Needy Will Face Hurdles to Getting Coronavirus Stimulus – The New York Times

Needy Will Face Hurdles to Getting Coronavirus Stimulus – The New York Times

Should Doctors Have the Right to Withhold Care From the Sickest Coronavirus Patients? – The New York Times

Should Doctors Have the Right to Withhold Care From the Sickest Coronavirus Patients? – The New York Times

April 3, 2020

One patient had lymphoma and heart failure. Another was 85 years old with metastatic cancer. A third was 83 and had dementia and lung disease. All were critically ill with the coronavirus, and, a doctor said, all were hooked up to ventilators in recent weeks at a major Manhattan hospital.

But soon, patients such as those might not receive similar aggressive treatment. As people with the virus overwhelm New York City hospitals, doctors have stepped up pressure on state health officials to give them a rare and unsettling power: the right to withhold care from patients who are not likely to recover.

Dwindling supplies mean there might not be enough ventilators or other items for everyone, and many doctors say they are growing increasingly uneasy with treating every patient equally. They believe medical workers soon might need to make difficult choices about treatment.

Usually, the standard is to intubate and do CPR and do all those things, said Dr. Angela Mills, the chief of emergency medicine services at NewYork-Presbyterian/Columbia University Medical Center. Theres no question about it; that will not most likely be sustainable.

New York is the epicenter of the coronavirus in the United States, but doctors have wrestled with questions over whether, and how, to ration care from the beginning of the global outbreak. In China, many patients with Covid-19 were initially turned away from hospitals, and in Italy, hospitals have given younger, healthier patients priority for ventilators over older, sicker adults.

The problem is a grim and wrenching one, and the experience of doctors in New York could signal what is to come for their colleagues in other states, which have begun dusting off triage plans.

As of Wednesday, there were 83,712 confirmed cases of the coronavirus in New York State, health officials said. More than 47,000 of those cases were in New York City, where, city officials said, 1,374 patients had died.

The New York chapter of the American College of Physicians, a national organization of internists, wrote to Gov. Andrew M. Cuomo last week, asking that he issue an executive order granting doctors immunity from liability for the decisions they make when the need for allocation of ventilators results in some patients being denied access.

Mr. Cuomo has repeatedly said he does not want to allow hospitals to ration care. No hospital has yet run out of ventilators, he has said. Some hospitals are experimenting with putting multiple people on one machine.

Theres no protocol, Mr. Cuomo said on Tuesday when asked if there would be a triage for patients if critical supplies run out.

Still, state health officials have had discussions with hospital representatives about how to quickly enact new rules if they are needed, according to people familiar with the matter. Two weeks ago, a draft was circulated, although nothing has been implemented.

A spokeswoman for the state Department of Health declined to answer questions about the discussions and instead referred to Mr. Cuomos stance that triage should not be necessary. She also pointed to a recent executive order by Mr. Cuomo that would protect doctors from lawsuits in Covid-related cases, but an American College of Physicians representative said on Wednesday that the order did not go far enough.

In the face of inaction from Albany, hospitals and physicians in New York have been talking among themselves in recent days to formalize common guidelines.

The goal is to have some kind of overarching concept of how to deal with a pandemic that weve never dealt with before how to deal with the level of illness weve never seen before, said Dr. Stuart Kessler, the emergency department director at Elmhurst Hospital Center, a particularly hard-hit public hospital in Queens.

The New York Times spoke to six doctors at five major city hospitals who said they worried they soon would have to decide on their own not to take the most aggressive lifesaving measures in every case. In addition to the moral anguish that may cause, some feared they would run the risk of lawsuits or even criminal charges if they went against the wishes of a patient or family.

Steven A. McDonald, an emergency room doctor at NewYork-Presbyterian, said he wrote to his supervisors on Tuesday asking for guidelines for making decisions about who should receive a ventilator and who should not.

The feedback I got from my department is that the hospital wants to wait for the governor to come down with their own guidelines, he said.

Hospitalizations and admissions to intensive care units are growing in New York, although at a slower pace than they were two weeks ago. Mr. Cuomo has said they are expected to peak in the next two weeks to a month, unnerving doctors.

We are on the battlefield. We are in the trenches and in the middle of a war, said Dr. Robert L. Klitzman, the director of the masters of bioethics programs at Columbia University. And we have not trained our medical staff to deal with military battlefield medicine and ethics.

At individual hospitals, there have been moments when a surge of patients has overwhelmed resources and staff.

We teeter on the brink of needing to ration ventilators, and then we back off for a little bit, said Dr. Tia Powell, the director of the Montefiore Einstein Center for Bioethics, part of Montefiore Medical Center in the Bronx.

Other equipment, such as intravenous pumps needed for delivering medicine to patients on ventilators, has also been in short supply in some places.

Dr. McDonald said that when he arrived to work at NewYork-Presbyterian/Allen hospital in Upper Manhattan on Monday, the hospital was redirecting ambulances to other facilities. When he asked why, he said he was told the hospital had run out of ventilators until a patients death freed one up.

He said he wondered what would happen if other hospitals were also at capacity.

At some point, were just going to have to take these patients and process them accordingly, he said. A spokeswoman for the hospital declined to comment.

A Connecticut man, John Schalhoub, said doctors seemed to be making decisions about rationing care when his mother- and father-in-law both were admitted to Elmhurst Hospital Center. Mr. Schalhoub said he learned through an insurance company that his mother-in-law had tested positive for the coronavirus, but he did not receive his father-in-laws results.

His in-laws, Rong-Hua Xie and Mei-Chun Huang, both 88, were given supplemental oxygen through face masks. But Mr. Schalhoub said doctors explained neither would be given a ventilator if they ultimately needed one.

Theyre basically saying that the use of ventilators is a last resort, but they have not had success with them with people of advanced age, Mr. Schalhoub said.

Dr. Mitchell Katz, the head of New York Citys public hospital system, said none of the facilities he oversees had yet had to prioritize who gets a ventilator. To my knowledge, no ethical system would ever use age as a sole criteria, Dr. Katz wrote in an email.

Ms. Huang died on Tuesday. She was not given a ventilator or other lifesaving measures, Mr. Schalhoub said.

Generally, hospitals follow the desires of patients or their families in how far doctors should go to save their lives. But soon those directives might not carry the same weight.

If you have an advance directive that says, I want everything done for me, in a pandemic that will not count, said Arthur L. Caplan, a professor of bioethics at the New York University School of Medicine. What will count is whether youre likely to benefit more than the next guy or next woman.

The state already had a plan for rationing ventilators in the event of a pandemic. In 2007, a state task force devised a formula, revised in 2015, to help hospitals decide who would get ventilators. It suggested hospitals form triage committees to weigh different factors, including likelihood of survival. It also envisioned a lottery system in some instances, and taking people off ventilators if they did not improve in a relatively short amount of time.

But the Department of Health has not instructed hospitals to use the guidelines, and they remain little more than a template for how hospitals might approach the problem. And some changes would be needed to adapt to what is known about Covid-19, such as that some patients need to be on ventilators for a week or two before improving, doctors said.

We know from the data coming in about Covid that they need more time, said Dr. Powell of Montefiore, who was a member of the task force that produced the 2015 report.

It is, however, receiving renewed interest. In mid-March, Dr. Powell and some other members of the task force participated in a conference call with the Department of Health and representatives of several major hospital systems, several participants said.

