Pfizer says it expects to have a vaccine ready for approval in October. What happens if they announce an effective vaccine on October 21, two weeks before the election ? Yes, FDA approval is still needed, but the announcement would be a game changer.
Very unlikely. Regulatory review takes time, and even if it's approved prior to the election, their scale-up, contracting with payers, etc is going to take a long time.
@Mark94 - approval of a vaccine any time before the election would certainly be a positive for President Trump. How much of a positive is hard to say.
With increased numbers of early ballots being casted across the country in recent election cycles, we no longer have an election day. We have an election month.
That is compounded by the number of people who will be voting by mail this year instead of in-person.
It will be up for review. Doesn't mean scalable for the public, and definitely doesn't mean ready for mass production. We will all be lucky if we see it in our cities on any kind of scale before the end if the year.
Will he see a bounce if it does clear trials? Who knows. He really screwed the pooch up to this point.
@TetraDon - any time prior to this year, and I would be in solid agreement with you. But Operation Warp Speed is showing that government can actually be useful in more circumstances that I thought they could be.
Not only has the FDA eliminated a lot of the red tape surrounding any approval related to the Corona Virus, but the government is signing early contracts with key players in the creation of anti-viruses.
No private company would ever commit to spending billions of dollars on producing a drug before Stage 3 testing was complete, and a drug had FDA approval.
But partnerships between the government and various drug companies are being created to do exactly that.
Drug manufacture will start before Stage 3 testing is completed for drugs that show promising data. A few contingent contracts have already been signed with monies waiting to change hands until more data is collected.
We are preparing to roll out any vaccine as soon as humanly possible.
Go back and read my post. I didn’t say it would be approved in October. I said they would announce completion of their trials, with a successful outcome. That’s enough to get a lot of Presidential votes.
In the meantime the disruption goes on 176K+ dead so far another false promise from the administration that has nothing but lies and false promises to offer
@ Richard_Head
"200K+ dead by election day. That will be tough to overcome."
Regardless of what you'd like to believe, most people don't blame President Trump. Quite the contrary, they blame irresponsible Democrat governors. In terms of Covid19 deaths, New York is BY FAR the worst of them (Cuomo), New Jersey is BY FAR the second worst (Murphy), and overall 9 of the 10 worst states are run by Democrats. Reasonable people (those not suffering from TDS) see right through the media's smoke-screen.
^ I guess we disagree on everything even the definition of reasonable people
Where I come from the guy in charge is responsible unless what you’re insinuating is that Trump isn’t in charge there could be some truth to that
Approvals typically take almost a year. Not sure how much it can be rushed, and there's no guarantee of it even succeeding in Phase 3 trials. I've seen hundreds of sure thing drugs crash. Odds are, some of them will fail, and few will generate real (sterilizing) immunity. We don't even know what immunity looks like, how long it lasts, or how effective it's going to be.
And my comments on the roll-out were straight out of Pfizer's press release.
^ 25
By your reasoning, I guess we shouldn't even have states anymore. Did you want Trump to implement a national policy that every state must subscribe to, regardless of their individual and unique circumstances? Or would you prefer that Trump sit down and devise 50 different plans based on what he believes is best for each of them? Obviously you don't think the Governors are in any position to govern their own states.
If a vaccine is in place less than 12 months after the first US death, it will be unprecedented in the history of medicine and public health. Nothing like that has ever happened. It’s all because of the aggressive Operation Warp Speed that Trump put in place. He should be awarded the Nobel Prize for Medicine. Instead, all the experts and journalists will declare that Trump got lucky. They might even try and give. Obama credit.
Biden said he was prepared to shut down the country if CoVid spread. Under the constitution, he doesn’t have the authority. It was the Governors who shut things down the first time around.
^ and here we are six months and onehundredandseventysix thousand Americans dead and you fools don’t think your president is utterly incompetent !
What a sad state of affairs this country is in
@TetraDon, for any other disease, you are right - the approval process is lengthy - and full of red tape. But things are being streamlined for this one.
