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Last night, both the NYT, Associated Press and Politico published “scoops” detailing an alleged effort from within the West Wing to improperly shape the FDA’s protocols and policies surrounding granting emergency-use authorization (EUA) to COVID-19 vaccines, with the goal of eliminating a provision that would effectively preclude a vaccine before election day.

Politico’s report claimed that the White House was interfering at the behest of the big drug makers hoping for more lax restrictions.

Since they were published during President Trump’s return to the White House, the reports didn’t get much oxygen on cable news. But on Tuesday morning, the FDA surprised observes by releasing the new guidance.

Also, Bloomberg reported last night that the FDA had communicated its new standards directly to the drug makers, eliminating the need to release the new guidance, which was still under White House review.

A spokesman for the FDA told the press that the agency has already reviewed the requirements with individual manufacturers, and any interference with the guidance is really more of a PR issue.

“This does not change how the FDA would evaluate an emergency use authorization request for a Covid-19 vaccine,” said Michael Felberbaum, an agency spokesman. “The FDA has already communicated with individual manufacturers about its expectations, data the agency intends to consider, and what we expect to see in a request for an emergency use authorization to demonstrate safety and efficacy.”

But as the public backlash intensified, the FDA decided to release a document on its website Tuesday morning making clear that the requirement for two months’ of safety data would remain, as would a requirement for an independent panel of experts to weigh in on each candidate before a final decision can be made.

Here’s more from Bloomberg:

The document is the agency’s most detailed public statement yet on what it will take to get a vaccine cleared under a fast-track emergency use authorization, or EUA. The agency has been working on a separate “guidance” document that details the requirements, but it remains under review by the White House and it’s not clear when or if it will be released.

While the exact contents of that guidance document haven’t been released, the FDA has said that it’s already communicated the requirements to drugmakers. Publishing those requirements in the document released Tuesday essentially makes them public, even if the official document is lodged at the White House. It also makes clear that the FDA will add an extra step to the review.

In Tuesday’s document, the FDA said it will require an additional, follow-up meeting of its Vaccine and Related Biological Products Advisory Committee to look at specific applications by drugmakers. “This discussion will be specific to the particular vaccine that is the subject of the EUA request and will be separate from, and in addition to, any general discussion by the VRBPAC regarding the development, authorization and/or licensure of vaccines to prevent Covid-19,” the FDA said in the document.

Then again, whether the agency requires 8 weeks or 6 weeks of safety data may not make much of a difference. Vaccine approval is a tedious process that typically takes years. The speedy approval process virtually guarantees there will be no study of long term ramifications and side effects.

Fed chair Powell is holding a virtual conference with National Association for Business Economics. As previewed earlier, there were  no notable surprises in his prepared remarks in which he emphasizes that the outlook remains highly uncertain, the expansion is far from complete, and in keeping with the Fed’s recent appeals to Congress, Powell asks Congress to quickly vote through more fiscal stimulus, assuring lawmakers that providing too much stimulus wouldn’t be a problem.

Powell’s remarks come amid continued gridlock in Congress and Republican opposition to a larger relief package that’s kept talks with Democrats at a stalemate in Congress since aid to jobless Americans and small businesses expired in July and August.

“Too little support would lead to a weak recovery, creating unnecessary hardship for households and businesses,” Powell said in the text of a speech for a virtual conference hosted by the National Association for Business Economics. “By contrast, the risks of overdoing it seem, for now, to be smaller. Even if policy actions ultimately prove to be greater than needed, they will not go to waste.”

While Powell didn’t explicitly reference either party’s position in his prepared remarks, he said that the “recovery will be stronger and move faster if monetary policy and fiscal policy continue to work side by side to provide support to the economy until it is clearly out of the woods.”

Meanwhile, the Fed chair confirmed what we said last week, namely that US consumer are rapidly burning through their savings, something which has so far allowed US consumption to remain stable, however at the current rate of spending, savings would will likely return to pre-covid levels in 2-3 months:

“Consumption held up well through August after the expiration of expanded unemployment insurance benefits, indicating that savings from transfer payments continue to support economic activity,” Powell said. “Still, since it appears that many will undergo extended periods of unemployment, there is likely to be a need for further support.”