About two weeks ago, a five-page draft based on the 2015 guidelines was circulating, the participants said. In interviews, some said they had expected the state would authorize a plan soon after the call.

There was always the expectation they would implement crisis standards of care guidelines, and they have not issued a statement doing that, Dr. Powell said.

A participant in the process, who requested anonymity because the person was not authorized to speak about sensitive internal discussions, said guidelines were still being drafted.

One doctor at Weill Cornell Medical Center, on Manhattans Upper East Side, said that he had been wondering what to do in a hypothetical scenario: There are two Covid-19 patients in hospital rooms, but only one ventilator left. Without guidelines that authorize him to use his judgment, does he let a colleague help one patient while I walk slowly to the door with the 90-year-old? he asked.

Jesse McKinley contributed reporting.


Read this article: Should Doctors Have the Right to Withhold Care From the Sickest Coronavirus Patients? - The New York Times
Answering Your Coronavirus Questions: Face Masks, Pregnancy And The 2020 Census – NPR

Answering Your Coronavirus Questions: Face Masks, Pregnancy And The 2020 Census – NPR

April 3, 2020

A man wearing a mask talks on the phone while walking on Capitol Hill in Washington, D. C. Mandel Ngan/AFP via Getty Images hide caption

A man wearing a mask talks on the phone while walking on Capitol Hill in Washington, D. C.

On this broadcast of The National Conversation, we answer your questions about the economy, face masks, pregnancy during the pandemic and the U.S. Census.


Go here to see the original: Answering Your Coronavirus Questions: Face Masks, Pregnancy And The 2020 Census - NPR
They Made New Lives in the U.S. The Coronavirus Sent Them Fleeing. – The New York Times

They Made New Lives in the U.S. The Coronavirus Sent Them Fleeing. – The New York Times

April 3, 2020

Spotty health insurance coverage has been the deciding factor for some expats. Anna Inglis, a 38-year-old freelance photo producer based in Brooklyn, said she had decided last month to return home to New Zealand in part because she did not have health coverage through her job.

The American system of private health insurance, with varying coverage and sometimes high premiums, deductibles or co-payments, is a stark contrast to the public systems in places like New Zealand, Australia and Britain, where government-subsidized access to doctors and many services is universal.

Some expats say their health insurance options in the United States are so poor that they have instead used travel insurance as their primary coverage. Others, like Ms. Inglis, have only the most basic level of health coverage in New York, but back home, that is not a consideration.

I feel reassured by the New Zealand political system, she said. Hopefully, the system can cope better than the New York system is currently.

This intuition to flee the United States, and its health care system, during a pandemic may be a good one.

The U.S. has been a leader in so many other areas, but when it comes to the health care system, it is behind, said Adam Kamradt-Scott, a global health security expert at the Center for International Security Studies at the University of Sydney.

Professor Kamradt-Scott said that as pressure mounted on the American system, it was possible that citizens would be prioritized over foreigners. Some hospitals in the United States, especially in New York, are literally so overwhelmed that people are only presenting when they are very, very sick.


Read more: They Made New Lives in the U.S. The Coronavirus Sent Them Fleeing. - The New York Times
A Month of Coronavirus in New York City: See the Hardest-Hit Areas – The New York Times

A Month of Coronavirus in New York City: See the Hardest-Hit Areas – The New York Times

April 3, 2020

The coronavirus has ravaged all of New York City, closing schools, emptying streets and turning stadiums into makeshift hospitals. And data made public by city health officials on Wednesday suggests it is hitting low-income neighborhoods the hardest.

Coronavirus cases by ZIP code

Coronavirus cases by ZIP code

Coronavirus cases by ZIP code

By The New York TimesNote: The map shows total number of cases as of April 1. Source: New York City Department of Health and Mental Hygiene

During the first month of the outbreak in the city the epicenter of Americas coronavirus crisis many of the neighborhoods with the most confirmed virus cases were in areas with the lowest median incomes, the data shows. The biggest hot spots included communities in the South Bronx and western Queens.

The data, collected by the New York City Department of Health and Mental Hygiene, offers the first snapshot of an outbreak that infected more than 40,000 and killed more than 1,000 in the city in its first month.

[Read the latest coverage of the coronavirus outbreak in the New York area.]

The coronavirus has spread into virtually every corner of the city, and some wealthier neighborhoods have been overrun with cases, including some parts of Manhattan and Staten Island. But that may be because of the availability of testing in those areas. Nineteen of the 20 neighborhoods with the lowest percentage of positive tests have been in wealthy ZIP codes.

The patterns are even more striking when analyzing the data on people who visited the citys 53 emergency rooms with the flulike symptoms that are a hallmark of the coronavirus.

Over all, nearly three times as many people with flulike symptoms like fever, cough or sore throat visited city emergency rooms this March when compared with the same month in previous years.

In the last four years, there were on average 9,250 flu-related visits to emergency rooms in March; this March, the number tripled to about 30,000.

Average of March

visits in 2016-19

Average of March

visits in 2016-19

Average of March

visits in 2016-19

By The New York TimesNote: E.R. visits are calculated to show the rate per 1,000 people. Source: New York City Department of Health and Mental Hygiene

The increases in flu-related emergency room visits varied widely by neighborhood, with many of the surges occurring among residents of neighborhoods where the typical household income is less than the city median of about $60,000, the data shows.

In Corona, Queens, for example, the median household income is about $48,000, according to the U.S. Census Bureau. That neighborhood is near the Elmhurst Hospital Center, which Mayor Bill de Blasio has cited as the hardest-hit hospital in the city. Doctors in the overwhelmed emergency room there have described the conditions as apocalyptic.

Visits in Central Harlem were up 220 percent.

Corona saw nearly 1,000 more flu-related visits than average.

Where Flu-Related E.R. Visits Have Increased

Circles are sized by the increase in the number of flu-related E.R. visits by residents in each ZIP code for the month of March in 2020, compared with 2016-19.

Yellow circles indicate ZIP codes in which the median household income is less than the city median, which is about $60,000.

Blue circles indicate areas with higher median incomes.

On the north shore of Staten Island, flu-related E.R. visits doubled.

Visits in Central Harlem were up 220 percent.

Corona saw nearly 1,000 more flu-related visits than average.

Where Flu-Related E.R. Visits Have Increased

Circles are sized by the increase in the number of flu-related E.R. visits by residents in each ZIP code for the month of March in 2020, compared with 2016-19.

Yellow circles indicate ZIP codes in which the median household income is less than the city median, which is about $60,000.

Blue circles indicate areas with higher median incomes.

On the north shore of Staten Island, flu-related E.R. visits doubled.

Where Flu-Related E.R. Visits Have Increased

Circles are sized by the increase in the number of flu-related E.R. visits by residents in each ZIP code for the month of March in 2020, compared with 2016-19.

Yellow circles indicate ZIP codes in which the median household income is less than the city median, which is about $60,000.

Blue circles indicate areas with higher median incomes.

Visits in Central Harlem were up 220 percent.

Corona saw nearly 1,000 more flu-related visits than average.

On the north shore of Staten Island, flu-related E.R. visits doubled.

Where Flu-Related E.R. Visits Have Increased

Circles are sized by the increase in the number of flu-related E.R. visits by residents in each ZIP code for the month of March in 2020, compared with 2016-19.

