U.S. Bet on Covid Vaccine Manufacturer Even as Problems Mounted

Because of the pandemic, most of the auditors drew their conclusions from documents and video tours, during which Emergent workers controlled the camera angles, one former company official said.

Johnson & Johnson’s auditors said monitoring reports for bacteria or other contaminants were filed four to six months late. AstraZeneca’s said that Emergent repeatedly loosened monitoring criteria so it appeared to meet them, resorting to measures like “historical averages.” But even then it failed the tests, the report said.

In another audit, BARDA officials documented similar concerns, classifying some of them, including the risks of microbiological contamination, as “critical.” That designation is reserved for the most serious problems that pose an immediate and significant risk.

Emergent’s own internal audit in July also said the flow of workers and materials through the plant was not adequately controlled “to prevent mix-ups or contamination.”

The reports echoed quality-control shortcomings documented in an April inspection by the F.D.A., reported earlier by The Associated Press, that concluded the facility was “not ready for commercial operations.”

Multiple audits underscore how poorly the company was prepared for the huge workload it accepted.

The Covid-19 projects required significantly more testing to ensure materials remained stable, but Emergent had just one employee coordinating it all, the BARDA audit found. Emergent acknowledged at the time that its testing system was “not ideal” and pledged to train at least one more Emergent worker and hire a third. BARDA did not respond to requests for comment on its audit or any of the others, beyond saying that it had “worked with Emergent to resolve the issues” raised during the F.D.A. inspection.

Another internal investigation in August found that Emergent approved four raw materials used to produce AstraZeneca’s vaccine without first fully testing them. That type of shortcut, called a conditional release of material, occurred on average twice a week in October, internal logs show. The measure was deemed necessary because the company was working with shortened production times, testing backlogs and the needs of Operation Warp Speed, the Trump administration’s crash vaccine development program. And while a manager “knowingly deviated” from standards, the report said, the batches of vaccine would be not released without quality and safety tests.

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New proposal would ban most foreclosures until 2022.

A wave of foreclosures and evictions threatens to arrive when pandemic-related pauses expire later this year, and the Consumer Financial Protection Bureau is considering restrictions on mortgage servicers that would spread the hit into 2022.

More than 3 million households are behind on their mortgage payments, and nearly 1.7 million will run out their forbearance periods in September, according to the bureau.

“We are at really an unusual point in history,” said Diane Thompson, a senior adviser at the bureau. “I don’t think anybody has ever before seen this many mortgages in forbearance at one time that are expected to exit at one time.”

So the bureau has come up with a proposal to ensure that homeowners don’t go straight from forbearance to foreclosure.

proposed a new rule that would prevent servicers from starting foreclosure proceedings until after Dec. 31. The intent, bureau officials said, is to give borrowers coming off forbearance time to consider their options, such as whether they need a mortgage modification to reduce their monthly payments. The restriction would apply only to mortgages on homes used as primary residences.

The agency also proposed a rule change that would allow servicers to extend loan modification offers to borrowers experiencing a Covid-related hardship without undertaking the full review normally required to adjust a mortgage. The intention is to let lenders quickly offer borrowers more affordable terms, so long as the change does not increase the borrower’s monthly payment or extend the loan’s term by more than 40 years.

The consumer bureau is seeking public comment on its proposals, a required step in the rule-making process that will allow industry groups a chance to raise concerns about the changes.

The Mortgage Bankers Association, a housing industry trade group, did not immediately comment on Monday.

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A Novel Way to Finance School May Penalize Students from HBCU’s, Study Finds

The typical student who borrows to attend college leaves with more than $30,000 in debt. Many struggle to keep up with their payments, and America’s ballooning tab for student loans — now $1.7 trillion, more than any other type of household debt except for mortgages — has become a political flash point.

So a financing approach known as an income-share agreement, which promises to eliminate unaffordable student debt by tying repayment to income, has obvious appeal. But a new study has found that income share agreements can also mask race-based inequalities.

The analysis, released on Thursday by the Student Borrower Protection Center, an advocacy group, found that borrowers at schools that focus on minority students can end up paying more than their peers at largely white campuses.

Income-share agreements are offered mainly by schools, although some private financiers have started marketing them directly to students. The selling point of such agreements is that, unlike loans, they don’t accumulate interest, and they come with both a predetermined repayment period and a cap on the total amount that the lender can seek as repayment. To students leery of accumulating educational debt that can snowball and stick around for decades, income-share agreements can offer a more flexible alternative.

Silicon Valley investors who are funding start-ups, as well as some policymakers. A growing number of colleges and vocational training programs are letting students finance some or all of their studies with such contracts. Purdue University was the first to offer them widely, starting in 2016. Private schools including Lackawanna College and Clarkson University have followed suit. Vemo Education, a venture that manages I.S.A. programs, said it has worked with 70 schools and training courses.

But the market is opaque and lightly regulated, making it challenging for borrowers to find the kind of consumer-protection disclosures that typically accompany financial products. Financiers are generally not required to reveal any information on how much money they have lent and how those deals have worked out for borrowers.

Student Borrower Protection Center researchers obtained data from the website of one private financier, Stride Funding in Dallas, and studied its agreements to illustrate how they can contain buried inequities. (Other companies that market the agreements directly to students include Align, Defynance and Lumni.)

Like most lenders in this market, Stride varies its repayment terms depending on the borrower’s earning potential. An English major typically will need to fork over a higher percentage of salary than an engineering student. (Stride caps its maximum repayment amount at two times the amount that was borrowed. Its contracts typically require recipients to make payments for five to seven years.)

repay 5.65 percent of their income for five years, according to a payment calculator on Stride’s website. But the same calculator showed that an economics student at Morehouse, an historically Black school in Atlanta, would be asked to repay 6.15 percent of their income.

asked the Consumer Financial Protection Bureau last year to investigate several lenders that they said might be discriminating against women and minority borrowers by charging them higher rates, based on their lending algorithms.

“The risk of discrimination arises because the lender is not evaluating the applicant based on their own characteristics, but instead based on the characteristics of other students at their school or who were in the same major or program,” the lawmakers wrote.

Officials at the NAACP Legal Defense & Educational Fund got an early look at the Student Borrower Protection Center’s report and found it disturbing. Stride’s lending might run afoul of the Equal Credit Opportunity Act, they said in a letter sent to the company on Thursday morning.

“Particularly given how the economic fallout of the ongoing Covid-19 pandemic has disproportionately hurt Black Americans, the need for equitable access to consumer financial products and services is more important than ever,” the fund said in the letter, which was also signed by Mr. Frotman’s group.

Ms. Michaels said Stride “shares the goals” of the two groups and “is excited to have the chance to work with them on our shared mission of providing access to financial products to those who have long been left out of traditional credit marketplaces.”

told Forbes that her company anticipated making loans to 1,800 students this year.

Government regulators have been keeping a cautious eye on the emerging market. Rohit Chopra, President Biden’s nominee to run the Consumer Financial Protection Bureau — which is often the federal enforcer of fair-lending laws — has spoken frequently about the risk of bias in algorithmic lending decisions. (Mr. Chopra, a commissioner on the Federal Trade Commission, is awaiting a Senate vote on his nomination.)

“Our student debt market is definitely broken, and it needs a massive overhaul,” Mr. Chopra said at a conference last year. “I’m not sure that new products like income share agreements will be an antidote, especially if they worsen disparities.”

Ashok Chandran, a lawyer at the NAACP fund, said he hoped state and federal watchdogs would pay close attention to the novel lending products. “This market operates in such a regulatory dark space,” he said. “We’re pretty troubled by the report, and in particular by how stark the disparities are.”

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