Watch him live …

… and red his prepared remarks are here (pdf link)

Powell 20201006 A by Zerohedge

Authored by Mike Shedlock via MishTalk,

A rush to get out checks resulted in claims being paid that shouldn’t have been paid.

Oops Money Already Spent

Please consider States Overpaid Coronavirus Unemployment Claims

Cher Haavind, deputy executive director of the Colorado Department of Labor and Employment, says many overpayments stemmed from workers incorrectly reporting their earnings.

States can waive recovery of overpayments for most unemployment insurance when there is no fraud involved, but the Pandemic Unemployment Assistance program follows a different set of rules. It is administered as a form of disaster relief, and the statute that guides it blocks states from forgiving the debts.

Adding to the complexity, the PUA program gave new categories of workers—including gig workers and the self-employed—access to unemployment checks. But state unemployment systems were designed to calculate benefits based on traditional jobs, employer records, W-2 tax documents and verifying income with pay stubs. Re-engineering the systems to account for far more complicated self-employment income was bound to create problems, experts say.

In Ohio, thousands of workers have been overpaid through the regular unemployment-benefits system and Pandemic Unemployment Assistance, says Michelle Wrona Fox, a staff attorney at Community Legal Aid Services in Youngstown, Ohio. For some of Ms. Fox’s clients, the state is docking their remaining benefits by half to recoup its money.

“I’m seeing complete panic,” she says. Many of Ms. Fox’s clients waited two to three months to get benefits in the first place, she says, and some are facing eviction. “They’re in dire straits,” she adds.

A spokesman for Ohio’s Department of Job and Family Services says about 20% of PUA claimants, or 108,000 people, had been overpaid as of Aug. 31 because of a combination of errors by the agency and claimants, but adds most of the errors arose from individuals failing to claim income they earned in weeks when they also received benefits.

Tip of the Iceberg

The article highlights errors in Pennsylvania, Ohio, and Colorado.

Some received $10,000 or more too much. One person was overpaid  overpaid by $13,969.

Three states is likely the tip of the iceberg.

Fraud?

I suspect so. Individuals failed to claim income they earned in weeks when they also received benefits.

The less money you reported, the higher the benefits you received. 

Some of this was accidental. But how much was purposeful?

Checks Stopped

Meanwhile the checks stopped on September 5. That’s when the PUA benefits expired. 

For discussion, please see Little Progress on Unemployment Claims but Checks Grind to a Halt.

It is not possible to lower payments to make up the difference, yet the money has been spent.

One month after a schizophrenic JOLTs report showed a concurrent surge in job openings accompanied by a record plunge in hirings, things returned somewhat to normal in August (as a reminder, the BLS’s Job Openings and Labor Turnover survey is two months delayed), when the number of job openings dipped dropped by 204K to 6.493 million after posting the biggest two-month increase in the previous two months when US employers announced 1.3 million job openings. This was the first monthly drop in total job-opening since the March/April crash in the labor market, suggesting the recent V-shaped recovery in the labor market may be peaking.

Job openings decreased in construction (-68,000), and information (-25,000). The number of job openings decreased in the Midwest region.

Separately,  we already knew that the series of 24 consecutive months in which there were more job openings than unemployed workers ended with a thud in March, in April it was an absolute doozy with 18 million more unemployed workers than there are job openings, the biggest gap on record. Since then the the gap has closed somewhat, and in July, there were 7.1 million more unemployed than available job openings (after 9.6 million in July).

As a result, there were just over 2 unemployed workers for every job opening, down from 2.4 last month.

Meanwhile, after a record and unexplained plunge in hiring in July, when the total number of job hires dropped by a 1.2 million to just 5.8 million, in August hiring stabilized modestly, increasing by 16k to 5.919MM from 5.903MM, which still is well below the record hiring pace set in May with 7.2MM.