But you are right, any drug can bomb out of any phase trial at any point in time. There is no such thing as a sure thing in drug discovery.
To the best of my knowledge, the drugs that have been approved for Corona virus to date have all been pre-existing drugs. So safety wasn't an issue, and given the alternative of no treatment at all, efficacy standards have been lowered.
In fact, from what I have heard, a vaccine will get FDA approval if it is safe even if it only protects 50% of recipients from infection.
This is not a sure thing. But it is nice to see twentyfive panic.
I'm on the other side of the aisle from @TwentyFive, but he's usually a reasonable voice (we all have our moments). Like I said elsewhere, one side blames every death on Trump, one thinks Trump saved millions of lives vs projections.
I think Trump bumbled this in a lot of key ways, including talking out his ass on pharmaceuticals (my field), but Operation Warp Speed is a good thing.
Still, if it gets approved, I'll have reservations. I'm a young, healthy, low-risk guy, and I want to see long-term data on any drug I take. I'll keep my mask on a bit longer and wait for others to take the hit.
Remember how we hoped churches and life will be back to normal by Easter? This year has been filled with so many false promises that the part of the brain that is excited by hope doesnt work anymore
A certain percent of the population is now immune, either because they had CoVid 19 or another CoVid. It won’t require a large percent of the population to be vaccinated to make CoVid 19 a minor issue going forward. Maybe 30%-40% of the population need to be vaccinated.
Last I heard, that percentage of people with antibodies--who might not even be immune--was pretty small.
"Herd immunity" is nothing but an excuse for people to do nothing and end the lockdowns. We barely have herd immunity on diseases every child is offered vaccination for.
In addition to what Tetradon said about the percentage of people with antibodies, antibodies don’t appear to be long lasting. They appear to disappear anywhere from 5 weeks to 3 months after being acquired.
I don’t work in the medical field, but in my mind that calls into question the long term viability of any vaccine.
Also what Tetradon said about waiting for time to pass after a great deal of others have been vaccinated before receiving a vaccination myself makes a great deal of sense.
You don’t need to vaccinate everyone. As few as 30%-40% vaccinated would bring the transmission rate lower than 1 transmission per infected person. Then, it’s just a matter of time and mathematics. CoVid 19 would nearly disappear.
There's so much we don't know. An interesting, reasonable speculation is that whatever vaccine is generated will become an annual/seasonal thing. The other thing that was interesting was the minor mutations that have occurred which weren't huge but that means even after the initial vaccine/vaccines are put in play, on-going work will be done to "update" it. I wonder if the same sense of urgency will be put in play to continue this work after one vaccine reaches the point of mass distribution.
@winex “To the best of my knowledge, the drugs that have been approved for Corona virus to date have all been pre-existing drugs. So safety wasn't an issue, and given the alternative of no treatment at all, efficacy standards have been lowered.”
Have you forgot about hydroxychloraquine? Safely used to treat malaria. Rushed through approval by Trump to treat Covid against the cautioning of Dr. Fauci. Disapproved as not only ineffective but dangerous for Covid patients. I believe the difference was the dosage required for malaria and a much great dose to use for Covid. It’s not science to say “because it’s preapproved safety isn’t an issue.” The doctors are still learning.
^ Truly fake news. HCQ has not been, and is not, dangerous. Oh, there have been a lot of “experts” and talking heads saying it is but there is no actual evidence or even anecdotal stories showing danger, other than to a very small number of heart patients.
The primary study claiming it was ineffective was done by a mysterious research group that suddenly sprung up, issued the report, and then disbanded. The study has been retracted.
What little evidence there is suggests HCQ is safe and might have some effectiveness in early stages of the disease. Admittedly, it’s not a miracle cure.
@McNulty
One of my best friends got Covid pretty soon after we first started hearing about it. He has several strikes against him - African American (statistically worse outcomes), obese, diabetic, and has high blood pressure. He said he was sicker than ever before in his life, having trouble breathing... he was so terrified he actually started texting his friends from the hospital saying he didn't think he'd survive.
