but I was suppose to start methotrexate injections as well but with the corona I decided to wait on the methotrexate. I really hope his isn’t true for when I refill my meds in a week
 

Arcadian

Ideal_Rock
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Joined
Sep 17, 2008
Messages
7,048
I’m worried, I didn’t know this till now, I try to stay away from the news since it gives me anxiety. This is the medicine I take to control my lupus, which has helped but I was suppose to start methotrexate injections as well but with the corona I decided to wait on the methotrexate. I really hope his isn’t true for when I refill my meds in a week
Whats happening is just disgusting, I hope you can get them filled. In hindsight, I'm very glad my mom's doc saw fit to "raise" her dose which meant she got more meds to cover her for 90 days. I'm now hearing and seeing others who now can't get their meds, pharmacists have ran out or they're locking it up like a schedule 2 med, or the med prices went from being about 10-15 dollars into the hundreds of dollars overnight, making them unaffordable to the average person. its gross, and thats price gouging.
 

missy

Super_Ideal_Rock
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Jun 8, 2008
Messages
34,092
@missy it shouldn't be, and even worse what some Dr's are doing (writing scripts for themselves and family members). I'm thankful for the Pharmacists out there putting a stop to it


I'm very angered by this. So many people use this med to function and not have their own bodies attack itself, they should not have to do without.
Shameful and unethical and I am speechless. :(
 

missy

Super_Ideal_Rock
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Joined
Jun 8, 2008
Messages
34,092
I’m worried, I didn’t know this till now, I try to stay away from the news since it gives me anxiety. This is the medicine I take to control my lupus, which has helped but I was suppose to start methotrexate injections as well but with the corona I decided to wait on the methotrexate. I really hope his isn’t true for when I refill my meds in a week
I hope you can get them filled @Smith3
 

voce

Ideal_Rock
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May 13, 2018
Messages
3,196
The one good thing reading statistics is that for the amount of cases you have much lower death rate % wise than China and Italy did, we know the US has better health resources and places like NY are really gearing up for this far faster than Italy did in response to the crisis.
......

People want a solution now. Medically so far there isn't one.... Shutting down the global economy (shutting society down to very basic resources) is a horrible prospect for anyone in politics but it's a matter of doing it for the greater good of everyone.
arkieb1, I agree with you about the vaccine and the fact that a lockdown is what's needed to prevent people from dying. I'm going to have to disagree with you about the medical solution.

I'm not personally a doctor, but I come from a family where 2 grandparents and a parent were Directors of their respective departments at a large hospital, and the other 2 grandparents were dentists, not to mention an aunt and a cousin who are nurses. My parents' social networks are made up almost entirely of doctors and medical researchers who are Chinese-American or Chinese. One of them is an editor at Nature, and another is a leading Chinese expert on COVID-19.

People are dying from sepsis. If you look at the death rate for closed cases (closed case statistics are the only statistics that, to me, are relevant, as the majority of coronavirus cases now are in earlier stages and not at the end stage), Italy is currently at 44.5%. China as of Feb 2 was at 43.2%. It is not enough to intubate people, because coronavirus affects the air sacs in the lungs, and by the time people go to the ER in the late stages, it's too late to treat. This is why in China they gave cocktails not just with antimicrobials/antivirals but also hormones acting as suppressants for the body's immune system, to combat the sepsis.

I believe that unless you give the injections that suppress the body's immune response to combat sepsis, the death rate for people going to the ER is going to remain that dismal 40-something-percent. Look how the Chinese death rate dropped over time from 43.2% to 4.3%. This is because they were using this treatment, which they have found to be the most effective.

I think I would differentiate between treatment and vaccination. Vaccination is preparedness before infection. Treatment is what happens after somebody is already infected. I think vaccination only helps out early stage carriers, but late stage the treatment needs to be very different. Looking at the death rates of closed cases, the US remains one of the worst, not because there IS no effective treatment, but because they are going their own way and not implementing the treatment the Chinese came up with. They might have rejected it based off of resource limitations, since maybe immune system suppressants are not widely or readily available, but I very much fear how long it's going to take before US hospitals are able to help late stage coronavirus patients recover.

I very much disagree with the opinion that the US "has much better health resources" when compared to China, at least in terms of PPE.

I think the control of the virus in China is very much related to how much PPE they are producing, and a national awareness and caution. I think other countries are aware and cautious, but since China is keeping most the PPE it manufactures, other countries are less prepared in terms of PPE.
 

OboeGal

Brilliant_Rock
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Mar 22, 2017
Messages
539
arkieb1, I agree with you about the vaccine and the fact that a lockdown is what's needed to prevent people from dying. I'm going to have to disagree with you about the medical solution.

I'm not personally a doctor, but I come from a family where 2 grandparents and a parent were Directors of their respective departments at a large hospital, and the other 2 grandparents were dentists, not to mention an aunt and a cousin who are nurses. My parents' social networks are made up almost entirely of doctors and medical researchers who are Chinese-American or Chinese. One of them is an editor at Nature, and another is a leading Chinese expert on COVID-19.

People are dying from sepsis. If you look at the death rate for closed cases (closed case statistics are the only statistics that, to me, are relevant, as the majority of coronavirus cases now are in earlier stages and not at the end stage), Italy is currently at 44.5%. China as of Feb 2 was at 43.2%. It is not enough to intubate people, because coronavirus affects the air sacs in the lungs, and by the time people go to the ER in the late stages, it's too late to treat. This is why in China they gave cocktails not just with antimicrobials/antivirals but also hormones acting as suppressants for the body's immune system, to combat the sepsis.

I believe that unless you give the injections that suppress the body's immune response to combat sepsis, the death rate for people going to the ER is going to remain that dismal 40-something-percent. Look how the Chinese death rate dropped over time from 43.2% to 4.3%. This is because they were using this treatment, which they have found to be the most effective.

I think I would differentiate between treatment and vaccination. Vaccination is preparedness before infection. Treatment is what happens after somebody is already infected. I think vaccination only helps out early stage carriers, but late stage the treatment needs to be very different. Looking at the death rates of closed cases, the US remains one of the worst, not because there IS no effective treatment, but because they are going their own way and not implementing the treatment the Chinese came up with. They might have rejected it based off of resource limitations, since maybe immune system suppressants are not widely or readily available, but I very much fear how long it's going to take before US hospitals are able to help late stage coronavirus patients recover.

I very much disagree with the opinion that the US "has much better health resources" when compared to China, at least in terms of PPE.

I think the control of the virus in China is very much related to how much PPE they are producing, and a national awareness and caution. I think other countries are aware and cautious, but since China is keeping most the PPE it manufactures, other countries are less prepared in terms of PPE.
@voce, I appreciate this information. Could you be more specific about the antimicrobial/antiviral/immune-suppressing cocktail? What exactly are they giving, and at what stage of the illness?

I'm not a doctor so I may be totally off base, but from what I'm reading of doctors' descriptions of how hospitals in the US are handling this, it seems they are so busy with people in the most severe stages who have to be in the ICU and at that point have a relatively low statistical chance at recovery that they are sending away people in the earlier stages of pneumonia who, with more support and intervention at that stage, might perhaps have a better shot at NOT ending up in the ICU. Several have said they are sending people who ordinarily would be admitted with pneumonia home - some with home oxygen - knowing that many of those people will be coming back needing to be in the ICU, but they can't keep them because of the space and resources going to the critical cases. Yet, anywhere from 70% to 86% who end up on a vent don't make it. It just seems that we're focusing all our resources on people who have progressed too far to have a decent chance at recovery, when we could be doing more earlier in the course to lower the number who even get to that point. @MakingTheGrade, am I making any sense here, or am I totally misunderstanding this?

ETA: @MakingTheGrade, I just realized in looking back over this that I may be coming across like I'm criticizing our health care providers or thinking I know better, and I definitely don't want to do that. You all are rock stars to me! I'm just a layperson who's always been curious and interested in medicine who is interested to understand the decision process a little better.
 
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voce

Ideal_Rock
Joined
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Messages
3,196
@voce, I appreciate this information. Could you be more specific about the antimicrobial/antiviral/immune-suppressing cocktail? What exactly are they giving, and at what stage of the illness?