Hires increased in federal government (+246,000), largely because of temporary 2020 Census hiring. Hires also increased in durable goods manufacturing (+41,000). Hires decreased in accommodation and food services (-177,000), health care and social assistance (-73,000), and real estate and rental and leasing (-28,000).

With hiring relatively flat in August, the number and rate of total separations decreased to 4.6 million (-394,000) and 3.3 percent, respectively. Total separations decreased in other services (-80,000) and in arts, entertainment, and recreation (-56,000). The number of total separations increased in federal government (+13,000). 

Of these, the number and rate of layoffs and discharges decreased to series lows of 1.5 million (-272,000) and 1.0 percent, respectively in August. Layoffs and discharges decreased in a few industries, with the largest decreases in professional and business services (-95,000), accommodation and food services (-62,000), and durable goods manufacturing (-42,000). The number of layoffs and discharges increased in federal government (+12,000).

Finally, after the record surge in the number of American quitting their jobs reported back in June, the number of quits edged down to 2.8 million (-139,000) and the quits rate was 2.0 percent. Quits decreased in a number of industries with the largest decreases in other services (-48,000), construction (-40,000), and arts, entertainment, and recreation (-18,000). The number of quits increased in finance and insurance (+36,000).

NYT White House reporter Maggie Haberman, who has spent the last 4 days relentlessly chronicling every update in the White House COVID-19 outbreak saga, including Trump’s 72-hour stay at Walter Reed, has just reported that Trump is considering giving a nationwide address on Tuesday.

The president is considering giving some kind of nationwide televised address today, per two people familiar with the discussions. This plus confirming CNN report on a military aide (valet) testing positive this weekend and other details from last 24 hrs https://t.co/nTTY7DALzv

— Maggie Haberman (@maggieNYT) October 6, 2020

Haberman, who also reported that Trump still sounds “short of breath”, citing close aides who still speak with him regularly, linked to a report from the NYT which claimed that a “culture of panic” had replaced the “culture of negligence” at the White House. She described the comms shop as “bereft of people”, since the outbreak has taken out both McEnany and some of her top aides.

She added that while Trump stays in the residence, the West Wing has been virtually empty as most White House staffers are working from, either because they have caught the virus, or have been in close contact with somebody who has. She added that the White House “resembled a ghost town” again on Tuesday.

She also confirmed a CNN report claiming another White House aide had tested positive, raising the total infected to an even 30.

Meanwhile, President Trump returned to Twitter Tuesday morning to attack Biden and the Democrats for their support of late-term abortion…

Wow. Joe Biden just took a more Liberal position on Roe v. Wade than Elizabeth Warren at her highest. He also wants to PACK our great United States Supreme Court. This is what the Dems will do. Remember as they try changing positions before elections end. GET OUT AND VOTE!

— Donald J. Trump (@realDonaldTrump) October 6, 2020

Biden and Democrats just clarified the fact that they are fully in favor of (very) LATE TERM ABORTION, right up until the time of birth, and beyond – which would be execution. Biden even endorsed the Governor of Virginia, who stated this clearly for all to hear. GET OUT & VOTE!!!

— Donald J. Trump (@realDonaldTrump) October 6, 2020

…before reiterating his comments from last night in a tweet where he urged Americans not to be afraid of the virus and insisted “we have learned to live with it”.

Flu season is coming up! Many people every year, sometimes over 100,000, and despite the Vaccine, die from the Flu. Are we going to close down our Country? No, we have learned to live with it, just like we are learning to live with Covid, in most populations far less lethal!!!

— Donald J. Trump (@realDonaldTrump) October 6, 2020

According to one source on Twitter, the US hasn’t counted more than 100,000 flu deaths since 1968. Still, Trump’s point that such outbreaks aren’t “unprecedented” stands.

