Covid-19 Live Updates: Antibody Treatment Given to Trump Gets F.D.A. Emergency Approval

17 min readNov 22, 2020

New York City and New York State differ on how they measure the crucial threshold of 3 percent positivity. Unlike the rest of the U.S., Hawaii has seen a decline in infections. South Korea and Japan face surges.

The Food and Drug Administration has granted emergency authorization for the experimental antibody treatment given to President Trump shortly after he tested positive for the coronavirus, giving doctors another option to treat patients as cases across the country continue to rise.

The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies that have shown promise in early studies at keeping the infection in check, reducing medical visits for patients who get the drug early in the course of their disease. A similar treatment, made by Eli Lilly, was given emergency approval earlier this month.

The emergency authorization for Regeneron’s drug is limited in scope: It is for people who have tested positive for the coronavirus and who are at high risk for developing severe Covid-19. And evidence so far suggests that Regeneron’s antibody treatment, like Eli Lilly’s, works best early in the course of the disease, before the virus has gained a foothold in the body. Like Eli Lilly’s treatment, Regeneron’s is not authorized for use in people who are hospitalized or who need oxygen.

The emergency authorization raises immediate questions about who will get access to the treatments. An average of more than 168,000 coronavirus cases are reported each day in the United States, and hospitals are running out of beds in some regions of the country. Regeneron has said it will have enough of the drug for only about 80,000 people by the end of November, enough for 200,000 patients by the first week of January, and 300,000 by the end of January. After that, the company said it would be able to ramp up production thanks to a partnership with the Swiss manufacturer Roche.

Regeneron has received more than $500 million from the federal government to develop and manufacture the treatments. Although the first 300,000 doses will be provided for free, patients may be charged for having the treatment administered; it must be infused in a clinic or a hospital.

Antibody treatments have gotten less attention than vaccines, but health officials have long held out hope that they may serve as a possible bridge until a coronavirus vaccine is more broadly available. Two vaccines, one made by Pfizer and another by Moderna, were recently shown to be more than 90 percent effective in early analyses. Pfizer, which has completed its trial, submitted an application on Friday for emergency authorization of the vaccine, and Moderna said it also planned to apply soon. Still, it will take weeks for the F.D.A. to consider the applications, and if it issues approvals, access will be limited to people in high-risk groups.

Dr. George D. Yancopoulos, Regeneron’s president and chief scientific officer, said in a statement that he was encouraged by the recent vaccine results, but “there remains a need to treat patients who develop Covid-19, especially as some may not have had access to or were not protected by vaccination.”

Regeneron enjoyed a burst of publicity in October, when Mr. Trump received an infusion of its cocktail and then enthusiastically promoted the drug as something that had lent him a superpower-like feeling. In a video released on Oct. 7, the president claimed without evidence that it had cured him, and that he had authorized it — something he does not have the power to do.

It remains impossible to know whether the Regeneron treatment helped Mr. Trump. He was given multiple drugs while at Walter Reed National Military Medical Center, and many people recover from the virus on their own.

This month, two very different companies — the pharmaceutical giant Pfizer and the biotech upstart Moderna — reported spectacular results from high-stakes clinical trials of their experimental coronavirus vaccines. It was a remarkable feat: developing a vaccine that appears safe and effective in a matter of months, rather than the years or decades that such developments usually take.

A team of Times reporters — Sharon LaFraniere, Katie Thomas, Noah Weiland, David Gelles, Sheryl Gay Stolberg and Denise Grady — tracked how the extraordinary race unfolded, with so much at stake and such a complex backdrop. At play were not just commercial rivalries and scientific challenges but an ambitious plan to put the federal government’s Operation Warp Speed — and an often toxic political atmosphere created by President Trump — in the middle of the effort.

Pfizer’s chief executive, Dr. Albert Bourla, had vowed to avoid the political minefield but was forced to maneuver through it nonetheless. After promising a timetable that seemed to support Mr. Trump’s prediction of a breakthrough before Election Day, Dr. Bourla pushed back the schedule in late October, fearing his firm’s clinical trial results would otherwise not be convincing enough for federal regulators to grant emergency approval of its vaccine.

Dr. Bourla had chosen from the start to keep Pfizer and its research partner, the German firm BioNTech, at arms length from the government, declining research and development money from Operation Warp Speed.

