Covid-19 Vaccine Development

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Russia already approved their first vaccine without completing the 3rd phase of trials yet. I'm skeptical about it's side effects and safety.
 
CSIDreamer said:
Debate begins for who's first in line for COVID-19 vaccine
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Distribution can be a major problem, as well as prioritization. Since at least 2 of the vaccines require low temperature refrigeration that most pharmacies lack, using the usual routes - pharmacies and community events - may be a problem. This might mean an administrative “stovepipe” with vaccination taking place only at a few centralized locations. Also, even if the CDC adopts guidelines, individual US states can defy them. In a prior post, I described what the state I lived in 2009 did with its vaccine for H1N1 - they hoarded it and kept it for the politically connected, ignoring the CDC recommendations for vaccinating those with pre-existing conditions. I think one method of getting vaccines to the US population would be to assure multiple channels of distribution. This might be possible if there are vaccine versions that can be stored in ordinary pharmacy refrigerators. If all of the vaccines require very low temperature storage, this will be a major challenge.
 
US says it plans to provide free COVID-19 vaccine to all Americans

WASHINGTON -- The federal government outlined a sweeping plan Wednesday to make vaccines for COVID-19 available for free to all Americans, even as polls show a strong undercurrent of skepticism rippling across the land.

In a report to Congress and an accompanying "playbook" for states and localities, federal health agencies and the Defense Department sketched out complex plans for a vaccination campaign to begin gradually in January or possibly later this year, eventually ramping up to reach any American who wants a shot. The Pentagon is involved with the distribution of vaccines, but civilian health workers will be the ones giving shots.
 
This is my cousin. He has been interviewed on national TV and writes about Covid-19. You can look him up online. I’m not sure if I’m allowed to use his work as a source?

Our family has been aware of this virus since Jan 2020 because of Daniel’s work. Can a mod verify if it’s ok to link his interviews and writings?

Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee. He has served as a volunteer medical responder to outbreaks that included the West Africa Ebola crisis. He has collected information on outbreaks starting in 2001 with cases of anthrax in 2001, and including smallpox vaccination 2002, SARS 2003, H5N1 Flu 2004, MERS in 2013, and Ebola in April, 2014, He has gathered, and updated information on the spread of the coronavirus here since Jan. 6.
 
Palindrom said:
Russia already approved their first vaccine without completing the 3rd phase of trials yet. I'm skeptical about it's side effects and safety.
Click to expand...

You may be skeptical, but Russia's vaccine trials roughly parallel our own system (except that they don't test outside their own population). The US wants local data (a lot of it), but also looks at international data.

I have several colleagues who are fluent in Russian and follow the Russian literature. Further, the Russian literature is always translated into English and published in a transparent fashion.

The biochemistry of their vaccine is virtually identical to every other vaccine (delivery platform is tried and true - you've probably already had a vaccine of this type).

So far, no word of Russians dying due to the vaccine. As is customary in many nations, the scientists and their families take it first, then the military and the politicians. It's not a bad plan.

You should certainly research side effects for any vaccine - but be aware that all vaccines have side effects (and huge benefits, when they are properly made). Russia has a large number of labs that have the right technology and a very long track record of meticulous research.
 
PayrollNerd said:
This is my cousin. He has been interviewed on national TV and writes about Covid-19. You can look him up online. I’m not sure if I’m allowed to use his work as a source?

Our family has been aware of this virus since Jan 2020 because of Daniel’s work. Can a mod verify if it’s ok to link his interviews and writings?

Daniel Lucey, M.D. MPH, FIDSA, FACP, is an infectious diseases physician and adjunct professor of infectious diseases at Georgetown University Medical Center, a senior scholar at the Georgetown University O’Neil Institute, Anthropology Research Associate, Smithsonian Museum of Natural History and a member of the Infectious Diseases Society of America Global Health Committee. He has served as a volunteer medical responder to outbreaks that included the West Africa Ebola crisis. He has collected information on outbreaks starting in 2001 with cases of anthrax in 2001, and including smallpox vaccination 2002, SARS 2003, H5N1 Flu 2004, MERS in 2013, and Ebola in April, 2014, He has gathered, and updated information on the spread of the coronavirus here since Jan. 6.
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Easiest if you just report your post and ask. He certainly seems reputable to me. JMO
 
Articles mentioning October as possible vaccine rollout.

Brits could get coronavirus vaccine as early as October – with dentists and vets being trained to administer jab

4 weeks ago


UK to give emergency approval to any Covid vaccine breakthrough
.
4 weeks ago




Coronavirus: Russia plans mass vaccination campaign in October

1 month ago

www.dailymail.co.uk › health › Unl...
Web results
Dr Fauci says COVID-19 vaccine by October is 'conceivable' but ...
3 Sep 2020 · Dr Anthony Fauci told CNN that it was possible a coronavirus vaccine could be ready by October but that the ...

www.express.co.uk
Coronavirus vaccine in UK in SIX WEEKS: Best scenario now mid ...

