Virus testing in the US is dropping, even as deaths mount

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Virus testing in the US is dropping, even as deaths mount

U.S. testing for the coronavirus is dropping even as infections remain high and the death toll rises by more than 1,000 a day, a worrisome trend that officials attribute largely to Americans getting discouraged over having to wait hours to get a test and days or weeks to learn the results.

An Associated Press analysis found that the number of tests per day slid 3.6% over the past two weeks to 750,000, with the count falling in 22 states. That includes places like Alabama, Mississippi, Missouri and Iowa where the percentage of positive tests is high and continuing to climb, an indicator that the virus is still spreading uncontrolled.

Amid the crisis, some health experts are calling for the introduction of a different type of test that would yield results in a matter of minutes and would be cheap and simple enough for millions of Americans to test themselves — but would also be less accurate.

“There’s a sense of desperation that we need to do something else,” said Dr. Ashish Jha, director of Harvard’s Global Health Institute.

Widespread testing is considered essential to managing the outbreak as the U.S. approaches a mammoth 5 million confirmed infections and more than 157,000 deaths out of over 700,000 worldwide.

Testing demand is expected to surge again this fall, when schools reopen and flu season hits, most likely outstripping supplies and leading to new delays and bottlenecks.

Some of the decline in testing over the past few weeks was expected after backlogged commercial labs urged doctors to concentrate on their highest-risk patients. But some health and government officials are seeing growing public frustration and waning demand.

In Iowa, state officials are reporting less interest in testing, despite ample supplies. The state’s daily testing rate peaked in mid-July but has declined 20% in the last two weeks.

“We have the capacity. Iowans just need to test,” Gov. Kim Reynolds said last week.

Jessica Moore of rural Newberry, South Carolina, said that after a private lab lost her COVID-19 test results in mid-July, she had to get re-tested at a pop-up site organized by the state.

Moore and her husband arrived early on a Saturday morning at the site, a community center, where they waited for two hours for her test. Moore watched in the rear-view mirror as people drove up, saw the long line of cars, and then turned around and left.

“If people have something to do on a Saturday and they want to get tested, they’re not going to wait for two hours in the South Carolina heat for a test, especially if they’re not symptomatic,” Moore said.

Before traveling from Florida to Delaware last month, Laura DuBose Schumacher signed up to go to a drive-up testing site in Orlando with her husband. They were given a one-hour window in which to arrive.

They got there at the start of the window, but after 50 minutes it looked as if the wait would be another hour. Others who had gone through the line told them that they wouldn’t get their results until five days later, a Monday, at the earliest. They were planning to travel the next day, so they gave up.

“Monday would have been pointless, so we left the line,” Schumacher said.

The number of confirmed infections in the U.S. has topped 4.7 million, with new cases running at nearly 60,000 a day on average, down from more than 70,000 in the second half of July.

U.S. testing is built primarily on highly sensitive molecular tests that detect the genetic code of the coronavirus. Although the test is considered the gold standard for accuracy, experts increasingly say the country’s overburdened lab system is incapable of keeping pace with the outbreak and producing results within two or three days, the time frame crucial to isolating patients and containing the virus.

“They’re doing as good a job as they possibly can do, but the current system will not allow them to keep up with the demand,” said Mara Aspinall of Arizona State University’s College of Health Solutions.

Testing delays have led researchers at Harvard and elsewhere to propose a new approach using so-called antigen tests — rapid technology already used to screen for flu, strep throat and other common infections. Instead of detecting the virus itself, such tests look for viral proteins, or antigens, which are generally considered a less accurate measure of infection.

A number of companies are studying COVID-19 antigen tests in which you spit on a specially coated strip of paper, and if you are infected, it changes color. Experts say the speed and widespread availability of such tests would more than make up for their lower precision.

While no such tests for the coronavirus are on the U.S. market, experts say the technology is simple and the hurdles are more regulatory than technical. The Harvard researchers say production could quickly be scaled into the millions.

A proposal from the Harvard researchers calls for the federal government to distribute $1 saliva-based antigen tests to all Americans so that they can test themselves regularly, perhaps even daily.

Even with accuracy as low as 50%, researchers estimate the paper strip tests would uncover five times more COVID-19 cases than the current laboratory-based approach, which federal officials estimate catches just 1 in 10 infections.

But the approach faces resistance in Washington, where federal regulators have required at least 80% accuracy for new COVID-19 tests.

To date, the Food and Drug Administration has allowed only two COVID-19 antigen tests to enter the market. Those tests require a nasal swab supervised by a health professional and can only be run on specialized machines found at hospitals, doctor’s offices, nursing homes and clinics.

Also, because of the risk of false negatives, doctors may need to confirm a negative result with a genetic test when patients have possible symptoms of COVID-19.

On Tuesday, the governors of Maryland, Virginia, Louisiana and three other states announced an agreement with the Rockefeller Foundation to purchase more than 3 million of the FDA-cleared antigen tests, underscoring the growing interest in the technology.

When asked about introducing cheaper, paper-based tests, the government’s “testing czar,” Adm. Brett Giroir, warned that their accuracy could fall as low as 20% to 30%.

“I don’t think that would do a service to the American public of having something that is wrong seven out of 10 times,” Giroir said last week. “I think that could be catastrophic.”

___

This story has been corrected to show that Iowa’s daily testing rate has declined 20%, not 40%.

 

 

 

A Viral Epidemic Splintering into Deadly Pieces

Once again, the coronavirus is ascendant. As infections mount across the country, it is dawning on Americans that the epidemic is now unstoppable, and that no corner of the nation will be left untouched.

As of Wednesday, the pathogen had infected at least 4.3 million Americans, killing more than 150,000. Many experts fear the virus could kill 200,000 or even 300,000 by year’s end. Even President Trump has donned a mask, after resisting for months, and has canceled the Republican National Convention celebrations in Florida.

Each state, each city has its own crisis driven by its own risk factors: vacation crowds in one, bars reopened too soon in another, a revolt against masks in a third.

“We are in a worse place than we were in March,” when the virus coursed through New York, said Dr. Leana S. Wen, a former Baltimore health commissioner. “Back then we had one epicenter. Now we have lots.”

To assess where the country is heading now, The New York Times interviewed 20 public health experts — not just clinicians and epidemiologists, but also historians and sociologists, because the spread of the virus is now influenced as much by human behavior as it is by the pathogen itself.

Not only are American cities in the South and West facing deadly outbreaks like those that struck Northeastern cities in the spring, but rural areas are being hurt, too. In every region, people of color will continue to suffer disproportionately, experts said.

While there may be no appetite for a national lockdown, local restrictions must be tightened when required, the researchers said, and governors and mayors must have identical goals. Testing must become more targeted.

In most states, contact tracing is now moot — there are simply too many cases to track. And while progress has been made on vaccines, none is expected to arrive this winter in time to stave off what many fear will be a new wave of deaths.

