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caulfield12
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Derek Lowe's done a good job on following the vaccines and has some initial thoughts:

 

https://blogs.sciencemag.org/pipeline/archives/2020/11/09/vaccine-efficacy-data

 

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Pfizer/BioNTech say that the protection looks like it should last at least a year – no numbers on that yet, but it can only be based on neutralizing antibody titers and/or T-cell levels and their change over time. The only way to get better numbers on that is to wait and collect better numbers; there is absolutely no way to tell without waiting to see. But if we’re already out to about a year’s protection, that’s very good to hear.

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What does this mean for the pandemic vaccine effort in general? The first big take-away is that coronavirus vaccines can work. I have already said many times (here and in interviews) that I thought that this would be the case, but now we finally have proof. The worst “oh-God-no-vaccine” case is now disposed of. And since all of the vaccines are targeting the same Spike protein, it is highly likely that they are all going to work

 

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3 minutes ago, mqr said:

This vaccine needing to be stored at -94 F is going to cause some problems.

It will make things more expensive and may mean the logistics are slightly slower, but production is going to be the main bottleneck for a while. They are fridge-stable for a day or two, so they're ok in regular fridges every pharmacy or doctor's office already has. 

Bad news for less-developed countries, though.

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1 hour ago, StrangeSox said:

So, grimly dark here that we may get a vaccine quicker because of how bad things have gotten. But trying to read through the lines of this press release, and it seems like there's an indication of sterilizing immunity. That would be huge. That means not only that you don't personally get sick, but also that you don't get an infection in the first place and become an asymptomatic or mildly symptomatic spreader.

Worth noting - I don't think Pfizer has any ability to test for this based on their study design. They are testing people for the virus when they first get each dose, and then again if they show symptoms. There's no testing being done of people who don't show symptoms - without that, there's no way to rule out the hypothesis that people get the virus, carry it, and pass it on efficiently. It certainly could be the case, but I don't see any way Pfizer could test for that.

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https://buildbackbetter.com/press-releases/biden-harris-transition-announces-covid-19-advisory-board/

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CO-CHAIRS
Dr. David Kessler

David A. Kessler, MD, is Professor of Pediatrics and Epidemiology and Biostatistics at UCSF. Dr. Kessler served as FDA Commissioner from 1990 to 1997, appointed by President George H.W. Bush and reappointed by President Bill Clinton.

Dr. Vivek Murthy
Vivek Murthy, MD, MBA, served as the 19th Surgeon General of the United States from 2014-2017.  As the Vice Admiral of the US Public Health Service Commissioned Corps, he commanded a uniformed service of 6,600 public health officers globally. The officers focused on helping underserved populations, protecting the nation from Ebola and Zika, responding to the Flint water crisis, and natural disasters such as hurricanes.

Dr. Marcella Nunez-Smith
Marcella Nunez-Smith, MD, MHS, is an Associate Professor of Internal Medicine, Public Health, and Management at Yale University and the Associate Dean for Health Equity Research at the Yale School of Medicine. Dr. Nunez-Smith’s research focuses on promoting health and healthcare equity for structurally marginalized populations.

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Dr. Luciana Borio
Luciana Borio, MD, is VP, Technical Staff at In-Q-Tel. She is also a senior fellow for global health at the Council on Foreign Relations. Dr. Borio specializes in biodefense, emerging infectious diseases, medical product development, and complex public health emergencies. She served in senior leadership positions at the FDA and National Security Council, including as Assistant Commissioner for Counterterrorism Policy and Acting Chief Scientist at the FDA, and Director of FDA’s Office of Counterterrorism and Emerging Threats.

Dr. Rick Bright
Rick Bright, PhD, is an American immunologist, virologist, and former public health official.  Dr. Bright was the director of the Biomedical Advanced Research and Development Authority (BARDA) from 2016 to 2020 and the Deputy Assistant Secretary for Preparedness and Response at the Department of Health and Human Services. He also previously served as an advisor to the World Health Organization and the United States Department of Defense. His career has focused on the development of vaccines, drugs, and diagnostics to address emerging infectious diseases and national security threats.

Dr. Ezekiel Emanuel
Ezekiel J. Emanuel, MD, PhD, is an oncologist and Vice Provost for Global Initiatives and chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania. From January 2009 to January 2011, he served as special advisor for health policy to the director of the White House Office of Management and Budget. Since 1997, he has served as chair of the Department of Bioethics at The Clinical Center of the National Institutes of Health (NIH).