30 Aug 2020 · Coronavirus vaccine in UK in SIX WEEKS: Best scenario now mid-October as testing ramped up. A VACCINE for ...

uk.reuters.com
COVID-19 vaccine could come in late October; White House says ...

2 Sep 2020 · U.S. public health officials and Pfizer Inc said a COVID-19 vaccine could be ready for distribution as soon as ...
 
My assumption (yep, you know what that means)... is that the governments have already CONTRACTED to give the companies reimbursements for their developments of the vaccines. We're talking millions/billions here.. yet I've not seen published as to what each was promised, has anyone?

Once all is said and done, many will fall short (e.g. too difficult to do cold storage and $$ through the entire distribution chain etc.). So, those companies will have spent hundreds of millions.. and the governments will have to fill their obligation to pay to front load research and development and production.

So... who eats the $$ if those millions of vials which they have been producing for months ahead of approval are just put to the garbage heap when one comes out on top? Is a lesser active to be first to market a good thing, or will it be outed and more questioning as to trust of governments and "big pharma" if they do such.

It indeed is a quandry. MOO
 
Getting the general population to trust the vaccine enough to actually take it will be key. There’s still so many naysayers in regards to the flu vaccine. This is a huge hurdle to overcome. JMO

9.21.2020
Four steps to build trust in COVID-19 vaccines

COVID-19 vaccine availability will be accelerated by receiving U.S. Food and Drug Administration emergency use authorization as opposed to the longer approval and licensure process. No unlicensed new vaccine candidate has ever received an EUA. For this reason and others, too many Americans may not trust the safety of the vaccines enough to accept them. As a result, United States businesses and institutions will be less likely to reopen as widely as needed in 2021.
 
PayrollNerd said:
Getting the general population to trust the vaccine enough to actually take it will be key. There’s still so many naysayers in regards to the flu vaccine. This is a huge hurdle to overcome. JMO

9.21.2020
Four steps to build trust in COVID-19 vaccines

COVID-19 vaccine availability will be accelerated by receiving U.S. Food and Drug Administration emergency use authorization as opposed to the longer approval and licensure process. No unlicensed new vaccine candidate has ever received an EUA. For this reason and others, too many Americans may not trust the safety of the vaccines enough to accept them. As a result, United States businesses and institutions will be less likely to reopen as widely as needed in 2021.
Click to expand...

I think the four steps your cousin Dr. Lucey lays out are absolutely necessary to building trust in a vaccine. Sadly, I don’t think they will happen. I also think the FDA is losing trust along with the CDC. If it’s rushed I will be suspicious of political intervention. I always get a flu shot, but I would rather wait a bit longer for a trustworthy Covid vaccine.
JMO
 
PayrollNerd said:
Getting the general population to trust the vaccine enough to actually take it will be key. There’s still so many naysayers in regards to the flu vaccine. This is a huge hurdle to overcome. JMO

9.21.2020
Four steps to build trust in COVID-19 vaccines

COVID-19 vaccine availability will be accelerated by receiving U.S. Food and Drug Administration emergency use authorization as opposed to the longer approval and licensure process. No unlicensed new vaccine candidate has ever received an EUA. For this reason and others, too many Americans may not trust the safety of the vaccines enough to accept them. As a result, United States businesses and institutions will be less likely to reopen as widely as needed in 2021.
Click to expand...

I think the Ebola vaccine was authorised for compassionate use long before the FDA approved it in Dec 2019. The EU did not approve it until this year.

Ebola vaccine - Wikipedia
 
All the UK MSM are running with this story today. Volunteers are going to be deliberately infected with Covid to test the vaccine.

UK volunteers could be given virus to test vaccine

The UK could be the first country in the world to carry out Covid "challenge trials" - where healthy volunteers are deliberately infected with coronavirus to test possible vaccines.

It is understood the studies - first reported by the Financial Times - would be conducted in London.

The UK government said it was holding discussions about developing a vaccine through such "human challenge studies".

No contracts have yet been signed, the BBC understands.

p08p7wyk.jpg


Media captionWhat are human challenge trials?
'Out of the pandemic'
Alastair Fraser-Urquhart, an 18-year old university student, is planning on volunteering for the trial if it is given the green light to go ahead. He helps run the advocacy group, 1Day Sooner.

He told the BBC Radio 4 Today programme: "I think the challenge trial has the potential to save thousands of lives and really bring the world out of the pandemic sooner. It is just something that made instant sense to me."

