Group items tagged

But the F.D.A. advisory committee, along with an independent think tank and several prominent experts — including some Alzheimer’s doctors who worked on the aducanumab clinical trials — said the evidence raised significant doubts about whether the drug is effective.

The F.D.A. authorized the drug under a program called accelerated approval, which has been applied to therapies for some cancers and other serious diseases for which there are few, if any, treatments.

The risks with aducanumab involve brain swelling or bleeding experienced by about 40 percent of Phase 3 trial participants receiving the high dose. Most were either asymptomatic or had headaches, dizziness or nausea. But such effects prompted 6 percent of high-dose recipients to discontinue. No Phase 3 participants died from the effects, but one safety trial participant did.

About two million Americans may fit the description of the patients the drug was tested on: people in the early stages of Alzheimer’s or the stage just before that, Alzheimer’s-related mild cognitive impairment. About six million people in the United States and roughly 30 million globally have Alzheimer’s, a number expected to double by 2050. Currently, five medications approved in the United States can delay cognitive decline for several months in various Alzheimer’s stages.

The crux of the controversy over aducanumab involved two Phase 3 trials with results that contradicted each other: One suggested the drug slightly slowed cognitive decline while the other trial showed no benefit. The trials were stopped early by a data monitoring committee that found aducanumab didn’t appear to be showing any benefit. Consequently, over a third of the 3,285 participants in those trials were never able to complete them.

Aducanumab, a monoclonal antibody, targets a protein, amyloid, that clumps into plaques in the brains of Alzheimer’s patients and is considered a biomarker of the disease. One thing both critics and supporters of approval agree on is that the drug substantially reduces levels of amyloid, and the F.D.A. said that the drug’s effect on a biomarker qualified it for the accelerated approval program.

He estimates 25 to 40 percent of the clinic’s roughly 3,000 patients might be eligible, but it doesn’t have enough neurologists.

But only a handful of cancers—of the breast, lung, colon and cervix—have screening tests recommended by the U.S. Preventive Services Task Force

Many companies are developing blood tests that can detect cancer signals before symptoms occur, and Grail’s is the most advanced. A study found it can identify more than 50 types of cancer 52% of the time and the 12 deadliest cancers in Stages I through III 68% of the time.

There’s a hitch. The test costs $949 and isn’t covered by Medicare or most private insurance.

The trouble is that this cancer is almost never caught early. There’s no routine screening for it, and symptoms don’t develop until it is advanced. Mr. Royse, 64, had no idea he was sick until he took a blood test called Galleri, produced by the Menlo Park, Calif., startup Grail. He had surgery and chemotherapy and is now cancer-free.

Mr. Royse visited Grail’s website, which referred him to a telemedicine provider who ordered a test. Another telemedicine doctor walked him through his results, which showed a cancer signal likely emanating from the pancreas, gallbladder, stomach or esophagus.

An MRI revealed a suspicious mass on his pancreas, which a biopsy confirmed was cancerous. Mr. Royse had three months of chemotherapy, surgery and another three months of chemotherapy, which ended last February. Because pancreatic cancer often recurs, he gets CT and MRI scans every three months. In addition, he has signed up for startup Natera’s Signatera customized blood test, which checks DNA specific to the patient’s cancer and can signal its return before signs are visible on the scans

Grail’s test likewise looks for DNA shed by cancer cells, which is tagged by molecules called methyl groups that are specific to a cancer’s origin. Grail uses genetic sequencing and machine learning to recognize links between DNA methyl groups and particular cancers

The test “is based on how much DNA is being shed by tumor,” Grail’s president, Josh Ofman, says. “Some tumors shed a lot of DNA. Some shed almost none.

ut slow-growing tumors typically aren’t shedding a lot of DNA.” That reduces the probability that Grail’s test will identify indolent cancers that pose no immediate danger.

Grail’s test has a roughly 0.5% false-positive rate, meaning 1 in 200 patients who don’t have cancer will get a positive signal

Its positive predictive value is 43%, so that of every 100 patients with a positive signal, 43 actually have cancer

the legislation’s price tag could reduce political support. According to one private company’s estimate, the test could cost the government $39 billion to $145 billion over a decade. Mr. Goldman counters that analysts usually overestimate the costs and underestimate the benefits of medical interventions.

Because Grail uses machine learning to detect DNA-methylation cancer linkages, the Grail test’s accuracy should improve as more tests and patient data are collected

regulators may balk at approving the test, and insurers at covering it, until it becomes cheaper and more reliable.

