talkingpointsmemo--2020-09-28--A Real Vaccine Before the Election? It’d Take a Miracle.

This story first appeared at ProPublica .
ProPublica is a Pulitzer Prize-winning investigative newsroom .
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Despite President Donald Trump ’ s promises of a vaccine next month and pundits ’ speculation about how an “ October surprise ” could upend the presidential campaign , any potential vaccine would have to clear a slew of scientific and bureaucratic hurdles in record time .
In short , it would take a miracle .
We talked to companies , regulators , scientific advisers and analysts and @ @ @ @ @ @ @ study protocols to understand all the steps needed for a coronavirus vaccine to be scientifically validated and cleared for public use .
As you ’ ll see , it ’ s a long shot in 38 days .
There are three key milestones that must be met : • A clinical trial would need to observe enough infections to demonstrate that the vaccine is better than a placebo .
Right now , Pfizer ’ s trial is the furthest along .
Pfizer has said it expects results by the end of October , @ @ @ @ @ @ @ ’ t so sure it ’ ll be that soon or whether the results will be conclusive .
• Pfizer would have to turn its trial data into an application to the Food and Drug Administration .
The company could either apply for full approval — a very high bar for proving the vaccine is safe , effective and able to be reliably manufactured by the millions of doses — or for an emergency use authorization , which is more flexible .
Pfizer has said it could submit its application almost immediately .
@ @ @ @ @ @ @ data and decide whether the vaccine is ready to go to market .
That could take several weeks to a month , said Dr. Mark McClellan , who led the FDA from 2002 to 2004 .
“ All of this put together makes it more likely that it ’ ll be a late 2020 availability , ” McClellan said .
None of this is to say that Trump couldn ’ t suddenly call a White House press conference to try to grab headlines and declare victory .
But knowing all the steps that @ @ @ @ @ @ @ the public discern between a true , scientifically validated vaccine and a mere political stunt .
Yes , Pfizer could have trial results by the end of October .
Results from ongoing trials are closely guarded so that researchers ( and investors ) have no opportunity to mess with them .
Under strict trial rules that vaccine makers and the FDA set up in advance , there are only a few predetermined times when a data monitoring board is scheduled to look at the data .
The purpose of those check-ins ( known @ @ @ @ @ @ @ to see if there ’ s already enough evidence to conclude that the vaccine either works or doesn ’ t .
According to the trial rules that Pfizer released last week , it has four of these check-ins before the final analysis .
The first one occurs when 32 people in the trial get sick with COVID-19 .
Yes , that is a tiny number in a study designed to enroll 30,000 participants .
But it could be enough to show that the vaccine works if far more of the infections occur in @ @ @ @ @ @ @ those who got the vaccine , so much so that it ’ s probably not random .
The vaccine “ would have to be way , way better to meet an interim stopping boundary , ” said Frank Harrell Jr. , professor of biostatistics at Vanderbilt University .
If six or fewer of the first 32 cases are people who got the vaccine , that suggests the vaccine reduced COVID-19 cases by 76 % .
Under Pfizer ’ s trial rules , the company can then conclude that its vaccine is effective enough @ @ @ @ @ @ @ .
If , on the other hand , 15 or more of the first 32 infections are people who got the vaccine , it would mean the vaccine doesn ’ t work and the study ends .
The better the vaccine works , the longer it would take to reach 32 cases , because fewer vaccinated people would get sick and more of the infections would have to occur in the placebo group .
So when exactly will Pfizer get to 32 cases ?
Analysts at JPMorgan estimate that this first readout would @ @ @ @ @ @ @ is 70 % effective , or on Nov. 2 if the vaccine is 80 % .
Their model also estimates that Pfizer is more than twice as likely to be able to file for approval at 80 % effectiveness vs 70 % effectiveness .
The JPMorgan analysts ’ prediction is roughly in line with official public statements from Pfizer , though the company has projected even more confidence .
“ We have a good chance that we will know if the product works by the end of October , ” CEO Albert Bourla @ @ @ @ @ @ @ Face the Nation.
” The key thing we don ’ t know is how fast people in Pfizer ’ s trial are getting sick .
The trial doesn ’ t intentionally expose people to the virus ; it waits to see who catches it on their own .
Even though the pandemic is far from under control , the coronavirus is not spreading as fast as it was a few months ago .
The study started with a baseline assumption that just 1.3 % of participants would be infected over the course of @ @ @ @ @ @ @ that the thousands of people who signed up for Pfizer ’ s study could be getting sick faster or slower than that , depending on how bad the outbreak is where they are .
If Pfizer ’ s trial infection rate is 1.5 to 2 times faster than publicly reported case counts , then Pfizer ’ s first readout could be Oct. 12-19 with a 70 % effective vaccine , or Oct. 14-22 with 80 % efficacy , according to JPMorgan ’ s model .
“ When the trials started there were a @ @ @ @ @ @ @ that time , ” said Dr. Vamil Divan , an analyst at the bank Mizuho .
“ That ’ s a key unknown .
How many of these participants are enrolled in hotter areas versus New York or Boston ?
” To protect the integrity of trials like this , the drugmakers running them aren ’ t supposed to know what the data is showing as it comes in .
And yet , company executives have led some observers to believe they know how many people have tested positive for COVID-19 .
“ @ @ @ @ @ @ @ how rapidly they ’ re accruing data , and they probably know the total number of events , ” said Susan Ellenberg , professor of biostatistics at the University of Pennsylvania .
“ When they say things like that , first of all , it does some wonders for their stock prices , ” she added .
In a statement , Pfizer said that it expects results “ as early as the end of October ” based on current infection rates .
The trial , the company said , “ was designed to @ @ @ @ @ @ @ vaccine candidate as fast as possible.
” “ Having said that , ” the company added , “ neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial.
” It ’ s highly unlikely that the next front-runner , Moderna , could have results before the election .
The JPMorgan analysts ’ model suggests that infection rates would have to be four times the publicly reported rate for Moderna to be able to report results before Nov. 3 .
Dr. Tal Zaks , Moderna ’ @ @ @ @ @ @ @ on Sept. 17 that “ some time in November is sort of a reasonable base case ” for the first look at Moderna ’ s results .
( ProPublica ’ s board chairman , Paul Sagan , is a member of Moderna ’ s board and a company stockholder . )
Other developers are further behind .
AstraZeneca ’ s trial is paused in the U.S. while the company investigates what happened with a participant who had a bad reaction .
Johnson & Johnson is just beginning its large-scale , end-stage trial , @ @ @ @ @ @ @ Pfizer is the only company with a shot at results before the election .
And if the company has results to share , it ’ s unlikely to let political implications get in the way .
The company has an ethical obligation not to delay a product that is ready to save lives , despite the risk that a vaccine announced on the eve of a contentious election could stoke partisan perceptions .
“ Once you have signs of a vaccine ’ s effectiveness , it ’ s very difficult to argue anything @ @ @ @ @ @ @ to those most at risk , ” Dr. Mani Foroohar , an analyst with the investment bank SVB Leerink , said .
“ But it ’ s also very difficult to make the argument that you should do anything that undermines public trust .
That ’ s one of the problems when you introduce powerful political pressures into what is meant to be a boring , dry , unemotional process.
” Once Pfizer gets results , it ’ s poised to seek the FDA ’ s go-ahead swiftly .
As soon as Pfizer @ @ @ @ @ @ @ an application to the FDA .
The application will include data from all previous trials as well as proof that the company can consistently manufacture millions of vaccine doses .
Pfizer ’ s CEO has indicated that the company is ready to turn around its application in a flash , if not on the same day it has results .
“ We will try to be able to be ready to submit with the speed of light , once we have the results ready , ” Bourla said at an investor presentation on @ @ @ @ @ @ @ when submitting its FDA application .
It can apply for an EUA or a full approval , known as a biologics license application , or BLA .
An EUA would only allow Pfizer to market its vaccine for the pandemic ’ s duration — during the declared “ emergency ” period that we are currently in .
If the company receives full licensure , on the other hand , its product can remain on the market forever .
In its statement , Pfizer said it plans to continue its study after a possible @ @ @ @ @ @ @ The bar for an EUA is lower than for full approval .
By law , an EUA can be issued so long as “ the product may be effective in diagnosing , treating , or preventing ” the disease and “ the known and potential benefits of the product … outweigh the known and potential risks.
” In contrast , the standard for a full approval requires a drugmaker to prove not only that the product is safe and effective , but also that the product is pure and can be consistently made @ @ @ @ @ @ @ from living materials .
For the COVID-19 vaccine , the FDA has said that it is going to raise the bar for an EUA , going beyond the usual requirements .
Previously , the FDA has said a vaccine should be at least 50 % effective .
The FDA is reportedly close to announcing new standards to include at least two months of monitoring the health of trial participants after they receive their second shot .
That could end up being the biggest hurdle to authorizing a vaccine before the election .
Trump @ @ @ @ @ @ @ the new guidelines , but companies and FDA officials might still choose to observe them .
In a statement , the FDA said that “ for a vaccine for which there is adequate manufacturing information , ” an EUA “ may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or the FDA has completed its formal review of the biologics license application.
” Pfizer said in a statement that it anticipates providing the agency safety data , including the median of two @ @ @ @ @ @ @ , on a rolling basis .
The trial has enrolled more than 31,000 participants , and 19,000 have received the second dose so far , the company said .
“ The standards FDA is reportedly considering for a covid vaccine EUA represent appropriate balance between speed and safety in a crisis , ” Dr. Scott Gottlieb , who led the FDA earlier in the Trump administration and serves on Pfizer ’ s board , tweeted on Thursday .
“ Even under EUA ; you want higher assurance of safety and benefit for vaccine @ @ @ @ @ @ @ to those already sick.
” “ Any political effort to shortcut [ the ] process or degrade reasonable standards will be [ a ] Pyrrhic victory if people lack confidence in a vaccine , ” Gottlieb added .
The FDA will thoroughly review the application , and that ’ ll take a while .
Once the FDA receives a company ’ s submission , the agency ’ s review process consists of several steps which , put together , could take weeks to complete .
The FDA is the only health regulator in @ @ @ @ @ @ @ data files and does its own analysis , said Dr. Joshua Sharfstein , the FDA ’ s former principal deputy commissioner from 2009 to 2011 .
“ Now would not be the moment to stop ” that practice , he said , despite the urgent need for a vaccine .
Besides reviewing clinical trial data , the FDA also inspects vaccine developers ’ manufacturing capabilities to ensure that every vaccine batch can be made consistently and that the process is squeaky clean , so that no impurities can make their way into a @ @ @ @ @ @ @ a lot of paperwork sent from the companies to the agency and also , usually , on-site inspections at manufacturing plants .
The agency declined to comment on whether it had already completed on-site inspections for Pfizer and Moderna .
After the FDA finishes its assessment of the company ’ s application , it typically presents the data to an external advisory committee in a public meeting .
Dr. Peter Marks , director of the Center for Biologics Evaluation and Research , has said that the agency is committed to holding advisory committee @ @ @ @ @ @ @ Those meetings will take time to schedule , but it ’ s an essential step , according to experts both inside and outside the agency .
“ How will [ the public ] know that we ’ re not , like , holding something in and sweeping something under the rug ?
Well , the way they ’ re going to know that is because any vaccine that we issue an emergency use authorization for will go to a public advisory committee meeting , ” Marks said in a Sept. 10 webinar hosted @ @ @ @ @ @ @ Policy .
“ It ’ ll be critical for people to see what ’ s in the briefing packages , they ’ ll be able to see the discussion among an impartial group of advisers , they ’ ll see the committee recommendation and they ’ ll see the public dialogue that will take place at that committee.
” Advisory committee members vote on whether they recommend product approval .
While the FDA does not have to follow the committee ’ s recommendations , the votes are public .
We contacted every advisory @ @ @ @ @ @ @ about how they would evaluate an EUA application for a COVID-19 vaccine .