I'm not a doctor so I may be totally off base, but from what I'm reading of doctors' descriptions of how hospitals in the US are handling this, it seems they are so busy with people in the most severe stages who have to be in the ICU and at that point have a relatively low statistical chance at recovery that they are sending away people in the earlier stages of pneumonia who, with more support and intervention at that stage, might perhaps have a better shot at NOT ending up in the ICU. Several have said they are sending people who ordinarily would be admitted with pneumonia home - some with home oxygen - knowing that many of those people will be coming back needing to be in the ICU, but they can't keep them because of the space and resources going to the critical cases. Yet, anywhere from 70% to 86% who end up on a vent don't make it. It just seems that we're focusing all our resources on people who have progressed too far to have a decent chance at recovery, when we could be doing more earlier in the course to lower the number who even get to that point. @MakingTheGrade, am I making any sense here, or am I totally misunderstanding this?
1) People test positive with no symptoms
2) People test positive and are showing very minor symptoms
3) People test positive and have some symptoms at a moderate level
4) People are positive and have flu like symptoms heading into pneumonia
5) People are positive and have pneumonia and are being treated in ICU centres

6) People are on ventilation and are the worst presentation and the most advanced and severe cases of the disease

I do not know the exact prescription, as I'm only passing on information I heard from my parents, and we do not communicate the scientific names of drugs. I am fluent in Chinese except for when it comes to technical language, since I never had to learn the names of chemical elements and compounds in Chinese, and the names for a lot of substances are based largely on chemical structure. I believe the cocktail can vary depending on the antimicrobial substance available. They were treating people who were at "stages" 3, 4, 5, as broken down by arkieb1, with this. I don't know what they were doing for stage 6.

The reason I put "stages" in quotation marks, is because some people test positive with no symptoms and may never progress past 1 or 2.

It sounds to me like the 70% to 86% who don't make it are stage 6; only a matter of time before they pass.
 

OboeGal

Brilliant_Rock
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539
1) People test positive with no symptoms
2) People test positive and are showing very minor symptoms
3) People test positive and have some symptoms at a moderate level
4) People are positive and have flu like symptoms heading into pneumonia
5) People are positive and have pneumonia and are being treated in ICU centres

6) People are on ventilation and are the worst presentation and the most advanced and severe cases of the disease

I do not know the exact prescription, as I'm only passing on information I heard from my parents, and we do not communicate the scientific names of drugs. I am fluent in Chinese except for when it comes to technical language, since I never had to learn the names of chemical elements and compounds in Chinese, and the names for a lot of substances are based largely on chemical structure. I believe the cocktail can vary depending on the antimicrobial substance available. They were treating people who were at "stages" 3, 4, 5, as broken down by arkieb1, with this. I don't know what they were doing for stage 6.

The reason I put "stages" in quotation marks, is because some people test positive with no symptoms and may never progress past 1 or 2.

It sounds to me like the 70% to 86% who don't make it are stage 6; only a matter of time before they pass.
Thank you for the additional info!
 

Smith3

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Messages
133
I’m I the Midwest and was able to get a refill, but they said it’s becoming out of stock everywhere. They had to call a different store to get it,I go through CVS and they said they are not giving it to people who are prescribed it for the coronavirus only for people with lupus and auto immune issues Who have already been taking it. The only problem is it’s becoming scarce and hard to find and I can only use the one generic form because the other brand gives me flareups. Fingers crossed. They made it seem like they’re not getting any more in just what they have In stock because I guess companies now are hoarding it.
 

voce

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Messages
3,196
I was initially worried about the high death rate in Italy. They were said to have an excellent healthcare system, but it got overwhelmed. Now having looked at some other countries, especially Germany with only a 5.5% death rate for closed cases and South Korea with 3.3% death rate, I am more hopeful. The US should look to these countries for help.
 

arkieb1

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I was initially worried about the high death rate in Italy. They were said to have an excellent healthcare system, but it got overwhelmed. Now having looked at some other countries, especially Germany with only a 5.5% death rate for closed cases and South Korea with 3.3% death rate, I am more hopeful. The US should look to these countries for help.
Yes it should look to those countries, containment is the key once the numbers get over a certain amount. I'm not disagreeing with you on treatment, I agree both the vaccines which are not yet available treat people before they get the virus and the drugs they have been using in Australia, I suspect treat people at the very early stages of the virus which has become much harder to detect in the US.

We have, and will have the same issues at the US with running out of PPE, so do many countries, the point I was making is that our government recognised that and is trying to slow down the curve of infection so that it hopefully can be better managed.

A huge part of the problem of why there is a lack of resources in the US and why there was in Italy is the blase way both governments and indeed many people themselves dealt with the virus initially, in both cases it was only when it spread rapidly putting health and emergency services into crisis situations and when it started killing a noticeable number of people that your government, and many citizens finally were ready to admit they needed to be doing major things to combat this.

What I was trying to point out to @missy, is that our resources are not better than yours, they and the spread of the disease itself have been better managed than yours.

An example in Australia, it is thought several hundred police may have been accidentally infected because they didn't have adequate PPE, so we aren't managing everything perfectly either.
 
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arkieb1

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@voce - I just looked at the infection rate and death rate statistics of various countries, look at the UK, there is another country with a good health care system and we would assume fairly decent resources, yet they are not handling it well, they have a higher % death rate than the US at this point. They have 7 times less infected people than the US, yet their death rate is already at around half of yours.
 

GardenLady21

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I’m worried, I didn’t know this till now, I try to stay away from the news since it gives me anxiety. This is the medicine I take to control my lupus, which has helped but I was suppose to start methotrexate injections as well but with the corona I decided to wait on the methotrexate. I really hope his isn’t true for when I refill my meds in a week
I'm so glad I am not alone! I use methotrexate injections, Orencia injections and Plaquenil (hydroxychloroquine) and I am sooooo worried. Just today I heard that 47% of the hydroxychloroquine is made in India. The news just reported the India has said it will no longer be exporting any hyroxychloroquine to any country, as they want to make sure they have enough for themselves. While I can totally understand the thought behind it, I selfishly worry because the medicine prevents my Lupus and RA from going haywire. I have to avoid news story because my anxiety is starting to get elevated. I get a refill shortly and have been told there may only be a partial fill available due to the amounts in stock at the pharmacy. :(
 

GardenLady21

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I’m I the Midwest and was able to get a refill, but they said it’s becoming out of stock everywhere. They had to call a different store to get it,I go through CVS and they said they are not giving it to people who are prescribed it for the coronavirus only for people with lupus and auto immune issues Who have already been taking it. The only problem is it’s becoming scarce and hard to find and I can only use the one generic form because the other brand gives me flareups. Fingers crossed. They made it seem like they’re not getting any more in just what they have In stock because I guess companies now are hoarding it.
Thank God!! I am afraid they won't be able to fill my re-order. Maybe they will be able to give me some after all! Yay! (I have Lupus/RA/Sjogren's)
 

Arcadian

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Microsoft (MSFT) founder and philanthropic billionaire Bill Gates is spending billions of dollars on seven possible vaccines for the coronavirus and the disease it causes, COVID-19, in hopes of finding an end to the pandemic.
 

Smith3

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Messages
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I'm so glad I am not alone! I use methotrexate injections, Orencia injections and Plaquenil (hydroxychloroquine) and I am sooooo worried. Just today I heard that 47% of the hydroxychloroquine is made in India. The news just reported the India has said it will no longer be exporting any hyroxychloroquine to any country, as they want to make sure they have enough for themselves. While I can totally understand the thought behind it, I selfishly worry because the medicine prevents my Lupus and RA from going haywire. I have to avoid news story because my anxiety is starting to get elevated. I get a refill shortly and have been told there may only be a partial fill available due to the amounts in stock at the pharmacy. :(
What state are you in? This is all so scary, I can only use the one generic the other gives me flare ups. I’m sorry your going through this too.
 

missy

Super_Ideal_Rock
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I am sharing this here but please know I am not stating this as fact or accurate. Just sharing it with a healthy dose of skepticism but always hopeful.


(Just the) Highlights for those who don't want to click.

"
STORY AT-A-GLANCE
  • Vitamins C and D are finally being adopted in the conventional treatment of novel coronavirus, SARS-CoV-2. This fortunate turn of events is likely to save thousands of lives, while keeping health care costs down
  • Seriously ill coronavirus patients in New York state’s largest hospital system receive 1,500 milligrams of intravenous vitamin C three to four times a day, in conjunction with other conventional treatments
  • Vitamin C at extremely high doses acts as an antiviral drug, actually killing viruses
  • In recent articles, former CDC chief Dr. Tom Frieden and Dr. John C. Umhau, a public health specialist at NIH, highlight the usefulness of sun exposure and/or vitamin D supplementation to reduce your risk of SARS-CoV-2 infection
  • Although vitamin D does not appear to have a direct effect on viruses, it does strengthen immune function, thus allowing the host body to combat the virus more effectively. It also suppresses inflammatory processes"
 

missy

Super_Ideal_Rock
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Messages
34,092
I’m I the Midwest and was able to get a refill, but they said it’s becoming out of stock everywhere. They had to call a different store to get it,I go through CVS and they said they are not giving it to people who are prescribed it for the coronavirus only for people with lupus and auto immune issues Who have already been taking it. The only problem is it’s becoming scarce and hard to find and I can only use the one generic form because the other brand gives me flareups. Fingers crossed. They made it seem like they’re not getting any more in just what they have In stock because I guess companies now are hoarding it.
@Smith3 and @GardenLady21 and all others who are taking this med and are affected I am sending out lots of good luck dust and keeping you in my thoughts. I hope you can continue getting what you need.
 

