Re: Coronavirus
Posted: Tue Nov 17, 2020 3:01 pm
I calculated the numbers for an infection rate with an r0 value of 2 on Page 4, I think. I said:
The first documented cases appeared around January 22nd (Week 4 of 2020)Week 32: 43046883 people.
So, I know some peeps in pharmacovigilance/drug safety, and I can tell you with absolute certainty that the requirements for FDA approval are stringent. They will see the data. Companies are required to report directly to the FDA ALL adverse events (SAEs) during clinical trials, BEFORE it's established whether or not the AE was caused by the drug. In fact, there's a strict timeline for that reporting, and trials are stopped if certain thresholds for AEs are crossed. By the time a drug has reached in-human clinical trials, it has already passed multiple animal safety and efficacy trials. There is absolutely a team of people (always overseen by MDs) reporting literally every recorded headache, rash, soreness, eye-twitch experienced by the people in these trials.chaos wrote: ↑Tue Nov 17, 2020 1:01 pmReally? Where? You think the vaccines are going to work based on a total of 55K people who have gotten doses two different vaccines, where one showed protection for a seven day study period.
No one has seen the actual trial data. The process has been accelerated, and is moving down the road to being fast tracked based on minimal preliminary data.
Oh and this if from the Pfizer website regarding the only public information that is available:
Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists.
You're right, maybe people getting these highly expedited vaccines don't keel over or have serious complications, but certainly close to a trillion dollars of resources should go through proper channels and critical testing and proven scientific studies should not be sidelined in the name of "saving lives"....?The FDA memo outlining the EUA for convalescent plasma cites just two randomized controlled trials, both of which were stopped early — one because it failed to recruit enough participants and the other because they found that the patients that were receiving plasma already had high levels of antibodies. Both found little to no benefit from the treatment, but they remain some of the best-constructed studies.
The memo also cites a handful of observational and retrospective studies as the basis for its decision. It was one of these retrospective studies that served as the basis for the White House’s boldest claim about the effectiveness of convalescent plasma to treat Covid-19.
During the August 23 press conference, Hahn reported that convalescent plasma would yield a 35 percent improvement in the survival rate of Covid-19 patients.
“A 35 percent improvement in survival is a pretty substantial clinical benefit,” said Hahn during a Sunday press conference. “What that means is, if the data continue to pan out, if 100 people are sick with Covid-19, 35 would have been saved with the administration of plasma.”
"A 35 percent improvement in survival is a pretty substantial clinical benefit," FDA Commissioner @SteveFDA said in relation to the convalescent plasma emergency use authorization issued today. pic.twitter.com/Dd97vLSZeL
— U.S. FDA (@US_FDA) August 23, 2020
But other researchers said that Hahn’s 35 percent improvement in survival claim was wildly misleading. It came from a retrospective preprint study that hasn’t undergone peer review, so some of the methods and findings may have flaws that would ordinarily be caught in the review process.
“For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy,” Walid Gellad, of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told the New York Times.
The study doesn’t compare patients who received convalescent plasma to patients who received a placebo, either. Rather, it compares patients who received plasma early versus those who received it later in their course of treatment.
Even within that comparison, the results showed that the seven-day mortality rate was 11.9 percent in patients who received plasma four days or more after they were diagnosed with Covid-19, while those who received plasma three days after diagnosis had a mortality rate of 8.7 percent. In other words, getting plasma to Covid-19 patients one day earlier reduced the absolute mortality by 3.2 percent.
And when the researchers compared the doses of convalescent plasma, they found that those that received the low dose had a seven-day mortality rate of 13.7 percent while those that received the high dose had a rate of 8.9 percent. That’s a only 4.8 percent improvement in absolute terms, but a 35 percent change in relative terms. It’s progress, but not the massive leap forward that Hahn and other officials made it sound like.
Faust pointed out that this retrospective study only sampled patients who were sick enough to go to the hospital. Out of those, the patients studied were only the ones who received convalescent plasma, were under the age of 80, and who did not receive mechanical ventilation.