These members ( speaking for themselves , not for the FDA ) indicated they would expect to see a level of evidence that could be tough to meet in the next 38 days .
One factor in their caution is that a premature EUA could make it harder to definitively evaluate an effective vaccine , because subjects in ongoing trials may drop out and new enrollments in trials with placebos would no longer be feasible .
“ If an EUA @ @ @ @ @ @ @ t have sufficient clinical efficacy data , it would make it very hard to actually complete the study as written , ” Dr. Paul Spearman , director of infectious diseases at Cincinnati Children ’ s Hospital , said .
“ You would want to have enough clinical efficacy data by the time of an EUA to be pretty darn certain.
” Another committee member is Dr. Archana Chatterjee , dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine .
She also expressed caution about basing a hugely consequential @ @ @ @ @ @ @ cases , like the 32 in Pfizer ’ s first look .
“ It ’ s hard for me to say with these small numbers will we have meaningful data to make a decision on , ” Chatterjee said .
“ I have not made up my mind on any of this because I need to see and discuss with colleagues what the data are and what the implications might be.
” One option would be for the FDA to grant an EUA for a specific group of people , such as health @ @ @ @ @ @ @ are more vulnerable to COVID-19 .
The data would have to support a specific vaccine use that aligns with a recognized unmet medical need , said Dr. Michael Kurilla , an advisory committee member and the director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences , part of the National Institutes of Health .
For example , it ’ s possible a vaccine could work well in young people but not so well in older people .
In that case , it might not be that beneficial @ @ @ @ @ @ @ vulnerable to serious disease .
“ It ’ s not simply a matter of saying we will EUA this product , ” Kurilla said .
“ We have to be very careful to define what it is we ’ re trying to address.
” Dr. Paul Offit , director of the vaccine education center at the Children ’ s Hospital of Philadelphia , said he would like to see robust safety data , to make sure there are no neurological side effects , from Pfizer and Moderna .
Both companies are developing so-called @ @ @ @ @ @ @ technology that has never been approved before .
He noted that most people who get vaccines are healthy , so the bar for letting a vaccine go to market is necessarily much higher than for treatments intended for severely ill COVID-19 patients .
Finally , the FDA considers the committee ’ s advice and makes its final decision on whether it will greenlight the product .
Normally , the FDA aims to review applications for full approval within 10 months for standard reviews and six months for priority reviews .
It ’ s @ @ @ @ @ @ @ can be completed for the COVID-19 vaccine .
The only other vaccine that has ever received an EUA was an anthrax vaccine , but it ’ s not a useful comparison because the vaccine was already in use and the 2005 authorization was granted to allow the US .
Department of Defense to resume giving the shots to military personnel after the mandatory vaccination program had been suspended .
Some steps could potentially be skipped when doing a review for an EUA as compared with a full approval , according to McClellan , @ @ @ @ @ @ @ , any vaccines needed for this pandemic won ’ t need long-term storage , because they ’ ll all be used quickly , so companies won ’ t need to run tests and demonstrate to the agency that their vaccines can be stored for months on end .
But to receive full approval , the agency might require that .
Still , McClellan estimated , the agency ’ s review process from the time it receives an application to issuing an EUA could take up to a month .
All of this is @ @ @ @ @ @ @ vaccine .
Getting shots in millions of people ’ s arms is another story .
The two vaccine front-runners from Pfizer and Moderna pose additional logistical challenges because they have to be kept frozen .
What could go wrong ?
Having read through all these steps , you can start to see the points where the process could break down and how the public might find out about it .
• If a company lowers the bar for efficacy .
The first four vaccine contenders have all released their clinical trial rules ( @ @ @ @ @ @ @ & Johnson ) , so the public should be able to assess whether the shots have met the companies ’ own standards to prove it works .
If they unexpectedly change their schedules or the standards , that ’ s concerning .
• If the FDA backtracks on its commitment to consult the independent advisory board , or if the agency ’ s leaders reject the committee ’ s advice , it would be a sign that they ’ re acting under political pressure without scientific support .
• If FDA career scientists @ @ @ @ @ @ @ would also be a major sign of political pressure .
The decision on whether or not to authorize a vaccine will fall on Marks , head of the biologics division .
FDA Commissioner Stephen Hahn , however , has authority to overrule Marks ’ decision , and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn ’ s call .
• If FDA officials quit .
Marks has said he ’ d resign if the agency authorizes an unproven or unsafe vaccine .
Ultimately @ @ @ @ @ @ @ vaccine development are seeking the perfect balance between speed and caution : Faced with a deadly virus that ’ s taken the lives of more than 200,000 Americans and upended life , devastating the economy and tearing away the livelihoods of so many , of course there is an imperative not to waste any time and an urgent desire for a vaccine .
Yet a bad vaccine could do more harm than good , and even the perception of a vaccine that is not thoroughly vetted could be just as bad , if @ @ @ @ @ @ @ in taking it .
“ A vaccine only works if it ’ s safe , effective and administered , ” meaning people have to be willing to take it , said Bruce Mehlman , a political adviser to companies at the lobbying firm Mehlman Castagnetti Rosen & Thomas .
( He doesn ’ t represent any pharmaceutical clients . )
“ If it becomes another culture war football like masks , it will not help us get past the virus and return to normal.
” It ’ s unlikely we ’ ll see @ @ @ @ @ @ @ to ensure the shot is safe , effective , pure and trustworthy , waiting a little longer with the knowledge that no steps have been skipped may be well worth it .
Do you have access to information about Operation Warp Speed that should be public ?
Email caroline.chen @ propublica.org .
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This story first appeared at ProPublica. ProPublica is a Pulitzer Prize-winning investigative newsroom. Sign up for The Big Story newsletter to receive stories like this one in your inbox.
Despite President Donald Trump’s promises of a vaccine next month and pundits’ speculation about how an “October surprise” could upend the presidential campaign, any potential vaccine would have to clear a slew of scientific and bureaucratic hurdles in record time.
In short, it would take a miracle.
We talked to companies, regulators, scientific advisers and analysts and reviewed hundreds of pages of transcripts and study protocols to understand all the steps needed for a coronavirus vaccine to be scientifically validated and cleared for public use. As you’ll see, it’s a long shot in 38 days.
There are three key milestones that must be met:
A clinical trial would need to observe enough infections to demonstrate that the vaccine is better than a placebo. Right now, Pfizer’s trial is the furthest along. Pfizer has said it expects results by the end of October, but analysts who follow the company aren’t so sure it’ll be that soon or whether the results will be conclusive. Pfizer would have to turn its trial data into an application to the Food and Drug Administration. The company could either apply for full approval — a very high bar for proving the vaccine is safe, effective and able to be reliably manufactured by the millions of doses — or for an emergency use authorization, which is more flexible. Pfizer has said it could submit its application almost immediately. The FDA has to review the data and decide whether the vaccine is ready to go to market. That could take several weeks to a month, said Dr. Mark McClellan, who led the FDA from 2002 to 2004.
“All of this put together makes it more likely that it’ll be a late 2020 availability,” McClellan said.
None of this is to say that Trump couldn’t suddenly call a White House press conference to try to grab headlines and declare victory. But knowing all the steps that would have to come first can help the public discern between a true, scientifically validated vaccine and a mere political stunt.
Yes, Pfizer could have trial results by the end of October.
Results from ongoing trials are closely guarded so that researchers (and investors) have no opportunity to mess with them. Under strict trial rules that vaccine makers and the FDA set up in advance, there are only a few predetermined times when a data monitoring board is scheduled to look at the data. The purpose of those check-ins (known as “interim analyses”) is to see if there’s already enough evidence to conclude that the vaccine either works or doesn’t.
According to the trial rules that Pfizer released last week, it has four of these check-ins before the final analysis. The first one occurs when 32 people in the trial get sick with COVID-19.
Yes, that is a tiny number in a study designed to enroll 30,000 participants. But it could be enough to show that the vaccine works if far more of the infections occur in people who took the placebo than in those who got the vaccine, so much so that it’s probably not random.
The vaccine “would have to be way, way better to meet an interim stopping boundary,” said Frank Harrell Jr., professor of biostatistics at Vanderbilt University.
If six or fewer of the first 32 cases are people who got the vaccine, that suggests the vaccine reduced COVID-19 cases by 76%. Under Pfizer’s trial rules, the company can then conclude that its vaccine is effective enough to submit its application to the FDA. If, on the other hand, 15 or more of the first 32 infections are people who got the vaccine, it would mean the vaccine doesn’t work and the study ends.
The better the vaccine works, the longer it would take to reach 32 cases, because fewer vaccinated people would get sick and more of the infections would have to occur in the placebo group.
So when exactly will Pfizer get to 32 cases?
Analysts at JPMorgan estimate that this first readout would occur on Oct. 31 if the vaccine is 70% effective, or on Nov. 2 if the vaccine is 80%. Their model also estimates that Pfizer is more than twice as likely to be able to file for approval at 80% effectiveness vs 70% effectiveness.
The JPMorgan analysts’ prediction is roughly in line with official public statements from Pfizer, though the company has projected even more confidence. “We have a good chance that we will know if the product works by the end of October,” CEO Albert Bourla said Sept. 13 on CBS’ “Face the Nation.”
The key thing we don’t know is how fast people in Pfizer’s trial are getting sick. The trial doesn’t intentionally expose people to the virus; it waits to see who catches it on their own. Even though the pandemic is far from under control, the coronavirus is not spreading as fast as it was a few months ago. The study started with a baseline assumption that just 1.3% of participants would be infected over the course of a year.
It’s possible that the thousands of people who signed up for Pfizer’s study could be getting sick faster or slower than that, depending on how bad the outbreak is where they are. If Pfizer’s trial infection rate is 1.5 to 2 times faster than publicly reported case counts, then Pfizer’s first readout could be Oct. 12-19 with a 70% effective vaccine, or Oct. 14-22 with 80% efficacy, according to JPMorgan’s model.
“When the trials started there were a lot more cases in the U.S. at that time,” said Dr. Vamil Divan, an analyst at the bank Mizuho. “That’s a key unknown. How many of these participants are enrolled in hotter areas versus New York or Boston?”
To protect the integrity of trials like this, the drugmakers running them aren’t supposed to know what the data is showing as it comes in. And yet, company executives have led some observers to believe they know how many people have tested positive for COVID-19.
“They’re making projections based on how rapidly they’re accruing data, and they probably know the total number of events,” said Susan Ellenberg, professor of biostatistics at the University of Pennsylvania.
“When they say things like that, first of all, it does some wonders for their stock prices,” she added.
In a statement, Pfizer said that it expects results “as early as the end of October” based on current infection rates. The trial, the company said, “was designed to evaluate the safety and efficacy of the vaccine candidate as fast as possible.”
“Having said that,” the company added, “neither Pfizer nor the FDA can move faster than the data we are generating through our clinical trial.”
It’s highly unlikely that the next front-runner, Moderna, could have results before the election. The JPMorgan analysts’ model suggests that infection rates would have to be four times the publicly reported rate for Moderna to be able to report results before Nov. 3.
Dr. Tal Zaks, Moderna’s chief medical officer, told investors on Sept. 17 that “some time in November is sort of a reasonable base case” for the first look at Moderna’s results. (ProPublica’s board chairman, Paul Sagan, is a member of Moderna’s board and a company stockholder.)