How would the FDA weigh the risk that a false positive on a test like Grail’s could require invasive follow-up testing against the dire but hard-to-quantify risk that a deadly cancer wouldn’t be caught until it’s much harder to treat? It’s unclear.

some experts urge the FDA to require large randomized controlled trials before approving blood cancer tests. “Multicancer screening would entail tremendous costs and potentially substantial harms,” H. Gilbert Welch and Tanujit Dey of Brigham and Women’s Hospital wrote

Dr. Welch and Mr. Dey also suggested that companies should be required to prove their tests reduce overall mortality, even though the FDA doesn’t require drugmakers to prove their products reduce deaths or extend life. Clinical trials for the mRNA Covid vaccines didn’t show they reduced deaths.

One alternative is to rely on real-world studies, which Grail is already doing. One study of patients 50 and older without signs of cancer showed that the test doubled the number of cancers detected.

One recurring problem he has seen: “Epidemiologists are always getting cancer wrong,” he says. “Epidemiologists a decade ago said U.S. overtreats cancers. Well, no, the EU undertreats cancer.”

A 2012 study that he co-authored found that the higher U.S. spending on cancer care relative to Europe between 1983 and 1999 resulted in significantly higher survival rates for American patients than for those in Europe

By his study’s calculation, U.S. spending on cancer treatments during that period resulted in $556 billion in net benefits owing to reduced mortality.

He expects Galleri and other multicancer early-detection tests to reduce deaths and produce public-health and economic benefits that exceed their monetary costs

Expanding access to multicancer early-detection tests could also help solve the chicken-and-egg problem of drug development. Because few patients are diagnosed at early stages of some cancers, it’s hard to develop treatments for them

the positive predictive value for some recommended cancer screenings is far lower. Fewer than 1 in 10 women with an abnormal finding on a mammogram are diagnosed with breast cancer.

Mr. Royse makes the same point with personal force. “I would be dead right now if not for multicancer early-detection testing,” Mr. Royse told an FDA advisory committee last fall. “The longer the FDA waits, the more people are going to die. It’s that simple.”

COVID-19 translational research is moving science from the bench preclinical stage of cell and animal research and rapidly through three phases of clinical trials. We can anticipate vaccines being at the patient/population “bedside” in the next few months.

Delaware has created a framework for COVID-19 vaccine distribution when it becomes available which can be found on coronavirus.Delaware.gov. Delaware’s distribution will have three phases

The state will begin with healthcare workers and those caring for vulnerable populations and other first responders and critical infrastructure workers. The second phase will vaccinate vulnerable persons: people over 65, those with chronic health conditions, homelessness and other vulnerabilities.Lastly, the rest of our Delaware population of more than 970,000 will be vaccinated.

And sadly, Black and Brown communities have been disproportionately infected and affected by COVID-19 here in Delaware and throughout the U.S. These communities remain vulnerable.

When COVID-19 vaccines become available, Black and Brown communities must be given equitable access to the vaccine.

The disproportionate effects of the COVID-19 pandemic on Black and Brown communities has pulled back a curtain of silence on the systemic racism in the health and healthcare systems in Delaware and across the United States.

A new composite forecast from the US Centers for Disease Control and Prevention projects a total of 332,000 to 362,000 Covid-19 deaths by January 2.

Covid-19 hospitalizations also reached a new record high of 106,688 on Wednesday, according to the COVID Tracking Project.

more than 221,000 new infections were reported in just one da

"We are in a totally unprecedented health crisis in this country,"

Health care workers are exhausted. Hospitals are totally full."

"Unfortunately, with the volume of new cases that we are seeing and the implications it has on hospital utilization, during a period of widespread, community transmission, activities such as eating, drinking and smoking in close proximity to others, should not continue."

If the FDA grants emergency use authorization in the coming days, the first Americans outside of clinical trials could start getting inoculated this month.

in the coming months it's crucial that Americans stay vigilant and follow safety guidelines, like wearing face masks, social distancing and hunkering down in their social bubbles.

The daily death toll from Covid-19 reached a record high of 3,124 Wednesday, according to Johns Hopkins University.

"Let's say we get 75%, 80% of the population vaccinated. I believe if we do it efficiently enough over the second quarter of 2021, by the time we get to the end of the summer ... we may actually have enough herd immunity protecting our society that as we get to the end of 2021, we could approach very much, some degree of normality that is close to where we were before,"

"We want to make sure that the vaccines are actually administered, and we're afraid that won't happen," Paul Ostrowski, who is leading supply, production and distribution for Operation Warp Speed, told "Good Morning America" Wednesday.

"Baltimore City has not had to implement such severe restrictions since the very earliest days of the pandemic and the implementation of the stay-at-home order," the city's health department tweeted.

But the country will likely not see any meaningful impact until well into 2021 -- and that's if enough people get vaccinated, said Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases.

Indiana's Republican Gov. Eric Holcomb ordered hospitals to postpone or reschedule non-emergency procedures done in an inpatient hospital setting from December 16 through January 3 to preserve hospital capacity.