Overall, the scientists conveyed a pervasive sense of sadness and exhaustion. Where once there was defianceand then a growing sense of dread, now there seems to be sorrow and frustration, a feeling that so many funerals never had to happen and that nothing is going well. The United States is a wounded giant, while much of Europe, which was hit first, is recovering and reopening — although not to us.

“We’re all incredibly depressed and in shock at how out of control the virus is in the U.S.,” said Dr. Michele Barry, the director of the Center for Innovation in Global Health at Stanford University.

With so much wealth and medical talent, they asked, how could we have done so poorly? How did we fare not just worse than autocratic China and isolated New Zealand, but also worse than tiny, much poorer nations like Vietnam and Rwanda?

“National hubris and belief in American exceptionalism have served us badly,” said Martha L. Lincoln, a medical anthropologist and historian at San Francisco State University. “We were not prepared to see the risk of failure.”

Since the coronavirus was first found to be the cause of lethal pneumonias in Wuhan, China, in late 2019, scientists have gained a better understanding of the enemy.

It is extremely transmissible, through not just coughed droplets but also a fine aerosol mist that is expelled when people talk loudly, laugh or sing and that can linger in indoor air. As a result, masks are far more effective than scientists once believed.

Virus carriers with mild or no symptoms can be infectious, and there may be 10 times as many people spreading the illness as have tested positive for it.

The infection may start in the lungs, but it is very different from influenza, a respiratory virus. In severely ill patients, the coronavirus may attach to receptors inside the veins and arteries, and move on to attack the kidneys, the heart, the gut and even the brain, choking off these organs with hundreds of tiny blood clots.

Most of the virus’s victims are elderly, but it has not spared young adults, especially those with obesity, high blood pressure or diabetes. Adults aged 18 to 49 now account for more hospitalized cases than people aged 50 to 64 or those 65 and older.

Children are usually not harmed by the virus, although clinicians were dismayed to discover a few who were struck by a rare but dangerous inflammatory versionYoung children appear to transmit the virus less often than teenagers, which may affect how schools can be opened.

Among adults, a very different picture has emerged. Growing evidence suggests that perhaps 10 percent of the infected account for 80 percent of new transmissions. Unpredictable superspreading events in nursing homes, meatpacking plants, churches, prisons and bars are major drivers of the epidemic.

Thus far, none of the medicines for which hopes were once high — repurposed malaria drugs, AIDS drugs and antivirals — have proved to be rapid cures. One antiviral, remdesivir, has been shown to shorten hospital stays, while a common steroid, dexamethasone, has helped save some severely ill patients.

One or even several vaccines may be available by year’s end, which would be a spectacular achievement. But by then the virus may have in its grip virtually every village and city on the globe.

Some experts, like Michael T. Osterholm, the director of the University of Minnesota’s Center for Infectious Disease Research and Policy, argue that only a nationwide lockdown can completely contain the virus now. Other researchers think that is politically impossible, but emphasize that localities must be free to act quickly and enforce strong measures with support from their state legislators.

Danielle Allen, the director of Harvard University’s Edmond J. Safra Center for Ethics, which has issued pandemic response plans, said that finding less than one case per 100,000 people means a community should continue testing, contact tracing and isolating cases — with financial support for those who need it.

Up to 25 cases per 100,000 requires greater restrictions, like closing bars and limiting gatherings. Above that number, authorities should issue stay-at-home orders, she said.

Testing must be focused, not just offered at convenient parking lots, experts said, and it should be most intense in institutions like nursing homes, prisons, factories or other places at risk of superspreading events.

Testing must be free in places where people are poor or uninsured, such as public housing projects, Native American reservations and churches and grocery stores in impoverished neighborhoods.

None of this will be possible unless the nation’s capacity for testing, a continuing disaster, is greatly expanded. By the end of summer, the administration hopes to start using “pooling,” in which tests are combined in batches to speed up the process.

But the method only works in communities with lower infection rates, where large numbers of pooled tests turn up relatively few positive results. It fails where the virus has spread everywhere, because too many batches turn up positive results that require retesting.

At the moment, the United States tests roughly 800,000 people per day, about 38 percent of the number some experts think is needed.

Above all, researchers said, mask use should be universal indoors — including airplanes, subway cars and every other enclosed space — and outdoors anywhere people are less than six feet apart.

Dr. Emily Landon, an infection control specialist at the University of Chicago Pritzker School of Medicine, said it was “sad that something as simple as a mask got politicized.”

“It’s not a statement, it’s a piece of clothing,” she added. “You get used to it the way you got used to wearing pants.”

Arguments that masks infringe on personal rights must be countered both by legal orders and by persuasion. “We need more credible messengers endorsing masks,” Dr. Wen said — just before the president himself became a messenger.

“They could include C.E.O.s or celebrities or religious leaders. Different people are influencers to different demographics.”

Although this feels like a new debate, it is actually an old one. Masks were common in some Western cities during the 1918 flu pandemic and mandatory in San Francisco. There was even a jingle: “Obey the laws, wear the gauze. Protect your jaws from septic paws.”

“A libertarian movement, the Anti-Mask League, emerged,” Dr. Lincoln of San Francisco State said. “There were fistfights with police officers over it.” Ultimately, city officials “waffled” and compliance faded.

“I wonder what this issue would be like today,” she mused, “if that hadn’t happened.”

Images of Americans disregarding social distancing requirements have become a daily news staple. But the pictures are deceptive: Americans are more accepting of social distancing than the media sometimes portrays, said Beth Redbird, a Northwestern University sociologist who since March has conducted regular surveys of 8,000 adults about the impact of the virus.

“About 70 percent of Americans report using all forms of it,” she said. “And when we give them adjective choices, they describe people who won’t distance as mean, selfish or unintelligent, not as generous, open-minded or patriotic.”

The key predictor, she said in early July, was whether or not the poll respondent trusted Mr. Trump. Those who trusted him were less likely to practice social distancing. That was true of Republicans and independents, “and there’s no such thing as a Democrat who trusts Donald Trump,” she added.

Whether or not people support coercive measures like stay-at-home orders or bar closures depended on how scared the respondent was.

“When rising case numbers make people more afraid, they have more taste for liberty-constraining actions,” Dr. Redbird said. And no economic recovery will occur, she added, “until people aren’t afraid. If they are, they won’t go out and spend money even if they’re allowed to.”

As of Wednesday, new infections were rising in 33 states, and in Puerto Rico and the District of Columbia, according to a database maintained by The Times.

Weeks ago, experts like Dr. Anthony S. Fauci, the director of the National Institute for Allergy and Infectious Diseases, were advising states where the virus was surging to pull back from reopening by closing down bars, forbidding large gatherings and requiring mask usage.

Many of those states are finally taking that advice, but it is not yet clear whether this national change of heart has happened in time to stop the newest wave of deaths from ultimately exceeding the 2,750-a-day peak of mid-April. Now, the daily average is 1,106 virus deaths nationwide.