Other developers are further behind. AstraZeneca’s trial is paused in the U.S. while the company investigates what happened with a participant who had a bad reaction. Johnson & Johnson is just beginning its large-scale, end-stage trial, months behind the other three.
So Pfizer is the only company with a shot at results before the election. And if the company has results to share, it’s unlikely to let political implications get in the way. The company has an ethical obligation not to delay a product that is ready to save lives, despite the risk that a vaccine announced on the eve of a contentious election could stoke partisan perceptions.
“Once you have signs of a vaccine’s effectiveness, it’s very difficult to argue anything is ethical other than making it available to those most at risk,” Dr. Mani Foroohar, an analyst with the investment bank SVB Leerink, said. “But it’s also very difficult to make the argument that you should do anything that undermines public trust. That’s one of the problems when you introduce powerful political pressures into what is meant to be a boring, dry, unemotional process.”
Once Pfizer gets results, it’s poised to seek the FDA’s go-ahead swiftly.
As soon as Pfizer has conclusive data, it will submit an application to the FDA. The application will include data from all previous trials as well as proof that the company can consistently manufacture millions of vaccine doses.
Pfizer’s CEO has indicated that the company is ready to turn around its application in a flash, if not on the same day it has results. “We will try to be able to be ready to submit with the speed of light, once we have the results ready,” Bourla said at an investor presentation on Sept. 16.
Pfizer has two options when submitting its FDA application. It can apply for an EUA or a full approval, known as a biologics license application, or BLA. An EUA would only allow Pfizer to market its vaccine for the pandemic’s duration — during the declared “emergency” period that we are currently in. If the company receives full licensure, on the other hand, its product can remain on the market forever. In its statement, Pfizer said it plans to continue its study after a possible EUA to collect more long-term data.
The bar for an EUA is lower than for full approval. By law, an EUA can be issued so long as “the product may be effective in diagnosing, treating, or preventing” the disease and “the known and potential benefits of the product … outweigh the known and potential risks.” In contrast, the standard for a full approval requires a drugmaker to prove not only that the product is safe and effective, but also that the product is pure and can be consistently made, because vaccines are biological products made from living materials.
For the COVID-19 vaccine, the FDA has said that it is going to raise the bar for an EUA, going beyond the usual requirements. Previously, the FDA has said a vaccine should be at least 50% effective. The FDA is reportedly close to announcing new standards to include at least two months of monitoring the health of trial participants after they receive their second shot. That could end up being the biggest hurdle to authorizing a vaccine before the election. Trump said on Wednesday that he might reject the new guidelines, but companies and FDA officials might still choose to observe them.
In a statement, the FDA said that “for a vaccine for which there is adequate manufacturing information,” an EUA “may be appropriate once studies have demonstrated the safety and effectiveness of the vaccine but before the manufacturer has submitted and/or the FDA has completed its formal review of the biologics license application.”
Pfizer said in a statement that it anticipates providing the agency safety data, including the median of two months safety information after the second dose, on a rolling basis. The trial has enrolled more than 31,000 participants, and 19,000 have received the second dose so far, the company said.
“The standards FDA is reportedly considering for a covid vaccine EUA represent appropriate balance between speed and safety in a crisis,” Dr. Scott Gottlieb, who led the FDA earlier in the Trump administration and serves on Pfizer’s board, tweeted on Thursday. “Even under EUA; you want higher assurance of safety and benefit for vaccine given to healthy people vs. drug given to those already sick.”
“Any political effort to shortcut [the] process or degrade reasonable standards will be [a] Pyrrhic victory if people lack confidence in a vaccine,” Gottlieb added.
The FDA will thoroughly review the application, and that’ll take a while.
Once the FDA receives a company’s submission, the agency’s review process consists of several steps which, put together, could take weeks to complete.
The FDA is the only health regulator in the world that asks drugmakers for raw data files and does its own analysis, said Dr. Joshua Sharfstein, the FDA’s former principal deputy commissioner from 2009 to 2011. “Now would not be the moment to stop” that practice, he said, despite the urgent need for a vaccine.
Besides reviewing clinical trial data, the FDA also inspects vaccine developers’ manufacturing capabilities to ensure that every vaccine batch can be made consistently and that the process is squeaky clean, so that no impurities can make their way into a vial of product. This process involves a lot of paperwork sent from the companies to the agency and also, usually, on-site inspections at manufacturing plants. The agency declined to comment on whether it had already completed on-site inspections for Pfizer and Moderna.
After the FDA finishes its assessment of the company’s application, it typically presents the data to an external advisory committee in a public meeting. Dr. Peter Marks, director of the Center for Biologics Evaluation and Research, has said that the agency is committed to holding advisory committee meetings to review individual vaccine candidates.
Those meetings will take time to schedule, but it’s an essential step, according to experts both inside and outside the agency.
“How will [the public] know that we’re not, like, holding something in and sweeping something under the rug? Well, the way they’re going to know that is because any vaccine that we issue an emergency use authorization for will go to a public advisory committee meeting,” Marks said in a Sept. 10 webinar hosted by the Duke Margolis Center for Health Policy. “It’ll be critical for people to see what’s in the briefing packages, they’ll be able to see the discussion among an impartial group of advisers, they’ll see the committee recommendation and they’ll see the public dialogue that will take place at that committee.”
Advisory committee members vote on whether they recommend product approval. While the FDA does not have to follow the committee’s recommendations, the votes are public.
“It protects against political interference — it’s important,” Sharfstein said.
We contacted every advisory committee member and interviewed six of them about how they would evaluate an EUA application for a COVID-19 vaccine. These members (speaking for themselves, not for the FDA) indicated they would expect to see a level of evidence that could be tough to meet in the next 38 days.
One factor in their caution is that a premature EUA could make it harder to definitively evaluate an effective vaccine, because subjects in ongoing trials may drop out and new enrollments in trials with placebos would no longer be feasible.
“If an EUA came too soon where we don’t have sufficient clinical efficacy data, it would make it very hard to actually complete the study as written,” Dr. Paul Spearman, director of infectious diseases at Cincinnati Children’s Hospital, said. “You would want to have enough clinical efficacy data by the time of an EUA to be pretty darn certain.”
Another committee member is Dr. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine. She also expressed caution about basing a hugely consequential decision on such a small number of cases, like the 32 in Pfizer’s first look.
“It’s hard for me to say with these small numbers will we have meaningful data to make a decision on,” Chatterjee said. “I have not made up my mind on any of this because I need to see and discuss with colleagues what the data are and what the implications might be.”
One option would be for the FDA to grant an EUA for a specific group of people, such as health care workers or the elderly, who are more vulnerable to COVID-19.
The data would have to support a specific vaccine use that aligns with a recognized unmet medical need, said Dr. Michael Kurilla, an advisory committee member and the director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, part of the National Institutes of Health. For example, it’s possible a vaccine could work well in young people but not so well in older people. In that case, it might not be that beneficial, because older people are much more vulnerable to serious disease.
“It’s not simply a matter of saying we will EUA this product,” Kurilla said. “We have to be very careful to define what it is we’re trying to address.”
Dr. Paul Offit, director of the vaccine education center at the Children’s Hospital of Philadelphia, said he would like to see robust safety data, to make sure there are no neurological side effects, from Pfizer and Moderna. Both companies are developing so-called mRNA vaccines, a type of vaccine technology that has never been approved before. He noted that most people who get vaccines are healthy, so the bar for letting a vaccine go to market is necessarily much higher than for treatments intended for severely ill COVID-19 patients.
Finally, the FDA considers the committee’s advice and makes its final decision on whether it will greenlight the product. Normally, the FDA aims to review applications for full approval within 10 months for standard reviews and six months for priority reviews.
It’s unclear exactly how quickly an EUA review can be completed for the COVID-19 vaccine. The only other vaccine that has ever received an EUA was an anthrax vaccine, but it’s not a useful comparison because the vaccine was already in use and the 2005 authorization was granted to allow the US. Department of Defense to resume giving the shots to military personnel after the mandatory vaccination program had been suspended.
Some steps could potentially be skipped when doing a review for an EUA as compared with a full approval, according to McClellan, the former FDA commissioner. For example, any vaccines needed for this pandemic won’t need long-term storage, because they’ll all be used quickly, so companies won’t need to run tests and demonstrate to the agency that their vaccines can be stored for months on end. But to receive full approval, the agency might require that.
Still, McClellan estimated, the agency’s review process from the time it receives an application to issuing an EUA could take up to a month.
All of this is just to get to yes on a vaccine. Getting shots in millions of people’s arms is another story. The two vaccine front-runners from Pfizer and Moderna pose additional logistical challenges because they have to be kept frozen.
What could go wrong?
Having read through all these steps, you can start to see the points where the process could break down and how the public might find out about it.
If a company lowers the bar for efficacy. The first four vaccine contenders have all released their clinical trial rules (Pfizer, Moderna, AstraZeneca and Johnson & Johnson), so the public should be able to assess whether the shots have met the companies’ own standards to prove it works. If they unexpectedly change their schedules or the standards, that’s concerning.
If the FDA backtracks on its commitment to consult the independent advisory board, or if the agency’s leaders reject the committee’s advice, it would be a sign that they’re acting under political pressure without scientific support.
If FDA career scientists get overruled by political appointees, that would also be a major sign of political pressure. The decision on whether or not to authorize a vaccine will fall on Marks, head of the biologics division. FDA Commissioner Stephen Hahn, however, has authority to overrule Marks’ decision, and Secretary Alex Azar of the Department of Health and Human Services has the right to further overturn Hahn’s call.
If FDA officials quit. Marks has said he’d resign if the agency authorizes an unproven or unsafe vaccine.
Ultimately, the FDA and everyone involved in vaccine development are seeking the perfect balance between speed and caution: Faced with a deadly virus that’s taken the lives of more than 200,000 Americans and upended life, devastating the economy and tearing away the livelihoods of so many, of course there is an imperative not to waste any time and an urgent desire for a vaccine.
Yet a bad vaccine could do more harm than good, and even the perception of a vaccine that is not thoroughly vetted could be just as bad, if the public doesn’t feel confident in taking it.
“A vaccine only works if it’s safe, effective and administered,” meaning people have to be willing to take it, said Bruce Mehlman, a political adviser to companies at the lobbying firm Mehlman Castagnetti Rosen & Thomas. (He doesn’t represent any pharmaceutical clients.) “If it becomes another culture war football like masks, it will not help us get past the virus and return to normal.”
It’s unlikely we’ll see a vaccine authorized in October, but to ensure the shot is safe, effective, pure and trustworthy, waiting a little longer with the knowledge that no steps have been skipped may be well worth it.
Do you have access to information about Operation Warp Speed that should be public? Email [email protected]. Here’s how to send tips and documents to ProPublica securely.