They quickly began treating him with hydroxychloraquine and in 24 hours he felt somewhat better, 2 days a lot better, and by the 3rd day he felt almost completely normal. They kept him a few more days for observation and then he walked out of the hospital good as new. Self-quarantined another couple weeks and went back to work at his contracting business.
The FDA, fake news media and liberal fuck sacks like you can say all you want that it "doesn't work" but I know first hand that it does. The left would gladly accept more deaths rather than admit Trump was right about something.
Operation Warp Speed involved keeping the FDA from putting up roadblocks and giving billions to pharmaceuticals to fund research. If this works for CoVid, let’s try it for other viruses like Hepatitis.
In fact, given their failures, let’s clean house at the FDA and rewrite their mission to help find cures, not slowdown research. It could spark a golden age in medicine.
@Mark - I think that a lot of lessons can be learned from Operation Warp Speed. But if Trump loses in November, it is highly unlikely that any lessons will be learned.
On hydrochloroquine - in malaria patients, it works be weakening the immune system and preventing a cytokine storm. A cytokine storm is the mechanism that COVID-19 uses to do most of its damage.
In studies where organ damage already occurred before use of HCQ, it was simply a case of being too late with treatment. But it does control the problem when given early enough.
And now, Trump has given emergency authorization to allow using plasma from previously infected patients to provide anti-bodies. This is another approach that shows promise and appears safe. Why not use it for patients who are seriously ill ? Or, we could wait 12 months until a triple blind, FDA monitored, highly scrutinized assessment was complete. If it’s my relative facing an incubator followed by death, I’d fight to get the treatment.
@Mark, plasma from patients who have cleared the virus works. Think they've already been doing that. The problem is scaling it up. You can only take and process so much. And the immune system will clear those antibodies out fairly quickly. So, it's a start, but just that.
It seems like doctors now have several tools for treating CoVid patients at different stages of the disease. Night and Day from where we were as recently as March.
Trump's own FDA revoked emergency use of Hydroxychloroquine in July (or was it June?).
Arguing topics like this is futile with people who consume Fox News all day, who read conspiracy-theory & pseudo-science websites, and who insist that Fauci is "preening asshole." The same people insist that Obama was born in Kenya and that climate change is a Chinese hoax. Why bother arguing with tinfoil-hat nutcases.
I don't think Covid is at the top of reasons people are gonna vote one way or the other - neither party caused the worldwide pandemic and neither party can make it go away - most people understand it's a novel-virus and it will take time to beat it back - I doubt Covid will be *thee* reason most people will vote for a particular candidate - for folks that are in the middle and are not diehard Republicans or Democrats, I think it will come down to a referendum on America and choosing b/w the continuation of America, or the dismantling of America.
@25 & others
Not sure if you are just fanning the flames or you have a valid concern about Covid-19. Possibly you are in a high risk category..."..over weight, diabetes, heart issues etc.? Then I can understand the comments better.
Just so people sleep better tonight, let’s do some basic math. You know scientists actually use actual hard data when drawing conclusions..
So how to determine percentages...
Deaths = 176,000
US Citizens = 350,000,000
176,000 divided by 350,000,000 x 100= 0.0502% Dead from COVID-19
Numbers and percentages sometimes are hard to follow, so let’s break it down this way.
We would need 3.5 million Deaths to say we have lost 1% of the USA population.
I hope some people sleep better tonight, when you look at the metrics.
Remember panic is not the virtue of a warrior!!!
Supposedly @RandomMember has me on ignore, and although what I am about to say sounds funny, it's the absolute truth. I don't watch much TV. I would rather read.
I am not formally education in biosciences or medicine.
The knowledge I have of the mechanisms that CHQ uses that are beneficial to COVID patients came to me from conversations with a friend who is a doctor. His speciality? He is an ophthalmologist.
And, that’s why Trump is President. Everyone on the left, from Obama on down, believes in their heart that anyone who disagrees with them is uneducated and racist. And, they look for every opportunity to say that. Then, they can’t understand why everyone in the middle of the country, and the south, votes for someone who tells working people he admires them.