But Pfizer’s main rival, Moderna, made the opposite bet, embracing the assistance of a government led by a science-denying president. Moderna got nearly $2.5 billion to develop, manufacture and sell its vaccine to the federal government and teamed up with the National Institutes of Health on the scientific work, a highly successful partnership that managed to sidestep the political meddling by Mr. Trump and his aides that had bedeviled other efforts to confront the virus.

Both companies were aided by a confluence of three factors. A new method of developing vaccines was already waiting to be tested, with the coronavirus a perfect target. Sky-high infection rates accelerated the pace of clinical trials, the most time-consuming part of the process. And the government was willing to spend whatever it took, eliminating financial risks and bureaucratic roadblocks and allowing mass production to begin even before the trials were done.

Their apparent success showed that in an era of polarized politics, science was able to break down barriers between government, countries and industry to produce one of the few pieces of good news in a year of suffering and division.

With coronavirus cases rising in every other state, Hawaii stands alone with a gradual decline in new cases in November.

Hawaii is averaging 80 cases per day on its collection of islands, a decrease of about a quarter from two weeks earlier. Hospitalizations have fallen by a similar amount.

So how has Hawaii managed to keep its caseload in check?

“Being surrounded by ocean has helped,” said Brooks Baehr, a spokesman for the Hawaii State Department of Health. “Hawaii has more control over interstate and international travel than other states.”

The recent decline in Hawaii cases has come amid an influx of several thousand more daily visitors since the authorities removed a 14-day quarantine requirement for travel to the state in mid-October. Rather than quarantining, everyone entering Hawaii must now obtain a negative test result from a verified lab in the 72 hours before arriving.

The restrictions have helped slow the travel-related rates of the coronavirus — most cases are from community spread — but they have come at a steep cost. Hawaii’s tourism industry, which accounts for 21 percent of the state’s total economy, has all but come to a standstill. In the first nine months of 2020, visitor arrivals were down 71.6 percent compared with the same period a year ago.

For residents, this meant many businesses closed and jobs lost. In the particularly fraught seven-week period between late March and early May, new unemployment claims averaged more than 30,000 per week; the same period in 2019 had a weekly average of around 1,200.

With cases exploding across the mainland and in other parts of the world, Hawaii is once again bolstering its protections.

Starting Tuesday, if an inbound air traveler’s negative test result is not available before boarding — even if that is because of a laboratory delay, as has often been the case lately — a quarantine becomes mandatory.

Also last week, Gov. David Ige issued the first statewide mask mandate, which requires everyone over age 5 to wear a face covering in public or risk penalties that include a $5,000 fine or up to a year in jail.

Senator Kelly Loeffler of Georgia, a Republican who is campaigning in a high-stakes runoff election that could determine control of the Senate, is isolating after receiving both a negative and positive test for the coronavirus on Friday and then receiving an inconclusive result on Saturday, a campaign spokesman said.

Ms. Loeffler has worn masks while interacting with people, but was indoors and unmasked among unmasked crowds at an event on Thursday. She wore a mask while greeting voters who lined up to meet her.

On Friday morning, she took two coronavirus tests, according to her campaign spokesman, Stephen Lawson.

One of those was a rapid test, which came back negative, and Ms. Loeffler “was cleared to attend” events on Friday, including a rally with Vice President Mike Pence and Senator David Perdue of Georgia, Mr. Lawson said. But the second test, a polymerase chain reaction, or P.C.R., test — which is considered more accurate — came back with a positive result after her events on Friday evening, he said.

Ms. Loeffler, 49, was tested once again on Saturday morning and received an “inconclusive” result on Saturday evening, Mr. Lawson said.

The senator followed C.D.C. guidelines by notifying those with whom she had had sustained contact while she awaits further test results, he said.

Ms. Loeffler has held recent events with prominent Republicans, including Mr. Pence, Senator Tom Cotton of Arkansas and Mr. Perdue, who is also engaged in a runoff election that could determine control of the Senate.

“She has no symptoms and she will continue to follow C.D.C. guidelines by quarantining until retesting is conclusive and an update will be provided at that time,” Mr. Lawson said in a statement.

Ms. Loeffler, a businesswoman who is the Senate’s richest member, was temporarily appointed to her Senate seat late last year. She faces the Rev. Dr. Raphael G. Warnock, a Democrat, in an election on Jan. 5, when Georgia voters will also decide between Mr. Perdue and his opponent, Jon Ossoff, a Democrat.