talkingpointsmemo--2020-09-28--WH Spox Clashes With CNN Anchor As He Attempts To Deflect From NYT Report

White House deputy press secretary Brian Morgenstern found himself in a fiery exchange with CNN anchor Poppy Harlow on Monday as he repeatedly attempted to deflect from the New York Times ’ bombshell report on President Trump ’ s decades-long tax evasion .
When pressed on the Times ’ damning report — which reveals that the President largely avoided paying taxes over the past 15 years prior to his first year in the White House ( when he paid a mere $ 750 in federal income taxes ) and is under audit by the IRS as he sits in hundreds @ @ @ @ @ @ @ during an interview on CNN , Morgenstern echoed Trump ’ s dismissal of the report by calling it “ completely false ” and insisting that the President paid “ quite a lot ” in taxes .
After Harlow told Morgenstern that she ’ s asking him specifically about Trump ’ s federal income taxes and the absence of his tax returns , Morgenstern turned his ire toward the Times for declining to share the documents obtained for its report .
Harlow brought up that Trump and his attorneys have access to his tax @ @ @ @ @ @ @ in how much the President has paid in federal income taxes , according to the Times report , compared to average Americans .
Morgenstern went on to launch an unfounded allegation that Democratic presidential nominee Joe Biden ’ s campaign collaborated with the Times on its report as part of a smear campaign against Trump .
“ So the New York Times reported basically the same thing four years ago on the eve of the debate , ” Morgenstern said .
“ The Democrats had ads up and running within minutes of this @ @ @ @ @ @ @ ’ s probably a coordinated political smear.
” Morgenstern then brought up Hunter Biden — a deflection tactic commonly used among the Trump administration and Republicans .
Harlow pushed back , telling Morgenstern that she “ absolutely should not ” be asking the President ’ s spokesperson about “ someone that is not germane to this ” and is not running for President .
The CNN anchor urged Morgenstern to answer her questions regarding the Times ’ report , but he once again defaulted to accusing the Times of colluding with Democrats in @ @ @ @ @ @ @ We know that he donates his salary to the government even when he doesn ’ t have to , ” Morgenstern said .
“ That ’ s a million and a half dollars in taxes he didn ’ t even have to pay , but this is a story that is another version of it from four years ago on the eve of the debate .
Coordinated with the Democrats as a political hit.
” Harlow shut down Morgenstern again , saying that “ these are remarkable reporters from The New York Times @ @ @ @ @ @ @ ” and that it ’ s not OK to baselessly accuse reporters of colluding with the Democratic Party .
After the CNN anchor urged Morgenstern to stop attacking the press and that the President can put the controversy that has ensued over the Times ’ report to rest if he would just release his tax records himself , Morgenstern griped that the “ press can attack ” Trump , but “ he can not defend himself.
” Harlow replied that she hopes Trump comes on CNN because “ the easiest defense would be @ @ @ @ @ @ @ as every modern president has done since the 1970s .
”

White House deputy press secretary Brian Morgenstern found himself in a fiery exchange with CNN anchor Poppy Harlow on Monday as he repeatedly attempted to deflect from the New York Times’ bombshell report on President Trump’s decades-long tax evasion.
When pressed on the Times’ damning report — which reveals that the President largely avoided paying taxes over the past 15 years prior to his first year in the White House (when he paid a mere $750 in federal income taxes) and is under audit by the IRS as he sits in hundreds of million of dollars in debt — during an interview on CNN, Morgenstern echoed Trump’s dismissal of the report by calling it “completely false” and insisting that the President paid “quite a lot” in taxes.
After Harlow told Morgenstern that she’s asking him specifically about Trump’s federal income taxes and the absence of his tax returns, Morgenstern turned his ire toward the Times for declining to share the documents obtained for its report.
Harlow brought up that Trump and his attorneys have access to his tax returns before pointing out the significant discrepancies in how much the President has paid in federal income taxes, according to the Times report, compared to average Americans.
Morgenstern went on to launch an unfounded allegation that Democratic presidential nominee Joe Biden’s campaign collaborated with the Times on its report as part of a smear campaign against Trump.
“So the New York Times reported basically the same thing four years ago on the eve of the debate,” Morgenstern said. “The Democrats had ads up and running within minutes of this coming out, which means that it’s probably a coordinated political smear.”
Morgenstern then brought up Hunter Biden — a deflection tactic commonly used among the Trump administration and Republicans.
Harlow pushed back, telling Morgenstern that she “absolutely should not” be asking the President’s spokesperson about “someone that is not germane to this” and is not running for President.
The CNN anchor urged Morgenstern to answer her questions regarding the Times’ report, but he once again defaulted to accusing the Times of colluding with Democrats in a hit job against Trump.
“We know that he donates his salary to the government even when he doesn’t have to,” Morgenstern said. “That’s a million and a half dollars in taxes he didn’t even have to pay, but this is a story that is another version of it from four years ago on the eve of the debate. Coordinated with the Democrats as a political hit.”
Harlow shut down Morgenstern again, saying that “these are remarkable reporters from The New York Times that went through 20 years of documents” and that it’s not OK to baselessly accuse reporters of colluding with the Democratic Party.
After the CNN anchor urged Morgenstern to stop attacking the press and that the President can put the controversy that has ensued over the Times’ report to rest if he would just release his tax records himself, Morgenstern griped that the “press can attack” Trump, but “he cannot defend himself.”
Harlow replied that she hopes Trump comes on CNN because “the easiest defense would be for him to lay out his records as every modern president has done since the 1970s.”
Watch the exchange below:


talkingpointsmemo--2020-09-28--Trump Tries To Distract On Eve Of Debate With Whiplash-Inducing Tweets