Smith3

Shiny_Rock
Joined
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Messages
133
@Smith3 and @GardenLady21 and all others who are taking this med and are affected I am sending out lots of good luck dust and keeping you in my thoughts. I hope you can continue getting what you need.
That is so nice of you! And thank you for posting about vitamins, I just started taken vit D.
 

Arcadian

Ideal_Rock
Premium
Joined
Sep 17, 2008
Messages
7,048
I am sharing this here but please know I am not stating this as fact or accurate. Just sharing it with a healthy dose of skepticism but always hopeful.


(Just the) Highlights for those who don't want to click.

"
STORY AT-A-GLANCE
  • Vitamins C and D are finally being adopted in the conventional treatment of novel coronavirus, SARS-CoV-2. This fortunate turn of events is likely to save thousands of lives, while keeping health care costs down
  • Seriously ill coronavirus patients in New York state’s largest hospital system receive 1,500 milligrams of intravenous vitamin C three to four times a day, in conjunction with other conventional treatments
  • Vitamin C at extremely high doses acts as an antiviral drug, actually killing viruses
  • In recent articles, former CDC chief Dr. Tom Frieden and Dr. John C. Umhau, a public health specialist at NIH, highlight the usefulness of sun exposure and/or vitamin D supplementation to reduce your risk of SARS-CoV-2 infection
  • Although vitamin D does not appear to have a direct effect on viruses, it does strengthen immune function, thus allowing the host body to combat the virus more effectively. It also suppresses inflammatory processes"
I have lots to say about Mercola, :roll2: now is not the time....

however with C being used, at high doses intravenously it will kill cancer cells, (a small cancer center in Kansas uses this method) So he's not wrong in that there is clinical use for C.

Vit D is anti inflammatory. Its best not to just take D like crazy though, it can stick around in the body for a very long time. But yes it does help.

Another Cancer Doctor here uses NAC /glutothione which does greatly help for cytokine storms, binding feritin and helping to prevent sepsis. It might sound wacky but again, he's a cancer doc, they will sometimes go out on a limb to help their patients. I asked if he could write something up for his site.. he's working on it in between a whole lot of other stuff going on.
 

missy

Super_Ideal_Rock
Premium
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Jun 8, 2008
Messages
34,092
From Medscape.


"
COVID-19 Daily: Early Remdesivir Data Published, World Leader Recovers
Liz Neporent
April 12, 2020


Editor's note: Find the latest COVID-19 news and guidance in Medscape's Coronavirus Resource Center.
Compassionate Use of Remdesivir
More than two thirds of severely ill COVID-19 patients improved after being given the experimental drug remdesivir (Gilead Sciences, Inc), according to an analysis published in the New England Journal of Medicine.
However, numerous experts expressed concern about the interpretability of the findings. The 53 patients included in the analysis were given a 10-day course of the experimental drug for "compassionate use" consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment.

The findings, which showed significant improvements in 32 of the patients (68%), are "hopeful," the paper said. But the authors also caution that the number of patients was small and there was no control group.
British Prime Minister Leaves Hospital
With much of the world celebrating the Easter holiday today, here is a bit of good news from the United Kingdom. British Prime Minister Boris Johnson is on the mend after being hospitalized with COVID-19 last week.
Johnson was discharged earlier today from London's St Thomas' Hospital, Medscape News UK reports. A Downing Street spokesperson said that on the advice of his medical team the Prime Minister would not be back at work immediately. Johnson, who entered the hospital last Sunday for persistent symptoms of COVID-19 and spent 3 days in intensive care, will continue his recovery at his country residence, Chequers.



"It is hard to find the words to express my debt to the NHS for saving my life," Johnson said in a tweet quoted in the Medscape report.
The Hydroxychloroquine Controversy Continues
Elsevier weighed in on its controversial paper about the use of hydroxychloroquine to treat COVID-19. The publisher defended the peer review process for the article after concerns about including the top editor of the journal as one of the paper’s lead authors, Retraction Watch reports.
Earlier this month, Medscape reported that the International Journal of Antimicrobial Agents expressed concern that the March 20 article, "Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial" did not meet the International Society of Antimicrobial Chemotherapy's expected standard, especially relating to the lack of clear explanations of the inclusion criteria and the triage of patients to ensure patient safety.

A Shift in Thinking
Asymptomatic or presymptomatic for COVID-19? Experts with the Infectious Diseases Society of America (IDSA) discussed the difference between the two terms and announced new guidelines on management of COVID-19.

"Pre" is really the right terminology, Carlos del Rio, MD, professor of medicine, Division of Infectious Diseases, Emory University School of Medicine, Atlanta, Georgia, said during a news briefing. It's not that people are asymptomatic but that they develop symptoms later and start transmitting the virus 24 to 48 hours before they develop symptoms, he said. The briefing also included a discussion of racial disparities in COVID-19. For example, in Alabama, around 20% of the population is African American, yet this population accounts for about 40% of COVID-19 deaths.

Quantifying Infections
The US National Institutes of Health (NIH) has announced a recruitment drive for a new study to determine how many adults in the United States without a confirmed history of infection with SARS-CoV-2 have antibodies to the virus.


SARS-CoV-2 is the virus that causes COVID-19. The presence of its antibodies in the blood indicates a prior infection, the announcement on the NIH website says. Researchers leading the "serosurvey" hope to collect and analyze blood samples from as many as 10,000 subjects to provide critical data for epidemiologic models. Results should help illuminate previously undetected infections and identify which communities and populations have been hit the hardest.


The study will be conducted by researchers at the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Biomedical Imaging and Bioengineering (NIBIB), with additional support from the National Center for Advancing Translational Sciences (NCATS) and the National Cancer Institute (NCI), all divisions of NIH. Healthy volunteers over the age of 18 from anywhere in the United States can participate. Anyone interested in joining the study should contact the NIH directly, referencing the clinical trial identifier NCT04334954 in their query.


Possible Re-infections Under Investigation
The World Health Organization (WHO) is investigating reports of recovered COVID-19 patients testing positive for a second time.


Ninety-one patients who were thought to be clear of the novel coronavirus have tested positive again after initially testing negative for the disease while being considered for discharge, according to South Korean officials. Jeong Eun-kyeong, director of the Korea Centers for Disease Control and Prevention, told a news briefing that the virus may have been "reactivated" rather than the patients being re-infected.


"As COVID-19 is a new disease, we need more epidemiological data to draw any conclusions of virus shedding profile," said a brief statement from the Geneva-based World Health Organization. It remains unclear what is behind the trend, the statement added. South Korean researchers say that epidemiologic investigations are underway.


Patients With Mental Illness May Be Hit Hardest by COVID-19
In an interview with Medscape Medical News , the author of a new JAMA Psychiatry study said patients with severe mental illness have "a whole range of vulnerabilities" that put them at higher risk for COVID-19. These include high rates of smoking, cardiovascular and lung disease, poverty, and homelessness, said Benjamin Druss, MD, MPH, from Emory University's Rollins School of Public Health in Atlanta, Georgia. He says that the looming crisis COVID-19 presents for those with mental illness can be avoided if their healthcare providers stay up to date on risk mitigation and communicate clearly with their patients.


ARDS Reference
Patients with severe illness related to COVID-19 may quickly progress to acute respiratory distress syndrome (ARDS). With so many healthcare professionals stepping outside their specialties to help out with coronavirus patients, Medscape has published a short quiz to help review best practices in ARDS management.


Liz Neporent is Medscape's executive editor of social media and community. She has previously worked at ABC News National as well as other major news outlets. She's based in New York City and can be reached at [email protected] or @lizzyfit on Twitter."
 

missy

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"
There are 70 coronavirus vaccines in development globally, with three candidates already being tested in human trials, according to the World Health Organization, as drugmakers race to find a cure for the deadly pathogen.



The furthest along in the clinical process is an experimental vaccine developed by Hong Kong-listed CanSino Biologics Inc. and the Beijing Institute of Biotechnology, which is in phase 2. The other two being tested in humans are treatments developed separately by U.S. drugmakers Moderna Inc. and Inovio Pharmaceuticals Inc., according to a WHO document.




Chinese Vaccine Approved for Human Testing at Virus Epicenter



Progress is occurring at unprecedented speed in developing vaccines as the infectious pathogen looks unlikely to be stamped out through containment measures alone. The drug industry is hoping to compress the time it takes to get a vaccine to market -- usually about 10 to 15 years -- to within the next year.




Drugmakers big and small have jumped in to try to develop a vaccine, which would be the most effective way to contain the virus. Pharmaceutical giants like Pfizer Inc. and Sanofi have vaccine candidates in the preclinical stages, according to the WHO document.

