Latest Dozens of coronavirus antibody tests on the market were never vetted by the FDA
The Food and Drug Administration, which was harshly criticized for being slow in authorizing tests to detect the coronavirus, has taken a strikingly different approach to antibody tests, allowing more than 90 on the market without prior review, including some that are being marketed fraudulently and are of dubious quality, according to testing experts and the agency itself.
Antibody, or serological, tests are designed to identify people who may have overcome covid-19, including those who had no symptoms, and developed an immune response. They are not designed to detect active infections. Some officials tout the blood tests as a way to reopen the economy by identifying individuals who have developed immunity and can safely return to work. But many scientists, as well as the World Health Organization, say evidence is lacking that even high-quality antibody tests can prove someone has immunity to the novel coronavirus.
Now, the emergence of dozens of tests never reviewed by the FDA - many of which are being aggressively marketed - could confuse doctors, hospitals, employers and consumers clamoring for the products, according to critics who say the agency's oversight has been lax. The questions are taking on special importance as federal and state officials debate various strategies, including using serological testing, to help determine when they can end state and local lockdowns.
“A test is only as good as its results,” said Kelly Wroblewski, director of infectious disease programs at the Association of Public Health Laboratories, which has been urging the FDA to take a close look at the unapproved antibody tests. “Having many inaccurate tests is worse than having no tests at all.”
— Washington Post
Federal coronavirus stimulus deal could be reached by ‘today,’ Treasury Secretary Steve Mnuchin says
U.S. Treasury Secretary Steve Mnuchin said he is hopeful a deal can be reached with Democratic congressional leadership Sunday on a coronavirus stimulus bill being considered by federal lawmakers.
"I think we’re very close to a deal today,” Mnuchin said Sunday on CNN’s State of the Union.
The stimulus bill is intended to aid small businesses. Lawmakers are debating over how much funding should also be included to aid testing efforts, hospitals, and state budgets. If a deal is reached Sunday, Mnuchin said it could be passed as early as Wednesday.
— Pranshu Verma
Backlash against quarantine has started in Pennsylvania
Everyone wants life to get back to normal, to have their hair cut or get a sunburn at a baseball game, to go to work, and walk shoulder-to-shoulder in a park. Some people want all of that now, not next month, and they’re planning to converge on Harrisburg on Monday, coronavirus pandemic be damned, to demand it.
Not all of them will be wearing masks.
“I’m definitely not going to be out there shouting at people for not wearing masks,” said Chris Dorr, organizer of a rally at the statehouse. “This is a free country, right?”
Dorr, an Ohio gun activist, created the Pennsylvanians Against Excessive Quarantine Facebook group earlier this week to give people a voice. On Thursday morning, the page had 20,000 members. By Friday afternoon, it had more than 46,000.
“It’s going insane, quite frankly,” he said.
— Jason Nark, Cynthia Fernandez of Spotlight PA
The U.S. must triple coronavirus testing capacity before it can reopen, Harvard researchers say
The United States would need to triple the amount of coronavirus tests it conducts each day for the nation to safely reopen, Harvard researchers said.
Currently, 150,000 people are getting tested per day, according to the COVID Tracking Project. Researchers at Harvard University’s Global Health Institute recommend that number be closer to 500,000 for states to safely reopen.
“The moment we open up, the virus is going to start spreading,” Ashish Jha, the director of the Harvard Global Health Institute, said Sunday on NBC’s Today show. “We’ve got to be ahead of it. The only way to do that is through testing, tracing, and isolation. And I don’t know any state that’s quite ready to do that.”
President Donald Trump issued guidelines last week saying states could start returning to normal life once they see a two-week period of decreased infections. He has also said testing efforts should be coordinated on the state level. Many governors and public health experts have pushed back and called for a robust, federal-led testing strategy.
— Pranshu Verma
Coronavirus interrupts Philadelphia’s busy spring housing market
Marlin and Anne Kinzey, parents of adult children, want to sell their home of 25 years in Washington Square West and downsize to live in their Brooklyn co-op.
They planned to show the townhouse at the start of the spring buying season. But “things kind of went awry,” Marlin Kinzey said.
The coronavirus pandemic interrupted a bustling Philadelphia real estate market and halted in-person open houses and showings. The Kinzeys decided to delay listing and ride out the crisis at their home with attached courtyard. They don’t anticipate selling the house and moving until fall at the earliest.
“This just isn’t the right time to do it,” Kinzey said.
— Michaelle Bond
Pennsylvania liquor stores to offer curbside pickup starting Monday
You might have some trouble getting through on the phones, but starting Monday some of Pennsylvania’s state-run liquor stores will be offering curbside pickups on a limited basis, the state announced Saturday.
Only one order will be accepted per caller per day and it cannot exceed six bottles, the Pennsylvania Liquor Control Board said, adding that store staff would inform callers about what was available at each location.
Orders will be accepted from 9 a.m. to 1 p.m. Monday through Saturday.
Curbside pickup will be available at 10 stores in Philadelphia and about 45 in the collar counties. A list of stores and phone numbers can be found here.
— Anthony Wood
Philly business owners stand firm on keeping closed
The owner of three Philadelphia bars and restaurants says he’s afraid of letting anyone back inside: “You think you’d take a seat at an empty bar stool near a bunch of strangers?”
The head of Boscov’s, the department-store chain that’s been shut for weeks, is anxious but staying focused on how to make customers and employees feel safe returning: “The masks that we need. The special cleaning policies and procedures.”
And the chairman of a major Center City law firm expects some employees won’t come back to the office until there’s a vaccine for the coronavirus — which even under optimistic scenarios could be 18 months away.
President Donald Trump has eagerly pushed to restart an American economy largely frozen by the pandemic, and the outlines of a gradual reopening came into focus this week with new federal guidelines. On Friday, Pennsylvania Gov. Tom Wolf laid out his own three-phase plan for slowly getting the state back to work, saying it would take place region by region, and could only begin once there is sufficient testing for the virus and personal protective equipment for health-care workers.
“Moving to reopen large swaths of our economy now is only going to prolong this crisis," he said. “There isn’t going to be one big day.”
— Andrew Seidman, Sam Wood, Juliana Feliciano Reyes, Christian Hetrick
Tensions grow over when the Philadelphia region can safely reopen
The tensions over whether and when America can safely reopen accelerated in the Philadelphia region Saturday, with health authorities warning that people planning to join a Harrisburg back-to-work rally could be sickened by the coronavirus.
That Monday protest would follow shouting, sign-waving demonstrations in Florida, North Carolina, Virginia, Michigan, and elsewhere, driven by the frustration of the isolated and unemployed, and encouraged amid the worldwide pandemic by President Donald Trump, who has tweeted out “LIBERATE MICHIGAN!” and “LIBERATE MINNESOTA!”
On Saturday, the mounting sense of grievance was counterpointed by announced increases in infections across the country and in the region, where Philadelphia, Pennsylvania, and New Jersey authorities reported scores of new deaths. In University City, three refrigerated trailers were parked to handle an overflow of bodies.
“In the United States and in Pennsylvania, people have the right to protest, but I have significant concerns depending on how that happens,” Health Secretary Rachel Levine warned. “If people do not practice social distancing, … that could facilitate the spread and I would actually worry very much about the health of those people.”
— Jeff Gammage, Laura McCrystal, Vinny Vella
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