President Trump had a lot on his mind as he took to Twitter on the eve of his first debate against Democratic presidential nominee Joe Biden .
Trump ’ s Monday morning tweets went from reviving his ongoing baseless crusade against mail-in voting to launching yet another nonsensical attack against Biden , all while he continues to vehemently dismiss the New York Times ’ bombshell report on his decades of tax avoidance as “ fake news.
” The President , without evidence , first re-upped his unfounded claims that mail-in voting will lead to voter fraud .
His tweet prompted @ @ @ @ @ @ @ debunking Trump ’ s baseless claim .
Last week , during a White House press conference , Trump refused to guarantee a peaceful transfer of power if he loses the November presidential election to Biden , while ranting against mail-in voting as more states expand access in light of the COVID-19 pandemic that has killed more than 200,000 Americans thus far .
“ Get rid of the ballots and you ’ ll have a very peaceful — there won ’ t be a transfer , frankly .
There will be a continuation .
@ @ @ @ @ @ @ You know it , ” Trump said at the time .
“ And you know who knows it better than anybody else ?
Democrats know it better than anybody else.
” Minutes later , Trump once again denied the Times ’ bombshell report on his decades-long tax evasion as “ fake news , ” much like he did during his press conference at the White House on Sunday .
The President didn ’ t take long to pivot back to attacking Biden by renewing his call for the former VP — who Trump @ @ @ @ @ @ @ mental agility — to take a drug test ahead of their first presidential debate .
On Sunday , Trump “ strongly ” demanded that Biden take a drug test before the debate as he baselessly suggested that the former VP used drugs to improve his public performance .
“ I will be strongly demanding a Drug Test of Sleepy Joe Biden prior to , or after , the Debate on Tuesday night .
Naturally , I will agree to take one also .
His Debate performances have been record setting UNEVEN , to @ @ @ @ @ @ @ have caused this discrepancy ?
?
?
” Trump tweeted on Sunday morning .
The President reiterated his unfounded allegations against Biden while speaking to reporters during his press conference at the White House on Sunday .
“ I am not joking .
I am willing to take a drug test , and he should too , ” Trump said , as he characterized Biden ’ s performance in past debates as uneven .
The President then claimed , without evidence , that “ a lot of people ” say that Biden was @ @ @ @ @ @ @ debates , before telling reporters to look on the Internet .
Trump ’ s first debate against Biden on Tuesday evening comes as trails Biden by a substantial margin in nationwide polls .
The President told reporters on Monday that his personal attorney Rudy Giuliani and former New Jersey Gov .
Chris Christie ( R ) are helping him prepare for the upcoming presidential debate .

What debate prep?
President Trump had a lot on his mind as he took to Twitter on the eve of his first debate against Democratic presidential nominee Joe Biden. Trump’s Monday morning tweets went from reviving his ongoing baseless crusade against mail-in voting to launching yet another nonsensical attack against Biden, all while he continues to vehemently dismiss the New York Times’ bombshell report on his decades of tax avoidance as “fake news.”
The President, without evidence, first re-upped his unfounded claims that mail-in voting will lead to voter fraud. His tweet prompted a Twitter label that links to reports debunking Trump’s baseless claim.
Last week, during a White House press conference, Trump refused to guarantee a peaceful transfer of power if he loses the November presidential election to Biden, while ranting against mail-in voting as more states expand access in light of the COVID-19 pandemic that has killed more than 200,000 Americans thus far.
“Get rid of the ballots and you’ll have a very peaceful — there won’t be a transfer, frankly. There will be a continuation. The ballots are out of control. You know it,” Trump said at the time. “And you know who knows it better than anybody else? Democrats know it better than anybody else.”
Here’s Trump’s Monday morning tweet:
The Ballots being returned to States cannot be accurately counted. Many things are already going very wrong! — Donald J. Trump (@realDonaldTrump) September 28, 2020
Minutes later, Trump once again denied the Times’ bombshell report on his decades-long tax evasion as “fake news,” much like he did during his press conference at the White House on Sunday.
The Fake News Media, just like Election time 2016, is bringing up my Taxes & all sorts of other nonsense with illegally obtained information & only bad intent. I paid many millions of dollars in taxes but was entitled, like everyone else, to depreciation & tax credits….. — Donald J. Trump (@realDonaldTrump) September 28, 2020
…..Financial Statements, from the time I announced I was going to run for President, showing all properties, assets and debts. It is a very IMPRESSIVE Statement, and also shows that I am the only President on record to give up my yearly $400,000 plus Presidential Salary! — Donald J. Trump (@realDonaldTrump) September 28, 2020
The President didn’t take long to pivot back to attacking Biden by renewing his call for the former VP — who Trump has repeatedly mocked for his age and mental agility — to take a drug test ahead of their first presidential debate.
Joe Biden just announced that he will not agree to a Drug Test. Gee, I wonder why? — Donald J. Trump (@realDonaldTrump) September 28, 2020
On Sunday, Trump “strongly” demanded that Biden take a drug test before the debate as he baselessly suggested that the former VP used drugs to improve his public performance.
“I will be strongly demanding a Drug Test of Sleepy Joe Biden prior to, or after, the Debate on Tuesday night. Naturally, I will agree to take one also. His Debate performances have been record setting UNEVEN, to put it mildly. Only drugs could have caused this discrepancy???” Trump tweeted on Sunday morning.
The President reiterated his unfounded allegations against Biden while speaking to reporters during his press conference at the White House on Sunday.
“I am not joking. I am willing to take a drug test, and he should too,” Trump said, as he characterized Biden’s performance in past debates as uneven.
The President then claimed, without evidence, that “a lot of people” say that Biden was on “performance-enhancing drugs” during past debates, before telling reporters to look on the Internet.
Trump’s first debate against Biden on Tuesday evening comes as trails Biden by a substantial margin in nationwide polls. The President told reporters on Monday that his personal attorney Rudy Giuliani and former New Jersey Gov. Chris Christie (R) are helping him prepare for the upcoming presidential debate.


talkingpointsmemo--2020-09-28--Pelosi Says Trump’s Massive Debt Is A ‘National Security’ Concern

House Speaker Nancy Pelosi ( D-CA ) sounded the alarm on Monday over the New York Times ’ report on President Donald Trump ’ s tax returns showing mountains of debt and shady tax schemes that allowed him to pay as a little as $ 750 in taxes in 2016 and 2017 .
“ This president appears to have over $ 400 million in debt , $ 420 million in debt , ” Pelosi told MSNBC anchor Andrea Mitchell .
“ To whom ?
Different countries ?
What is the leverage they have ?
” “ So for me , @ @ @ @ @ @ @ ” she continued .
The Democratic leader also said Trump paying little to no taxes between 2000 and 2017 , as shown reported by the Times , is a “ disdain ” for “ America ’ s working families.
” “ This is a president who wants parades of military armament and military paying homage to him in front of the White House like he ’ s some kind of a dictator , and yet is he paying for any of that ?
The protection of our country ?
” Pelosi asked .

House Speaker Nancy Pelosi (D-CA) sounded the alarm on Monday over the New York Times’ report on President Donald Trump’s tax returns showing mountains of debt and shady tax schemes that allowed him to pay as a little as $750 in taxes in 2016 and 2017.
“This president appears to have over $400 million in debt, $420 million in debt,” Pelosi told MSNBC anchor Andrea Mitchell. “To whom? Different countries? What is the leverage they have?”
“So for me, this is a national security question,” she continued.
The Democratic leader also said Trump paying little to no taxes between 2000 and 2017, as shown reported by the Times, is a “disdain” for “America’s working families.”
“This is a president who wants parades of military armament and military paying homage to him in front of the White House like he’s some kind of a dictator, and yet is he paying for any of that? The protection of our country?” Pelosi asked.
Watch Pelosi below:


talkingpointsmemo--2020-09-28--Neal Jabs Trump For Having ‘Gamed Tax Code To His Advantage’ After NYT Report

Rep. Richard Neal ( D-MA ) , chairman of the House Ways and Means Committee , took aim at President Trump late Sunday shortly after the New York Times dropped its bombshell report on Trump ’ s decades-long history of tax avoidance .
In a statement released Sunday night , Neal wrote that the Times ’ report “ shines a stark light on the vastly different experience people with power and influence have ” compared to the average American taxpayer when dealing with the IRS .
Neal then slammed Trump for having “ gamed the tax code to his advantage @ @ @ @ @ @ @ legal fights as a tool to delay or avoid paying the taxes he owes .
Neal pointed to the Times ’ reporting that the President has been roiled in a “ lengthy audit battle with the IRS ” that could potentially result in him owing the federal government $ 100 million , before arguing that Trump is “ the boss of the agency he considers an adversary.
” Neal urged that the IRS ’ s presidential audit program remain independent , and that the Times ’ report “ underscores the importance ” of @ @ @ @ @ @ @ ongoing lawsuit to access Trump ’ s tax returns .
“ I remain confident that the law is on the Committee ’ s side , and that our request meets the standard the Supreme Court set with its July 2020 rulings , ” Neal wrote .
“ Our case is very strong , and we will ultimately prevail.
” During a press conference at the White House on Sunday shortly after the Times released its report on his tax avoidance , the President dismissed the report as “ fake news ” and griped @ @ @ @ @ @ @ badly ” while acknowledging that he ’ s been under IRS audit for “ a long time .
”

Rep. Richard Neal (D-MA), chairman of the House Ways and Means Committee, took aim at President Trump late Sunday shortly after the New York Times dropped its bombshell report on Trump’s decades-long history of tax avoidance.
In a statement released Sunday night, Neal wrote that the Times’ report “shines a stark light on the vastly different experience people with power and influence have” compared to the average American taxpayer when dealing with the IRS.
Neal then slammed Trump for having “gamed the tax code to his advantage” and accused the President of using legal fights as a tool to delay or avoid paying the taxes he owes.
Neal pointed to the Times’ reporting that the President has been roiled in a “lengthy audit battle with the IRS” that could potentially result in him owing the federal government $100 million, before arguing that Trump is “the boss of the agency he considers an adversary.”
Neal urged that the IRS’s presidential audit program remain independent, and that the Times’ report “underscores the importance” of the Ways and Means Committee’s ongoing lawsuit to access Trump’s tax returns.
“I remain confident that the law is on the Committee’s side, and that our request meets the standard the Supreme Court set with its July 2020 rulings,” Neal wrote. “Our case is very strong, and we will ultimately prevail.”
During a press conference at the White House on Sunday shortly after the Times released its report on his tax avoidance, the President dismissed the report as “fake news” and griped that the IRS treats him “very badly” while acknowledging that he’s been under IRS audit for “a long time.”


talkingpointsmemo--2020-09-28--Don Jr. Accuses NYT Of Publishing Trump Tax Bombshell To Give Biden ‘Attack Line’ Before Debate

Donald Trump Jr. , the eldest son of President Donald Trump and executive vice president of Trump Organization , on Monday morning accused the New York Times of deliberately releasing its bombshell report on the President ’ s tax avoidance to help Democratic candidate Joe Biden ahead of the presidential debate on Tuesday .
During an interview on “ Fox and Friends , ” Trump Jr. attacked the report , which revealed the astonishingly meager federal income taxes his father had paid from 2000 to 2017 , in some years paying no taxes at all , and how the President @ @ @ @ @ @ @ in massive tax refunds .
The Times also detailed how one of the business expenses Trump Organization reported as a tax write off were legal fees for the criminal defense lawyer who represented Trump during Special Counsel Robert Mueller ’ s Russia investigation .
“ Of course the New York Times does this , ” Trump Jr. complained on Monday .
“ They put out a selective picture of all of these things the day before the debates to try to give someone like Joe Biden an attack line , ” he added @ @ @ @ @ @ @ the Times published the report on Sunday , the debate is on Tuesday ) .
“ They come up with one or two catchy soundbites , and that ’ s the game.
” Trump dismissed his father ’ s tax dodges and questionable tax write offs as standard business practice .
“ People don ’ t understand what goes into a business , ” the President ’ s son said .
White House Press Secretary Kayleigh McEnany launched a similar attack during an appearing on “ Fox and Friends , ” calling the @ @ @ @ @ @ @ This is the same playbook they tried in 2016 , the same playbook that the American people rejected and will do so again , ” McEnany said , referring to the Times ’ report on Trump ’ s 1995 tax returns in which he declared a loss of a whopping $ 916 million .