In Alabama, Republican Gov. Kay Ivey announced Wednesday she's extending the state's Safer at Home order, which includes a statewide mask mandate for another six weeks.

About 53% of respondents said they would get the vaccine promptly -- up from 51% before Thanksgiving and 38% in early October.

The first emergency use authorization for a vaccine is expected soon, and about 20 million people could likely get vaccinated in the next few weeks, Secretary of Health and Human Services Alex Azar said Wednesday.

In the UK, "thousands" of people were already vaccinated Tuesday, the first day of the Pfizer/BioNTech vaccine rollout there, according to the National Health Service (NHS).

The FDA will not "cut any corners" when deciding whether to authorize the vaccine, Azar said, saying he was sure what happened in the UK would be "something the FDA looks at."

"For now, we need to double down on the steps that can keep us all safe."

President-elect Joe Biden's team has magnified the giant hurdles that loom for government officials as they try to ensure the smooth delivery of millions of vaccine doses within the 50 states and cities with different ideas about the best way to administer them.

Trump told guests that with the help of "certain very important people -- if they have wisdom and if they have courage -- we're going to win this election." The crowd chanted "four more years."

the crucial question is whether Trump and his administration are equipping the incoming Biden administration with the knowledge and tools they need to carry out an unprecedented vaccination operation as Trump's White House grudgingly passes the baton.

Trump answered a question this week about why he wasn't including Biden aides in a vaccine summit by insisting the election still wasn't settled.

There were signs Wednesday, however, that cooperation is slowly beginning to take shape behind the scenes. Health and Human Services Secretary Alex Azar said that he has met with Biden's team -- a rare acknowledgment of the former vice president's victory from a top Trump official -- and he insisted that he wants "to make sure they get everything that they need."

"Twenty million people should get vaccinated in just the next several weeks, and then we'll just keep rolling out vaccines through January, February, March as they come off the production lines," Azar said, trying to offer a note of reassurance about continuity during an interview on CNN's New Day.

The vaccine distribution challenges surrounding a once-in-a-lifetime pandemic would normally be at the top of the agenda for any commander-in-chief. But unsurprisingly, Trump is refusing to acknowledge the potential problems as he spreads disinformation to his supporters, and his administration -- at his behest -- continues to target Biden's son Hunter, who revealed Wednesday that his taxes are under federal investigation.

The attorney representing Trump, John Eastman, is known for recently pushing a racist conspiracy theory -- that Trump himself later amplified -- claiming Vice President-elect Kamala Harris might not be eligible for the role because her parents were immigrants.

Kansas Sen. Jerry Moran, a Republican, said "it is unhealthy for the well-being of the country" to continue debating the outcome of the election "once the presidential race has been determined."

"Unless a court makes some other decision, the Electoral College is the defining outcome of the presidential race," Moran said. Asked what would be next if Trump doesn't concede, Moran said: "There is a transition that just occurs -- occurs under our laws under the Constitution."

With hopes riding on the vaccine authorization discussion Thursday, the country continued to grapple with an alarming rise in cases around the country as medical professionals began to see the post-Thanksgiving spike materialize and some regions reverted to shutdowns to try to preserve hospital capacity.

"This is by far, the worst surge to date," Colfax said. "The reality is unfortunately proving to be as harsh as we expected. ... The vaccine will not save us from this current surge -- there is simply not enough time."

"The more terrible truth is that over 8,000 people, ... who were beloved members of their family, are not coming back. And their deaths are an incalculable loss to their friends and their family, as well as our community."

Though Trump has said that the vaccination program will "quickly and dramatically reduce deaths," a new White House task force report warns that the vaccine "will not substantially reduce viral spread, hospitalizations, or fatalities until the 100 million Americans with comorbidities can be fully immunized, which will take until the late spring."

The FDA is expected to conduct its authorization review between December 11 and the 14, with first shipment of the vaccine going out by December 15. Needles, syringes and other materials to deliver the vaccines are already on their way to states.

Gen. Gustave Perna, said that 2.9 million doses of vaccine will go out in the first shipment from Pfizer once the FDA grants emergency use authorization.

Initially the federal government expected to receive 6.4 million doses from Pfizer as the first shipment. But because the vaccine is administered in two doses, the math is more complicated. About 500,000 doses will be set aside as a reserve supply, and the remaining number was divided in half to set aside what is needed for the second dose of the Pfizer vaccine, which brought down the total in the first shipment to 2.9 million doses.

"We just want to make sure that Americans understand exactly the science that went into this, understand the gold standard of the FDA and the approval process. We want to make sure that the vaccines are actually administered, and we're afraid that that won't happen," Ostrowski said.

Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

As for mixing and matching, the FDA said it’s OK to use any brand for the booster regardless of which vaccination people got first.

FDA officials said they wanted to make the booster guidance as flexible as possible, given that many people don’t remember which brand of vaccine they received.

“Being able to interchange these vaccines is a good thing — it’s like what we do with flu vaccines,” FDA’s Dr. Peter Marks told reporters Wednesday evening.

That study also showed recipients of the single-dose J&J vaccination had a far bigger response if they got a full-strength Moderna booster or a Pfizer booster rather than a second J&J shot. The study didn’t test the half-dose Moderna booster.

FDA recommended that everyone who’d gotten the single-shot J&J vaccine get a booster since it has consistently shown lower protection than its two-shot rivals.

Some warn that the U.S. government hasn’t clearly articulated the goals of boosters given that the shots continue to head off the worst effects of COVID-19

FDA regulators said they would move quickly to expand boosters to lower age groups, such as people in their 40s and 50s, if warranted.

The vast majority of the nearly 190 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while about 15 million have received the J&J vaccine.

“What we’ve learned is that every variant seems to have its own characteristics, and it’s important that we not be locked into thinking we know everything based on what we’ve learned from the last variant,” he said

“The virus grows in your nose and throat and somewhat at different time scales,” Michael Mina, chief science officer for the biotech software company eMed, who was an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, said at a testing technology news briefing this week.

“The agency recommends that individuals closely follow the tests’ instructions,” FDA spokesperson Jim McKinney told NBC News in an email.

Dr. Jonathan Li, an infectious disease physician at the Brigham and Women’s Hospital in Boston, cautions against altering the testing strategy that has been validated and authorized by the FDA.

The United Kingdom’s National Health Service recommends swabbing both the nose and the throat when using a rapid antigen, or later flow, Covid test, the kind used at home.

Before advocating the altered approach, Li said, he would need to see data that showed it was effective. User error will likely be higher with self-administered throat swabs compared with nasal swabs, he said.

“The nose and the throat have different pH levels and we have seen people take Coke or coffee and put it in an antigen test and had a line to appear,” she said. “We don’t know exactly why this happens, but the hypothesis is acidity.” 

Miller notes that a small preprint paper out of South Africa, which has not yet been peer-reviewed, suggested that more detectable virus may reside in the throat than in the nose when a person is infected with omicron compared to the delta variant, though the study compared PCR to antigen, or rapid, tests, which are not the same type of tests. 

Miller said that although she would not be surprised if omicron indeed does show up in the throat before it does in the nose, that concrete data has yet to be shown. 

According to Matt Binnicker, director of clinical virology at the Mayo Clinic, the fact that positivity rates are soaring in the U.S. is a testament to how well Covid tests are still working.

According to Miller, it’s best to take a rapid test on day one, day two and day three of symptoms if you are testing negative but your symptoms persist. You should also isolate. “If you have symptoms, you have Covid until proven otherwise,” she said. 

"The vaccine was 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention (CDC), and 95.3% effective against severe COVID-19 as defined by the U.S. Food and Drug Administration (FDA)," Pfizer and BioNTech said in a joint statement.

volunteers aged12 to 15 showed 100% efficacy in that age group.

"These data confirm the favorable efficacy and safety profile of our vaccine and position us to submit a Biologics License Application to the U.S. FDA," Albert Bourla, Pfizer's chairman and chief executive officer, said in a statement. A BLA is an application for full approval. The vaccine currently has emergency use authorization, EUA, which falls short of full approval.

he company has been studying the vaccine in more than 46,000 volunteers and has noted 927 cases of confirmed Covid-19."From the 927 confirmed symptomatic cases of COVID-19 in the trial, 850 cases of COVID-19 were in the placebo group and 77 cases were in the BNT162b2 group, corresponding to vaccine efficacy of 91.3%," it said.

"Thirty-two cases of severe disease, as defined by the CDC, were observed in the placebo group versus none in the BNT162b2 vaccinated group, indicating that the vaccine was 100% efficacious in this analysis against severe disease by the CDC definition. Twenty-one cases, as defined by the FDA, were observed in the placebo group versus one case in the BNT162b2 vaccinated group, indicating 95.3% efficacy by the FDA definition."

he FDA's definition of severe disease included a raised respiratory rate indicating respiratory distress; raised heart rate, an oxygen saturation level of 93% or lower; respiratory failure severe enough to need additional oxygen or ventilation; a blood pressure drop indicating shock; significant kidney, liver or neurological dysfunction, admission to an intensive care unit or death.

CDC's definition includes a blood oxygen level of 94% or lower and an x-ray finding of lung infiltrates -- an indication of pneumonia -- of greater than 50%

"In South Africa, where the B.1.351 lineage is prevalent and 800 participants were enrolled, nine cases of COVID-19 were observed, all in the placebo group, indicating vaccine efficacy of 100%," the company said.