Big Pharma Makes a Big Bet on Coming Up Fast With a Vaccine

CanSino said last month it received Chinese regulatory approval to start human trials of its vaccine. Cambridge, Massachusetts-based Moderna -- which has never put out a product -- received regulatory approval to move quickly to human trials in March, skipping the years of animal trials that are the norm in developing vaccines. Inovio began its human trials last week."




"
Much about the coronavirus has defied belief—the speed at which it has spread around the world, the insidious way it penetrates the lungs, the unexpected impact it’s having on young people in some parts of the world while sparing them elsewhere. The most effective way to stop it would be to vaccinate the global population. For that to happen in the next year or so, an almost equally implausible set of circumstances has to occur: flawless scientific execution, breakneck trials, and a military-style manufacturing mobilization unlike any the pharmaceutical industry has put in place before. Normally it takes 10 or 15 years of careful lab work and meticulous testing to bring a totally new vaccine to market. For the coronavirus, the drug industry hopes to compress this time frame by tenfold.



This may sound like mission impossible, but Big Pharma wouldn’t be working this hard if it didn’t think it had a shot at pulling it off. Already, Cambridge, Mass.-based biotech Moderna Inc., a company that’s never launched a product, has started human trials of a vaccine harnessing a brand-new type of RNA technology to protect against coronavirus. Drug giant Pfizer Inc., with German partner BioNTech SE, is working on a vaccine with a similar new technology, while Johnson & Johnson is building off a template for its experimental Zika and Ebola vaccines. French drugmaker Sanofi is adapting technology used for manufacturing its flu shots to see if it will protect against the coronavirus.



All told, more than two dozen coronavirus vaccines are already in early stages of testing. “There is no precedent for the speed at which we are moving,” says Clement Lewin, an associate vice president at Sanofi. In his two and a half decades of work on vaccines, “I can’t think of a parallel.”




It’s a sentiment echoed throughout the halls of pharma and biotech as leaders of some of the world’s biggest companies race to rewrite the rules in a bid to slow or stop the coronavirus. To accomplish this, they’re going to need to radically change the way drug development works. This for a vaccine that J&J, for one, is promising it won’t even make a cent from. From a public-health perspective, a vaccine can’t come soon enough: More than 1 million people have been infected with the coronavirus globally, with hot spots such as New York and Seattle building field hospitals to accommodate sick patients.




The mere hope of a vaccine has generated so much excitement that shares in drug giants such as Pfizer and Johnson & Johnson have shot up in recent weeks, with one-day spikes of 6% and 8%, respectively, rare moves for large companies that normally aren’t prone to big swings. Moderna is up more than 75% year-to-date. This could easily be a vaccine bubble. The time frame the U.S. government has given out, of having a shot within 12 to 18 months, has drawn skepticism from many vaccine experts. “You would have to have everything go perfectly to get there,” says Seth Berkley, chief executive officer of the nonprofit Gavi, the Vaccine Alliance, which helps developing countries finance and distribute vaccines. “The most important thing is to have people understand that science is miraculous and can make things happen but it isn’t going to happen tomorrow.”

Still, the first steps are happening remarkably quickly. To understand the buzz around Moderna, one must understand how much it’s accomplished in just a few short months. On Jan. 11, when few in the West were paying attention to the virus, Chinese scientists posted the genetic sequence of the new coronavirus that was spreading in Wuhan. Researchers at Moderna took note. They’d been pioneering a novel vaccine technology for another coronavirus disease and went to work on devising a vaccine against the new one. By late February, when President Trump was still downplaying the risk of coronavirus, Moderna’s scientists had already delivered the first batch of candidate vaccines to researchers at the U.S. National Institutes of Health. When the coronavirus was starting to explode in the U.S. in mid-March, the first healthy patient received a dose in a small, government-sponsored safety trial.


The technology being used by Moderna, Pfizer, and several others relies on the body’s own cells to produce viral proteins. Moderna’s vaccine consists of genetic material that codes for the spike protein on the surface of the coronavirus. (Those red bumps in the ubiquitous coronavirus image that’s emblazoned in your brain by now.) Once injected into the body, the RNA slips into human cells and tells them to produce the viral proteins. “When you inject a person in the arm with our vaccine, what you are really injecting is instructions for their body to make thousands of copies of proteins from the surface of the virus,” says Stephen Hoge, president of Moderna. If the vaccine works, those proteins will then trigger the body to generate protective antibodies against the virus.

In practical terms, the RNA technology can move faster into trials because, unlike traditional vaccines, it doesn’t involve brewing batches of protein or inactivated viral particles in living cells, a bespoke process that can take months to ramp up. Some flu vaccines are still made in chicken eggs. If the RNA technology sounds exotic and unproven, that’s because it is. There isn’t an approved RNA vaccine yet for any disease, nor are there existing plants already making these vaccines in enormous quantities.

In additional to betting on new technologies to speed the process, companies are throwing caution to the wind by performing numerous testing steps in parallel. Pfizer, working in a partnership with the German group BioNTech, hopes to get an experimental RNA vaccine into humans later this month. Pfizer is taking a novel approach to improve its odds: Instead of testing the single vaccine candidate it thinks will work best, it’s planning to move into human trials with four different options simultaneously, to see which of those is the most successful before taking the studies to bigger populations. Vaccine makers normally do three stages of human trials, moving sequentially from small safety studies to bigger and bigger efficacy trials. But Pfizer is considering an all-encompassing trial that would grow larger over time as results flow in. And the company hopes to share incoming trial data with regulators in real time for quicker decision-making about how to proceed. “We are proposing to basically change the way we do development as a result of this crisis,” says Kathrin Jansen, head of vaccine research and development at Pfizer.

RNA vaccine technology isn’t without its risks. Less is known about its efficacy, and while there’s a decent amount of early-stage safety data showing the technology should be safe, there are concerns some RNA vaccines could induce unwanted immune responses. Another issue that all Covid-19 vaccines will have to avoid is a troublesome complication called “disease enhancement,” hints of which were seen in animal tests of vaccines for SARS, another coronavirus disease.

And as the battle against HIV shows, there’s no guarantee a vaccine is possible. Some of the approaches touted now are likely to fizzle, either because of side effects or lack of efficacy. But coronavirus experts are guardedly hopeful that with so many of the best and brightest pharmaceutical minds working on the problem, at least one vaccine will work.

Another challenge for any coronavirus vaccine would be scaling up production. Say it works. There would then be the need to meet the global demand for inoculations. Pfizer has started making plans to invest in manufacturing capacity both in the U.S. and abroad. Moderna says it already has the ability to produce millions of doses of bulk vaccine per month at a factory that was gearing up to produce a different vaccine. But for a development-stage company with no marketed products, it will be a tall order. Moderna is talking to potential partners to get that off the ground, but it didn’t name names.

And as ambitious as “millions” of vaccines sounds, it’s only a fraction of what the demand for a Covid-19 vaccine could be. While not precisely comparable to the situation now, a 2018 planning road map for a pandemic influenza vaccine, put out by the U.S. Centers for Disease Control and Prevention, shows the enormity of demand for such a vaccine.

First in line would be millions of doctors, nurses, and other first responders as well as infants, toddlers, and pregnant women. That’s 26 million people in the U.S. alone. Next in line would be millions of other essential personnel plus children with preexisting conditions. After that would be broader groups of higher-risk patients, including 41 million adults over age 65 and 38 million younger adults with preexisting conditions. Add all together, and you get well north of 100 million Americans who would be high-priority candidates to get a vaccine.


And that’s just the U.S. It doesn’t include hundreds of millions more in China, Europe, India, and elsewhere, all of whom will be clamoring for inoculations. The real question isn’t just proving whether a vaccine works, “but how quickly can you ramp up manufacturing to meet global need,” says Mark Feinberg, a former Merck & Co. vaccine executive who now leads the International AIDS Vaccine Initiative.

“There aren’t a lot of drugs in the industry that are filled at these scales, period,” says Moderna’s Hoge. “Even large pharma companies don’t usually operate on this kind of a scale. No one entity or one company” will be able to do it on their own, he says.

While drug giants such as J&J and Sanofi may not be able to get into trials as fast as Moderna, their proven manufacturing capabilities do give them an edge in scaling up to hundreds of millions of doses should their vaccines work. Sanofi says the coronavirus vaccine it’s working on uses the same technology already used in one of its licensed flu vaccines, making it easier to produce in large quantities. Sanofi hopes to begin human trials of its first vaccine, which uses the protein technology of its Flublok flu vaccine, by fall. Its U.S. manufacturing plants have capacity for 100 million to 600 million doses a year, depending on the amount of vaccine that ends up being needed for each shot, says Lewin, the associate vice president. Sanofi isn’t stopping there: The company also hopes to begin trials on a second vaccine that uses RNA technology similar to Moderna’s by yearend.