Summary:

• NYC closes schools in ‘hot spots’

• Horace Mann school also closes amid outbreak

• US in the grip of “dangerous” COVID-19 comeback

• Cases continue to rise across US as Midwest drives new wave

• GSK + VIR say new antibody treatment enters Phase 3

• Ireland’s cabinet suggests raising alert level

• China in talks to have WHO ‘assess’ vaccines

• India reports fewest new cases since Aug. 25

* * *

Schools in ‘hot spots’ across NYC are closing Tuesday – a day earlier than NYC Mayor Bill de Blasio had hoped – as Gov Cuomo, de Blasio’s political arch-rival, makes changes to the mayor’s proposal, which was subject to state approval. De Blasio had wanted to shutter all “non-essential” business, in the first rollback of the city’s summertime reopening efforts, but Gov. Cuomo wisely staid his hand.

Of course, NY isn’t alone, as outbreaks are worsening across the Midwest and other parts of the country, while states like NY and NJ see incipient new outbreaks of their own.

In addition to the public schools in NYC’s hot spots, Horace Mann, a private school in the Bronx, has suspended in-person classes for its middle and upper grades for two weeks after the school was alerted to a mini outbreak among its teaching staff.

But, as Bloomberg points out, South Dakota and North Dakota are seeing some of the worst outbreaks relative to their populations.

While big states like California, Florida and Texas are seeing cases continue to decline, outside of the Sun Belt, the US outbreak is growing.

Scientists in the US have long warned of a looming “Twindemic” as the coronavirus mixes with the common cold and the seasonal flu. And in the Midwest, where falling temperatures are starting to send people indoors, many states are seeing the virus arrive in towns and small communities where it has been almost totally absent. In Nebraska, the seven-day average of cases hit a record Saturday, joining Midwestern and Western states including Wisconsin, Montana and the Dakotas in confronting a virus that had eluded them until recently.

“We’re in very bad shape, never having achieved any sense of containment, never gotten below 20,000 new confirmed cases per day,” said Eric Topol, director of Scripps Research Translational Institute. “Things can only get worse on this course.”

Meanwhile, as Trump’s return to the White House captivated the country on Monday, the NYT reported – as we mentioned last night – that the administration is once again pressuring the FDA to make changes to its proposed new vaccine guidelines to strip out a section that would essentially rule out the approval of a vaccine before election day.

Despite rising case numbers, Texas Gov Greg Abbott is reportedly preparing to announce another round of rollbacks for the state’s COVID-19-related restrictions.

Finally, on the pharmaceutical side, GlaxoSmithKline and VIR have announced that their antibody therapy, which is similar to convalescent plasma and other techniques seeking a ‘cure’ for COVID-19.

Here’s more COVID-19 news from last night and this morning:

Global cases reach 35,485,738. The worldwide death toll has hit 1,044,085 (Source: JHU)

US COVID cases +39,562 (prev. +35,504) and deaths +460 (prev. +690). New York COVID cases +933 (prev. +1,222) and deaths +8 (prev. +14). (Source: Newswires).

Biontech and Pfizer have initiated a rolling submission to the European Medicines Agency for COVID-19 vaccine candidate as the EU scrambles to approve the leading vaccine projects, which also includes AstraZeneca and Oxford (which has also struck a deal for rolling submission of trial data) (Source: AFP).

France COVID cases +5,084 (prev. +12,565) and deaths +69 (prev. +32). (Source: AFP).

Ireland’s Cabinet recommended to raise the country’s alert level to 3, from, at midnight Tuesday (Source: RTE).

Iranian President Hassan Rouhani reportedly may have contracted COVID-19 (Source: FARS).

China is in talks to have its locally produced COVID-19 vaccines assessed by the World Health Organization, as a step toward making them available for international use, a WHO official says. Hundreds of thousands of essential workers and other groups considered at high risk in China have been given locally developed vaccines even though clinical trials had not been completed, raising safety concerns (Source: Nikkei).

India’s latest daily new case count was just 61,267, fewer than the 74,442 a day earlier and the lowest single-day tally since Aug. 25. India has seen a total of 6.69 million. Deaths rose by 884 to 103,569 (Source: Nikkei).