Yellow circles indicate ZIP codes in which the median household income is less than the city median, which is about $60,000.

Blue circles indicate areas with higher median incomes.

Visits in Central Harlem were up 220 percent.

Corona saw nearly 1,000 more flu-related visits than average.

On the north shore of Staten Island, flu-related E.R. visits doubled.

Where Flu-Related E.R. Visits Have Increased

Circles are sized by the increase in the number of flu-related E.R. visits by residents in each ZIP code for the month of March in 2020, compared with 2016-19.

Yellow circles indicate ZIP codes in which the median household income is less than the city median, which is about $60,000.

Blue circles indicate areas with higher median incomes.

Visits in Central Harlem were up 220 percent.

Corona saw

nearly

1,000 more

flu-related

visits than

average.

On the north shore of Staten Island, flu-related E.R. visits doubled.

By The New York TimesE.R. visits are calculated to show the rate per 1,000 people. Sources: New York City Department of Health and Mental Hygiene; 2014-18 American Community Survey

Dr. Jessica Justman, an epidemiologist at Columbia University in Manhattan, said the numbers were most likely because many immigrants and low-income residents live with large families in small apartments and cannot isolate at home.

I think unfortunately this is showing how devastating that can be, Dr. Justman said.

In New York, experts said, a vast majority of people visiting emergency rooms with flu-like symptoms probably have the coronavirus.

Weve actually stopped testing for the flu because its all coronavirus, said Bruce Farber, chief of infectious disease at North Shore University Hospital, part of Northwell Health, a network of 23 hospitals throughout the state. Almost anybody who has an influenza illness right now almost certainly has coronavirus.

Many of the emergency rooms with the biggest increases in patients who have flulike symptoms are in Queens, the borough that has the highest number of confirmed coronavirus cases. There are about 616 confirmed cases for every 100,000 residents in Queens, and 584 confirmed cases for every 100,000 residents in the Bronx. Thats far more per 100,000 than the 376 in Manhattan and 453 in Brooklyn.

With infections across all five boroughs, New York has far more confirmed cases than any other city in the United States.

The emergency room data also tracks admissions the number of E.R. visitors who end up treated at a hospital. On that metric, the data shows that older visitors are far more likely to be admitted than younger visitors.

There is a simple reason for that difference, according to the hospital officials and experts: The coronavirus seems to take a bigger toll on older people, as well as those with compromised immune systems.

I dont think that infection rates are necessarily different between older and younger people, said Dr. Isaac Weisfuse, the former deputy head for disease control at the citys Department of Health. Elderly have worse clinical outcomes than younger patients, and may have more pre-existing conditions.

By The New York TimesNote: The chart shows E.R. admissions as of March 31. Source: New York City Department of Health and Mental Hygiene

Over all, more than 8,500 people have been hospitalized with the coronavirus in New York City. That number is expected to soar in the coming weeks.

But officials are hopeful that the social distancing restrictions put in place by the state may have finally started to at least slow the spread of the coronavirus. They have noted that the number of hospitalizations is now doubling every six days, instead of every two or three days.

The citys data shows a slight decline in emergency room admissions over last weekend, and then continuing increases this week.

Dr. Denis Nash, an epidemiologist at the City University of New Yorks School of Public Health, said it was still too soon to tell whether the social distancing restrictions were working.

It may be too soon to say whats really going on here, he said. I just hope it means something good.

ZIP code

Borough

Total cases

Cases per 1,000 people

11368

Queens

947

9

11373

Queens

831

9

11219

Brooklyn

771

9

10467

Bronx

638

7

11230

Brooklyn

631


More here: A Month of Coronavirus in New York City: See the Hardest-Hit Areas - The New York Times
Opinion | Coronavirus vs. Governors: Ranking the Best and Worst State Leaders – POLITICO

Opinion | Coronavirus vs. Governors: Ranking the Best and Worst State Leaders – POLITICO

April 3, 2020

New York Governor Andrew Cuomo has received the lions share of attention, as his informative and emotive press conferences have made him an overnight national political star, albeit halfway through his third term. But his record in responding to the crisis is more complicated than the sheen lets on: his coronavirus containment policies were not the most aggressive in the country, and did not prevent catastrophe. He hesitated to close all schools statewide even as other states began to do so, and resisted a statewide stay-at-home order for a few days before relenting.

So, if not Cuomo, then who? I see six governors who are poised to break out, and another six who risk serious damage to their political futures.

Perhaps no single governor has done more to put the nation on a war footing in the fight against coronavirus than DeWine, whose actions have contributed to Ohios relatively modest number of cases, with a per capita infection rate currently ranked 27th out of 50 states.

On March 12, even though Ohio had yet to suffer a major outbreak of Covid-19, DeWine called for the statewide closure of public schoolsthe first governor in the nation to do so, forcing most of his fellow governors to recognize they had to follow suit, and fast. Likewise, DeWine set the pace on delaying primary elections, even if his snubbing of an initial court order was constitutionally questionable.

The lifelong Republican public servant has been calm, sober and data-driven. He has not only been uninterested in emulating Donald Trumps style, he has been willing to defy Trumps edicts. When Trump tried to set a goal for reopening the economy by Easter, DeWine gently but firmly pushed back, When people are dying, when people don't feel safe, the economy is not gonna come back.

At 73 years old, DeWine is probably not going to ascend to higher office after this is all over. But if he has any interest in steering the post-Trump Republican Party away from Trumpism, he now has a much bigger national platform on which to do so.

Cuomos proximity to New York City the media capital of America has shifted much of the spotlight away from the other hungrily ambitious governor of a big blue state. But on March 19, Newsom was the first governor in America to issue a statewide order to shutter businesses and keep people at home. (Newsom had help when, three days earlier, public health officials in six Bay Area counties went first and issued a joint stay-at-home order.)

The strong action appears to be bending the curve. Californias number of Covid-19 confirmed cases and deaths is rising slower than in hard-hit states like New York, New Jersey, Louisiana and Michigan. (The death number may be a better indicator of spread than the confirmed cases number, because testing has been so poorly administered.)

National media outlets are starting to notice. Even Trump, who has repeatedly tangled with Newsom over the past three years, conceded this week that California has done a good job. But both Newsom and Trump acknowledge that California may still be facing a surge of cases, and that could strain its hospital system. Newsom is scrambling to fortify the system with additional hospital beds on ships and convention centers, and with an effort to enlist medical retirees and students in joining an expanded health care workforce.

Whether he succeeds may ultimately determine if Newsom is heralded as a skilled administrator who might warrant a promotion to the presidency someday.

Coming into 2020, Inslee had already burnished his national reputation by running for president as a visionary leader on climate change. Now, after his state identified the first American case of Covid-19, and suffered the first cluster of nursing home deaths, Inslee is adding crisis manager to his rsum.

After being shown data in early March that argued for severe social distancing, Inslee immediately moved to ban large gatherings and prepared the public for more stringent measures. The quick action has paid off: Washingtons curve of coronavirus deaths is flatter than any other state with more than 50 deaths.

At the same time, Inslee has been a public thorn in Trumps side. On February 27, Inslee provoked the president by recounting on Twitter a pointed exchange he had with Vice President Mike Pence: I told him our work would be more successful if the Trump administration stuck to the science and told the truth, Inslee said. Trump has responded with insults, calling Inslee a snake, and publicly encouraging Pence not to call him anymore.