“This big ‘breakthrough’ that they say is a 35 percent reduction in mortality, this is a subset of a subset of a subset in a retrospective study which has not been confirmed with a trial,” he said. “There’s nothing wrong with the study itself for what it is; what’s wrong is to rely on it to say that there’s been a breakthrough.”
On August 24, Hahn acknowledged, after much criticism, that he overplayed his hand. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” he wrote.
But for some researchers, it was not enough. A few responded on Twitter that they wanted a more forceful retraction of the claim and other statements Hahn made during the press conference.
You need to correct the 35 lives saved per 100 sick with covid-19 so people understand that was absolutely wrong, Steve. That there is no evidence to support that. That there is no evidence at this juncture to support *any* survival benefit. That we need RCTs.
— Eric Topol (@EricTopol) August 25, 2020
https://www.vox.com/2020/8/24/21399007 ... ephen-hahn
Convalescent plasma is not a vaccine. It's a treatment for people who already have COVID-19. The accelerated vaccine schedules are a completely different issue from needing immediate treatments for dying people.mockbee wrote: ↑Mon Nov 23, 2020 9:26 amThe FDA, (along with, of course, WHO, etc) are no gold standard.
Even NIH has grave doubts about the expedited/politicized process currently in place.
You're right, maybe people getting these highly expedited vaccines don't keel over or have serious complications, but certainly close to a trillion dollars of resources should go through proper channels and critical testing and proven scientific studies should not be sidelined in the name of "saving lives"....?The FDA memo outlining the EUA for convalescent plasma cites just two randomized controlled trials, both of which were stopped early — one because it failed to recruit enough participants and the other because they found that the patients that were receiving plasma already had high levels of antibodies. Both found little to no benefit from the treatment, but they remain some of the best-constructed studies.
The memo also cites a handful of observational and retrospective studies as the basis for its decision. It was one of these retrospective studies that served as the basis for the White House’s boldest claim about the effectiveness of convalescent plasma to treat Covid-19.
During the August 23 press conference, Hahn reported that convalescent plasma would yield a 35 percent improvement in the survival rate of Covid-19 patients.
“A 35 percent improvement in survival is a pretty substantial clinical benefit,” said Hahn during a Sunday press conference. “What that means is, if the data continue to pan out, if 100 people are sick with Covid-19, 35 would have been saved with the administration of plasma.”
"A 35 percent improvement in survival is a pretty substantial clinical benefit," FDA Commissioner @SteveFDA said in relation to the convalescent plasma emergency use authorization issued today. pic.twitter.com/Dd97vLSZeL
— U.S. FDA (@US_FDA) August 23, 2020
But other researchers said that Hahn’s 35 percent improvement in survival claim was wildly misleading. It came from a retrospective preprint study that hasn’t undergone peer review, so some of the methods and findings may have flaws that would ordinarily be caught in the review process.
“For the first time ever, I feel like official people in communications and people at the FDA grossly misrepresented data about a therapy,” Walid Gellad, of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, told the New York Times.
The study doesn’t compare patients who received convalescent plasma to patients who received a placebo, either. Rather, it compares patients who received plasma early versus those who received it later in their course of treatment.
Even within that comparison, the results showed that the seven-day mortality rate was 11.9 percent in patients who received plasma four days or more after they were diagnosed with Covid-19, while those who received plasma three days after diagnosis had a mortality rate of 8.7 percent. In other words, getting plasma to Covid-19 patients one day earlier reduced the absolute mortality by 3.2 percent.
And when the researchers compared the doses of convalescent plasma, they found that those that received the low dose had a seven-day mortality rate of 13.7 percent while those that received the high dose had a rate of 8.9 percent. That’s a only 4.8 percent improvement in absolute terms, but a 35 percent change in relative terms. It’s progress, but not the massive leap forward that Hahn and other officials made it sound like.
Faust pointed out that this retrospective study only sampled patients who were sick enough to go to the hospital. Out of those, the patients studied were only the ones who received convalescent plasma, were under the age of 80, and who did not receive mechanical ventilation.