Donald Trump Jr., the eldest son of President Donald Trump and executive vice president of Trump Organization, on Monday morning accused the New York Times of deliberately releasing its bombshell report on the President’s tax avoidance to help Democratic candidate Joe Biden ahead of the presidential debate on Tuesday.
During an interview on “Fox and Friends,” Trump Jr. attacked the report, which revealed the astonishingly meager federal income taxes his father had paid from 2000 to 2017, in some years paying no taxes at all, and how the President used his many business failures to rake in massive tax refunds. The Times also detailed how one of the business expenses Trump Organization reported as a tax write off were legal fees for the criminal defense lawyer who represented Trump during Special Counsel Robert Mueller’s Russia investigation.
“Of course the New York Times does this,” Trump Jr. complained on Monday.
“They put out a selective picture of all of these things the day before the debates to try to give someone like Joe Biden an attack line,” he added, seemingly mixing up the dates (the Times published the report on Sunday, the debate is on Tuesday). “They come up with one or two catchy soundbites, and that’s the game.”
Trump dismissed his father’s tax dodges and questionable tax write offs as standard business practice.
“People don’t understand what goes into a business,” the President’s son said.
Don Jr. accuses NYT of publishing its report on Trump's tax returns to give Biden an "attack line" before the presidential debate tomorrow. pic.twitter.com/GrcBRYOFel — TPM Livewire (@TPMLiveWire) September 28, 2020
White House Press Secretary Kayleigh McEnany launched a similar attack during an appearing on “Fox and Friends,” calling the report a “hit piece.”
“This is the same playbook they tried in 2016, the same playbook that the American people rejected and will do so again,” McEnany said, referring to the Times’ report on Trump’s 1995 tax returns in which he declared a loss of a whopping $916 million.


talkingpointsmemo--2020-09-28--NBC: Everything Trump’s COVID Adviser Says Is False, Proclaims CDC Director

Centers for Disease Control Director Dr. Robert Redfield was overheard on an airplane candidly expressing his real feelings on Friday , revealing to all his dim view of President Trump ’ s new favorite COVID-19 adviser , NBC reported .
“ Everything he says is false , ” Redfield said of Dr. Scott Atlas , a neurologist who hasn ’ t practiced medicine since 2012 .
Before joining the White House ’ s coronavirus task force in August 2020 , Atlas had not spent time on epidemiology but rather on advocacy against “ socialized medicine.
” An NBC News reporter @ @ @ @ @ @ @ flight from Atlanta to Washington D.C. After the flight landed , Redfield confirmed to NBC that he was discussing Atlas .
Atlas has faced widespread criticism for advocating a contrarian approach to managing the virus while lacking epidemiological expertise , recommending , for example , that all schools be reopened .
Faculty members at Stanford University Medical School sent an open letter on September 10 accusing Atlas of peddling “ falsehoods , ” to which he responded with a threat of a defamation lawsuit sent by Trump attorney Marc Kasowitz .
Dr. Deborah @ @ @ @ @ @ @ who has managed to stay in the President ’ s good graces , is reportedly “ distressed ” over how enamored Trump has become with Atlas .
“ Everything I have said is directly from the data and the science .
It echoes what is said by many of the top medical scientists in the world , including those at Stanford , Harvard , and Oxford , ” Atlas told NBC in a statement .

Centers for Disease Control Director Dr. Robert Redfield was overheard on an airplane candidly expressing his real feelings on Friday, revealing to all his dim view of President Trump’s new favorite COVID-19 adviser, NBC reported.
“Everything he says is false,” Redfield said of Dr. Scott Atlas, a radiologist who hasn’t practiced medicine since 2012.
Before joining the White House’s coronavirus task force in August 2020, Atlas had not spent time on epidemiology but rather on advocacy against “socialized medicine.”
An NBC News reporter overheard Redfield discussing Atlas while on a flight from Atlanta to Washington D.C. After the flight landed, Redfield confirmed to NBC that he was discussing Atlas.
Atlas has faced widespread criticism for advocating a contrarian approach to managing the virus while lacking epidemiological expertise, recommending, for example, that all schools be reopened.
Faculty members at Stanford University Medical School sent an open letter on September 10 accusing Atlas of peddling “falsehoods,” to which he responded with a threat of a defamation lawsuit sent by Trump attorney Marc Kasowitz.
Dr. Deborah Birx, another prominent task force member who has managed to stay in the President’s good graces, is reportedly “distressed” over how enamored Trump has become with Atlas.
“Everything I have said is directly from the data and the science. It echoes what is said by many of the top medical scientists in the world, including those at Stanford, Harvard, and Oxford,” Atlas told NBC in a statement.
This post has been corrected.


talkingpointsmemo--2020-09-28--Report: Trump Repeatedly Pushed For Ivanka To Be His Running Mate In 2016

Then-presidential candidate Donald Trump reportedly insisted on having his daughter , Ivanka Trump , on the ticket during the 2016 elections .
According to Bloomberg News , former Trump campaign deputy director and convicted felon Rick Gates described in his upcoming memoir one of Trump ’ s conversations with campaign staffers , Ivanka Trump and her husband Jared Kushner in which the GOP candidate floated the idea of having his daughter as his running-mate .
“ During a VP discussion that included Jared and the other kids all assembled in one room , Trump said , ‘ I think it @ @ @ @ @ @ @ as my VP ?
’ ” Gates reportedly wrote .
“ All heads turned toward her , and she just looked surprised .
We all knew Trump well enough to keep our mouths shut and not laugh.
” “ She ’ s bright , she ’ s smart , she ’ s beautiful , and the people would love her !
” ’ he said during the meeting , according to Gates .
The candidate would bring up the idea several more times to the point where Paul Manafort , the campaign manager @ @ @ @ @ @ @ on the subject .
Ivanka Trump “ didn ’ t poll tremendously high , but higher than we expected , ” Gates reportedly wrote .
And after campaign aides presented him with several potential candidates for running-mate , including now-Vice President Mike Pence , Trump reportedly told the staffers “ Look , I don ’ t like any of these people ” and “ I think it should be Ivanka.
” Ultimately , Ivanka Trump reportedly convinced her father to take her name off the list .
“ She went to her father @ @ @ @ @ @ @ .
It ’ s not a good idea , ’ ” Gates wrote .
“ And he capitulated.
” Trump would go on to appoint Ivanka and Kushner as his senior advisers after winning the election .
“ This is not true and there was never any such poll , ” Murtaugh said in a statement .
Gates ’ book , titled “ Wicked Game : An Insider ’ s Story on How Trump Won , Mueller Failed and America Lost , ” will be released on October 13 .
He is currently @ @ @ @ @ @ @ guilty to conspiracy and lying to the FBI in Special Counsel Robert Mueller ’ s Russia probe .
He was also sentenced to 45 days in prison , which he was permitted to carry out during the weekends .

Then-presidential candidate Donald Trump reportedly insisted on having his daughter, Ivanka Trump, on the ticket during the 2016 elections.
According to Bloomberg News, former Trump campaign deputy director and convicted felon Rick Gates described in his upcoming memoir one of Trump’s conversations with campaign staffers, Ivanka Trump and her husband Jared Kushner in which the GOP candidate floated the idea of having his daughter as his running-mate.
“During a VP discussion that included Jared and the other kids all assembled in one room, Trump said, ‘I think it should be Ivanka. What about Ivanka as my VP?’” Gates reportedly wrote. “All heads turned toward her, and she just looked surprised. We all knew Trump well enough to keep our mouths shut and not laugh.”
Trump reportedly insisted that voters would “love” Ivanka.
“She’s bright, she’s smart, she’s beautiful, and the people would love her!”’ he said during the meeting, according to Gates.
The candidate would bring up the idea several more times to the point where Paul Manafort, the campaign manager at the time, polled voters twice on the subject. Ivanka Trump “didn’t poll tremendously high, but higher than we expected,” Gates reportedly wrote.
And after campaign aides presented him with several potential candidates for running-mate, including now-Vice President Mike Pence, Trump reportedly told the staffers “Look, I don’t like any of these people” and “I think it should be Ivanka.”
Ultimately, Ivanka Trump reportedly convinced her father to take her name off the list.
“She went to her father and said, ‘No, Dad. It’s not a good idea,’” Gates wrote. “And he capitulated.”
Trump would go on to appoint Ivanka and Kushner as his senior advisers after winning the election.
Trump campaign spokesperson Tim Murtaugh denied Gates’ account on Monday.
“This is not true and there was never any such poll,” Murtaugh said in a statement.
Gates’ book, titled “Wicked Game: An Insider’s Story on How Trump Won, Mueller Failed and America Lost,” will be released on October 13. He is currently serving a three-year probation sentence after pleading guilty to conspiracy and lying to the FBI in Special Counsel Robert Mueller’s Russia probe. He was also sentenced to 45 days in prison, which he was permitted to carry out during the weekends.


talkingpointsmemo--2020-09-29--Trump Denies Hyping Ivanka As His Potential Running Mate In 2016: ‘Totally Ridiculous’

President Donald Trump on Monday night denied reports that he had insisted on making his daughter , Ivanka Trump , his running mate during the 2016 elections .
“ Now Fake News @ CNN is actually reporting that I wanted my daughter , Ivanka , to run with me as my Vice President in 2016 Election , ” Trump tweeted , incorrectly attributing the report to CNN ( it was the Washington Post and Bloomberg News ) .
“ Wrong and totally ridiculous .
These people are sick !
” On Monday , the Post and Bloomberg News reported on @ @ @ @ @ @ @ Gates ’ upcoming book that alleged then-candidate Trump had pushed for Ivanka to be his running mate .
“ She ’ s bright , she ’ s smart , she ’ s beautiful , and the people would love her !
” Trump told campaign staffers , according to Gates .
The GOP candidate would reportedly go on to recommend his daughter several times in the following weeks , prompting the campaign to include Ivanka in the polling for potential running mates twice .
Gates recounted that Ivanka eventually told her father that @ @ @ @ @ @ @ not a good idea.
” Later , then-Indiana Gov .
Mike Pence ( R ) became Trump ’ s running mate instead .
After winning the race in 2016 , Trump appointed Ivanka and her husband , Jared Kushner , as White House senior advisers .