Instigating a spat with the president during a national crisis can run the risk of making a governor look petty and political. But that risk is negated if you can still deliver results, which Inslee has done. Further, most Democrats dont mind seeing Inslee take Trump to task, and Inslee doesnt have to worry about swing voters right now. Either he is strengthening his ability to win a third gubernatorial term, or he is cannily positioning himself for a Cabinet post in a potential Biden administration.

Like DeWine, Hogan is a Republican governor who has acted aggressively to contain the virus. Unlike DeWine, Hogan is more willing to criticize the White House.

When asked on CNN last week if Marylands social distancing policies matched Trumps suggestion that it would soon be time to ease up, Hogan was pointed: They dont really match. Quite frankly, some of the messaging is pretty confusing. And I think its not just that it doesnt match with what were doing here in Maryland, some of the messaging coming out of the administration doesnt match.

On Monday, Hogan penned a bipartisan Washington Post op-ed with Michigan Governor Gretchen Whitmer, listing all the ways Washington and the federal government havent sufficiently helped the nations governors. And on Tuesday, when asked by NPR whether Trump was correct when he suggested recently that states have enough testing kits, Hogan was blunt: Thats just not true.

As governor of a deep blue state, Hogan has more political leeway than DeWine to complain about the presidents handling of the pandemic. But Hogan, who is term-limited, has flashed grand ambitions, flirting last year with a primary challenge to Trump. He concluded, accurately, he had no path to success and passed. But if, by 2024, some GOP-ers rediscover the value of managerial competence, and he continues to limit the spread of coronavirus in his state, Hogan will have distinguished himself as a different kind of Republican.

Perhaps no governor has gotten under Trumps skin more than Whitmer, who has repeatedly criticized the administrations handling of the pandemic. He has snidely referred to her as the woman in Michigan and Gretchen Half Whitmer, and like Inslee, suggested Pence should not call her. She has responded in kind on her Twitter feed and in TV interviews.

For the moment, Whitmer has gotten the better out of their tussle. A poll taken in mid-March, in the midst of the initial clash between the governor and the president, showed Whitmer with a 60 percent approval rating, and Trump at only 45 percent. Michigan Republicans have been warning Trump to tone it down.

But Whitmer also appears aware she should go only so far. In recent days, as Detroit hospitals are suffering from strain, she has toned it down. She praised the White House and the Federal Emergency Management Agency for shipments of masks and ventilators. She had civil phone calls with Trump and Pence. As New York Times reporter Annie Karni suggested, Whitmers gender might have something to do with Trumps particularly harsh tone. But perhaps another major factor is that Michigan is a major Electoral College prize one Trump barely won in 2016. As Covid-19 cases explode in Detroit, if Whitmer successfully pins the blame on Trump, that could help flip the state back to blue in November. But if Trump can successfully tag her for blame-shifting while the pandemic raged, that could cripple Whitmers ability to deliver the state to Joe Biden.

In the meantime, Whitmer has been getting more buzz as Bidens potential running mate (which Biden stirred himself Tuesday night on MSNBC). After lowering the temperature of her presidential fight, but with the states caseload rising quickly, she now has to assure her constituents she is doing the best she can with what resources are available.

On the mainland, California was the first state to shut down nonessential businesses and largely keep people in their homes. But in Puerto Rico, Vazquez moved four days earlier, shutting down businesses, schools and beaches; ordering people inside and installing a nighttime curfew.

With Puerto Ricos health care infrastructure still fragile in the aftermath of Hurricane Maria, the territory is acutely vulnerable to a pandemic. (In early January, a 13-year-old in Vieques with flu-like symptoms died in part because the lone hospital on the island has been shuttered since Maria.) So Vazquez had every incentive to move quickly and boldly.

Shes also in a fragile political state. She ascended to her position after evidence of corruption forced out Ricardo Rossell, the last elected governor. But some accused her, while serving as secretary of justice, of failing to properly investigate Rossell. In January, she suffered another scandal when, after a series of earthquakes, unused emergency supplies were discovered in a warehouse. She now faces a close race in her partys primary to earn a nomination for a full term later this year.

According to the most recent data, Puerto Rico has a lower rate of infection than any of the 50 states. That may be partly because Puerto Rico has a lower rate of testing than almost every state. But Vazquezs swift and sweeping action on social distancing likely is helping to prevent a worst-case scenario and could well help her keep her job.

DeSantis is one of Trumps favorite governors and a potential 2024 presidential prospect. But he has made a bad first impression on the rest of the country by failing to fully shut down Floridas beaches before or after they were overrun with partiers on spring break, many of whom then traveled home to locations throughout the United States.

He also resisted making a statewide stay-at-home order until finally relenting on Wednesday in the wake of intense pressure from Florida Democrats, and televised comments Wednesday morning by the surgeon general urging all governors to get their residents to stay at home. Before that point, his seemingly toughest measure was issuing a quarantine for travelers coming from the New York City tri-state area or Louisiana, but the focus on hot spots ignores all the community spread inside Florida and in other states. Florida already has nearly 7,000 confirmed cases, ranking it 17th among the states on a per capita basis.

Earlier, DeSantis justified eschewing broader measures. Were also in a situation where we have counties who have no community spread, he said on March 19. We have some counties that dont have a single positive test yet. But everything we have experienced strongly suggests you don't want to wait until you have community spread before taking strong action.

DeSantis may still be helped by Trump, who may be giving Florida preferential treatment. According to the Washington Post, other governors have had difficulty getting supplies from the Strategic National Stockpile, but not DeSantis. And Trump has been influenced by DeSantis argument that some social distancing measures are too harmful to the economy. The Post quoted an anonymous White House official, who explained, The president knows Florida is so important for his reelection, so when DeSantis says that, it means a lot. He pays close attention to what Florida wants.

For now, DeSantis remains on the GOPs 2024 shortlist. But if DeSantis encourages Trump to make bad decisions, and if Florida is getting supplies while other states scrounge, the governors ties to the president may become a serious liability for his own future prospects.

Aside from its next-door neighbor Louisiana, Mississippi is the Southern state with the most confirmed Covid-19 cases on a per capita basis. Yet Reeves has made a hash out of the response.

As Mississippis localities began issuing stay-at-home edicts, Reeves issued his own order on March 24, broadly defining what business and social activity is essential including religious services and declared any order from any other governing body which conflicts with the state order to be suspended and unenforceable. Two days later, under pressure, he tried to clarify that the state order provided only a floor, which counties and cities could surpass, but confusingly added that no order can keep those essential services from going on. Mississippi mayors have been confused and have interpreted the governor differently.

Reeves had resisted a statewide stay-at-home order on ideological grounds, insisting that Mississippi's never going to be China. Mississippi's never going to be North Korea. Yet as the virus spreads, Reeves may find himself dragged into a more expansive response.

On Tuesday, Reeves issued his first stay-at-home order, but in just one county, Lauderdale, where a nursing home has suffered an outbreak. The businesses in Lauderdale County are simply losing customers to surrounding counties and BTW covid doesnt stop at the county line, tweeted the mayor of Tupelo, which is in Lee County.

On Wednesday, Reeves issued a stay-at-home order that encompasses the whole state but which doesn't take effect for another two days. If Mississippis spread becomes severe, Reeves haphazard response will come back to haunt him.