Inoculations began in the U.S. on Monday with health care workers and the elderly being the first in line to get it.

Leading health experts say that even if all goes well, the vaccine will not be available to the general public until the end of March or beginning of April.

Permission to use the additional portions means the limited supply could increase by up to 40%, Politico reported.

A vaccine developed by Moderna is expected to get emergency use authorization from the FDA as early as this week. Clinical data shows it is nearly as effective as the Pfizer injections.

"It's pretty unusual to have a full extra dose or more though — but it does seem to be there!" Erin Fox, a pharmacist at University of Utah who monitors drug shortages, told the news outlet.

However, because there are no preservatives in the vaccines, partial doses from separate vials shouldn't be combined.

There are conflicting reports about when the U.S. is poised to receive another batch of the medicine from Pfizer.

Meanwhile, The New York Times reported that a second allotment of the Pfizer-BioNTech vaccine may not be available to the U.S. until next June, given the combination of short supply and global demand.

Dr. Anthony Fauci, the nation's senior official for infectious diseases, told NPR this week that half of all Americans would need to be vaccinated before seeing an impact on the spread of the virus, and that 75% to 85% of the population would need to be vaccinated to create herd immunity. He predicted the U.S. could begin to see early stages of herd immunity by late spring or summer.

Most everyone experienced pain at the injection site — 92%. Other common reactions included fatigue (69%), headache (63%) and muscle pain (60%).

Serious adverse reactions were uncommon. There were three reports of a facial paralysis called Bell's palsy in the vaccine group and one in the placebo group. The FDA said there wasn't enough information to determine if the vaccine caused the cases.

The FDA analysis supports a case that the Moderna vaccine should be authorized for emergency use, a quicker approach than the standard for full licensure.

Authorization of Moderna's vaccine will be considered only for adults, so the meeting may go more smoothly.

The decision has to come this month “because of the time required for manufacturing the necessary doses,” three of FDA’s top officials – FDA Commissioner Robert Califf, vaccine expert Peter Marks and principal deputy commissioner Janet Woodcock – wrote in a paper published by the journal JAMA in May.Both Pfizer and Moderna are studying vaccines designed to combat omicron and other strains. However, data on the shots remains scarce.

Despite mounting anticipation for the decision, the percentage of parents who will get their young children vaccinated is likely to be low compared to other age groups. A survey from February found that 31% of parents of children in the age range will get their kid vaccinated right away if a vaccine is authorized.

Clinical data from Moderna’s shot is expected this month, according to the company. Moderna in April released findings to support its booster shot development strategy, but the data comes after research in animals suggested the omicron-specific shot might not provide additional protection. A study from scientists at the National Institutes of Allergy and Infectious Diseases’s Vaccine Research Center found that primates boosted with the original vaccine had similar levels of protection as monkeys who got an omicro

The Biden administration has warned of potential fall and winter surges infecting up to 100 million Americans as it gears up for a fall booster shot campaign, whether that is with an omicron-specific shot or not. The FDA authorized a fourth vaccine dose for people ages 50 and older in March, and expanding the shot to more age groups is under consideration.“Administering additional COVID-19 vaccine doses to appropriate individuals this fall around the time of the usual influenza vaccine campaign has the potential to protect susceptible individuals against hospitalization and death, and therefore will be a topic for FDA consideration,” the officials wrote.In fact, the officials said that coronavirus booster shots could be on their way to becoming a yearly occurrence.

It is time to “accept that the presence of SARS-CoV-2, the virus that causes COVID-19, is the new normal,” according to the officials.“It will likely circulate globally for the foreseeable future, taking its place alongside other common respiratory viruses such as influenza,” they wrote.But paying for the shots remains an issue for the Biden administration as Congress shows little appetite for approving more COVID-19 funding.

AquaBounty developed the salmon by altering its genes so that it would grow faster than farmed salmon, and expects it will take about two more years to reach consumers' plates as it works out distribution.

AquaBounty says its salmon can grow to market size in half the time of conventional salmon, saving time and resources. The fish is essentially Atlantic salmon with a Pacific salmon gene for faster growth and a gene from the eel-like ocean pout that promotes year-round growth.

Activist groups have expressed concerns that genetically modified foods may pose risks to the environment or public health.

Kroger Co, the nation’s largest traditional grocery chain, has “no intention of sourcing or selling genetically engineered salmon,” spokesman Keith Dailey said. Trader Joe's and Whole Foods Market Inc also confirmed that they do not intend to carry the product.