Dr. Atul Gawande
Atul Gawande, MD, MPH, is the Cyndy and John Fish Distinguished Professor of Surgery at Brigham and Women’s Hospital, Samuel O. Thier Professor of Surgery at Harvard Medical School, and Professor of Health Policy and Management at Harvard T.H. Chan School of Public Health. Dr. Gawande is also the founder and chair of Ariadne Labs, a joint center between Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health for health systems innovation, and of Lifebox, a nonprofit organization making surgery safer globally. He previously served as a senior advisor in the Department of Health and Human Services in the Clinton Administration.

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Celine Gounder, MD, ScM, FIDSA is a Clinical Assistant Professor at the NYU Grossman School of Medicine and cares for patients at Bellevue Hospital Center. From 1998 to 2012, Dr. Gounder studied TB and HIV in South Africa, Lesotho, Malawi, Ethiopia and Brazil. While on faculty at Johns Hopkins, Dr. Gounder was the Director for Delivery for the Gates Foundation-funded Consortium to Respond Effectively to the AIDS/TB Epidemic. She later served as Assistant Commissioner and Director of the Bureau of Tuberculosis Control at the NYC Department of Health and Mental Hygiene.

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Dr. Michael Osterholm
Michael Osterholm, PhD, MPH, is Regents Professor, McKnight Presidential Endowed Chair in Public Health and the director of the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota. Dr. Osterholm previously served as a Science Envoy for Health Security on behalf of the State Department. For 24 years (1975 to 1999), he worked in the Minnesota Department of Health; the last 15 years as state epidemiologist.

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Michael Osterholm was a fan-favorite in this thread many moons ago.

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This is wonderful news, however...............

How many times have drugs been FDA approved and pulled 10 years later after multiple deadly side effects have been found? 

Hold your horses. 

Get back to me in 2022. Then we can talk. They're two months in. 

The profit motive can pervert science and create a dangerous situation. 

The consequences of an adverse side effect that doesn't show itself for 18-36 months or so, could be worse than the Rona itself, especially for something that would need to be distributed to the entirety of humanity. 

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16 minutes ago, Jack Parkman said:

This is wonderful news, however...............

How many times have drugs been FDA approved and pulled 10 years later after multiple deadly side effects have been found? 

Hold your horses. 

Get back to me in 2022. Then we can talk. They're two months in. 

The profit motive can pervert science and create a dangerous situation. 

The consequences of an adverse side effect that doesn't show itself for 18-36 months or so, could be worse than the Rona itself, especially for something that would need to be distributed to the entirety of humanity. 

Quite frankly, that's a reasonable gamble against this foe. 

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3 hours ago, StrangeSox said:

I dunno. Nobody is studying what happens if you take more than one vaccine. Would you be willing to potentially lock yourself out of the 90%+ effective vaccine forever in order to get the 60% effective one six months earlier? Not an easy call to make, imo.

 

 

 

I find this hard to believe, and the assumption should be this is not the case until we find out it is. Not vice versa.

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41 minutes ago, Jack Parkman said:

This is wonderful news, however...............

How many times have drugs been FDA approved and pulled 10 years later after multiple deadly side effects have been found? 

Hold your horses. 

Get back to me in 2022. Then we can talk. They're two months in. 

The profit motive can pervert science and create a dangerous situation. 

The consequences of an adverse side effect that doesn't show itself for 18-36 months or so, could be worse than the Rona itself, especially for something that would need to be distributed to the entirety of humanity. 

Do you know how many phase 3 studies get 40k+ participants? Do you know how often the pulled drugs are maintenance drugs or others that require constant usage? 

Pfizer had already been guaranteed purchases, and the cost of the vaccine to americans will be free.

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1 hour ago, bmags said:

Do you know how many phase 3 studies get 40k+ participants? Do you know how often the pulled drugs are maintenance drugs or others that require constant usage? 

Pfizer had already been guaranteed purchases, and the cost of the vaccine to americans will be free.

No matter how many people have participated in the phase three studies, there's absolutely nothing they can do to prove to me it's safe other than give it the proper time. (24-36 months) Long-term side effects are called such because they appear during a longer timescale. I don't trust anything that has been around for less than 2-3 years. Sorry. They have no idea what could happen a year or two down the road, until they actually have people that  have had the vaccine for 2-3 years. There's a reason why the record for a safe vaccine is 4 years. I take that as 3 years as the minimum amount of time to prove no adverse long-term reactions.  

Edited by Jack Parkman
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4 minutes ago, StrangeSox said:

Are there previous examples of vaccines having negative impacts that don't show up for 2-3 years?

So this vaccine blocks ACE receptors. That means that some drugs to treat other diseases that previously worked through ACE receptors could possibly become ineffective.

They have to investigate that stuff before they can give this to everyone.  

Edited by Jack Parkman
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