On March 14, Stitt tweeted a picture of his family eating at a restaurant, as if he deserved an award for defying the coronavirus panic. Its packed tonight! he enthusiastically shared, but facing blowback, later deleted the post.

The next day, Stitt declared a state of emergency. Then, the day after that, the governors spokesman said, the governor will continue to take his family out to dinner and to the grocery store without living in fear, and encourages Oklahomans to do the same. Stitt still has not issued a statewide stay-at-home order. In the absence of one, major Oklahoma cities have imposed their own over the past few days.

Two weeks later, Oklahomas rate of infection is intensifying, and testing is minimal. Stitt is not the only governor who has hesitated to implement stiff restrictions, but he may become a case study of the pitfalls of glib social media use in a time of crisis.

You may remember Ige as the governor who, for 17 minutes in 2018, couldnt correct a false warning of an incoming ballistic missile because he didnt know his Twitter password.

Earlier this month, Ige tapped his Lieutenant Governor Josh Green to play a key role in the states response to coronavirus. Green is an emergency room doctor, so his calls for strict travel restrictions and quarantines on arrivals carried great weight. But once Green publicly pushed for strong measures, Ige cut him out of the loop, instructing Cabinet officials not to consult with Green, and keeping Green out of his press conferences.

Hawaii faced an influx of crisis tourists looking to ride out the pandemic in paradise. But as the governor of a tourism-dependent state, Ige hesitated to act. On March 19, the state House speaker, fellow Democrat Scott Saiki, upbraided Ige in a letter, describing the administrations response as utterly chaotic, causing mass confusion among the public.

Ige has now made peace with Green, and recently ordered a 14-day quarantine for arrivals though there was a five-day gap between the announcement and the implementation. A stay-at-home order has been issued, though with exceptions for swimming and surfing. Ige better hope those steps are enough.

Ige isnt the only governor taking heat from his No. 2. Ivey is being shown up by her lieutenant governor, Will Ainsworth.

On March 25, Ainsworth, who serves on Iveys coronavirus task force, wrote a letter to the panels other members. After some perfunctory pleasantries, he lit into them: A tsunami of hospital patients is likely to fall upon Alabama in the not too distant future, and it is my opinion that this task force and the state are not taking a realistic view of the numbers or adequately preparing for what awaits us.

The day after, Ivey sounded a completely different note at a press conference, when she dismissed the idea of a statewide stay-at-home order. Yall, we are not Louisiana, we are not New York sate, we are not California, she said. (Washington Post data journalist Philip Bump warned Ivey that Alabamas caseload was growing faster than Californias.)

Then, at a press conference one day after that, Ivey dumped on Ainsworth, saying he was not helpful in raising challenges and criticism and issues we are aware of, and offering no solutions and showing no willingness to work with the task force and the team willing to fix it. (Ainsworths letter did, in fact, offer solutions regarding health care capacity.)

Ivey, who is not yet term-limited, would turn 78 before the 2022 election. By that time, Ainsworth, who won a separate election for lieutenant governor and did not run with Ivey on a ticket, would be 41, and well-positioned to move into the governors mansion. Perhaps Ivey will just want to retire by 2022. But if she does plan on seeking reelection, she now has to worry about a possible primary challenger who has successfully separated himself from her questionable pandemic response.

Justice is a billionaire political neophyte who won the 2016 gubernatorial election as a Democrat, then, in 2017, switched to become a Republican and a Trump ally. His lack of experience in crisis management has been glaringly obvious from his discordant statements and actions.

On March 16, he was preaching defiance. For crying out loud, go to the grocery stores, Jutice said. If you want to go to Bob Evans and eat, go to Bob Evans and eat. Then, the very next day, he shut down dine-in eating at the states restaurants.

The following Saturday, Justice gave a disjointed address which, according to the Associated Press, featured jumbled sets of numbers that puzzled viewers in their randomness. He warned of dire consequences, but neglected to issue a stay-at-home order. Governor Urges Action, Takes None, read a headline in the Charleston Gazette-Mail the next day. Later that week, Justice finally announced a stay-at-home order.

This wobbly performance is coming at the worst possible time for Justice politically, because he faces a contested party primary for the gubernatorial nomination this spring. (Justice just pushed back the primary from May 12 to June 9.) Justice faces six primary opponents, with the most spirited challenge coming from Justices former Commerce secretary, Woody Thrasher. Justice has been a heavy favorite to date, but a mismanaged crisis can change poll numbers very fast.

CLARIFICATION: An earlier version of this article said Mississippi Gov. Tate Reeves had issued a stay-at-home order only covering one county. As this piece was being edited and produced, he announced a new stay-at-home order covering the whole state. The piece has been updated accordingly.


Read the rest here: Opinion | Coronavirus vs. Governors: Ranking the Best and Worst State Leaders - POLITICO
A Heart Attack? No, It Was the Coronavirus – The New York Times

A Heart Attack? No, It Was the Coronavirus – The New York Times

April 3, 2020

The 64-year-old patient arrived at a hospital in Brooklyn with symptoms looking like those seen in patients having a serious heart attack.

An electrocardiogram revealed an ominous heart rhythm. The patient had high blood levels of a protein called troponin, a sign of damaged heart muscle. Doctors rushed to open the patients blocked arteries but found that no arteries were blocked.

The patient was not having a heart attack. The culprit was the coronavirus.

The Brooklyn patient recovered after 12 days in the hospital and is now at home. But there have been reports of similar patients in the United States and abroad, and the cases have raised troubling questions for doctors.

What should doctors do these days when they see patients with apparent heart attacks? Should they first rule out coronavirus infection or is that a waste of valuable time for the majority of patients who are actually having heart attacks?

Should every coronavirus patient be tested for high blood levels of troponin to see if the virus has attacked the heart?

I dont know what the right answer is, said Dr. Nir Uriel, a cardiologist at Columbia University and Weill Cornell Medicine in New York.

The Brooklyn patient had myocarditis, an inflammation of the heart that has been seen in patients with other viral infections, such as MERS also caused by a coronavirus and the H1N1 swine flu.

But the new coronavirus, called SARS-CoV-2, mostly infects the lungs, causing pneumonia in severe cases. Believing it caused respiratory disease, many cardiologists thought the coronavirus was outside their specialty.

We were thinking lungs, lungs, lungs with us in a supportive role, said Dr. John Rumsfeld, chief science and quality officer at the American College of Cardiology. Then all of a sudden we began to hear about potential direct impact on the heart.

A report on heart problems among coronavirus patients in Wuhan, China, was published in JAMA Cardiology on Friday.

The study, led by Dr. Zhibing Lu at Zhongnan Hospital of Wuhan University, found that 20 percent of patients hospitalized with Covid-19, the illness caused by the coronavirus, had some evidence of heart damage.

Many were not known to have underlying heart disease. But they often had abnormal electrocardiograms, like the patient in Brooklyn, in addition to elevated troponin levels, which sometimes soared to levels seen in patients with heart attacks.

The risk of death was more than four times higher among these patients, compared with patients without heart complications.

The journal also published a report, by doctors in Italy, describing a previously healthy 53-year-old woman who developed myocarditis.

Like the patient in Brooklyn, her electrocardiogram was abnormal, and she had high levels of troponin in her blood. Because of the coronavirus outbreak in Italy, doctors thought to test her and found she was infected.