Deaths may surge even higher, experts warned, when cold weather, rain and snow force Americans to meet indoors, eat indoors and crowd into public transit.

Oddly, states that are now hard-hit might become safer, some experts suggested. In the South and Southwest, summers are so hot that diners seek air-conditioning indoors, but eating outdoors in December can be pleasant.

Several studies have confirmed transmission in air-conditioned rooms. In one well-known case cluster in a restaurant in Guangzhou, China, researchers concluded that air-conditioners blew around a viral cloud, infecting patrons as far as 10 feet from a sick diner.

Rural areas face another risk. Almost 80 percent of the country’s counties lack even one infectious disease specialist, according to a study led by Dr. Rochelle Walensky, the chief of infectious diseases at Massachusetts General Hospital in Boston.

At the moment, the crisis is most acute in Southern and Southwestern states. But websites that track transmission rates show that hot spots can turn up anywhere. For three weeks, for example, Alaska’s small outbreak has been one of the country’s fastest-spreading, while transmission in Texas and Arizona has dramatically slowed.

Deaths now may rise more slowly than they did in spring, because hospitalized patients are, on average, younger this time. But overwhelmed hospitals can lead to excess deaths from many causes all over a community, as ambulances are delayed and people having health crises avoid hospitals out of fear.

The experts were divided as to what role influenza will play in the fall. A harsh flu season could flood hospitals with pneumonia patients needing ventilators. But some said the flu season could be mild or almost nonexistent this year.

Normally, the flu virus migrates from the Northern Hemisphere to the Southern Hemisphere in the spring — presumably in air travelers — and then returns in the fall, with new mutations that may make it a poor match for the annual vaccine.

But this year, the national lockdown abruptly ended flu transmission in late April, according to weekly Fluview reports from the Centers for Disease Control and Prevention. International air travel has been sharply curtailed, and there has been almost no flu activity in the whole southern hemisphere this year.

Assuming there is still little air travel to the United States this fall, there may be little “reseeding” of the flu virus here. But in case that prediction turns out be wrong, all the researchers advised getting flu shots anyway.

“There’s no reason to be caught unprepared for two respiratory viruses,” said Tara C. Smith, an epidemiologist at Kent State University’s School of Public Health.

Experts familiar with vaccine and drug manufacturing were disappointed that, thus far, only dexamethasone and remdesivir have proved to be effective treatments, and then only partially.

Most felt that monoclonal antibodies — cloned human proteins that can be grown in cell culture — represented the best hope until vaccines arrive. Regeneron, Eli Lilly and other drugmakers are working on candidates.

“They’re promising both for treatment and for prophylaxis, and there are companies with track records and manufacturing platforms,” said Dr. Luciana Borio, a former director of medical and biodefense preparedness at the National Security Council. “But manufacturing capacity is limited.”

According to a database compiled by The Times, researchers worldwide are developing more than 165 vaccine candidates, and 27 are in human trials.

New announcements are pouring in, and the pressure to hurry is intense: The Trump administration just awarded nearly $2 billion to a Pfizer-led consortium that promised 100 million doses by December, assuming trials succeed.

Because the virus is still spreading rapidly, most experts said “challenge trials,” in which a small number of volunteers are vaccinated and then deliberately infected, would probably not be needed.

Absent a known cure, “challenges” can be ethically fraught, and some doctors oppose doing them for this virus. “They don’t tell you anything about safety,” Dr. Borio said.

And when a virus is circulating unchecked, a typical placebo-controlled trial with up to 30,000 participants can be done efficiently, she added. Moderna and Pfizer have already begun such trials.

The Food and Drug Administration has said a vaccine will pass muster even if it is only 50 percent effective. Experts said they could accept that, at least initially, because the first vaccine approved could save lives while testing continued on better alternatives.

“A vaccine doesn’t have to work perfectly to be useful,” Dr. Walensky said. “Even with measles vaccine, you can sometimes still get measles — but it’s mild, and you aren’t infectious.”

“We don’t know if a vaccine will work in older folks. We don’t know exactly what level of herd immunity we’ll need to stop the epidemic. But anything safe and fairly effective should help.”

Still, haste is risky, experts warned, especially when opponents of vaccines are spreading fear. If a vaccine is rushed to market without thorough safety testing and recipients are hurt by it, all vaccines could be set back for years.

No matter what state the virus reaches, one risk remains constant. Even in states with few Black and Hispanic residents, they are usually hit hardest, experts said.

People of color are more likely to have jobs that require physical presence and sometimes close contact, such as construction work, store clerking and nursing. They are more likely to rely on public transit and to live in neighborhoods where grocery stores are scarce and crowded.

They are more likely to live in crowded housing and multigenerational homes, some with only one bathroom, making safe home isolation impossible when sickness strikes. They have higher rates of obesity, high blood pressure, diabetes and asthma.

Federal data gathered through May 28 shows that Black and Hispanic Americans were three times as likely to get infected as their white neighbors, and twice as likely to die, even if they lived in remote rural counties with few Black or Hispanic residents.

“By the time that minority patient sets foot in a hospital, he is already on an unequal footing,” said Elaine Hernandez, a sociologist at Indiana University.

The differences persist even though Black and Hispanic adults drastically altered their behavior. One study found that through the beginning of May, the average Black American practiced more social distancing than the average white American.

Officials in ChicagoBaltimore and other communities faced another threat: rumors flying about social media that Black people were somehow immune.

The top factor making people adopt self-protective behavior is personally knowing someone who fell ill, said Dr. Redbird. By the end of spring, Black and Hispanic Americans were 50 percent more likely than white Americans to know someone who had been sickened by the virus, her surveys found.

Dr. Hernandez, whose parents live in Arizona, said their neighbors who had not been scared in June had since changed their attitudes.

Her father, a physician, had set an example. Early on, he wore a mask with a silly mustache when he and his wife took walks, and they would decline friends’ invitations, saying, “No, we’re staying in our bubble.”

Now, she said, their neighbors are wearing masks, “and people are telling my father, ‘You were right,’” Dr. Hernandez said.

There was no widespread agreement among experts about what is likely to happen in the years after the pandemic. Some scientists expected a quick economic recovery; others thought the damage could persist for years.

Working at home will become more common, some predicted, while crowded, open-plan offices may be changed. The just-in-time supply chains on which many businesses depend will need fixing because the processes failed to deliver adequate protective gear, ventilators and test materials.

A disease-modeling system like that used by the National Weather Service to predict storms is needed, said Caitlin Rivers, an epidemiologist at the Johns Hopkins Center for Health Security. Right now, the country has surveillance for seasonal flu but no national map tracking all disease outbreaks. As Dr. Thomas R. Frieden, a former C.D.C. director, recently pointed out, states are not even required to track the same data.

Several experts said they assumed that millions of Americans who have been left without health insurance or forced to line up at food banks would vote for politicians favoring universal health care, paid sick leave, greater income equality and other changes.