Target Corp eliminated farm-raised salmon in favor of wild-caught salmon in 2010, which spokeswoman Molly Snyder said was the first step in a long-term commitment to improving the sustainability of our seafood assortment. "

Ever since President Trump came into office, a record high turnover and unfilled jobs have emptied offices across wide sections of the federal bureaucracy. Now, current and former administration officials and disaster experts say the coronavirus has exposed those failings as never before and left parts of the federal government unprepared and ill equipped for what may be the largest public health crisis in a century.

Some 80 percent of the senior positions in the White House below the cabinet level have turned over during Mr. Trump’s administration, with about 500 people having departed since the inauguration

At the Department of Veterans Affairs, workers are scrambling to order medical supplies on Amazon after its leaders, lacking experience in disaster responses, failed to prepare for the onslaught of patients at its medical centers.

Equally notable may have been the resignation last year of Scott Gottlieb, the commissioner of the Food and Drug Administration, who was an early advocate for broad coronavirus testing and stronger mitigation policies. He was succeeded by Dr. Stephen M. Hahn, a noted oncologist, who has struggled during Senate hearings to explain some of his positions. The agency is largely viewed as slow in engaging the private sector to develop tests for the coronavirus. Many members of Mr. Gottlieb’s team departed with him, leaving the agency with many people new to their jobs.

The Department of Homeland Security, the agency tasked with screening at airports and carrying out the travel restrictions that were Mr. Trump’s first major action to combat the coronavirus, is full of vacancies. Of the 75 senior positions listed on the department’s website, 20 are either vacant or filled by acting officials.

Even National Park Service vacancies have taken a toll. The park service — which has its own police force — in recent days closed some parking lots near the Tidal Basin on the National Mall, where the cherry blossoms attract huge crowds each year, and urged people to stay away. Mayor Muriel Bowser stepped in and limited access to the area and sent police officers and members of the National Guard to enforce the shutdown.

Even the Pentagon, which is broadly viewed as better positioned than many other agencies for the pandemic response, is not immune. More than a third of all Senate-confirmed civilian positions at the Defense Department are vacant or filled by temporary officials, a peak level for the administration outside of the transition period, according to Pentagon statistics. Of 60 senior positions, 21 lack permanent appointees.

Within a week of its first confirmed case, South Korea’s disease control agency had summoned 20 private companies to the medical equivalent of a war-planning summit and told them to develop a test for the virus at lightning speed. A week after that, the first diagnostic test was approved and went into battle, identifying infected individuals who could then be quarantined to halt the advance of the disease.

Some 357,896 tests later, the country has more or less won the coronavirus war. On Friday only 91 new cases were reported in a country of more than 50 million.

The US response tells a different story. Two days after the first diagnosis in Washington state, Donald Trump went on air on CNBC and bragged: “We have it totally under control. It’s one person coming from China. It’s going to be just fine.”

Though the decision to allow private and state labs to provide testing has increased the flow of test kits, the US remains starkly behind South Korea, which has conducted more than five times as many tests per capita. That makes predicting where the next hotspot will pop up after New York and New Orleans almost impossible.

Today, 86,012 cases have been confirmed across the US, pushing the nation to the top of the world’s coronavirus league table – above even China.

Most worryingly, the curve of cases continues to rise precipitously, with no sign of the plateau that has spared South Korea.

Jeremy Konyndyk, who led the US government’s response to international disasters at USAid from 2013 to 2017, frames the past six weeks in strikingly similar terms. He told the Guardian: “We are witnessing in the United States one of the greatest failures of basic governance and basic leadership in modern times.”

If Trump’s travel ban did nothing else, it staved off to some degree the advent of the virus in the US, buying a little time. Which makes the lack of decisive action all the more curious.

It was not until 29 February, more than a month after the Journal article and almost six weeks after the first case of coronavirus was confirmed in the country that the Trump administration put that advice into practice. Laboratories and hospitals would finally be allowed to conduct their own Covid-19 tests to speed up the process.

In the absence of sufficient test kits, the US Centers of Disease Control and Prevention (CDC) initially kept a tight rein on testing, creating a bottleneck. “I believe the CDC was caught flat-footed,” was how the governor of New York, Andrew Cuomo, put it on 7 March. “They’re slowing down the state.”The CDC’s botched rollout of testing was the first indication that the Trump administration was faltering as the health emergency gathered pace. Behind the scenes, deep flaws in the way federal agencies had come to operate under Trump were being exposed.

In 2018 the pandemic unit in the national security council – which was tasked to prepare for health emergencies precisely like the current one – was disbanded. “Eliminating the office has contributed to the federal government’s sluggish domestic response,” Beth Cameron, senior director of the office at the time it was broken up, wrote in the Washington Post.