J&J is relying on an old playbook, working off a vaccine platform the company used for experimental vaccines for several diseases including Ebola, Zika, and RSV, a respiratory illness that can be particularly problematic for young children. It’s an inactivated cold virus with a piece of the coronavirus spike protein on it to generate an immune response. J&J started by evaluating 10 different approaches to the coronavirus before selecting one on March 30, a development that sent its shares up 8%.



The drugmaker has seen its ability to do this type of epidemic vaccine research wax and wane; diseases such as Ebola and Zika petered out while it was studying experimental shots, slowing the pace of research. But the company managed to continue the work by using the vaccine in outbreaks prior to official approval. It’s ready for this possible outcome, too. “We have clinical trial capacity around the world in 80 countries, and we will be prepared to move around the world to where an outbreak is. If it is Brazil, we will be there. If it’s in Africa, we’ll be there. China, we’ll be there,” says Paul Stoffels, J&J’s chief scientific officer.

It would be ideal for the coronavirus to taper off to the point that all of these vaccine trials would grind to a halt. But top industry officials aren’t counting on this outcome, given that the curve of patients and deaths is only increasing. “It’s really scary. Most likely we need a vaccine to put a stop to the epidemic, and that’s where we go full bore with the input of a lot of scientific expertise from inside and outside but also a lot of discussions with governments around the world,” Stoffels says. “It’s at least an insurance that at a certain point we can put a stop to this virus.”
"
 

missy

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Info about vaccine trials.
From Medscape. April 19, 2020

"
Oxford COVID-19 Vaccine Trial 'Within Weeks': Q&A

UK experts have been giving updates on progress towards a COVID-19 vaccine in an online event hosted by the Science Media Centre.
The Jenner Institute and Oxford Vaccine Group clinical teams are developing a ChAdOx1 nCoV-19 vaccine based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein.

Prof Sarah Gilbert, lead researcher of the vaccine development programme, and professor of vaccinology, University of Oxford, told the Lancet she hopes to have vaccinated 500 volunteers by mid-May.

At yesterday's Downing Street briefing Business Secretary Alok Sharma announced a vaccines task force. It will be formed from Government, industry, academia, and regulators. "The task force will coordinate with regulators to facilitate trials, which are both rapid and well supervised, and it will work with industry in the UK, and internationally, so we're in a position to manufacture vaccines at scale," he said.

Chief Scientific Adviser Sir Patrick Vallance said: "Just to put some realism on vaccine development, that each single project does not have a high probability of success. So although everyone goes out with great enthusiasm, and we hope they work, it's never the case that you know you've got a vaccine that's going to work."

Prof Gilbert and colleagues have been answering questions.

Q&A
How does the lockdown affect clinical trials?



Prof Andrew Pollard, chief investigator on the study, and professor of paediatric infection and immunity, University of Oxford: "If there's no transmission of the virus and no cases, it really makes it very challenging to be able to test whether the vaccine works in preventing the cases.

"I think because we're very close to getting underway, and there is still some transmission there's a reasonable chance that we'll be able to pick up the efficacy of the vaccine over the next couple of months. But it's definitely a question that needs to be addressed within these trials.

"I think the main issue is, if there is not very much transmission, then it may take much longer to be able to demonstrate that the vaccine works in the wild, so to speak."

During lockdown would you target key workers or areas where the curve is rising?


Prof Pollard said that was something "we've been puzzling over, over the last weeks". He continued: "We need to make sure that we're identifying individuals who are more likely to be exposed to virus, that would be very important going forwards. So for example, studies involving healthcare workers might be one route to do that. We haven't made that a specific strategy at the moment. That's certainly a possibility.


"We are indeed already working with partners in other parts of the world to go through the regulatory and ethical processes to be able to set up trials elsewhere, particularly focusing on Africa, where there's clearly a great need, potentially, in the future to have vaccine available.
At yesterday's Downing Street briefing Business Secretary Alok Sharma announced a vaccines task force. It will be formed from Government, industry, academia, and regulators. "The task force will coordinate with regulators to facilitate trials, which are both rapid and well supervised, and it will work with industry in the UK, and internationally, so we're in a position to manufacture vaccines at scale," he said.
Chief Scientific Adviser Sir Patrick Vallance said: "Just to put some realism on vaccine development, that each single project does not have a high probability of success. So although everyone goes out with great enthusiasm, and we hope they work, it's never the case that you know you've got a vaccine that's going to work."

Prof Gilbert and colleagues have been answering questions. Q&A

How does the lockdown affect clinical trials?

Prof Andrew Pollard, chief investigator on the study, and professor of paediatric infection and immunity, University of Oxford: "If there's no transmission of the virus and no cases, it really makes it very challenging to be able to test whether the vaccine works in preventing the cases.

"I think because we're very close to getting underway, and there is still some transmission there's a reasonable chance that we'll be able to pick up the efficacy of the vaccine over the next couple of months. But it's definitely a question that needs to be addressed within these trials.

"I think the main issue is, if there is not very much transmission, then it may take much longer to be able to demonstrate that the vaccine works in the wild, so to speak."

During lockdown would you target key workers or areas where the curve is rising?



Prof Pollard said that was something "we've been puzzling over, over the last weeks". He continued: "We need to make sure that we're identifying individuals who are more likely to be exposed to virus, that would be very important going forwards. So for example, studies involving healthcare workers might be one route to do that. We haven't made that a specific strategy at the moment. That's certainly a possibility.
"We are indeed already working with partners in other parts of the world to go through the regulatory and ethical processes to be able to set up trials elsewhere, particularly focusing on Africa, where there's clearly a great need, potentially, in the future to have vaccine available."



Are challenge trials being considered?

"This is where volunteers are deliberately infected with coronavirus after they've been vaccinated."

He said: "There have historically been some challenge trials with coronavirus done in the past but those were the coronaviruses that caused the common cold, rather than the ones which caused the pandemic.

"Of course the risk of a challenge trial would be if you were to challenge a volunteer with the virus, and you had the dose wrong and it led to very severe disease. And that's going to make it quite difficult to initiate those sorts of studies, until we have some treatments that could be available if things went wrong in one of those trials.

"So I think at the moment, there's a lot of interest in this and people thinking about how it could be undertaken, because it would really accelerate vaccine development, but there are some major hurdles to make sure the safety of the volunteers in that setting."

What stopped you running a challenge trial alongside a normal phase 3 trial?

Prof Adrian Hill, director of the Jenner Institute, University of Oxford: "The fact that there is no challenge model for this disease established, or even initiated, anywhere in humans. At the moment it's an idea that's being discussed. The obvious problem with a challenge model is that you need to ensure that giving somebody the virus is safe.

"We haven't done that. It's difficult to do that very, very quickly, because you have to do it carefully.

"It's not at all clear that if you can do a real efficacy trial acting against natural infection you need a challenge model that takes longer to set up.

"But if we, for any reason, do not succeed in finding a vaccine while there's a lot of this virus around, and then it mainly disappears, I'm sure there will be efforts to develop a challenge model, ideally … once there's a drug available to treat the infection should you give too high a dose to any individual."

Do you expect vaccines to work better in some groups than others?

Prof Pollard: "For most vaccines the immune system in older adults, particularly those over 70, doesn't make such good responses.

"That's one of the things we need to evaluate in our trials, is how well does this vaccine work in that age group?

"The way around that is if you have poorer responses you can give additional doses of the vaccine to try to improve responses.

"If we did see weaker responses in older adults we also have in our plan that we would look at giving additional doses in that age group to try and improve the immune response."

Prof Sarah Gilbert: "With other vaccines that we've developed, particularly fluvaccines, we have tested them in older people going up to people in their 80s. And we do see that the immune response is a little bit lower, but not really very much lower.

"And so as we do the clinical trials, we're going to be trying to work out how strong the immune response needs to be to protect people and compare the response in adults up to 55, and then up to 70, and then over 70 and look at the differences.

"It's not that we don't expect to see anything at all in the older adults but it's just that it's likely to be somewhat less and then we'll have to try and work out if that's good enough to give full protection. And if not… we can think of giving an extra dose which is likely then to improve it.

"So it's not that it's going to work in young people and not at all in older people it's a bit more subtle than that."

How much investment is at risk if the 1m vaccine doses planned for September don't work?

Prof Hill: "Of course the amount of money you need depends on how ambitious you are in having huge amounts, or just large amounts, of vaccine available.

"Other groups are doing this as well, we think ours is probably the most ambitious scale-up programme that there is, at the moment. I guess that reflects to a degree our confidence that this vaccine probably could work and therefore the doses will be needed."