Speaking on the same programme, Prof Peter Horby of Oxford University, said he thought the trial was a good idea that had the real potential to advance science and get a better understanding of the disease.

He said: "We now know the risk in a healthy young adult with no underlying conditions is extremely low.

"We suspected this before, but we really did not have the strength of evidence to go forward with challenging people with the virus - but now I think there is clear data.

"The second thing that has changed is there are now some treatments that have been shown to have a benefit, so in the likely event that a a challenged person does becomes unwell, there are drugs that can be given very early to help control the disease."

Prof Horby said it is likely volunteers would be observed very closely and their immune systems would be monitored to see how they respond to the virus.

Continued at link
 
tresir2012 said:
Looks like FDA are thinking of asking for longer study of the vaccine by drug companies. Wouldn't this additional wait cause needless deaths? The trials in Brazil and Africa have been going for some time now I believe.

FDA set to announce greater restrictions for COVID-19 vaccine: Report
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Americans are very worried about vaccine safety in general, so circumventing standard protocols would lead to fewer people taking the upcoming vaccines. I suspect that what we’ll do is exactly what we’re already doing (fairly large third phase trials - in which up to 200,000 Americans will get an early vaccine). I might sign up for one myself, if there’s one close enough to where I live (they usually want to find places with higher positivity rates than where I live).

Russia and UK are doing similar things - doing the first two regular phases and then widening the third phase to include as many people as possible. However, it’s hard to imagine that the tracing of all these people would be as rigorous as in what the FDA expects in that phase.

Russia is interesting because most of the early vaccinations have occurred mostly in Moscow and St Petersburg and they are indeed keeping track on the recipients (Russia already has many ways of keeping track of citizens - workplace and state are not as divided as in other nations).

So it’ll be great if UK rushes through to open phase (instead of prolonged third phase) and keeps the data that we’ll all need to feel more confident. Keep in mind that UK already has two people with more serious side effects and IMO, until that’s published properly, I think people should be wary. Right now, there’s no way to know who, exactly, had those side effects (other than their age and sex, which has been published).

I’d bet a dozen donuts that the woman with the myelin issue had received the vaccine and was not in the control group (she was older, but myelin is known to be compromised due to COVID - and no where has it been published that this woman actually got CV, so I’m guessing she got the vaccine).

Americans are going to be slow to take any vaccine that is rushed through too quickly. We have too little trust in our government right now - particularly the HHS. But, our own pharma companies are being forthcoming about their protocols - Johnson and Johnson is my favorite, so far, but there are others.

I don’t think anyone cares if we’re a month or two behind UK or Russia in getting a vaccine. It will be no safer than wearing a mask, anyway, as no vaccine is 100%

For me, I just want a more moderate course of CV if I get it.

No needless deaths need to occur in either scenario nor will deaths drop dramatically in UK or Russia right away - it doesn’t work like that. It will take time to vaccinate millions of people...especially in the midst of the pandemic.
 
tresir2012 said:
All the UK MSM are running with this story today. Volunteers are going to be deliberately infected with Covid to test the vaccine.

UK volunteers could be given virus to test vaccine

The UK could be the first country in the world to carry out Covid "challenge trials" - where healthy volunteers are deliberately infected with coronavirus to test possible vaccines.

It is understood the studies - first reported by the Financial Times - would be conducted in London.

The UK government said it was holding discussions about developing a vaccine through such "human challenge studies".

No contracts have yet been signed, the BBC understands.

p08p7wyk.jpg


Media captionWhat are human challenge trials?
'Out of the pandemic'
Alastair Fraser-Urquhart, an 18-year old university student, is planning on volunteering for the trial if it is given the green light to go ahead. He helps run the advocacy group, 1Day Sooner.

He told the BBC Radio 4 Today programme: "I think the challenge trial has the potential to save thousands of lives and really bring the world out of the pandemic sooner. It is just something that made instant sense to me."

Speaking on the same programme, Prof Peter Horby of Oxford University, said he thought the trial was a good idea that had the real potential to advance science and get a better understanding of the disease.

He said: "We now know the risk in a healthy young adult with no underlying conditions is extremely low.

"We suspected this before, but we really did not have the strength of evidence to go forward with challenging people with the virus - but now I think there is clear data.

"The second thing that has changed is there are now some treatments that have been shown to have a benefit, so in the likely event that a a challenged person does becomes unwell, there are drugs that can be given very early to help control the disease."

Prof Horby said it is likely volunteers would be observed very closely and their immune systems would be monitored to see how they respond to the virus.

Continued at link
Click to expand...

Brave souls - hopefully from all age groups. My family would have a fit if I volunteered for this. Under the right circumstances, I’d do it, otherwise.
 
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