President Donald Trump on Monday night denied reports that he had insisted on making his daughter, Ivanka Trump, his running mate during the 2016 elections.
“Now Fake News @CNN is actually reporting that I wanted my daughter, Ivanka, to run with me as my Vice President in 2016 Election,” Trump tweeted, incorrectly attributing the report to CNN (it was the Washington Post and Bloomberg News). “Wrong and totally ridiculous. These people are sick!”
On Monday, the Post and Bloomberg News reported on former 2016 Trump campaign deputy manager Rick Gates’ upcoming book that alleged then-candidate Trump had pushed for Ivanka to be his running mate.
“She’s bright, she’s smart, she’s beautiful, and the people would love her!” Trump told campaign staffers, according to Gates. The GOP candidate would reportedly go on to recommend his daughter several times in the following weeks, prompting the campaign to include Ivanka in the polling for potential running mates twice.
Gates recounted that Ivanka eventually told her father that her being on the ticket was “not a good idea.” Later, then-Indiana Gov. Mike Pence (R) became Trump’s running mate instead.
After winning the race in 2016, Trump appointed Ivanka and her husband, Jared Kushner, as White House senior advisers.


talkingpointsmemo--2020-09-29--WH Pressured CDC To Downplay Risk To Children In Reopening Schools

Top White House officials pressured the Centers for Disease Control and Prevention this summer to minimize the risk of sending children back to school , according to a New York Times report .
Interviews with White House officials past and present , as well as the Times ’ review of internal documents revealed that White House officials actively sought data to publicly portray a weakening pandemic that posed little danger to children in an attempt to workaround CDC scientists .
The Times ’ report shows how White House spent weeks trying to press public health professionals to promote messaging that @ @ @ @ @ @ @ agenda to swiftly reopen schools even though data on the issue has not reinforced its safety .
Olivia Troye , a former top aide to Vice President Mike Pence who was involved in the task force , said she was repeatedly asked by Pence ’ s chief of staff , Marc Short , to get the agency to develop reports that showed declining COVID-19 cases among younger populations .
Troye told CNN ’ s Chris Cuomo on Monday that the situation was a “ nightmare.
” “ Unfortunately , this was an effort @ @ @ @ @ @ @ I would get blindsided , where there would be junior staffers being tasked to find different data for charts to show that the virus wasn ’ t as bad for certain populations , ages or demographics , ” Troye said .
She told the Times that she believed pressure from the White House was driven by Trump ’ s political agenda to have schools running when voters cast ballots .
“ You ’ re exchanging votes for lives , and I have a serious problem with that , ” Troye told the Times @ @ @ @ @ @ @ has become increasingly vocal speaking out against Trump since leaving the White House in August .
According to Troye , Short told other members of the vice president ’ s staff to dig for data that might bolster the White House ’ s reopening message .
In one example , Dr. Deborah Birx , the White House coronavirus response coordinator , pressured the CDC to incorporate assertions made by the Substance Abuse and Mental Health Services Administration warning that shuttered schools would have a long-term effect on children ’ s mental health .
@ @ @ @ @ @ @ a statement to the Times that top health officials were in agreement about the reopening of schools .
“ President Trump relies on the advice of all of his top health officials who agree that it is in the public health interest to safely reopen schools , and that the relative risks posed by the virus to young people are outweighed by the risks of keeping children out of school indefinitely , ” Morgenstern said .
Trump has repeatedly pushed for schools to be opened quickly .
He falsely told Fox News in @ @ @ @ @ @ @ the disease .
He has also sought to undermine the wisdom of health officials in his administration , complaining about the CDC ’ s stringent recommendations .
Recent data from the American Academy of Pediatrics shows however that hospitalizations and deaths from the coronavirus have increased at a faster rate in children and teenagers than among the general public .
The administration worked hard at whittling away the CDC ’ s cautious guidance on schools reopening to realize Trump ’ s vision .
A final document on the opening schools was published under @ @ @ @ @ @ @ Reopening America ’ s Schools This Fall , ” and contained information that had elicited objections from CDC officials , suggesting that the coronavirus was less deadly to children than the seasonal flu .

Top White House officials pressured the Centers for Disease Control and Prevention this summer to minimize the risk of sending children back to school, according to a New York Times report.
Interviews with White House officials past and present, as well as the Times’ review of internal documents revealed that White House officials actively sought data to publicly portray a weakening pandemic that posed little danger to children in an attempt to workaround CDC scientists.
The Times’ report shows how White House spent weeks trying to press public health professionals to promote messaging that fit President Donald Trump’s election-year agenda to swiftly reopen schools even though data on the issue has not reinforced its safety.
Olivia Troye, a former top aide to Vice President Mike Pence who was involved in the task force, said she was repeatedly asked by Pence’s chief of staff, Marc Short, to get the agency to develop reports that showed declining COVID-19 cases among younger populations.
Troye told CNN’s Chris Cuomo in an interview Monday, that the situation was a “nightmare.”
“Unfortunately, this was an effort, you know, at times where I would get blindsided, where there would be junior staffers being tasked to find different data for charts to show that the virus wasn’t as bad for certain populations, ages or demographics,” Troye said.
She told the Times that she believed pressure from the White House was driven by Trump’s political agenda to have schools running when voters cast ballots.
“You’re exchanging votes for lives, and I have a serious problem with that,” Troye told the Times in an interview. The former official has become increasingly vocal speaking out against Trump since leaving the White House in August.
According to Troye, Short told other members of the vice president’s staff to dig for data that might bolster the White House’s reopening message for schools.
In one example, Dr. Deborah Birx, the White House coronavirus response coordinator, pressured the CDC to incorporate claims made by the Substance Abuse and Mental Health Services Administration warning that shuttered schools would have a long-term effect on children’s mental health.
White House spokesman Brian Morgenstern contended in a statement to the Times that top health officials were in agreement about the reopening of schools and how its risks were weighed.
“President Trump relies on the advice of all of his top health officials who agree that it is in the public health interest to safely reopen schools, and that the relative risks posed by the virus to young people are outweighed by the risks of keeping children out of school indefinitely,” Morgenstern said.
Trump has repeatedly pushed for schools to be opened quickly. He falsely told Fox News in August that children were “almost immune” to the disease. He has also sought to undermine the wisdom of health officials in his administration, complaining about the CDC’s stringent recommendations.
Recent data from the American Academy of Pediatrics shows however that hospitalizations and COVID-19 deaths have increased at a more rapid rate in children and teenagers than among the general population.
The administration worked hard at whittling away the CDC’s cautious guidance on schools reopening to realize Trump’s vision, an effort that was reflected in a final document on the opening schools published under the doctored White House-approved title: “The Importance of Reopening America’s Schools This Fall.” The document contained information suggesting that the coronavirus was less deadly to children than the seasonal flu, a claim that had elicited clear objections from CDC officials.


talkingpointsmemo--2020-09-29--NYT: Trump Used ‘The Apprentice’ Fame To Get Involved In Shady MLMs, Tax Returns Show

The New York Times dropped another report on President Donald Trump ’ s tax returns on Monday night that not only exposed the extent to which Trump used his fame from “ The Apprentice ” to cultivate an image of a cunning businessman despite repeated financial failures , but also to boost shady multi-level marketing companies , including one allegedly involved in a pyramid scheme-like practices .
According to the Times , Trump signed a deal with ACN , a firm through which customers were supposedly given the opportunity to sell video phones and other tech services from their homes @ @ @ @ @ @ @ ACN has been accused of scamming its clients , who earn a fraction of what they had bought from the company , which has settled in court over its business practices .
However , Trump promoted ACN through event appearances and mentions of the company ’ s products on “ The Apprentice ” for some 10 years and raked in $ 8.8 million as the country was grappling with the Great Recession of the late ’ 00s , according to the Times .
ANC paid him $ 1 million in 2009 , the @ @ @ @ @ @ @ in yet another multi-level marketing firm that was rebranded as “ the Trump Network , ” which marketed vitamins .
Before the company went bankrupt , Trump reportedly made $ 2.6 million as he told potential clients that the Trump Network “ wants to give millions of people renewed hope , and with an exciting plan to opt out of the recession ” and convinced them to spend hundreds of dollars on starter kits to get their friends and family looped in .
White House spokesman Judd Deere slammed the Times ’ report @ @ @ @ @ @ @ whole in a statement to the Times , reportedly without refuting any specifics in the story .