He added: "If we thought the risk was low, or that the likelihood of success was low, we'd probably go to one manufacturer and have a small number of doses ready. We think that's unlikely. We think this vaccine has as good a chance, maybe a better chance, than any of the others, and there are lots around - this will be the fourth in the clinic.

"There are other groups doing similar sorts of technologies with adenovirus factors, but not with the chimpanzee adenovirus factor, which is better in several ways, and relatively efficient to manufacture.

"So, one of the big attractions here is that we have a process that was recently developed in the University which gives a higher yield. So the amount of money you need to invest to get to 1m doses is less if your productivity in vitrois five times better.

How much money is involved?

"It's £10s of millions not millions at the moment."

Will people need top up vaccinations?

Prof Pollard: "Based on our experience with other vaccines using this platform, it's unlikely they would need another dose soon.

"I think part of the information will depend on which population we're studying. As I mentioned before in older adults, it's certainly possible that the immune responses could be weaker. But in younger adults and certainly with other similar vaccines, for example, there's an Ebola vaccine, which has been very widely used, using a similar technology, the antibody responses are very strong even a year and more later.

"So I think it's very unlikely that further doses [would be] needed very quickly, but we will be monitoring all of that as part of the clinical trials that are being undertaken."

Will the vaccine be produced in the UK?

Prof Hill: "The answer is yes to manufacturing in Britain."

If it's being manufactured in the UK does it mean those doses are used in the UK?

"It's not as simple as that. We're very concerned that no one country tries to own all of the vaccine because it's going to be needed internationally.

"That has yet to be sorted out. It links to the funding question: who has funded the vaccine development of the particular batch that is being made?

"We're not quite at that stage yet, but I do want to emphasise that we're not trying to supply just one country or even one territory, we want to be able to use the vaccine where it's needed most. Clearly today that's in Europe and in North America, but in 3 or 4 months time that might all change, in the way that the pandemic disappeared in China. Africa is looking worrying it might be that a lot of vaccine is needed in low-income countries and we want to be able to provide for that eventuality as well."

How will everyone in the world get an equal chance of getting the vaccine at the same time?

Prof Hill: There are extensive discussions going on at different levels, about that. One of the organisations that has been particularly active in trying to steer that is the Coalition for Epidemic Preparedness Innovations (CEPI).

"They have been one of the funders for this programme. They are interested in allocation mechanisms that would try and bring together different manufacturers, different groups, assuming that multiple vaccines are shown to work, and having a scheme whereby one can ensure the vaccine is provided first where it's needed most.

"And it's unlikely we're going to have 7 billion doses available very very quickly, so there has to be some prioritisation."


What sort of antibodies will you be able to check for some months after people have been vaccinated?

Dr Teresa Lambe, associate professor & Jenner Investigator, The Jenner Institute, University of Oxford: "We don't have a reliable antibody test yet, but we're working hard on getting that established in our lab, and I'm fully confident that we will be able to look at the immune responses months after vaccination.

"We've done this before with emerging and outbreak pathogens, during Ebola, and I'm sure we'll be able to do it again. We've got some really great collaborators who are helping us with this as well."

Prof Hill: "We are interested in cellular immunity as well as antibodies. There's evidence from Sarah [Prof Gilbert]'s work on a MERS vaccine that cellular immunity is potentially very important in protecting against coronaviruses. That may well be the case here as well, which is one of the reasons we've chosen to use a vaccine technology which is… very good for inducing cellular immunity as well as antibodies."

Prof Gilbert: "We will be doing these antibody assays in our lab in the way that we always do in the clinical trials. It's not high throughput. It's very labour- intensive work. It's great for doing clinical trials, it's not really appropriate technology to roll out to serology testing of the whole country."

How many vaccine doses could be ready by Christmas?

Prof Hill: "Best case scenario, I guess you might have hundreds of millions by the end of the year, but I'm not promising that. Nobody can promise that, but that would not be an unreasonable target, particularly given the manufacturing team that are working on this."

Is there a drawback with RNA vaccines that, like cancer immunotherapies, may not work in all patients?

Prof Gilbert: The RNA vaccines, they're really unproven. But there's been a lot of interest in them because, unlike some other vaccines, such as the VSV [vesicular stomatitis virus-based] vaccines, there is now a VSV Ebola vaccine. That turned out to be really difficult to manufacture in large amounts. You can make it in small amounts for clinical trials, but when you want to make lots of it to use in large outbreaks it's really difficult to make a lot and have enough of it ready.

"So that was identified as a bottleneck and it's a really important bottleneck.

"It's one that doesn't exist for our adenovirus effective vaccines because as we've been talking about we can go to the millions, tens of millions, and hundreds of millions of dose scale per manufacturer per year."

She continued: "But one advantage of the RNA vaccines is that you can also make them in very large quantities, and fairly quickly. They're quite simple things to produce. The part that's missing with the RNA vaccines is knowing how good they are at inducing immune responses in humans and there's really very little data to go on with that."

When do you anticipate delivering the first dose of the vaccine candidate to a trial volunteer?

Prof Hill: "We'll have to wait until Cath [Dr Catherine Green, associate professor, and head of Clinical BioManufacturing Facility, Nuffield Department of Medicine, University of Oxford] has finished with the last bits of testing of the manufacturing before we can be absolutely sure on the date. But it should be within the next week or so."

Are you confident the virus will be able to cope with virus mutations?

Prof Gilbert: "With our MERS vaccine trial, which is another coronavirus, and again we use the spike protein of the coronavirus in the vaccine, spiked proteins are quite a large protein and we're measuring immune responses against it.

"And we took serum from the volunteers who had been vaccinated, and we tested its ability to neutralise MERS viruses that had been isolated from different years, different parts of the world, and from humans and camels.


"We looked for the most divergent MERS coronaviruses out there that we could find across the world, and the serum from the volunteers neutralised all of them.

"Yes, there were some changes, but the vaccine produced neutralising antibodies that neutralised all of those different versions. The diversity of coronaviruses within a particular isolate, a particular strain, doesn't seem to be anything like as high as you get with flu vaccines."

You've talked about being 80% confident the vaccine will work, what about the 20% unknown?

Prof Gilbert: "There's always an unknown. We can never be certain these vaccines are going to work. Personally, I have a high degree of confidence. This is my view, because I've worked with this technology a lot. And I've worked on the MERS vaccine trials, and I've seen what that can do.

"I think it has a very strong chance of working. So that's what that's based on."

But manufacturing would start at risk?

Prof Hill: "Yes. If the vaccine doesn't work and you have a million doses sitting there, the money has been wasted."

What's the risk of immune enhancement with the vaccine making a subsequent infection worse?

Prof Pollard: "One of the bits of work that's done before starting studies in humans is to do animal studies with the vaccine beforehand specifically to address that question.

"That has been done with several of the vaccines already in development. That will give I think increasing confidence about the safety of these approaches.

"When we then start doing these clinical trials, we do discuss the potential for immune enhancement of some sort happening in the clinical trials with all volunteers, because it is an unknown.

"But the characteristics of the vaccine that is being developed here should not drive towards the type of immune responses which cause problems.

"Clearly we have to monitor for it, make sure our volunteers are properly informed about it, but all of the possible risk mitigation is done before we go into the clinical trials."

When would the vaccine be ready for the general population?
Prof Hill: "Once you've shown efficacy in your clinical trial, you discuss with regulators what the timing would be for getting approval to use it essentially as an emergency use vaccine.

"This would not be final commercial licensure which will take much longer.

"The University of Oxford has a lot of experience with Ebola vaccines; we were involved with four of these that were tested back in 2014/2015. The one that actually worked in West Africa, took until quarter four of last year to be finally licenced, but of course it was used to help end the epidemic in West Africa, and has been extensively used in the Congo recently, before that final licensure.

"What we're really talking about is how quickly we could get an emergency use approval from the relevant regulator. And that's theoretically possible in a matter of about 6 weeks [from demonstrating efficacy and safety], but we just don't know for this vaccine. All this work has been done unusually quickly. So we need to keep that discussion going with regulators, who so far have been very positive about this."

What percentage of the population would need to be vaccinated to achieve herd immunity and interrupt transmission?

Prof Pollard: "We don't know the answer to that question yet for this virus… it's likely to be a reasonably high percentage in order to do that."

COIs
Prof Sarah Gilbert: The MERS vaccine development was funded by NIHR and CEPI. I am a founder and board member of Vaccitech, which holds the rights for commercial development of the ChAdOx1 MERS vaccine whereas the University of Oxford retains the right to develop the vaccine for public health use.

Initial seed stock development of ChAdOx1 nCoV-19 was funded by EPSRC via VaxHub. Further funding for process development was awarded by CEPI, and for GMP manufacture and the first clinical trial by UKRI. Under the founding agreement for Vaccitech from 2016, the company has non-exclusive rights to the vaccine.