“This big ‘breakthrough’ that they say is a 35 percent reduction in mortality, this is a subset of a subset of a subset in a retrospective study which has not been confirmed with a trial,” he said. “There’s nothing wrong with the study itself for what it is; what’s wrong is to rely on it to say that there’s been a breakthrough.”
On August 24, Hahn acknowledged, after much criticism, that he overplayed his hand. “What I should have said better is that the data show a relative risk reduction not an absolute risk reduction,” he wrote.
But for some researchers, it was not enough. A few responded on Twitter that they wanted a more forceful retraction of the claim and other statements Hahn made during the press conference.
You need to correct the 35 lives saved per 100 sick with covid-19 so people understand that was absolutely wrong, Steve. That there is no evidence to support that. That there is no evidence at this juncture to support *any* survival benefit. That we need RCTs.
— Eric Topol (@EricTopol) August 25, 2020
https://www.vox.com/2020/8/24/21399007 ... ephen-hahn
I blame Trump and Biden (repubs and dems) for politicizing this shit. All politicians have utterly failed in this recovery response effort.
I also don't think the US can/could really be able to respond in any different way than it did. If Biden was president we would have ALL been wearing masks since March just because he said so??? I don't think so. That's not America.
Also Europe should be doing great, if that were the case, and they are not.....
Maybe if we were all a mostly monolithic culture who lived on an isolated island like New Zealand, we would have this under control.....
Yeah, we'll see what happens. Looks like we'll know FDAs initial take, and whether they heed all advisory committee concerns, in the middle of December.
Pfizer Applies for Emergency F.D.A. Approval for Covid-19 Vaccine
A large team of regulators at the agency will take about three weeks to review an application spanning thousands of pages.
Pfizer and its partner BioNTech announced this week that the vaccine was 95 percent effective and that it worked well in older people and in preventing severe Covid-19.
By Noah Weiland and Katie Thomas
Published Nov. 20, 2020Updated Nov. 22, 2020
The drug maker Pfizer said on Friday that it had submitted an application to the Food and Drug Administration to authorize its coronavirus vaccine for emergency use, setting in motion an accelerated regulatory process that could allow the first Americans to get a vaccine by the middle of December.
Pfizer and its German partner, BioNTech, announced Wednesday that the vaccine was safe and 95 percent effective, and that it also worked well in older people and in preventing severe Covid-19.
Another front-runner, Moderna, said on Monday that its vaccine, which uses similar technology, was 94.5 percent effective and that the company also expected to apply soon for emergency authorization.
The two vaccines use a synthetic version of coronavirus genetic material, called mRNA, to program a person’s cells to churn out many copies of a fragment of the virus.
An emergency authorization would allow limited groups of Americans to get the vaccines before the F.D.A. has completed the typical monthslong approval process, but agency officials have made clear through new guidelines that their bar for emergency authorization will be high.
In a video message Friday, Pfizer’s chief executive, Dr. Albert Bourla, called it a “historic day,” and said: “It is with great pride and joy — and even a little relief — that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the F.D.A.’s hands.”
Both of the companies’ vaccine candidates began large human trials on the same day, July 27, leading the pack of six vaccines the federal government has invested in through its crash vaccine development program, Operation Warp Speed.
If the two vaccines are authorized for emergency use, federal and company officials have said there could be enough doses to immunize about 20 million Americans before the end of the year, a group that would most likely include health care workers and nursing home residents. There are an estimated 17 million to 20 million health care workers in the United States, and about a million people living in nursing homes.
After lowering expectations for how many millions of vaccines they can produce this year, the companies expect to ramp up their manufacturing early next year. Like with other kinds of vaccines, mass producing them for the coronavirus has proved to be a complex and delicate process requiring sterile conditions and precise control of temperature and humidity. The mRNA technology has also never been commercially manufactured. If other vaccines are also authorized, hundreds of millions of doses could be available by the spring, according to federal officials.