The New York Times dropped another report on President Donald Trump’s tax returns on Monday night that not only exposed the extent to which Trump used his fame from “The Apprentice” to cultivate an image of a cunning businessman despite repeated financial failures, but also to boost shady multi-level marketing companies, including one allegedly involved in a pyramid scheme-like practices.
According to the Times, Trump signed a deal with ACN, a firm through which customers were supposedly given the opportunity to sell video phones and other tech services from their homes. Similar other multi-level marketing companies, ACN has been accused of scamming its clients, who earn a fraction of what they had bought from the company, which has settled in court over its business practices.
However, Trump promoted ACN through event appearances and mentions of the company’s products on “The Apprentice” for some 10 years and raked in $8.8 million as the country was grappling with the Great Recession of the late ’00s, according to the Times.
ANC paid him $1 million in 2009, the same year Trump began a new venture in yet another multi-level marketing firm that was rebranded as “the Trump Network,” which marketed vitamins. Before the company went bankrupt, Trump reportedly made $2.6 million as he told potential clients that the Trump Network “wants to give millions of people renewed hope, and with an exciting plan to opt out of the recession” and convinced them to spend hundreds of dollars on starter kits to get their friends and family looped in.
White House spokesman Judd Deere slammed the Times’ report as “fake news” as a whole in a statement to the Times, reportedly without refuting any specifics in the story.


talkingpointsmemo--2020-09-30--Heckler-In-Chief: Trump Runs Amok As Biden Tries Direct Appeal To Voters

In the first half hour of the first presidential debate of the 2020 general election , President Donald Trump hardly let former Vice President Joe Biden — or , even , moderator Chris Wallace — get a word in edgewise .
Frustrated , Biden often simply spoke while facing the camera directly , rather than Trump or Wallace .
“ Do you believe for a moment what he ’ s telling you ?
” Biden said at one point , addressing the camera after Trump asserted that he ’ d spoken “ to the scientists in charge , and they @ @ @ @ @ @ @ ] very soon.
” Trump ’ s strategy , as it often is during contentious interviews , appeared to be simply talking over any inconvenient questions or effective attacks .
Most notably , when Wallace attempted to ask him about his attempt to eliminate Obamacare in federal court without a plan to replace it , Trump tried to smother the question entirely .
Wallace at times got Trump to follow the debate ’ s rules and allow Biden time to answer .
But Trump appeared frustrated at not being allowed to speak unfettered @ @ @ @ @ @ @ debating you , not him , ” he said to Wallace , after the moderator managed to get his health care question in .
“ Would you shut up , man ?
” he said at one point , before calling Trump “ unpresidential .
”

In the first half hour of the first presidential debate of the 2020 general election, President Donald Trump hardly let former Vice President Joe Biden — or, even, moderator Chris Wallace — get a word in edgewise.
Frustrated, Biden often simply spoke while facing the camera directly, rather than Trump or Wallace.
“Do you believe for a moment what he’s telling you?” Biden said at one point, addressing the camera after Trump asserted that he’d spoken “to the scientists in charge, and they’ll have the [COVID-19 vaccine] very soon.”
Biden Asks Voters: 'Do You Believe For A Moment What He's Telling You?' pic.twitter.com/BJXphGilWa — Matt Shuham (@mattshuham) September 30, 2020
Trump’s strategy, as it often is during contentious interviews, appeared to be simply talking over any inconvenient questions or effective attacks.
Most notably, when Wallace attempted to ask him about his attempt to eliminate Obamacare in federal court without a plan to replace it, Trump tried to smother the question entirely.
Fox News' Chris Wallace reminds Trump that he is the moderator of the debate pic.twitter.com/8hMI67mvWD — TPM Livewire (@TPMLiveWire) September 30, 2020
Wallace at times got Trump to follow the debate’s rules and allow Biden time to answer. But Trump appeared frustrated at not being allowed to speak unfettered.
“I guess I’m debating you, not him,” he said to Wallace, after the moderator managed to get his health care question in.
Biden was more blunt.
“Would you shut up, man?” he said at one point, before calling Trump “unpresidential.”


talkingpointsmemo--2020-09-30--Court Move Puts All Eyes On SCOTUS In Trump Bid To Hijack Census To Boost White Voters

The three-judge court that blocked the Trump administration ’ s efforts to exclude undocumented immigrants from congressional apportionment said Tuesday that it would not put that ruling on hold while the government appeals it .
The court , which is made up of two GOP appointees and one Democratic appointee , said that the Justice Department had put forward “ meritless ” and “ frivolous ” arguments in asking for the pause in the ruling .
Its refusal to grant the DOJ request means that the administration will now be relying on the Supreme Court to reinstate that policy while @ @ @ @ @ @ @ was brought in New York .
If the court does not intervene to put on hold the panel ’ s ruling , the ruling will likely remain in effect while a Supreme Court decision on the legality of the policy is pending .
That decision might not come until after the inauguration , presenting the risk for President Trump that he will no longer be in office to implement that policy .
The Justice Department has been incredibly aggressive in its approach to litigating the census disputes that have arisen during the Trump @ @ @ @ @ @ @ stakes of the decennial survey , particularly in how it allocates political power across the country for the decade to come .
The dispute that is now heading to the high court is over whether undocumented immigrants can be removed from the census population totals that are used to determine how many congressional seats each states get .
Doing so would starve immigrant rich states of congressional representation , while boosting the electoral advantage of whiter , more rural parts of the country .
Several lawsuits have been filed across the country challenging @ @ @ @ @ @ @ the Commerce Department , which oversees the census , to take on such an initiative .
The three-judge panel in the New York case previously said that the new apportionment policy violates laws dictating that a state ’ s entire population be used for the apportionment process .
The court did not weigh in on the constitutionality of the policy , though it is broadly believed to be a violation of the Constitution ’ s mandate that a “ whole number of persons ” be used for congressional apportionment .
In its previous @ @ @ @ @ @ @ policy , the panel said that its decision on the merits of Trump ’ s policy was a simple one .
The panel instead devoted much of its opinion explaining why it believed now was the appropriate time for the court to order that the new policy be blocked .
The Justice Department had been arguing that resolving the legality of the policy should wait until the Census Bureau actually presents the set of apportionment numbers Trump requested , since it is possible that Trump ’ s request might not be feasible to @ @ @ @ @ @ @ length at hearing in D.C. Tuesday morning , where a three-judge panel based there was hearing one of the other lawsuits filed challenging the policy .
That panel is made up of two Trump appointees and one Obama-nominated judge .
In that hearing , Judge Gregory Katsas , who worked in Trump ’ s White House counsel ’ s office before his appointment to the bench , seemed to suggest that he would prefer to wait to decide the legality of the policy .
He leaned into the idea that it ’ s @ @ @ @ @ @ @ ultimately try to exclude all undocumented immigrants or just some subset .
“ If we have to decide this all or nothing choice between the president , being able to wipe all illegal aliens off the apportionment base and the President being unable to say anything about people right on the cusp of being removed , man , that ’ s a pretty big deal , ” he said .
The other Trump-appointed judge on the panel , Dabney Friedrich , asked relatively few questions , but showed interest in the timing implications @ @ @ @ @ @ @ Cooper , who , on the flip side , asked about how delaying a decision could pose logistical challenges for those who use the census .
We could soon see whether the Supreme Court ’ s conservative majority thinks it ’ s appropriate to invalidate the policy now .
The administration is almost guaranteed to now ask that the Supreme Court put on hold the decision in the New York case blocking it .

The three-judge court that blocked the Trump administration’s efforts to exclude undocumented immigrants from congressional apportionment said Tuesday that it would not put that ruling on hold while the government appeals it.
The court, which is made up of two GOP appointees and one Democratic appointee, said that the Justice Department had put forward “meritless” and “frivolous” arguments in asking for the pause in the ruling.
Its refusal to grant the DOJ request means that the administration will now be relying on the Supreme Court to reinstate that policy while the justices review the case, which was brought in New York. If the court does not intervene to put on hold the panel’s ruling, the ruling will likely remain in effect while a Supreme Court decision on the legality of the policy is pending. That decision might not come until after the inauguration, presenting the risk for President Trump that he will no longer be in office to implement that policy.
The Justice Department has been incredibly aggressive in its approach to litigating the census disputes that have arisen during the Trump administration — a sign of the high stakes of the decennial survey, particularly in how it allocates political power across the country for the decade to come.
The dispute that is now heading to the high court is over whether undocumented immigrants can be removed from the census population totals that are used to determine how many congressional seats each states get. Doing so would starve immigrant rich states of congressional representation, while boosting the electoral advantage of whiter, more rural parts of the country.
Several lawsuits have been filed across the country challenging Trump’s July move to direct the Commerce Department, which oversees the census, to take on such an initiative.
The three-judge panel in the New York case previously said that the new apportionment policy violates laws dictating that a state’s entire population be used for the apportionment process. The court did not weigh in on the constitutionality of the policy, though it is broadly believed to be a violation of the Constitution’s mandate that a “whole number of persons” be used for congressional apportionment.
In its previous order blocking implementation of Trump’s policy, the panel said that its decision on the merits of Trump’s policy was a simple one. The panel instead devoted much of its opinion explaining why it believed now was the appropriate time for the court to order that the new policy be blocked.
The Justice Department had been arguing that resolving the legality of the policy should wait until the Census Bureau actually presents the set of apportionment numbers Trump requested, since it is possible that Trump’s request might not be feasible to implement.
That argument was discussed at length at hearing in D.C. Tuesday morning, where a three-judge panel based there was hearing one of the other lawsuits filed challenging the policy.
That panel is made up of two Trump appointees and one Obama-nominated judge. In that hearing, Judge Gregory Katsas, who worked in Trump’s White House counsel’s office before his appointment to the bench, seemed to suggest that he would prefer to wait to decide the legality of the policy. He leaned into the idea that it’s now yet known whether the administration would ultimately try to exclude all undocumented immigrants or just some subset.
“If we have to decide this all or nothing choice between the president, being able to wipe all illegal aliens off the apportionment base and the President being unable to say anything about people right on the cusp of being removed, man, that’s a pretty big deal,” he said.
The other Trump-appointed judge on the panel, Dabney Friedrich, asked relatively few questions, but showed interest in the timing implications, as did Obama appointee Judge Chris Cooper, who, on the flip side, asked about how delaying a decision could pose logistical challenges for those who use the census.
We could soon see whether the Supreme Court’s conservative majority thinks it’s appropriate to invalidate the policy now. The administration is almost guaranteed to now ask that the Supreme Court put on hold the decision in the New York case blocking it.