A 3 percent positive rate in coronavirus testing is a critical threshold for New York City. It is the point at which the mayor shut down public schools last week. The governor says that a sustained 3 percent level in the city will result in banning indoor dining, closing gyms and hair salons, and placing a 25-person cap on attendance at houses of worship even as the holidays approach.

But as important as that 3 percent rate is, it seems the city and the state can’t agree on whether it has been reached.

That conflict has played out over the past week, with Mayor Bill de Blasio saying 3 percent has been breached, while Gov. Andrew M. Cuomo said the positive test rate was well below that. Each relies on his own statistics, which are compiled and reported in different ways. And, it turns out, the state and city also can’t agree on which tests to include in the calculation.

The discrepancy can be striking: On Saturday, for instance, the city said its seven-day average was 3.11 percent. Mr. Cuomo’s office, however, put the city’s rate at more than half a point lower, at 2.54 percent.

It is the latest discordant message between two rivals that has played out over the entire pandemic, adding a level of dysfunction and confusion to the response.

The cause of the discrepancy lies in both the tests that are included and the time frame in which statistics are reported. The state treats a new case as arising on the day the test result comes in. The city dates each new case to when the sample was provided.

So if an infected person is tested on Monday and the result is reported to the health authorities on Wednesday, the state would include the positive test in Wednesday’s tally of new cases, while the city would add it to Monday’s column.

Because the 3 percent threshold is based on a seven-day rolling average, it matters which day a new case is registered.

Another factor: antigen tests, while generally faster, are less likely to detect an infection in people with a low viral load. New York State includes antigen test results in its official metrics. The city does not. It relies only on the more sensitive test known as a polymerase chain reaction. That’s why the state — which is counting both antigen and P.C.R. tests — may have a higher tally for overall cases in New York City but a lower percentage of positives.

This year, as they prepare to let turkeys brine and pie crusts thaw, people across the country are waiting for something extra: a coronavirus test they hope can clear them to mingle with loved ones.

Because a positive test filters out people who should definitely not be out with others, many people consider a negative coronavirus test to be a ticket to freely socialize without precautions. But scientists and doctors say this is dangerously misguided.

The main reason is that a test gives information about the level of the virus at the time of the test. A person could be infected but not have enough virus for it to register yet. Or, a person may become infected in the hours or days after taking a test. Also, the tests do not have 100 percent accuracy.

“If you require all of your guests to email you a negative test result before your Thanksgiving dinner, it will definitely decrease the risk of an outbreak — but not completely,” said Dr. KJ Seung, chief of strategy and policy for the Covid response at Partners in Health. Yet this is a common misperception contact tracers hear when talking to people, he said.

Laboratory tests that rely on a technique called polymerase chain reaction, or P.C.R., can detect the virus when it’s present even at very low levels. But it might take a couple of days to return results, leaving time for someone to be exposed.

Antigen tests are faster, less expensive and more convenient — they can deliver results in a matter of minutes — but are also more prone to missing the virus when it’s scarce. And that could give someone a false sense of security en route to Thanksgiving dinner, said Paige Larkin, a clinical microbiologist at NorthShore University HealthSystem in Chicago, where she specializes in infectious disease diagnostics.

“A negative result is a snapshot in time,” Dr. Larkin said. “It’s telling you that, at that exact second you are tested, the virus was not detected. It does not mean you’re not infected.”

In summary, as Dr. Esther Choo, an emergency medicine physician and a professor at Oregon Health and Science University, put it: “Testing negative basically changes nothing about behavior. It still means wear a mask, distance, avoid indoors if you can.”

Whether behind the cash register, stocking milk or unloading shipments of toilet paper, grocery store employees have for months been risking their safety to earn a paycheck and make necessities available to Americans, even as the hazard pay that some companies once offered has dwindled and government benefits dry up.

But as more workers fall ill, more supermarkets may be forced to close. In New Mexico this month, health officials have ordered 23 stores and restaurants to close for two weeks because of sick workers.

Walmart, Albertsons, Target and McDonald’s stores have all been affected. Some have stayed open after being ordered to close, The Albuquerque Journal reported. And in some places, lines are growing.

“I think everybody’s a little like, ‘Oh no, we got to go get our groceries. Everything’s going to close down,’” Anna Hagele told the newspaper. She was waiting in line with about 40 other people outside of an Albertsons.