Prof Andrew Pollard is chair of the UK Department of Health and Social Care’s (DHSC) Joint Committee on Vaccination and Immunisation (JCVI) and is a member of the World Health Organization’s (WHO) Strategic Advisory Group of Experts.

Prof Adrian Hill is a co-founder of Vaccitech Ltd which has non-exclusive rights to the ChAdOx1 vector platform and to certain coronavirus vaccines.

Prof Catherine Green is paid by the University of Oxford and Exeter College Oxford. I am on the Scientific Advisory Board of Duke Vaccine Centre. My research teams receive grant income from the Wellcome Trust, EPSRC and UKRI.

Dr Teresa Lambe: "I have received grant funding to develop a COVID vaccine as a Co-I from UKRI (Sarah Gilbert is the PI). I have done limited consultancy work on influenza vaccines and vaccines against shingles.


"
 

missy

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"
In the next few months, the drug industry is going to face a choice.

One of the more than 200 attempts to find a coronavirus drug or vaccine is going to work. And when it does, that product – and let’s hope it gets here soon – is going to be either a once-in-a-lifetime money-making opportunity, or a once-in-a-lifetime reputational opportunity.

The temptation for many pharma executives will be to try to do both, and be remembered only for the former.

Drug companies are the most-disliked industry in America, according to a 2019 Gallup survey. Only 27% of the country views them positively. People like advertising and public relations professionals more. Even lawyers do better. Pharma lags the federal government, oil drillers, the telephone companies, and, well, everyone. (Restaurants are the most liked.)


Gilead Sciences’ Remdesivir is among prospective treatments for coronavirus.

Photographer: Ulrich Perrey/AFP

And yet, here they are with an opportunity to save the world. That’s no understatement. The global economy has come to a standstill and trillions of dollars have been lost in the market. Social-distancing means people can’t go to their jobs or have lost the ones they had.

An effective drug or a working vaccine is the single-most important tool for the economy and society to get back to normal. A drug means people can be exposed to the virus, get sick, and get better. A vaccine means they can be exposed and not become sick at all. The big, scary virus becomes just another bug we beat.

Six months ago, the need to ding the pharma industry for a couple tens of billions was one of the only things Democrats and Republicans could agree needed doing. And every time a new drug price bill meandered a bit closer to passing, lobbyists would dust off hobby horses like, “all of these profits are necessary to fund future research.” And then they’d raise prices again.

The current leader in the race to come up with a treatment is Gilead Sciences. In 2013, Gilead kicked off the now-seven-years-old U.S. debate over high drug prices when it introduced a pill that cured another virus, hepatitis C. It charged $84,000 for the therapy, argued that it was cheaper than a liver transplant, and set off an ugly battle in which the company made billions of dollars and the drug industry became increasingly more despised.

The major drug companies working on treatments have suggested they’re focused on the research, not on how much money they’ll make for it. That’s good – opportunities to save the world don’t come along often. Don’t screw it up. —Drew Armstrong"
 

missy

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STEPH DAVIDSON/GETTY
These Are the Drugs and Vaccines That Might End the Coronavirus Pandemic
Clinical trials are almost all in the early stages, and it could take weeks or months to get answers on what works.
By Cristin Flanagan, Riley Griffin, Robert Langreth
April 16, 2020, 11:00 AM

More than 200 different programs have been launched to develop vaccines and therapeutics to combat the Covid-19 pandemic. From well-known industry giants such as Gilead Sciences Inc. to Johnson & Johnson, they're engaged in a global race to find and test the products. With a vaccine more than likely out of reach for this year, the near-term hope for a means to quell the global spread of the novel coronavirus rests on finding an anti-viral treatment that can improve the odds of survival for those that are stricken with Covid-19.
With more than 70 vaccines under development and at least as many drugs being examined, not every experimental therapy or vaccine is included here. The tracker will add new ones as they start or advance in trials, gain significant backing or show promise. Almost all of these programs are in the early stages, meaning that the gold standard of data ― clinical trials with "blinded" placebo and therapy groups ― is still hard to come by. With loosened rules and a desire to get a treatment to market quickly, it's important to cast a skeptical eye on too-good-to-be-true data.
Antivirals
Antiviral drugs work by stopping the virus from replicating or infecting cells. They can include everything from complex biotechnology therapies to older generics, such as a malaria drug that's being tested widely around the globe. Other examples of other antivirals include many HIV drugs, treatments for hepatitis C, and the influenza treatment Tamiflu.
COMPANY
Gilead Sciences Inc.
DRUG
Remdesivir
Remdesivir is an experimental medicine that targets genetic material called RNA and is meant to stop SARS-CoV-2 from replicating. Tried previously — without success — as an Ebola drug, it's complex to manufacture and has to be given intravenously.
LATEST NEWS
A report that patients in Chicago might have benefited from the drug sent Gilead's shares soaring on April 16. That news followed promising data earlier in April from another small group of patients. Results from more definitive trials are expected soon, which will show whether or not the drug works and if so, in what types of patients. A trial in severely-ill patients is expected to have results at the end of April, and a large, placebo-controlled U.S.-government sponsored trial and a company-run open-label study in the moderately sick are expected in late May.
COMPANY
Generic drugs made by Teva Pharmaceutical Industries Ltd., Sanofi, Mylan NV, Natco Pharma Ltd., Novartis AG, Bayer AG and others
DRUG
Hydroxychloroquine, chloroquine
Hydroxychloroquine and chloroquine are anti-malarial drugs that have been tested in other outbreaks. Years old, their side effects are relatively well-known and they're available as lower-cost generics.
LATEST NEWS
President Donald Trump had repeatedly touted the drugs despite limited evidence about whether they could treat or prevent infections. While trials are ongoing, there's been a rush by health systems and governments to stockpile the pills, which are in short supply for patients who use them for diseases like lupus. Two trials, from Duke University and the University of Washington, could have results in May. There are some questions about its safety in Covid-19 patients after earlier this month, France reported 43 heart incidents tied to hydoxychloroquine.
COMPANY
Zhejiang Hisun Pharmaceutical Co.
DRUG
Favipiravir
Favipiravir is a flu medicine that is branded and sold as Avigan by FujiFilm Holdings Corp. in Japan. Favipiravir also targets viral RNA to stop the spread of the virus.
LATEST NEWS
A March study of favipiravir in 80 patients found it appeared to help clear the virus from patients a week earlier than a HIV drug cocktail from AbbVie Inc. and was associated with improved chest symptoms.
COMPANY
Takeda Pharmaceutical Co.
DRUG
Convalescent plasma (TAK-888)
Takeda is exploring whether blood plasma from recovered Covid-19 patients, which can contain infection-fighting antibodies, can be used against the illness. Similar treatments have shown promise in treating other serious infections.
LATEST NEWS
The Japanese drugmaker says that it could have approval of a plasma-derived treatment for Covid-19 by the end of the year. The FDA has also offered guidance to researchers and hospitals that want to use convalescent plasma on an experimental basis.

Vaccines
Vaccines give broad parts of the population some level of immunity to a disease, and are considered crucial to ending the pandemic by creating widespread immunity to the virus. They also take longer to develop, in part because they must be proven to be extremely safe since they're given to well people. Global health authorities including the National Institutes of Health have said it will take at least a year before a vaccine is available to the public. There are 70 vaccines in some stage of development, according to the World Health Organization.
COMPANY
Moderna Inc.
DRUG
mRNA-1273
Moderna's mRNA-1273 uses messenger RNA to prompt the body to make a key protein from the virus, creating an immune response.
LATEST NEWS
The National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health, is studying the vaccine in a 45 patient trial and could have early results from a handful of patients in late May or June. The company announced on April 16 that it will get as much as $483 million from the U.S. government to develop and test the vaccine. The first 45 patients have been enrolled in an early trial, the company said.
COMPANY
Johnson & Johnson
DRUG
No name yet
J&J is working on an unnamed adenovirus-based vaccine as well as two backups.
LATEST NEWS
J&J plans to start first in human studies by September and is ramping up production to make up to 1 billion doses of the vaccine. The company has said it could be ready for emergency use in health workers by January, and it has a $1 billion agreement with the U.S. government's biomedical research unit, BARDA, to develop it.
COMPANY
Inovio Pharmaceuticals Inc.
DRUG
INO-4800
Inovio's experimental vaccine uses DNA to activate a patient's immune system.
LATEST NEWS
Inovio and Beijing Advaccine Biotechnology have an agreement to start studying the drug in China. Inovio kicked off its vaccine trial in early April, a larger study is expected by the end of the year.
COMPANY
BioNTech SE, Pfizer Inc.
DRUG
BNT162
BioNtech's BNT162 is another messenger RNA vaccine, the German company is developing the potential preventative treatment in partnership with Pfizer.
LATEST NEWS
The two companies expanded an existing accord for flu vaccines to encompass a Covid-19 vaccine in March and clinical testing is set to start in April.
COMPANY
CanSino Biologics Inc.
DRUG
Ad5-nCoV
CanSino's vaccine was developed alongside China's military and is genetically engineered with a replication-defective mutant virus.
LATEST NEWS
CanSino completed the first safety study for a Covid-19 vaccine in April. The company said a large mid-stage study to further establish safety and efficacy is expected to start "soon."
COMPANY
Novavax Inc.
DRUG
NVX-CoV2373
Novavax's vaccine is meant to create antibodies that block a protein "spike" that the virus uses to infect its host.
LATEST NEWS
Novavax selected its vaccine candidate in April after seeing a strong immune response in animal testing. The first-in-human trial in about 130 patients is expected to start mid-May with preliminary results in July, according to the company.
COMPANY
Sanofi and GlaxoSmithKline Plc
DRUG
Unnamed viral protein vaccine
Sanofi is working on a vaccine using technology already employed in one of its flu vaccines, which could speed development and production.
LATEST NEWS
The French drugmaker announced on April 14 that it would join forces with GlaxoSmithKline. Glaxo will supply so-called adjuvants, which improve efficacy and make the products easier to mass-produce. The companies plan to start human trials in the second half of this year, with the goal of having a vaccine available by the second half of 2021.