Both Pfizer and Moderna have arranged deals with the government so that the vaccines will be free to Americans and distributed according to plans worked out between the federal government and the states. CVS and Walgreens also have federal deals to begin immunizing nursing home residents. On Tuesday, Alex M. Azar II, the secretary of the Department of Health and Human Services, said that 99 percent of the country’s nursing homes had signed up to be part of the program.
Regulators at the F.D.A. plan to take about three weeks to review Pfizer’s vaccine before an outside panel of experts meets to review the application the second week of December. That meeting has been scheduled for Dec. 10.
The agency typically, though not always, follows the advice of its advisory committees. If committee members reach a consensus about the effectiveness of Pfizer’s vaccine, the company could receive emergency clearance by mid-December.
Because Moderna is also on the verge of submitting its vaccine for review, the outside panel could review the company’s vaccine soon after Pfizer’s.
Pfizer said on Friday that the company has begun regulatory submissions in Australia, Canada, Europe, Japan and Britain, and that it plans to apply in other countries “in the immediate future.”
Inside the F.D.A., Pfizer’s application will be reviewed by the agency’s Center for Biologics Evaluation and Research, which has organized large teams of medical and compliance officers, epidemiologists and statisticians to dig into thousands of pages of data about the safety and effectiveness for each vaccine, as well as information on how companies plan to safely and consistently manufacture large batches of the product.
The process could take longer if the reviewers come across errors, or if they need to ask for additional data. Regulators expect the manufacturing data to spur intense deliberation, as companies have scrambled to turn over that information in time.
There's also that whole surging virus thing causing longer lines.Pandemonium wrote: ↑Wed Nov 25, 2020 6:00 pmMy wife had to get a Covid test 4 times so far in the past month. She's having stomach problems again and has to go through a bunch of procedures that include upper/lower GI, CTs etc. So every time she has a procedure appt, she has to get a Covid test about 3 days prior. She does it at the Hospital test site which is done by having people stay in their cars in a long, slow moving line that snakes around the parking lot. The latest was this past Monday and because thousands of idiots think if they get a test, they're good to travel and get together with family. So the Hospital Covid test line was about 6 hours long instead of the usual 2 hour wait.
I agree. I've been ragging on a lot of the bullshit I've seen with the political establishment lately but this whole thing has also really exposed the soft underbelly of shocking stupidity of a big portion of the American public. Normally, I'd say fuck it, thin the herd but a lot of the worst offenders are the ones unknowingly carrying Covid around and spreading it to people who for the most part *are* following simple, basic health guidelines, which let's face it, are never going to be 100% effective in avoiding exposure and infection.Hokahey wrote: ↑Sat Dec 05, 2020 6:59 pmMost of the people I know bitching and complaining about government overreach are the same people out there without masks on, not social distancing, and all have inevitably contracted covid and inevitably spread it around prior to having symptoms.
I can't count how many times I've said "you are the reason these restrictions are happening."
The incredible abundance of anti-science, anti-intellectual, pro-conspiracy mentalities that have been exposed by this pandemic has honestly shook me to my fucking core. Even people I generally respect as reasonably intelligent, kind, decent, people are out fucking around and then posting "guys I got it, it's real" shit on social media. And when we talk it's always "well we decided we deserved a night out and that's when we got it. I started feeling sick when I was at my brother's house...."Pandemonium wrote: ↑Sat Dec 05, 2020 7:40 pmI agree. I've been ragging on a lot of the bullshit I've seen with the political establishment lately but this whole thing has also really exposed the soft underbelly of shocking stupidity of a big portion of the American public. Normally, I'd say fuck it, thin the herd but a lot of the worst offenders are the ones unknowingly carrying Covid around and spreading it to people who for the most part *are* following simple, basic health guidelines, which let's face it, are never going to be 100% effective in avoiding exposure and infection.Hokahey wrote: ↑Sat Dec 05, 2020 6:59 pmMost of the people I know bitching and complaining about government overreach are the same people out there without masks on, not social distancing, and all have inevitably contracted covid and inevitably spread it around prior to having symptoms.
I can't count how many times I've said "you are the reason these restrictions are happening."