Dr. Enrico Ammirati, an expert in myocarditis at Niguarda Hospital in Milan who consulted on the case, said the patients heart problems were likely caused by her bodys immune response to the virus.

But so much about this new pathogen is unknown, and it is not yet clear what might cause heart damage following infection.

Myocarditis can likely be caused either by the virus itself, or the bodys immune and inflammatory response to the virus, said Dr. Scott Solomon, a cardiologist at Harvard Medical School.

Infected patients who get myocarditis do not necessarily have any more virus in their bodies than those who do not develop the condition, he said.

It is possible but not yet established that myocarditis results from an immune system that lurches out of control while trying to turn back the coronavirus, pumping out such excessive levels of chemicals called cytokines that cause inflammation that they damage the lungs and the heart alike.

The condition, called a cytokine storm, is more serious in older people and in people with underlying chronic diseases, Dr. Solomon said. It is the primary reason for the severe respiratory complications that can lead to death in patients with the coronavirus.

Cytokines also promote blood coagulation and interfere with the bodys clot-busting system, said Dr. Peter Libby, a cardiologist at Harvard Medical School. Blood clots in coronary arteries can block blood flow and cause heart attacks.

Another possibility, Dr. Libby said, is that some coronavirus patients develop heart problems as a consequence of infections in their lungs.

The lungs are not working, so there is not enough oxygen, he said. That increases the risk for arrhythmias.

At the same time, fever caused by the virus increases the bodys metabolism and the hearts output of blood. The result is that the patients heart must struggle with an increased demand for oxygen but a reduced supply, an imbalance that may lead to heart damage.

But doctors cannot rule out the possibility that the coronavirus directly damages the heart, several experts said.

In Seattle, a patient infected with the virus recently died after experiencing so-called heart block: The electrical signals originating in the top of the organ, which sets the hearts normal rhythm, were not reaching the bottom of the heart.

When that happens, the heart goes into an emergency mode with so-called escape rhythm, which causes it to beat very slowly. The man had underlying lung disease, which worsened his prognosis.

Dr. April S. Stempien-Otero, a cardiologist at the University of Washington, hopes an autopsy will show whether the virus attacked the mans heart.

We thought it was older-person heart block, she said. Then all of a sudden Covid raises its head.

From now on, she said, we have to think, maybe that is what is going on.


Read more: A Heart Attack? No, It Was the Coronavirus - The New York Times
Why ‘Death Rates’ From Coronavirus Have Been ‘Very Confusing’ : Goats and Soda – NPR

Why ‘Death Rates’ From Coronavirus Have Been ‘Very Confusing’ : Goats and Soda – NPR

April 3, 2020

Coffins of deceased people stored in a warehouse near Bergamo a city at the heart of Italy's coronavirus crisis before being transported to another region for cremation. Piero Cruciatti/AFP via Getty Images hide caption

Coffins of deceased people stored in a warehouse near Bergamo a city at the heart of Italy's coronavirus crisis before being transported to another region for cremation.

The coronavirus appears to be much more lethal in some countries than in others.

In Italy, about 10% of people known to be infected have died. In Iran and Spain, the case fatality rate is higher than 7%. But in South Korea and the U.S. it's less than 1.5%. And in Germany, the figure is close to 0.5%.

So what gives?

The answer involves how many people are tested, the age of an infected population and factors such as whether the health care system is overwhelmed, scientists say.

"Case fatality rates have been very confusing," says Dr. Steven Lawrence, an infectious disease expert and associate professor of medicine at Washington University School of Medicine in St. Louis. "The numbers may look different even if the actual situation is the same."

So it's likely that the seemingly stark difference between Germany and Italy is misleading and will diminish as scientists get more data, Lawrence says.

Also, because of the way countries monitor pandemics like the coronavirus, he says, the case fatality rate tends to decrease over time. The reason: When a new disease first shows up, testing usually focuses on severely ill people who are at high risk of dying. Later on, testing is more likely to include people with milder illness who are less likely to die.

That's what happened with West Nile virus, which appeared in the U.S. in 1999. At first, when scientists only knew of about a few dozen cases, it appeared the mortality rate was higher than 10%. But wider testing eventually found hundreds of thousands of people who'd been infected but never got sick enough to notice. Today, more than 3 million Americans have been infected and studies show that fewer than 1% become seriously ill.

If that pattern holds for coronavirus, countries such as Italy, which have been testing only the sickest patients, are likely to see their case fatality rates fall. But countries such as Germany, which has been testing both critically ill people and those with milder symptoms from the beginning, are less likely to see major changes in the case fatality rate.

The U.S. is somewhere in between. Testing was severely limited when cases started to appear. Since then labs have begun testing tens of thousands of people with less severe illness.

A country's case fatality rate is simply the number of deaths (the numerator) divided by the number of infections (the denominator). The problem is, both of these numbers may be unreliable.

For example, when an outbreak begins and health officials aren't looking for the virus, some people may die at home and never be diagnosed. That would lower the numerator and "might lead to an underestimate of the case fatality rate," Lawrence says.

But a much more likely scenario, he says, is that early in an outbreak, testing is limited to people who are so sick they wind up in the hospital. That means the only infections that get counted are in the people most likely to die. So the denominator is missing a huge number of infected people who survive, and that makes the virus appear much more deadly than it really is.

This is probably one reason that early death rates in China appeared so high, says Gerardo Chowell, a professor of epidemiology and biostatistics in the department of population health sciences at Georgia State University. Chowell is part of a team that has been using statistical modeling to study the outbreak in China and South Korea.

When cases started showing up in the city of Wuhan, Chinese health officials "were obviously caught by surprise" and lacked the ability to test many patients, Chowell says. So testing was restricted to the sickest people. That probably contributed to early evidence that the fatality rate in Wuhan was 4% or more.

A study published last week estimated that in Wuhan, the chance that someone who developed coronavirus symptoms would die was actually 1.4%.

In South Korea, though, "they have been doing massive testing" since the first cases were detected, Chowell says. As a result, that nation has been able to count infected people with mild symptoms as well as those who become severely ill. That may be one reason the case fatality rate in South Korea has remained below 2%.

Another factor affecting coronavirus fatality rates is the characteristics of the population that is infected at any given moment, says Mary Bushman, a postdoctoral researcher at Harvard's Center for Communicable Disease Dynamics and an author of the Wuhan study.

In Washington state, Bushman says, the first cases appeared in nursing home residents, who tend to be extremely vulnerable to the disease. That produced "an alarming number of deaths being reported," Bushman says. At one nursing home, 34 of 81 infected residents died, which is a case fatality rate of 42%.

But as Washington began testing for the virus outside the nursing home, it became clear the case fatality rate in the general population was vastly lower.

And across the U.S., as testing has expanded to include younger and healthier segments of the population, the fatality rate has decreased to levels similar to those in South Korea. "And I think we'll probably continue to see further decreases," Bushman says.

Differences in testing aren't the only reason that case fatality rates vary, though. In some countries, infected people have been more likely to die because the health care system has been overwhelmed, leaving critically ill coronavirus patients without access to lifesaving care, Chowell says.

In Wuhan, he says, high case fatality rates early on were probably caused in part by the inability of local hospitals to handle the huge influx of patients sick with the coronavirus.