Indirect therapies
Supportive therapies don't directly treat or prevent the virus, but can help patients who have fallen ill by mitigating the disease's effects, such as difficulty breathing or severe inflammatory responses. Without other direct treatments for the virus, and with concerns about health-care systems being overwhelmed, such treatments are considered essential.
COMPANY
Regeneron Pharmaceuticals Inc. and Sanofi
DRUG
Kevzara
The biotechnology drug targets a pathway known as interleukin-6 or IL-6, which can affect inflammation. It's already approved for rheumatoid arthritis and could help very sick Covid-19 patients in respiratory distress.
LATEST NEWS
Regeneron and Sanofi started a late-stage U.S. study that's expected to enroll up to 400 patients, and results may become available at the end of April. Further studies outside the U.S. are also expected.
COMPANY
Roche Holding AG, Chugai Pharmaceutical Co.
DRUG
Actemra, alone or in combination with the flu drug Avigan
Actemra is an arthritis medication that also targets IL-6, like Kevzara does.
LATEST NEWS
Roche, working with the FDA and BARDA, in April started a late-stage trial in over 300 hospitalized Covid-19 patients with severe pneumonia.
 

missy

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Good news. Remdesivir might indeed help with the recovery of Covid 19.





 

missy

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Remdesivir Now 'Standard of Care' for COVID-19, Fauci Says
Multiple Trials Release Data, Some in Partial Form
Sue Hughes
April 29, 2020


Hospitalized patients who had advanced COVID-19 with lung involvement and who received the antiviral agent remdesivir (Gilead Sciences) recovered faster than similar patients who received placebo, according to a preliminary data analysis from a US-led randomized, controlled trial.

On the basis of as yet unpublished data, remdesivir "will be the standard of care" for patients with COVID-19, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), during a press conference at the White House today.

The randomized, placebo-controlled international trial was sponsored by NIAID, which is part of the National Institutes of Health, and enrolled 1063 patients. It began on February 21.



The interim results, discussed in the press conference and in a NIAID press release, show that time to recovery (ie, being well enough for hospital discharge or to return to normal activity level) was 31% faster for patients who received remdesivir than for those who received placebo (P < .001).

The median time to recovery was 11 days for patients treated with remdesivir, compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir and 11.6% for the patients who received placebo (P = .059).

The study, known as the Adaptive COVID-19 Treatment Trial (ACTT), is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. It is being conducted at 68 sites ― 47 in the United States and 21 in countries in Europe and Asia.



The data are being released after an interim review by the independent data safety monitoring board found significant benefit with the drug, Fauci said.

"The reason we are making the announcement now is something that people don't fully appreciate: Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to let the people in the placebo group know so they could have access," he explained.

"When I was looking at the data with our team the other night, it was reminiscent of 34 years ago in 1986 when we were struggling for drugs for HIV," said Fauci, who was a key figure in HIV/AIDS research. "We did the first randomized, placebo-controlled trial with AZT. It turned out to have an effect that was modest but that was not the endgame because, building on that, every year after, we did better and better."

Similarly, new trials of drugs for COVID-19 will build on remdesivir, with other agents being added to block other pathways or viral enzymes, Fauci said.

The study will be submitted to a journal for peer review, he noted, but the New York Times is reporting that the US Food and Drug Administration will approve remdesivir for emergency use later today.


Chinese Trial Inconclusive
In contrast to the positive results Fauci described from the NIAID-sponsored trial, a randomized, placebo-controlled clinical trial of remdesivir among hospitalized patients with severe COVID-19 in China was inconclusive.


The study, published online in the Lancet today, showed some nonsignificant trends toward benefit but did not meet its primary endpoint.

The study was stopped early after 237 of the intended 453 patients were enrolled, owing to a lack of additional patients who met the eligibility criteria. The trial was thus underpowered.


Results showed that treatment with remdesivir did not significantly speed recovery or reduce deaths from COVID-19, but with regard to prespecified secondary outcomes, time to clinical improvement and duration of invasive mechanical ventilation were shorter among a subgroup of patients who began undergoing treatment with remdesivir within 10 days of showing symptoms, in comparison with patients who received standard care.


"To me, the studies reported here in The Lancet appear to be less promising than some statements released today from the NIH, so the situation is a bit puzzling to me," commented Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, Texas, who was not involved in the study. "I would need to look more closely at the data which NIH is looking at to understand the differences."

Trial Details
The published trial was conducted at 10 hospitals in Hubei, China. Enrollment criteria included being admitted to hospital with laboratory-confirmed SARS-CoV-2 infection within 12 days of symptom onset, having oxygen saturation of 94% or less, and having radiologically confirmed pneumonia.


Patients were randomly assigned in a 2:1 ratio to receive intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids.


The primary endpoint was time to clinical improvement to day 28, defined as the time (in days) from randomization to the point of a decline of two levels on a six-point ordinal scale of clinical status (on that scale, 1 indicated that the patient was discharged, and 6 indicated death) or tothe patient's being discharged alive from hospital, whichever came first.

The trial was stopped early because stringent public health measures used in Wuhan led to marked reductions in new patient presentations and because lack of available hospital beds resulted in most patients being enrolled later in the course of disease.


Between February 6, 2020, and March 12, 2020, 237 patients were enrolled and were randomly assigned to receive either remdesivir (n = 158) or placebo (n = 79).


Results showed that use of remdesivir was not associated with a difference in time to clinical improvement (hazard ratio



ETA for some reason it won't let me copy and paste the entire article and I cannot link it because my name appears as I have to be logged on to read it.

This link has more info fyi.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31022-9/fulltext
 
Last edited:

missy

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Inside the extraordinary race to invent a coronavirus vaccine

Companies are launching trials at an unprecedented pace, but some worry about the trade-offs between speed and safety.

Ian Haydon, 29, a public information specialist at the University of Washington, was one of the first people to receive an experimental coronavirus vaccine.
Ian Haydon, 29, a public information specialist at the University of Washington, was one of the first people to receive an experimental coronavirus vaccine. (Ian Haydon)
By
Carolyn Y. Johnson
May 2, 2020 at 12:42 p.m. EDT

Ian Haydon, a healthy 29-year-old, reported to a medical clinic in Seattle for a momentous blood draw last week.
“Oh yeah,” said the nurse taking his blood. “That is liquid gold.”
Haydon is an obscure but important participant in the most consequential race for a vaccine in medical history. In early April, he was among the first people in the United States to receive an experimental vaccine that could help end the coronavirus crisis. He volunteered to be a test subject knowing about the risks and unknowns, but eager to do his part to help end the worst pandemic in a century.
Scientists at the National Institutes of Health in Bethesda, Md., will study blood from Haydon and others for signs that the vaccine triggered an immune response to a pathogen they have never encountered. It would be the first, preliminary signal that the vaccine could provide immunity to covid-19, the disease caused by the virus, that has claimed more than 200,000 lives.
AD

A coronavirus vaccine has become the light at the end of a very long tunnel, the tool that will bring the virus to heel, allowing people to attend sports events, hug friends, celebrate weddings and grieve at funerals. The goal to deliver a vaccine in 12 to 18 months, often repeated by the nation’s top infectious disease scientist, has become the one reassuring refrain during briefings on the crisis. The White House put together a task force called Operation Warp Speed to try to move even faster, making hundreds of millions of doses ready by January.

With at least 115 vaccine projects in laboratories at companies and research labs, the science is hurtling forward so fast and bending so many rules about how the process usually works that even veteran vaccine developers do not know what to expect.
 
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