The biggest issue with the FDA is funding. If you want more medicines approved faster you need to be willing to fund science at all levels. Covid was a big enough crisis there suddenly was cash to actually fight the problem.
The people who rise to the top in government agencies, like the FDA and CDC, are clever bureaucrats who make sure they can never be blamed for anything. Giving them more money gives them more power and makes them less likely to do anything that might benefit the country.
The only way to fix this is to replace them with business men, ideally wealthy ones who won’t take bribes from the industry they regulate.
These fucking(fricking) Left wing Dems. Do they really think we are all this stupid. Anything Trump said he was going to do on a national level got push back from the states.(You don't have the authority to do this such as sending in the army to put down riots for destroying personal property). Can you say dumb ass. Get you fucking story straight. I think even the basic police investigation would tell you to stick to your story and don't keep changing it.
The Dems have declared total war on Trump - if Trump found the cure to cancer the Dems would try to shoot it down and not let people be cured so Trump wouldn't get credit
@Mark94 - you can replace people at the top, but it is very difficult to replace federal workers in the countless departments that make up our oversized government. The “Deep State” is a very real thing, and they show their displeasure through resisting change from outside forces.
The only real cure is to follow the Constitution. If you do that, the Federal bureaucrats will be removed from the personal kingdoms that they have illegally created for themselves.
Trump could outlaw federal employee unions with the stroke of a pen. They weren’t allow until a presidential action last century.
Similarly, we need to radically change the employment rules for federal employees. Or, like the Ag Dept, we could simply move the various departments to cities in Red States. The President has that power. The bureaucrats would resign in the thousands.
There will be no Effective vaccine ... EVER. I am in the know and I will not expound further... other than stating that if they approve said vaccine (they won’t), it will kill your ass 67 to 100 percent of the time If you get exposed to Covid-19. So, if the FDA does its job, then the vaccine will not get approved due to death rate (depending on whether you take the Australian data or the United States data, specifically SLU data) I will not respond any further on this comment. The final thing that I will say is that when you inject interleukin 4 into the vacuole of a viral strain, you get a virus that replicates that shit. If you do not know what interleukin 4 does, then google it.
->@mark94: "The only way to fix this is to replace them with business men, ideally wealthy ones who won’t take bribes from the industry they regulate."
In what utopia does this exist? Nowhere on planet earth. Even the wealthy want to be wealthier. So many examples - savings and loan crisis, junk bond crisis, subprime mortgage crisis.
Wilbur Ross is a great example of a billionaire who has done a great job in Government. There are others. Hell, Bill Barr was in private practice for decades and is quite wealthy. He returned to serve, not to make more money.
Like most Liberals I believe in the Constitution. Free speech, right to assemble, separation between church and state, no colluding with foreign powers. The usual.
The Establishment clause of the first amendment. The Supreme Court has been called upon to determine the meaning of the establishment clause.
Though not explicitly stated in the First Amendment, the clause is often interpreted to mean that the Constitution requires the separation of church and state.
Not one fucking liberal on the planet believes in free speech, just their right to speak freely, which is why hate speech laws are a fucking joke and designed only to protect loser communities from the truth.
The Constitution requires no official state religion, not the banishment of religion from public life. If the dopes called progressives ever read a history book they would realize that our forefathers fled a country with an official state religion.
Nidan - controting the anti-establishment clause to mean that the State must try to ban religion is an example of legislating at the bench.
Such a practice is the antithesis of supporting the Constitution.
Similarly, courts have created something called "The War Powers Act". It is frequently used to allow Congress to avoid doing its job and allow the President alone to decide whether or not we should go to war.
This is a clear violation of the separation of powers called for by the Constitution.
Do you realize that the last time we followed the rules and engaged in a war authorized by Congress was World War II?
Fox News has been slowly shifting left under the younger Murdoch. The more liberal news division is reportedly at war with opinion leaders Tucker and Sean. In 5 years, it may be just another mainstream outlet.