But given the country’s deep political divisions, no researcher was certain what the outcome of the coming election would be.

Dr. Redbird said her polling of Americans showed “little faith in institutions across the board — we’re not seeing an increase in trust in science or an appetite for universal health care or workers equity.”

The Trump administration did little to earn trust. More than six months into the worst health crisis in a century, Mr. Trump only last week urged Americans to wear masks and canceled the Republican convention in Florida, the kind of high-risk indoor event that states have been banning since mid-March.

“It will probably, unfortunately, get worse before it gets better,” Mr. Trump said at the first of the resurrected coronavirus task force briefings earlier this month, which included no scientists or health officials. The briefings were discontinued in April amid his rosy predications that the epidemic would soon be over.

Mr. Trump has ignoredcontradicted or disparaged his scientific advisers, repeatedly saying that the virus simply would go away, touting unproven drugs like hydroxychloroquine even after they were shown to be ineffective and sometimes dangerous, and suggesting that disinfectants or lethal ultraviolet light might be used inside the body.

Millions of Americans have lost their jobs and their health insurance, and are in danger of losing their homes, even as they find themselves in the path of a lethal disease. The Trump presidency “is the symptom of the denigration of science and the gutting of the public contract about what we owe each other as citizens,” said Dr. Joia S. Mukherjee, the chief medical officer of Partners in Health in Boston.

One lesson that will surely be learned is that the country needs to be better prepared for microbial assaults, said Dr. Julie Gerberding, a former director of the C.D.C.

“This is not a once-in-a-century event. It’s a harbinger of things to come.”

 

 

 

KHN’s ‘What The Health?’: Trump Twists on Virus Response

KHN’s ‘What The Health?’: Trump Twists on Virus Response

KHN's 'What The Health?': Trump Twists on Virus Response | Kaiser ...

President Donald Trump — who has spent the past six months trying to play down the coronavirus pandemic — seems to have pivoted. In back-to-back briefings on July 21 and 22, Trump cautioned that the U.S. is in a dangerous place vis-a-vis the pandemic. He urged the public to wear masks — although he has rarely worn one in public.

Meanwhile, Republicans in the Senate are scrambling to put together a package for the next COVID-19 relief bill, facing a July 31 deadline, when some of the benefits passed in the spring expire. House Democrats passed their bill in May.

This week’s panelists are Julie Rovner of Kaiser Health News, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Tami Luhby of CNN.

Among the takeaways from this week’s podcast:

  • Although Trump’s renewed emphasis on COVID-19 has surprised some of his critics, it may persuade his supporters to take actions promoted by public health officials. Trump’s emphasis on the importance of face coverings, perhaps coupled with the rising number of cases in parts of the country, could convince people who were otherwise dismissive of masks. People who do not necessarily trust public health officials may listen to Trump.
  • Republicans on Capitol Hill are in disarray on how to approach the next coronavirus relief bill. They are not in lockstep with the White House and are not supporting Trump’s call for a payroll tax cut.
  • One reason members of Congress are not eager to cut the payroll taxes is that the economic downturn has spurred concerns the Medicare and Social Security trust funds are being depleted faster than expected. However, analysts point out that when employment rises again, some of those concerns could dissipate.
  • A key sticking point in the economic relief package is whether to extend the bump in unemployment benefits that Congress approved in the spring. Lawmakers are facing a hard deadline on the issue because that money runs out next week, and the prohibition on evictions that was also part of an earlier COVID-19 relief bill ends even sooner. With rent, mortgages and other bills coming due Aug. 1, unemployed consumers could face a tough beginning of the month.
  • The Food and Drug Administration has approved limited use of pool testing for COVID-19. That allows approved labs to put together a small number of tests to run at once, thus conserving some of the materials needed for the process. If the pool tests positive, then those people whose results were pooled have to be tested again individually. The efforts have limited usefulness when rates of transmission are high in a community, but they may be helpful in specific settings, such as schools or workplaces.
  • New data shows that opioid addiction ticked back up in 2019, after a slight decline. Part of the problem is the growing use of the powerful — and dangerous — drug fentanyl. Economic woes also play a role. Addiction is often referred to as an epidemic of despair.
  • Although it’s unlikely the judicial system will overrule the administration’s efforts to bolster short-term insurance plans — which are generally less expensive but don’t offer as much protection for consumers as policies sold on the Affordable Care Act’s marketplaces — they could be circumvented if Democrats take over the White House. Even still, Democrats would likely have to find a way to make ACA plans more affordable.

 

 

 

 

 

We’re still in the early stages of the vaccine race

https://www.axios.com/newsletters/axios-vitals-a91eb4fb-e10d-46cf-b919-96e1e6e08b22.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

Oxford and CanSino released coronavirus vaccine data. It's still ...

New clinical trial data from two experimental coronavirus vaccines — one from Oxford University and AstraZeneca in the U.K., and the other from CanSino Biologics in China — are providing cautious optimism in the race to combat the pandemic, Axios’ Bob Herman reports.

The big picture: Science has never moved this fast to develop a vaccine. And researchers are still several months away from a clearer idea of whether the leading candidates help people generate robust immune responses to this virus.

Driving the news: The Oxford and CanSino vaccines didn’t lead to any severe adverse reactions or hospitalizations, according to the results released yesterday.

  • Safety — not efficacy — was the main thing these studies were supposed to be testing. And they performed well enough to move on to further trials.
  • Competing candidates from Moderna and Pfizer/BioNTech have also performed well in safety trials.

Yes, but: Future trials will be the ones that tell us whether any of these potential vaccines actually trigger patients’ immune systems to respond to the virus.

  • In the results released yesterday, Oxford researchers gave their vaccine to 543 people but only tested 35 for “neutralizing antibodies.” A separate, nonrandomized group of 10 people got a booster dose of the Oxford vaccine a month after the initial dose.
  • Preliminary antibody responses from CanSino’s vaccine were “disappointing” to several experts.

The bottom line: There are 23 coronavirus vaccines in clinical testing right now, according to the World Health Organization.

  • We now have data on the first four, but the studies mostly are confirming that the vaccines aren’t severely harmful and that large-scale studies are warranted — not that they definitely work yet.
  • “It is good and hopeful news indeed, but we’ll only know when the large trials are done,” tweeted Robert Califf, a former FDA commissioner under President Obama.

 

 

 

Op-Ed: We Still Don’t Know the Risk Posed by COVID-19

https://www.medpagetoday.com/infectiousdisease/covid19/87629?xid=fb_o&trw=no&fbclid=IwAR2V6CbOCIXDf2K9sJCcRb0PhbqM4inXixe_poOFYudOcoUFZCmU2JzyrDg

Op-Ed: We Still Don't Know the Risk Posed by COVID-19 | MedPage Today

The need for a coordinated national research strategy

Confused about the risks of dying from the coronavirus or of catching it from someone who seems healthy? We all are, and the dizzying differences in scientific opinion are now linked to political perspectives. Progressives cite evidence that loosening restrictions would cost lives and offer little benefit to the economy, while conservatives embrace evidence that the risks are low. We offer a guide to help navigate the tangle of numbers and suggest a way forward.