It was hardly a morale-boosting gesture when Trump proposed a 16% cut in CDC funding on 10 February – 11 days after the World Health Organization had declared a public health emergency over Covid-19.

The Food and Drug Administration (FDA), which regulates the diagnostic tests and will control any new treatments for coronavirus, has also shown vulnerabilities. The agency recently indicated that it was looking into the possibility of prescribing the malaria drug chloroquine for coronavirus sufferers, even though there is no evidence it would work and some indication it could have serious side-effects.

As the former senior official put it: “We have the FDA bowing to political pressure and making decisions completely counter to modern science.”

Trump has designated himself a “wartime president”. But if the title bears any validity, his military tactics have been highly unconventional. He has exacerbated the problems encountered by federal agencies by playing musical chairs at the top of the coronavirus force.

The president began by creating on 29 January a special coronavirus taskforce, then gave Vice-President Mike Pence the job, who promptly appointed Deborah Birx “coronavirus response coordinator”, before the federal emergency agency Fema began taking charge of key areas, with Jared Kushner, the president’s son-in-law, creating a shadow team that increasingly appears to be calling the shots.“There’s no point of responsibility,” the former senior official told the Guardian. “It keeps shifting. Nobody owns the problem.”

So it has transpired. In the wake of the testing disaster has come the personal protective equipment (PPE) disaster, the hospital bed disaster, and now the ventilator disaster.Ventilators, literal life preservers, are in dire short supply across the country. When governors begged Trump to unleash the full might of the US government on this critical problem, he gave his answer on 16 March.In a phrase that will stand beside 20 January 2020 as one of the most revelatory moments of the history of coronavirus, he said: “Respirators, ventilators, all of the equipment – try getting it yourselves.”

In the absence of a strong federal response, a patchwork of efforts has sprouted all across the country. State governors are doing their own thing. Cities, even individual hospitals, are coping as best they can.

These days, lots of manufacturers offer a rainbow of ink colors. People can even go online and order a bottle. The Food and Drug Administration has not regulated the pigments in tattoo inks so far, but agency officials will investigate and recall tattoo inks if they hear of a specific safety concern, like bacterial contamination that could lead to infections.

Then there's the question of what happens to these inks over time, he says, and whether sunlight or the body can break the chemicals down into byproducts that have their own potential effects.

So, if some tattoo ink components can move through the body, researchers want to know:

Liszewski, who also is a cancer epidemiologist, says it's hard to investigate whether or not tattoo pigments in the body lead to any long-term increased risk of diseases like cancer.

In a presentation to the committee, Dr. Mary Chamberland, representing the CDC, said ACIP has agreed to follow the principles of maximizing benefits and minimizing harms, promoting justice and mitigating health inequities in determining early allocation groups.

To that end, a modeling study presented by CDC epidemiologist Matthew Biggerstaff showed that vaccinating all adults 65 years and older first (after health care workers) might have the greatest effect on reducing the overall number of deaths in the U.S.

There are 64 jurisdictions, including states, territories and some large cities, that have submitted preliminary plans to the CDC for distributing the vaccines. The CDC provided feedback on the plans this week, and expects states to be enrolling providers, setting up data systems to track who's getting vaccines, and working with community leaders, so states are ready to give out vaccines as soon as one is authorized by the FDA.

It's up to the FDA to approve or give emergency authorization to any vaccine. There are currently four candidate vaccines in the final phase of clinical study in the U.S. None of the companies so far has applied for authorization or approval from the FDA.

our risk sensor is fixed to the anxieties and illusions of the 1900s

We’re arming and empowering the police like it’s 1990, when urban crime had reached historic highs. But violent-crime rates have fallen by more than 50 percent in almost every major American city in the past generation, while police still drape themselves in military gear and kill more than 1,000 people annually.

Too many police are instructed to believe that the 20th-century crime wave never ended.

Between the 1960s and the early 1990s, the violent-crime rate in many U.S. cities rose “to levels seen only in the most violent, war-torn nations of the developing world,”

As American cities became perceived as war zones, police responded by adopting a “warrior” mentality.

Then violent crime plunged by more than 70 percent from 1993 to 2018, according to data maintained by the Department of Justice. Although officers routinely face threats that most white-collar workers never will, cops are safer now than at any point in nearly 50 years.

The U.S. has about the same number of police officers per capita as, say, Australia; but adjusted for population, U.S. law enforcement kills 10 times more people.

The message is clear: Be a warrior, because it’s a war out there.