^^ the media has traditionally been left-of-center - and this seems more-so with the new crop of journalists being pumped out of these super-liberal universities
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With increased numbers of early ballots being casted across the country in recent election cycles, we no longer have an election day. We have an election month.
That is compounded by the number of people who will be voting by mail this year instead of in-person.
Will he see a bounce if it does clear trials? Who knows. He really screwed the pooch up to this point.
Not only has the FDA eliminated a lot of the red tape surrounding any approval related to the Corona Virus, but the government is signing early contracts with key players in the creation of anti-viruses.
No private company would ever commit to spending billions of dollars on producing a drug before Stage 3 testing was complete, and a drug had FDA approval.
But partnerships between the government and various drug companies are being created to do exactly that.
Drug manufacture will start before Stage 3 testing is completed for drugs that show promising data. A few contingent contracts have already been signed with monies waiting to change hands until more data is collected.
We are preparing to roll out any vaccine as soon as humanly possible.
"200K+ dead by election day. That will be tough to overcome."
Regardless of what you'd like to believe, most people don't blame President Trump. Quite the contrary, they blame irresponsible Democrat governors. In terms of Covid19 deaths, New York is BY FAR the worst of them (Cuomo), New Jersey is BY FAR the second worst (Murphy), and overall 9 of the 10 worst states are run by Democrats. Reasonable people (those not suffering from TDS) see right through the media's smoke-screen.
Where I come from the guy in charge is responsible unless what you’re insinuating is that Trump isn’t in charge there could be some truth to that
And my comments on the roll-out were straight out of Pfizer's press release.
By your reasoning, I guess we shouldn't even have states anymore. Did you want Trump to implement a national policy that every state must subscribe to, regardless of their individual and unique circumstances? Or would you prefer that Trump sit down and devise 50 different plans based on what he believes is best for each of them? Obviously you don't think the Governors are in any position to govern their own states.
What a sad state of affairs this country is in
But you are right, any drug can bomb out of any phase trial at any point in time. There is no such thing as a sure thing in drug discovery.
To the best of my knowledge, the drugs that have been approved for Corona virus to date have all been pre-existing drugs. So safety wasn't an issue, and given the alternative of no treatment at all, efficacy standards have been lowered.
In fact, from what I have heard, a vaccine will get FDA approval if it is safe even if it only protects 50% of recipients from infection.
This is not a sure thing. But it is nice to see twentyfive panic.
I think Trump bumbled this in a lot of key ways, including talking out his ass on pharmaceuticals (my field), but Operation Warp Speed is a good thing.
Still, if it gets approved, I'll have reservations. I'm a young, healthy, low-risk guy, and I want to see long-term data on any drug I take. I'll keep my mask on a bit longer and wait for others to take the hit.
"Herd immunity" is nothing but an excuse for people to do nothing and end the lockdowns. We barely have herd immunity on diseases every child is offered vaccination for.
I don’t work in the medical field, but in my mind that calls into question the long term viability of any vaccine.
Also what Tetradon said about waiting for time to pass after a great deal of others have been vaccinated before receiving a vaccination myself makes a great deal of sense.
Have you forgot about hydroxychloraquine? Safely used to treat malaria. Rushed through approval by Trump to treat Covid against the cautioning of Dr. Fauci. Disapproved as not only ineffective but dangerous for Covid patients. I believe the difference was the dosage required for malaria and a much great dose to use for Covid. It’s not science to say “because it’s preapproved safety isn’t an issue.” The doctors are still learning.
The primary study claiming it was ineffective was done by a mysterious research group that suddenly sprung up, issued the report, and then disbanded. The study has been retracted.
What little evidence there is suggests HCQ is safe and might have some effectiveness in early stages of the disease. Admittedly, it’s not a miracle cure.
One of my best friends got Covid pretty soon after we first started hearing about it. He has several strikes against him - African American (statistically worse outcomes), obese, diabetic, and has high blood pressure. He said he was sicker than ever before in his life, having trouble breathing... he was so terrified he actually started texting his friends from the hospital saying he didn't think he'd survive.