Google and many others display the number of cases and deaths (3.6 million and 138,840, respectively, by July 17). This invites a simple calculation for understanding the risk: divide the number who have died by the number who have been diagnosed. So, the chance of dying if infected is about 3.9%. Right? Well, not so fast. Six months into the pandemic, neither the number of deaths nor the number of people infected is known.

Some argue that deaths have been overemphasized since people who die of COVID are mostly older and sicker. Others suggest deaths have been overcounted since if a patient tests positive for COVID-19, it will likely be listed as the cause of death even if the person succumbs to another illness or, in some jurisdictions, dies due to an accident or suicide. Others argue that deaths have been undercounted.

Missing from the tally on any given day are those who died before testing was available, those who died shortly before or after but whose death has not yet been reported, or who died as an indirect result of the epidemic such as failing to seek medical care for fear of going to the hospital.

One carefully designed recent analysis compared deaths this year to the number of people who die during a “normal” year. The analysis concluded that through May, almost 100,000 people died from COVID-19 in addition to 30,000 who died from other causes related to the pandemic.

In short, uncertainty remains about the number of deaths due to COVID-19, which is supposed to be the easy part.

Estimating the number of people who have been infected is harder still. Most infected people are never formally diagnosed and never become one of the “cases” in the news. The limitations of the tests and the difficulty of attracting a representative population to be tested make it hard to estimate the true number of infections. The preferred test (reverse transcription polymerase chain reaction-based tests) uses RNA technology to see if the virus is present in nasal or oral swabs. It is a good test, but still may miss infections in up to 30% of cases.

A second type of test uses blood samples to look for an antibody called immunoglobulin (Ig)G that implies the person was previously infected. Based on IgG test results, the CDC assumes that 5% to 8% of the population has been infected. That would mean 24 million Americans have already had COVID-19 or a very similar illness. That is more than 10 times the number of confirmed cases.

The number is consequential: a higher infection rate for the same number of deaths implies that the virus is less deadly.review by a prominent epidemiologist considered 23 population studies with sample sizes of at least 500 people and found the percentage who have positive antibodies ranged from 0.1% to 48% — a 480-fold difference. Although the study was robustly criticized and at odds with highly citedpeer-reviewed research, it has appeared in over 30 news outlets, and the range of estimates allows people to pick a number that justifies their political position.

Contributing to this uncertainty is the FDA decision to, in a hurry to catch up for lost time, temporarily relax its standards for approving tests. Among over 300 antibody tests currently on the market, data on only a handful are publicly available, and some are being recalled.

The other number we need to know is how many people are spreading the infection without knowing it. Estimates are all over the place. Some major employers, including Stanford Healthcare, have systematically tested all of their employees and found very few infected people who do not have symptoms. In contrast, a CDC study of young, healthy adults working on an aircraft carrier found that 20% of those infected reported no symptoms.

So here we are, months into the epidemic without consensus on the basic information about how many people are infected, the risk of death for those infected, or the risk of asymptomatic transmission. In contrast to official agencies that use transparent methods to report the weather or the unemployment rate, trust in our official health statistics agencies has broken down as reports continue to emerge form myriad sources with conflicting methodologies and motivations.

The time has come to activate impartial groups, like the National Academy of Medicine, to build consensus on how to monitor the epidemic. We know the risks are serious. As cases have started to rise, whether or not the number of U.S. deaths is higher or lower than 130,000, the risk of inaction is too high.

We are staying near home, wearing masks, and treating COVID-19 as a serious threat to public health.

 

 

Coronavirus drugmakers’ latest tactics: Science by press release

https://www.politico.com/news/2020/06/05/drugmakers-media-coronavirus-303895

Coronavirus drugmakers' latest tactics: Science by press release ...

Pharmaceutical companies are using the media to tout treatments that are still under review.

Vaccine maker Moderna attracted glowing headlines and bullish investors when it revealed that eight participants in a preliminary clinical trial of its coronavirus vaccine had developed antibodies to the virus. The company’s share price jumped nearly 20 percent that day as it released a massive stock offering.

But the full results of the 45-person safety study haven’t been published, even though Moderna began a second, larger trial in late May aimed at determining whether the vaccine works. Several vaccine researchers say the scant public information on the earlier safety study is hard to evaluate because it addresses less than 20 percent of participants.

Call it science by press release — a tactic that pharmaceutical companies are increasingly relying upon to set their experimental coronavirus drugs and vaccines apart in a crowded field, shape public opinion and court regulators. Public health experts say the approach could increase political pressure on federal health officials to green-light drugs and vaccines before it is clear they are safe or effective, with potentially dangerous consequences.

“There’s a long history of pharmaceutical manufacturers putting out self-serving press releases related to clinical trial data that they’re developing that present an overly rosy picture of the data, usually with a boilerplate disclaimer at the end, which is fairly useless,” said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug regulation and pricing.

There are already signs of hype and political pressure influencing the U.S.’ coronavirus response. The Food and Drug Administration authorized emergency use of the malaria drug hydroxychloroquine in March without any proof that it was safe or effective for coronavirus patients — but with the backing of President Donald Trump, who had begun touting the treatment during daily White House briefings.

Subsequent studies have found that hydroxychloroquine doesn’t help those with Covid-19 and can cause potentially fatal side effects. And a top government scientist, Rick Bright, filed a whistleblower complaint in May alleging that he was ousted from his job leading the Biomedical Advanced Research Authority after he resisted political pressure to greenlight widespread use of the drug.

“The FDA has remained an unwavering, science-based voice helping to guide the all-of-government response,” agency Commissioner Stephen Hahn said in a statement. “I have never felt any pressure to make decisions, other than the urgency of the situation around COVID-19.”

But observers aren’t so sure. “From the outside looking in, there seems to be more political pressure than ever,” said Marc Scheineson, a former associate commissioner at the FDA and head of the FDA group at Alston & Bird. “The example in the White House is trickling down and there is a lot of pressure on the FDA … to color information on the optimistic side for political purposes and that is a hugely disturbing trend.”

A spokesperson for Moderna, which has received nearly a half billion dollars from the U.S. government and praise from Trump, said the company previewed its vaccine trial results by press release because it was concerned that the data might leak. The National Institutes of Health’s top infectious disease expert, Anthony Fauci, had hinted at the results in an interview with National Geographic, and data from a trial of the experimental drug remdesivir had leaked in April.

“You had this data moving widely around NIH and the remdesivir leak was also in our minds,” the Moderna spokesperson said.