An overburdened health care system may also be contributing to the high case fatality rate in Italy. "During those high peaks where the health care systems can be overwhelmed, there may not be enough people or ICU beds or ventilators to be able to provide the critical care that is needed," Lawrence says.

Ultimately, it will take a different sort of test to assess how lethal coronavirus has been, Lawrence says. Most current tests only detect active infections when the virus is still present in the body. But a different type of test now being developed but still probably months away from wide use can reveal whether a person has ever been infected. And that is what scientists need to know to establish the true denominator for coronavirus and to find the true case fatality rate.

In the U.S., it's likely that the case fatality rate from coronavirus will end up somewhere between 0.5% and 1%, once a broad cross-section of the population has been tested, Lawrence says.

But that's no reason for the nation to relax, he adds.

"To put it into perspective, that's 5 to 10 times more fatal than flu," Lawrence says, a disease that kills between 12,000 and 61,000 people a year.


Go here to see the original:
Why 'Death Rates' From Coronavirus Have Been 'Very Confusing' : Goats and Soda - NPR
Tests of potential coronavirus vaccine spur growth of virus-fighting antibodies – USA TODAY

Tests of potential coronavirus vaccine spur growth of virus-fighting antibodies – USA TODAY

April 3, 2020

A potential vaccine for COVID-19 has been developed and tested successfully in mice, researchers reported Thursday.

"We'd like to get this into patients as soon as possible," said Andrea Gambotto, associate professor of surgery at the University of Pittsburgh School of Medicine and co-author of a paper announcing the vaccine in the journal EBioMedicine.

As far as reaching clinical trials,"we would like to thinka month, give or take. Maybe two months. We just started the process," said co-author Louis Falo, a professor and chairman of the Department of Dermatology at the University of Pittsburgh.

Thursday'sannouncement, more than three months into a pandemic that has killed 50,000 people and sickened almost 1 million worldwide, presents an urgent challenge to government regulators, who must weigh how much to speed up the vaccine approval process.

Plasma: The first US coronavirus patients are being treated with convalescent plasma therapy.

'Its time to save people': Synagogue members who had coronavirus donate blood to help others

Vaccinesoften take years to receive approval from the U.S. Food and Drug Administration. Yet on March 16, the first four healthy volunteersin Seattle received adifferent potential COVID-19 vaccine, made by a company called Moderna and administered in a small clinical trial at Kaiser Permanente Washington Health Research Institute.

Though the vaccine being tested in Seattle uses a new, faster but untested technology,the one developed in Pittsburgh employs the sametechnique used influ shots. The Pittsburgh vaccine uses lab-made viral proteinto builda person's immunity to the virus.

Tests in mice found that the vaccine spurred a wave of virus-fighting antibodies within two weeks.

"There are many, many vaccine candidates in various stages of testing," saidDavid O'Connor, professor at the University of Wisconsin School of Medicine and Public Health, who saw the published paper for the first time Thursday.

O'Connor saidshowing that a vaccine generates an immune response is"an important first step in determining which vaccines should move forward, but is only the first of many steps along the way to a useful vaccine. This paper shows some of this 'first step'data."

The potential COVID-19 vaccinefollows up on researchGambottoand Falo did in December 2003 when they were poisedto proceed to clinical trials with a vaccine for another coronavirus, Severe Acute Respiratory Syndrome. At the time, the journal Nature reported, "SARS vaccines speed toward clinic."

But the outbreak had already waned. The World Health Organization declared SARS contained in July 2003.

Funding for the SARS vaccine vanished.

"SARS CoV-2 is teaching us that it is important to react and (follow) all the way through," Gambottosaid. "Yes, it was a mistake not to test the vaccine back then."

Some scientists suggested that a vaccine for one coronavirus would probably have offered at least some protection from all of them.

The Pittsburghresearchers developed a vaccine to treat Arabian camels for another coronavirus, Middle East Respiratory Syndrome (MERS). Like SARS and COVID-19, MERS jumped from animals to people,infectingalmost 2,500 andkilling almost 860 since its discovery in 2012.

Gambotto saidtheyadapted techniques they had developed for previous coronavirusesto create one specifically designed for the virus that causesCOVID-19; theprocess of translating their work foruse onCOVID-19took the scientists 10 to 12 days. They collaboratedwith11 other scientists, including two from Erasmus Medical Center in Rotterdam, the Netherlands.

Gambotto and Falo said theirvaccine would be delivered to the upper armbut would not requirea shot from a needle asthe flu vaccine does.

The scientists developed a fingertip-sized patch that contains 400tiny needles, each just half a millimeter. The two scientistscompared the patch to a Band-Aid and said it would feel a lot like having Velcro pressed against the skin.

The needles, made from sugar and protein pieces, would penetrate the upper level of skin, absorb moisture from the skin and release molecules. The molecules would prompt the immune system to makeantibodies thatattack the virus.

The Pittsburgh researchers touted two advantages tothevaccine they call PittCoVacc.

US state coronavirus curvesshow many could be close behind New York

Your coronavirus questions, answered: Are malaria meds working? Is there relief for landlords? How many people have recovered?

The vaccine does not have to be frozenwhen stored or transported; it can sit atroom temperature. That wouldmake the vaccine much cheaper to deliver to poorer countries.

Though the researchers could not say exactly how much a dose of the vaccine would cost, they estimated that the patchof needles used to deliver the vaccine would probably cost less than $10 apatch.

The technique employing the tiny needlesreleases a highly concentrated, much smaller amount of viral protein. The scientists said a single person would be able to make hundreds of vaccine patches a day.

The vaccine was developed without using the live virus that causes COVID-19. Scientists used DNA molecules made in the lab.

When released from the patch, the vaccineexploits the crucial part of the virus that latches onto human cells, the Spike protein.

The virus' Spike protein usually acts like a key opening up human cells and allowing the virus to invade. The vaccine acts a little like gum in a lock, preventing the key from working and keeping the virus from entering human cells.

Early in the pandemic, health officials took pains to stress that a vaccine would probably take18 months to develop, test and be ready for human use. Whether the first vaccines will take that long to reach people is not known, and many scientists greetnew reports such as the one from Pittsburgh with caution.

O'Connor, from the University of Wisconsin,stressed that vaccine makers have been forced by the urgency of fighting a pandemic to move when "there is much that we don't know about this virus." In particular, it's unknownhow long a person has immunity both natural immunity from having fought the virus and survivedand theimmunity inducedby vaccines.

"Dovaccines last for months? Years? An entire lifetime?" he asked.

Scientists have been working furiously to develop two possible treatment methods: the use of plasma from recovered COVID-19 patientsand drugs that have been found safe for use in people, such as the anti-malarial chloroquine.

Hospitals have begun using survivorplasmaon a compassionate, experimental basis.

Follow Mark Johnson on Twitter:@majohnso

Autoplay

Show Thumbnails

Show Captions

Read or Share this story: https://www.usatoday.com/story/news/health/2020/04/02/researchers-develop-potential-coronavirus-vaccine/5112675002/


More here:
Tests of potential coronavirus vaccine spur growth of virus-fighting antibodies - USA TODAY
The race is on for coronavirus vaccines and treatments: current R&D status – The Pharma Letter

The race is on for coronavirus vaccines and treatments: current R&D status – The Pharma Letter

April 3, 2020

Since the first reports of coronavirus (COVID-19) in Wuhan, China in December 2019 there have been more

To continue reading The Pharma Letter please login,subscribeorclaim a 7 dayfree trial subscriptionand access exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space.