They quickly began treating him with hydroxychloraquine and in 24 hours he felt somewhat better, 2 days a lot better, and by the 3rd day he felt almost completely normal. They kept him a few more days for observation and then he walked out of the hospital good as new. Self-quarantined another couple weeks and went back to work at his contracting business.
The FDA, fake news media and liberal fuck sacks like you can say all you want that it "doesn't work" but I know first hand that it does. The left would gladly accept more deaths rather than admit Trump was right about something.
By the time it's widely available we would be looking at between Thanksgiving and New Year's.
In fact, given their failures, let’s clean house at the FDA and rewrite their mission to help find cures, not slowdown research. It could spark a golden age in medicine.
On hydrochloroquine - in malaria patients, it works be weakening the immune system and preventing a cytokine storm. A cytokine storm is the mechanism that COVID-19 uses to do most of its damage.
In studies where organ damage already occurred before use of HCQ, it was simply a case of being too late with treatment. But it does control the problem when given early enough.
Arguing topics like this is futile with people who consume Fox News all day, who read conspiracy-theory & pseudo-science websites, and who insist that Fauci is "preening asshole." The same people insist that Obama was born in Kenya and that climate change is a Chinese hoax. Why bother arguing with tinfoil-hat nutcases.
https://thefoolishnessofgod.blogspot.com…
Not sure if you are just fanning the flames or you have a valid concern about Covid-19. Possibly you are in a high risk category..."..over weight, diabetes, heart issues etc.? Then I can understand the comments better.
Just so people sleep better tonight, let’s do some basic math. You know scientists actually use actual hard data when drawing conclusions..
So how to determine percentages...
Deaths = 176,000
US Citizens = 350,000,000
176,000 divided by 350,000,000 x 100= 0.0502% Dead from COVID-19
Numbers and percentages sometimes are hard to follow, so let’s break it down this way.
We would need 3.5 million Deaths to say we have lost 1% of the USA population.
I hope some people sleep better tonight, when you look at the metrics.
Remember panic is not the virtue of a warrior!!!
I am not formally education in biosciences or medicine.
The knowledge I have of the mechanisms that CHQ uses that are beneficial to COVID patients came to me from conversations with a friend who is a doctor. His speciality? He is an ophthalmologist.
And, that’s why Trump is President. Everyone on the left, from Obama on down, believes in their heart that anyone who disagrees with them is uneducated and racist. And, they look for every opportunity to say that. Then, they can’t understand why everyone in the middle of the country, and the south, votes for someone who tells working people he admires them.
The only way to fix this is to replace them with business men, ideally wealthy ones who won’t take bribes from the industry they regulate.
The only real cure is to follow the Constitution. If you do that, the Federal bureaucrats will be removed from the personal kingdoms that they have illegally created for themselves.
Similarly, we need to radically change the employment rules for federal employees. Or, like the Ag Dept, we could simply move the various departments to cities in Red States. The President has that power. The bureaucrats would resign in the thousands.
In what utopia does this exist? Nowhere on planet earth. Even the wealthy want to be wealthier. So many examples - savings and loan crisis, junk bond crisis, subprime mortgage crisis.
Let me give you a hint - separation of church and State are not the same thing as the antiestablishment clause.
Though not explicitly stated in the First Amendment, the clause is often interpreted to mean that the Constitution requires the separation of church and state.
The Constitution requires no official state religion, not the banishment of religion from public life. If the dopes called progressives ever read a history book they would realize that our forefathers fled a country with an official state religion.
Such a practice is the antithesis of supporting the Constitution.
Similarly, courts have created something called "The War Powers Act". It is frequently used to allow Congress to avoid doing its job and allow the President alone to decide whether or not we should go to war.
This is a clear violation of the separation of powers called for by the Constitution.
Do you realize that the last time we followed the rules and engaged in a war authorized by Congress was World War II?
Not in Korea.
Not in Vietnam.
Not in Grenada (if you want to count that)
Not in Iraq (twice)
Not in Kosovo.
Not in Afghanistan.