But Peter Bach, director of Memorial Sloan-Kettering’s Center for Health Policy and Outcomes, said Moderna’s effort to preview its findings in the press “could be construed as an effort to make sure they are part of the conversation — and it worked on that front.”

Other groups have also previewed their hotly anticipated vaccine studies in the press. In late April, The New York Times revealed that six monkeys given a vaccine developed by researchers at the U.K.’s University of Oxford had stayed healthy for 28 days despite sustained exposure to the coronavirus. The article quoted Vincent Munster, a researcher at the NIH’s Rocky Mountain Laboratory, which conducted the monkey study at the British scientists’ behest.

The Oxford researchers, who signed a deal with AstraZeneca two days later to develop the experimental vaccine, did not publish a formal scientific analysis of the monkey data until mid-May. The study revealed that the noses of vaccinated monkeys and unvaccinated monkeys contained similar levels of coronavirus particles, suggesting that the vaccinated animals could still spread the disease — and the vaccine might not be as effective as the earlier data had hinted.

AstraZeneca has since inked a $1.2 billion deal with the U.S. government to provide 300 million vaccine doses, and a £65.5 million ($80 million) agreement with the U.K. government to supply 30 million doses.

Liz Derow, a spokesperson for Oxford’s Jenner Institute, where the vaccine researchers are based, said they did not give the monkey data to The New York Times. The NIH’s National Institute of Allergy and Infectious Disease, which operates the Rocky Mountain Laboratory, said it did not provide the data to the newspaper — but one of its researchers, Vincent Munster, spoke to a Times reporter about the monkey findings at the request of the Jenner Institute.

“I was really disturbed by not just Moderna, but the Oxford group as well, presenting a press release without data, without a scientific review, without knowing what the press release was based on,” said Barry Bloom, an immunologist at the Harvard School of Public Health. “And very positively enough to raise the stock price so two days later officials within the company sold their stock and made a whole lot of money, whether or not the vaccine works.”

Four of the pharmaceutical firm’s top executives together saw gains of $29 million from prescheduled sales of shares in the company in the two days following the vaccine announcement. The company has not yet responded to a request for comment on the stock sales.

Neither the Oxford nor Moderna vaccines are available to the public. But some drugs whose safety and efficacy are now being studied have already been repurposed or authorized for emergency use during the pandemic. The rush to release snippets of information on drug trials to the press ahead of full results has left some doctors wondering how to best treat their patients.

After leaked data from a trial of Gilead’s experimental antiviral remdesivir suggested the drug might be the first shown to help coronavirus patients, the company put out a press release in late April teasing results from a larger, government-run study. Hours later, Fauci revealed some findings of the study during an Oval Office press spray.

But the full analysis of the NIAID trial results was not published until three weeks later. Until that point, frontline physicians had no way to know that patients on ventilators did not benefit from remdesivir treatment — meaning that doctors may have inadvertently wasted some of the United States’ limited stock of the drug.

This lack of understanding on how to use remdesivir was evident in a recent survey more than 250 hospitals by the American Society of Health-System Pharmacists, which found that just 15 percent planned to use their remdesivir doses as described in the FDA’s emergency authorization for the drug.

Andre Kalil, an infectious disease doctor at the University of Nebraska Medical Center who led the NIAID trial, told POLITICO that physicians could have patterned their use of remdesivir on the dosages given during the trial.

Others say doctors using experimental treatments should have as much information as possible.

“If we want doctors to make rational medical decisions based on data, then before an authorized product reaches patients, the data should be available to review in some way, not just a press release,” said Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing.

Kesselheim, too, said that clinical trial data should be made public alongside any emergency authorizations to give physicians “the maximum amount of help they need in figuring out how to prescribe the drug.”

Gilead did not respond to a request for comment. But NIAID said that the urgency of the coronavirus prompted Fauci to share initial results before a full analysis was ready for publication.

Ivan Oransky, a professor of medical journalism at New York University and co-founder of the blog Retraction Watch, which monitors errors and misconduct in scientific research, told POLITICO he fears that the temptation to conduct science by press release will get “worse before it gets better.”

The world is growing more desperate for drugs and vaccines that could bring the coronavirus to heel. And many members of the public and politicians are treating every scrap of scientific information about the pandemic equally, he said — whether data comes from a peer-reviewed study or a company press release.

“There have been mechanisms to review science critically that, given the speed of Covid, have gone out the window,” said Bloom.

And interpreting results of clinical trial data can be difficult under the best of circumstances — especially when that data concerns a virus that was unknown to science until December of last year. When to end a trial and which conclusions to highlight are in many cases a matter of discretion, said Scheineson.

“It’s an art, not a science, in that respect,” he said. “I, for one, will not be the first in line to the new Moderna vaccine.”

 

 

 

 

FDA ends emergency use authorization for hydroxychloroquine

https://www.axios.com/hydroxychloroquine-fda-ends-emergency-use-authorization-f5353a2c-115a-4a57-b8e2-360b735b4937.html?stream=health-care&utm_source=alert&utm_medium=email&utm_campaign=alerts_healthcare

FDA withdraws emergency use authorization for hydroxychloroquine ...

The FDA ended Monday its emergency use authorizations for two controversial drugs, hydroxychloroquine and chloroquine, as a potential coronavirus treatment.

Why it matters: Despite gaining President Trump’s adamant support and use, the drugs have failed in several clinical trials and have been found to possibly cause serious heart problems.

What they’re saying: The FDA said it believes the drugs “are unlikely to be effective in treating COVID-19” under the emergency use authorization.

  • It also said that “in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of [the drugs] no longer outweigh the known and potential risks for the authorized use.”

Read the letter and memo regarding the revocation:

 

 

 

Optum says payers should keep a close eye on these 3 drugs. Here’s why

https://www.fiercehealthcare.com/payer/optum-says-payers-should-keep-a-close-eye-these-3-drugs-here-s-why?mkt_tok=eyJpIjoiTXpReVptRTBOemxoWW1OaCIsInQiOiJcL0FZVXVvVmhwQWpxdFBoV1VKRjhON29CaWhLY3g2bXFhT0doXC9tWVFpWTd0blh3TEY3MTN0M3lsZEs3K002d0hLS25BNld4dlk0b3NhWDBYaUhWYkNTUGc5SVRlRjBEMERoS01kWlZER1hVMmhFTkczdTAzMDhxWWpIaWxORk1mIn0%3D&mrkid=959610

The outside of Optum's headquarters

OptumRx researchers are highlighting three more drug products that payers should be keeping an eye on in 2020. 

Experts said in the pharmacy benefit manager’s second-quarter drug pipeline report echoed expectations from the first quarter that orphan drugs will be a major trend to watch as the year continues. Sumit Dutta, M.D., chief medical officer at OptumRx, wrote in the report these drugs will likely account for close to 40% of Food and Drug Administration approvals this year. 

Dutta said Optum is seeing more drug manufacturers jump into developing orphan drug products, which are generally considered less appealing as their market—and thus financial value—is more limited. 