The warrior mentality encourages an adversarial approach in which officers needlessly escalate encounters.

calls the idealization of the warrior “the most problematic aspect of modern [police] policy.”

the CDC had waited “its entire existence for this moment,” but it was so unprepared to deal with COVID-19 that the group initially in charge of the response, the Division of Viral Diseases, had to cede responsibilities to the Influenza Division, despite the fact that COVID-19 is not caused by any kind of influenza virus

Police aren’t just trained to feel like warriors; many are armed for war

Over time, SWAT itself served as a gateway drug for police militarization, as equipment once reserved for special teams, such as AR-15 rifles, were made available to ordinary officers.

the War on Drugs has been roundly discredited as a trillion-dollar failure that incurs thousands of unnecessary deaths. But it has bequeathed us a world where police bearing semiautomatics are armed with the wrong tools for the actual job

“The world has changed dramatically since the most violent years of the 1990s, but police training trails lived experience,”

the U.S. mental-health crisis has been effectively outsourced to the streets, where police who aren’t trained as social workers or behavioral therapists must perform the ad hoc duties of both.

Rather than respond to the drastically changing nature of American life, our cities and counties use police as a civic Swiss Army knife to solve problems such as homelessness and mental-health emergencies that have little to do with police training.

the failures of American police are not unique, but rather a symptom of a broader breakdown in high-quality governance.

Before it stood for the Centers for Disease Control and Prevention, the CDC was founded as the Communicable Disease Center in the 1940s. Its original mission was to stop an epidemic. The organization’s first 400, Atlanta-based employees were tasked with arresting an outbreak of malaria in the Southeast

Today, the center’s 14,000 employees work “at the speed of science”—that is, slowly and deliberately—to understand an array of health issues, including cancer, obesity, and vaping.

its mission creep has transformed what was once a narrowly focused agency into a kaleidoscopic bureaucracy with no fast-twitch instinct for achieving its founding mission to protect Americans from an epidemic.

The CDC’s recent failures are well known, but worth repeating. It failed to keep track of early COVID-19 cases in part because of a leaden-footed reliance on fax machines and other outdated record-keeping technology. It failed to compile accurate case counts, forcing private actors—such as The Atlantic’s COVID Tracking Project—to fill the void. It failed its most basic coordination functions as an agency

Violent crime plays a minuscule role in the day of a modern officer, who spends most of his or her time driving around, taking ho-hum radio calls, and performing the tertiary duties of traffic patroller and mental-health counselor.

Most important, the CDC failed to manufacture basic testing equipment. Its initial test kits were contaminated and unusable, which allowed the disease to spread undetected throughout the U.S. for weeks.

Compare the situation in the U.S. with the one in East Asia, where several countries have navigated the pandemic far more deftly. China, South Korea, Taiwan, Singapore, and Vietnam all updated their infectious-disease protocols based on what they learned from 21st-century epidemics: SARS in 2003, H1N1 in 2009, and MERS in 2012. These countries quickly understood what artillery would be necessary to take on COVID-19, including masks, tests, tracing, and quarantine spaces. Yet the CDC—armed with an $8 billion budget and a global team of scientists and officials—was somehow unprepared to read from the playbook.

The FDA fumbled just as tragically. In January, Alex Greninger, a virologist at the University of Washington, was prepared to build an in-house coronavirus test

By the time Greninger was ready to set up his lab, the calendar had turned to March. Hundreds of thousands of Americans were sick, and the outbreak was uncontrollable.

the White House cannot be entirely blamed for the ponderous incompetence of what ought to be the greatest public-health system in the world.

Not every American institution is trapped in amber. For a perhaps surprising example of one that has adapted to 21st-century needs, take the Federal Reserve.

Ben Bernanke, the Fed chair during the Great Recession, used his expertise about the 1930s economy to avoid a similar collapse in financial markets in 2008. Today’s Fed chair, Jerome Powell, has gone even further, urging Congress and the Treasury to “think big” and add to our already-historic deficits.

the Federal Reserve has junked old shibboleths about inflation and deficit spending and embraced a policy that might have scandalized mainstream economists in the 1990s. Rejecting the status-quo bias that plagues so many institutions, this 106-year-old is still changing with the world.

what strikes me is that America’s safekeeping institutions have forgotten how to properly see the threats of the 21st century and move quickly to respond to them. Those who deny history may be doomed to repeat it. But those who deny the present are just doomed

“The U.S. requires testing of six to 10 million people per day to contain and monitor the infection,” Fluidigm CEO Chris Linthwaite says.

Fresh options can help. Food and Drug Administration regulators last week authorized a new test by Abbott for emergency use that can yield results in as little as 15 minutes. Regulators also authorized a new test developed by Fluidigm that uses saliva rather than a nasal swab. The clinical study associated with Fluidigm’s submission to the FDA demonstrated 100% agreement between the saliva results and paired nasopharyngeal samples. Fluidigm’s test returns results in several hours. Meanwhile, OraSure Technologies is developing a nasal-swab test that is potentially suitable for at-home use and could be ready this fall.