Or, if you're only interested in reading the content about a specific topic (generics, biosimilars, coronavirus/COVID-19, digital pharma, Asia Pacific), then you can take our 10 per month channel subscription offer, which gives you access to all our news articles and in-depth content on this subject.


See the article here: The race is on for coronavirus vaccines and treatments: current R&D status - The Pharma Letter
Why A Coronavirus Vaccine May Be Years Away – The National Interest

Why A Coronavirus Vaccine May Be Years Away – The National Interest

April 3, 2020

Jacob Heilbrunn: How does the COVID-19 crisis end?

Paul Offit: German chancellor Angela Merkel said it best: We need to get to a doubling time of longer than ten days. The number of hospital admissions and deaths caused by COVID-19, those doubling intervals, is more than ten days. For example, on March 26 we had one thousand deaths; on March 28, two thousand. Thats a doubling time of two days. By April 1 we had four thousand deaths. That means we had a doubling time of four days. If you can get to a ten-day doubling time, it is likely that hospital discharges will exceed admissions and you can say that you accomplished what you wantedno longer overwhelming the healthcare system. Thats what you are worried aboutnot that you cant take care of these patients, but that you cant take care of any patients.

Once you get there, things can loosen up and you can go back to work even though there still may be cases and deaths. But that is not the goal. The goal is to not overwhelm the health system and allow us to go back to work. When do we get there? Im going to predict that by the end of April, things start to look better and we start to see a gradual increase in our doubling times.

Heilbrunn: Do you think we are likely to reach the high end of the predictions of deaths? Or is that just unknowable?

Offit: Its surprising, isnt it? We know that lockdowns, or sheltering in place, works. China, Singapore, Japan, and South Korea were all able to pretty much end the spread of this virus while knowing that therehad to be tens of millions of people in those countries who were still susceptible. Yet still, they were able to end itthats a good sign.

Now Vice President Mike Pence has said that he thinks we are mimicking Italy. Italy has 13,000 deaths right now and they are roughly one-fifth our size. That would come out to 65,000 deaths, but they are predicting as many as 240,000 deaths. Which means that Italy would have to have 50,000 deaths, for us to be Italy. Its just surprising that it could get that bad; even though Italy is still suffering deaths, it looks like their doubling time is about eight days. So it should be coming off this curve and I dont see this 240,000 death estimate. I dont see that. But they are also close to the data, so they could be seeing something Im not.

We did many things wrong. We were slow to ban travel from China. We were very slow to do testingSouth Korea had already done 150,000 tests by the time we had done fewer than 500. We were slow to lockdown. We had a president who, if anything, tried to play this down: We've got it under control, its only a few cases, dont worry about it. And we were very slow to supply protective gear, ventilators, etc. so people were not getting the care they need or being protected in the manner they need to be. So weve done a lot of things wrong. As a consequence, we are doing worse than most countries.

Heilbrunn: So you would have banned travel from China earlier? President Donald Trump keeps bragging that he did it quickly.

Offit: Right, but if you look a little more closely at how that played out, he had to be convinced to do that. He didnt want to offend his friend President Xi [Jinping]. China was not a good actor here. We should not have had to have a whistleblower to tell us that there was a novel virus that was killing people in Wuhan. They should have been quick to tell the world that this was going on so the world could prepare for it. They didnt do that. But the moment it did become clear, Trump was very slow to ban travel. But once the virus was here, once there was community spread, it didnt really matter.

You can make the same case for what is happening in New York. We were pretty slow to ban travel from Europe, when clearly there were problems in Spain, Italy, and France. I suspect that may be the reason that New York suffers so much nowthere was a lot of travel from COVID-heavy territories, regions, or countries, coming into LaGuardia, coming into JFK.

Heilbrunn: You were the co-inventor of the rotavirus vaccine. How critical do you think it is that we develop a vaccine against the coronavirus? Or do you think the virus will largely burn itself out?

Offit: We certainly should not assume that it will burn itself out. We should make a vaccine as quickly, efficiently, and safely as possible. There is some good news about the vaccine. Human trial studies done decades ago show that if you are inoculated with one of the four strains of human coronavirus that circulates in our country every year and are challenged with that virus a year later, you are protected. Good. That means that there is protectionits probably years, not decadesbut thats a good sign. You also know which protein you are interested in. You are interested in that spike proteinthe glycoproteinthats the protein that attaches to cells. If you can prevent the virus from attaching to cells, then you cant get infected. And we live in an age of recombinant DNA technology where we can make that protein itself in a manner similar to the Hepatitis-B or HPV vaccine, or we can use either messenger RNA or DNA vaccines that express that protein.

So the messenger RNA approach is the one being used by Moderna and that is already in the human trials that Dr. Anthony Fauci has talked about. But they are really at the beginning of this process. You still dont have an immunological correlate of protection; you still dont really have a dose. The forty-five people who are being tested in Washington state have been divided into three groups of fifteen and each given a different dose. They started with a low dose, then they moved to a middle dose, and now they are moving to a higher dose. But thats only fifteen people in each group. Really, to do this right, you would need thousands of people to make sure you are giving the right dosenot too much or too little. I presume that they will move to that, but it takes time.

Heilbrunn: What is a realistic timeline for a vaccine?

Offit: You want to make sure that a vaccine induces an immune response that you think will be safe. Im assuming that they are not doing animal-model studies because it seems that they moved very quickly to human trials. It would have been nice to do animal-model studies. While mice arent bad, they do give you hints to what could be potential safety problems. But it looks like that is not happening.

When you are where they are nowwhich is about forty-five people testedyou do need to gradually expand that to thousands of people at the dose you think youre looking at and make sure a significant percentage of the population is receiving that, and that that population represents the U.S. population. You want those people to develop an immune response that would protect them, even though you dont, right now, have immunological correlate protection. We dont know that, because we arent doing animal studies and we obviously arent doing human trial studies with this virus. Then you would need an efficacy trial, and that would best be done on healthcare workers.

Healthcare workers are the ones who are most likely to come in contact with COVID-19 patients, both by frequently being in contact and in close contact with them because they have to examine them. That would probably be the group with which to do an ethicaltrial, but that takes time. That takes years. For us, in the development of the Rotavirus vaccine, that took sixteen years before we got to the large, definitive, phase three trial. That was a placebo-controlled, prospective, eleven-country, four-year, $350 million trial, on 70,000 babies. That was a definitive phase three trial.

My sense is that they are moving along in this break the glass mode, which is to say that they will use fewer people in these studies and may bypass the FDA. They might just move to offer this. That said, to put this in perspective, Dr. Fauci is certainly right. The mRNA approach is very quickly scale-uppable. You can make very large numbers, remember you are talking about making billions, hundreds of millions of doses. But the mRNA still needs to be delivered in this complex lipid delivery system, which is not so easy to scale up. It could take a year to just scale up that part of it. And the filling takes time. Even if they use multi-dose vials, the filling alone could take a year. So, I dont see eighteen monthsDr. Fauci could see something I dont here, he is certainly closer to itbut I think eighteen months is a very, very, very optimistic timeline.


More:
Why A Coronavirus Vaccine May Be Years Away - The National Interest