“What is new is that we now are starting to see the development of orphan drugs become more competitive, increasing the potential for reduced costs and broader patient accessibility,” he wrote.

In 2018, the FDA approved more orphan drugs than non-orphan drugs for the first time. Optum’s first-quarter report also noted that these products are often pricey, as they target specific conditions. On average, orphan drugs cost $147,000 or more per year.

Of the three products highlighted in the second-quarter report, two are orphan drugs. Here’s more on what Optum’s analysts think payers need to know:

1. Risdiplam

If the FDA gives risdiplam a thumbs-up, it would become the first oral therapy for spinal muscular atrophy (SMA), a rare group of severe neuromuscular disorders. SMA is one of the most common genetic causes for infant mortality and affects about 1 in 11,000 babies.

There are only two treatments for SMA that are currently approved by the FDA, meaning there’s a significant unmet need for therapies, particularly oral medications, Optum said. The other treatments available are Spinraza, which requires repeated spinal injections, and gene therapy Zolgensma, the world’s most expensive drug.

Risdiplam would be administered orally once a day, which would likely draw significant interest from patients and their families, according to the report.

“Practically speaking, the competitive advantage for risdiplam will rest mainly in its oral route of administration, and perhaps, a lower cost,” according to the report. 

The analysts did caution that risdiplam is still in clinical trials and while results are promising, long-term outcomes associated with the drug are unclear. 

2. Viltolarsen

Viltolarsen is in development to treat Duchenne muscular dystrophy (DMD), a rare genetic disease that impacts young boys. There is a large unmet need for drugs to treat DMD, Optum said in the report, as it’s linked with significant sickness and death.

About 6,000 people in the U.S. have this disease, according to the report.

Vitolarsen is an “exon-skipping” drug that “short circuits” the genetic mutations that cause DMD. If approved, it would be the third such drug for the disease, and the second targeting a specific mutation that affects about 8% of those with DMD.

The drug has only been tested in small sample sizes, and there are limited safety data available, according to the report. 

3. Trodelvy

Trodelvy, the brand name of an antibody-drug conjugate (ADC) therapy aimed at metastatic triple-negative breast cancer, was approved in April.  

Triple-negative breast cancers test negative for the three most common causes of cancer and are thus untreatable by many front-line therapies, though they are treatable by chemotherapy, according to the report. ADC products like Trodelvy combine genetically engineered antibodies and traditional chemotherapy drugs into one intravenous therapy.

Optum is highlighting Trodelvy as it expects ADC medications to be a trend to monitor in the near future, because they could be applied to conditions outside of oncology, according to the report.

“We can think of ADCs as a refinement or extension of precision medicine, which aims at maximizing therapeutic benefits while minimizing undesired side effects for an individual patient,” the researchers wrote. “As the field advances, we can look for new conjugate ‘payloads’ that will go far beyond hunting cancer cells.”

“Various manufacturers are exploring how to leverage the ADC approach to produce vaccines, radiological treatments, immunosuppressive, cardiovascular and more,” they wrote.

 

 

Huge Study Throws Cold Water on Antimalarials for COVID-19

https://www.medpagetoday.com/infectiousdisease/covid19/86642?xid=nl_mpt_DHE_2020-05-23&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%20Top%20Cat%20HeC%20%202020-05-23&utm_term=NL_Daily_DHE_dual-gmail-definition

Huge Study Throws Cold Water on Antimalarials for COVID-19 ...

— No support for continued use seen in analysis of 15,000 patients who got controversial drugs

Chloroquine or hydroxychloroquine (HCQ), with or without an antibiotic, in hospitalized COVID-19 patients were associated with increased risk of death in the hospital and higher rates of arrhythmias, analysis of outcomes in nearly 100,000 patients indicated.

The 15,000 patients who received HCQ or chloroquine were about twice as likely to die compared to controls who did not receive these agents after adjusting for covariates (18.o% for hydroxychloroquine and 16% for chloroquine versus 9.3% for controls), reported Mandeep Mehra, MD, of Brigham and Women’s Hospital in Boston, and colleagues.

The drug was also associated with a higher risk of ventricular arrhythmia during hospitalization (6.1% for hydroxychloroquine, 4.3% for chloroquine versus 0.3% for controls), the authors wrote in The Lancet.

Moreover, risks for both in-hospital mortality and ventricular arrhythmia were even higher compared to controls when either drug was combined with a macrolide antibiotic, they noted.

Mehra said in a statement these drugs should not be used as treatments for COVID-19 outside of clinical trials.

“This is the first large scale study to find statistically robust evidence that treatment with chloroquine or hydroxychloroquine does not benefit patients with COVID-19,” he said. “Instead, our findings suggest it may be associated with an increased risk of serious heart problems and increased risk of death. Randomised clinical trials are essential to confirm any harms or benefits associated with these agents.”

Mehra’s group analyzed some 96,000 patients from 671 hospitals on six continents with COVID-19 infection, from Dec. 20 to April 14, all of whom had either died or been discharged from the hospital by April 21.

Overall, 14,888 patients were treated with hydroxychloroquine, chloroquine, hydroxychloroquine with a macrolide antibiotic or chloroquine with an antibiotic, and their results were compared to 81,144 controls who did not receive these drugs.

Authors adjusted for demographic factors, as well as cardiovascular disease, diabetes, lung disease, smoking, immunosuppressed conditions and baseline disease severity.

The estimated excess risk attributable to the drug regimen rather than other factors, such as comorbidities, ranged from 34% to 35%.

Arrhythmia’s greatest risk was in the group who received hydroxychloroquine and a macrolide antibiotic such as azithromycin (8% versus 0.3% of controls), and this regimen was associated with a more than five-fold risk of developing an arrhythmia while hospitalized, though cause and effect cannot be inferred, the group noted.

“Previous small-scale studies have failed to identify robust evidence of a benefit and larger, randomised controlled trials are not yet completed,” said co-author Frank Ruschitzka, MD, Director of the Heart Center at University Hospital Zurich in a statement. “However, we now know from our study that the chance that these medications improve outcomes in COVID-19 is quite low.”

An accompanying editorial by Christian Funck-Brentano, MD, PhD, and Joe-Elie Salem, MD, PhD, of Sorbonne Université in Paris, noted limitations of the observational data, but said the authors “should be commended for providing results from a well designed and controlled study … in a very large sample of hospitalized patients.”

They also cautioned against attributing the increased risk of hospital deaths to the higher incidence of arrhythmias, noting that “the relationship between death and ventricular tachycardia was not studied and causes of deaths (i.e., arrhythmic vs non-arrhythmic) were not adjudicated.”

The editorialists nevertheless concluded both hydroxychloroquine and chloroquine, with or without azithromycin, “are not useful and could be harmful in hospitalized patients with COVID-19,” and stressed the importance of clinical trials for these drugs.

“The global community awaits the results of ongoing, well powered randomized controlled trials showing the effects of chloroquine and hydroxychloroquine on COVID-19 clinical outcomes,” they wrote.

 

 

 

 

Perspective: The Pandemic Has Created a Food Insecurity Crisis. The Federal Response Has Been Swift, but Is it Enough?

https://altarum.org/news/pandemic-has-created-food-insecurity-crisis-federal-response-has-been-swift-it-enough?utm_source=Altarum+Updates&utm_campaign=05b6c1511b-EMAIL_CAMPAIGN_2020_05_20_07_13&utm_medium=email&utm_term=0_4220252dfe-05b6c1511b-347615961

The Pandemic Has Created a Food Insecurity Crisis. The Federal ...

Our ability to access nutritious food is a critical factor to our health and well-being, which is why it has been alarming to see images in recent weeks of cars lining up by the thousands at food banks across the country. Indeed, a university survey taken since the onset of the crises found nearly 4 in 10 Americans reported having moderate to high levels of food insecurity, compared to 11 percent of households who were food insecure in 2018, according to the USDA Economic Research Service.

In response, the federal government has given states administrative relief and funding through various Covid-19 response packages. USDA also has authorized temporary waivers that grant states greater flexibility to address the increased demands and to align with shelter-in-place and social-distancing orders.

USDA also created two new programs: the Pandemic EBT (P-EBT) and the Coronavirus Food Assistance Program (CFAP). P-EBT allows states to issue eligible households an EBT card, a type of debit card used to purchase food, with the value of the free school breakfast and lunch reimbursement rates for the number of weekdays that schools are closed due to Covid-19 (estimated to be around $5.70 per day).

As of the first week of May, 18 states have been approved to provide benefits through P-EBT and 20 additional states have submitted plans for approval. CFAP aims not only to assist families in accessing food but also ranchers and farmers who have an excess supply. Through CFAP, the USDA will procure an estimated $100 million per month of fresh fruits and vegetables and $300 million per month in dairy and meat products for food banks and other nonprofits providing food to Americans in need.

Are these measures enough? Let’s examine the changes, particularly the USDA waivers for the federal food assistance programs.

The Supplemental Nutrition Assistance Program (SNAP), formerly known as food stamps, provides financial support to supplement the food budget of needy families. USDA waivers that increased flexibility in the administration of SNAP include:

  • waived the requirements for in-person interviews during the SNAP enrollment process,
  • provided emergency supplementary benefits up to the maximum benefit a household can receive for up to two months,
  • removed the requirement for SNAP recipients to re-certify midway through their participation,
  • provided flexibility for jobless workers to remain eligible, and
  • expanded the SNAP online grocery purchase pilot from the original eight states adding an additional 12 states and the District of Columbia.

These efforts are a step in the right direction to ease family burdens, but the supplemental benefits and program flexibilities are time-limited by the federal public health emergency declaration for Covid-19. Also, the 40 percent of SNAP households who already receive the maximum benefit are excluded from the supplemental benefits. Especially as we are experience the sharpest increase in food costs in decades, we need to provide additional support to the lowest income SNAP recipients. To assist families during the longer economic recovery, advocates and policy experts are calling for the following expansions to ensure these benefits cover a larger share of the people who need them:

  • boost the benefit for households by 15 percent (an additional $25 per person per month),
  • increase the minimum benefit per month from $16 to $30, and
  • suspend implementation of all administrative rules that restrict access for millions of Americans.

The Supplemental Nutrition Program for Women Infants and Children (WIC), a public health nutrition program that provides nutrition education, breastfeeding support and nutritious foods to low-income pregnant women and mothers of small children, has been providing services remotely. USDA waivers that increased flexibility in the administration of WIC include:

  • waived requirements for the physical presence for certification,
  • waiver for deferment of measurements and blood tests,
  • ability to issue benefits remotely, and
  • food package substitutions.

That’s a good start and more can be done. The Center on Budget and Policy Priorities recommends temporarily extending WIC certification periods for infants to two years as well as extending WIC eligibility from age five to age six. The National WIC Association is also advocating for an increase in the Cash Value Benefit to enhance fruit and vegetable purchases by WIC families.

The National School Lunch Program (NSLP) and Breakfast Programs, Summer Food Service Program, and the Child and Adult Care Food Program (CACFP), which serve low-income school children, quickly revamped and developed innovative ways to distribute meals to families, often expanding their regular productions. USDA waivers that increased flexibility to help better serve families during the pandemic include:

  • ability to serve non-congregate meals,
  • allowing for pick-up and delivery of meals,
  • allowing modification in the meals components requirements,
  • waiving time elements and meal spacing requirements,
  • allowing virtual desk enrollment of new CACFP providers, and
  • waive requirement that afterschool meals and snacks be accompanied by educational activities.

CACFP provides meals to preschool-aged children in Child Care Centers and licensed child care family homes.  During the pandemic, most centers have been closed, while a majority of family homes remained open and provided services for essential workers.

According to Paula James, director of child health and nutrition at CocoKids in northern California, about 68 percent of the Contra Costa county’s family homes participating in CACFP remained open in April, and these waivers were helpful. Moving forward, she believes CACFP should continue the allowance of virtual enrollment and expand the use of that technology to regular monitoring site visits, specifically in rural areas or locations where safety could be a concern.  While the pandemic has provided the opportunity to test technological advances that could streamline program operations in the future, it also revealed some systemic weaknesses, including that CACFP has no centralized database system, which is needed at the state level and requires federal guidance. Lack of technology throughout the program was a hinderance to providing additional services to families during COVID-19.  “Continued use of technology into the future will be very important,” said James.

What more can be done? The federal government should extend COVID-19 related waivers for all nutrition programs until September 30, the date provided by congressional authority. While the public health restrictions may be lifting across the states, the economic fallout will likely be felt by families for many months to come.

In addition, states should leverage communication, technology, all federal supports, and evaluation to ensure they are successfully reaching as many in need as possible. This includes:

  • conducting a public information campaign to alert newly unemployed families in need about available food assistance programs and how to apply and access benefits;
  • utilizing technology solutions to provide remote program services and enrollment including mobile uploading of required documents;
  • taking advantage and apply for all available waiver options from the federal government; and
  • evaluating the revised work systems and if appropriate, take actions to allow for permanent program changes.

This week House Democrats passed the Health and Economic Recovery Omnibus Emergency Solutions (HEROES) Act, the fifth Covid-related legislative package, which includes a boost in funding for SNAP, WIC, and Child Nutrition Programs. The bill also provides support to local food banks and emergency food providers. Any bill that goes to the president should include these food access supports.

It is critical to strengthen federal food assistance programs and the social safety net while working to address the root causes of poverty to reduce health and social disparities. To learn how Altarum can assist your state in program assessment, planning, evaluation, training and analytic support for quality services, contact Tara Fowler, PhD, director of the Center for Healthy Women and Children, at tara.fowler@altarum.org.