Gov. Michelle Lujan Grisham, a Democrat, defended the unpopular closures at a virtual news conference this week. Some shoppers have complained to the local news media about long lines of panicking buyers at the stores that remain open.

“You can’t have a grocery store or another big box store that sells groceries if all of their employees — or the vast majority of them — have Covid,” Ms. Lujan Grisham said. “There’s so much of this infection that it’s inside the very places need to access.”

The state is ordering shops to close for two weeks if they have four separate instances of an employee testing positive for the virus in a two-week period. At least 14 businesses are under closure orders, including some which will not be allowed to reopen until Dec. 2.

A sharp jump in virus cases in New Mexico — the number of average cases reported each day this week is up 127 percent from the week before — has led the state to issue some of the tightest restrictions of any state in recent weeks.

The latest wave of the coronavirus has inundated Europe after a summer in which many of its countries appeared to have brought the pandemic under control more effectively than the Americas did.

The tide in Europe appears to have crested in recent days, but not before setting records that prompted another series of shutdowns and, for the first time since the spring, stretching hospitals to their limits. And the struggle there against the virus is far from over.

From late September to early November, the rate of new cases reported across the continent quintupled, to about 300,000 a day, accounting for about half the global total, before declining a bit, according to data compiled by The New York Times and the European Centre for Disease Prevention and Control. Deaths have shot up from about 700 a day to almost 5,000, and a clear pattern of receding has yet to emerge. Hospitalization numbers have begun to flatten, but at a level that is nearly as high as the spring peak.

As recently as late August, Austria and the Czech Republic each had fewer than 30 Covid-19 patients in intensive care units. Earlier this month, they reported record highs — 599 in Austria and 1,244 in the Czech Republic. Belgium had fewer than 60 Covid-19 intensive-care patients in early September; that figure peaked two months later at 1,474. Those numbers are now receding in all three countries.

When the first wave peaked in April, it was concentrated in a few western European countries, but the latest crisis has struck nearly every part of Europe, including countries that were largely spared in the spring.

While some countries are showing progress, many — including Italy, Poland, Portugal, Switzerland and Austria — are recording new cases and Covid-19 deaths faster than the United States, relative to their populations. Many others, including France, Britain, Spain, Romania and Belgium, have lower case rates but higher fatality rates.

Montenegro is leading the world with the highest daily average of cases per person, according to Times data, which shows a global top 10 of entirely European countries. Montenegro is under a two-week curfew, with citizens barred from leaving their homes from 11 p.m. to 5 a.m. except for essential work and needs.

On Friday, Patriarch Irinej, the leader of the Serbian Orthodox Church, died of Covid-19, the church confirmed, after he attended a funeral in neighboring Montenegro for the country’s senior bishop. Thousands were in attendance, many of whom are shown unmasked in a video.

Almost a third of Portugal’s total cases have come in the last two weeks, the number rising to more than 250,000 from just over 170,000 on Nov. 7.

On Saturday, Prime Minister António Costa of Portugal said the country would restrict domestic travel around two upcoming national holidays, on Dec. 1 and Dec. 8, Reuters reported. Travel between municipalities will be banned from 11 p.m. on Nov. 27 to 5 a.m. on Dec. 2, and from 11 p.m. on Dec. 4 to 5 a.m. on Dec. 9. Schools will also be closed the Mondays before both holidays, and businesses will be required to close early.

In Britain, Prime Minister Boris Johnson has continued to quarantine after coming into contact last week with a lawmaker who had tested positive for the coronavirus.

Mr. Johnson, who had the virus in March, announced on Oct. 31 that tough measures would be ordered in England, including shutting down pubs and retail shops while allowing restaurants to serve only takeout food. The measures are set to expire on Dec. 2 and will be replaced with a tiered regional system, in which each tier carries a different set of restrictions. Mr. Johnson is set to announce details of a “Covid winter plan” on Monday.

But speaking at the Group of 20 summit in Riyadh, Saudi Arabia, European leaders stressed the need for a global response to the pandemic, not one that focuses just on the needs of wealthier countries like theirs.

President Emmanuel Macron of France warned against “a two-speed world where only the richer can protect themselves against the virus and restart normal lives.”

As more countries return to shutdowns, governments are straining to find ways to support furloughed and unemployed workers, and to keep restaurants and other businesses from going bankrupt. This week, in an extraordinary move, the European Central Bank all but promised to unleash new relief measures by December at the latest.

A team of researchers at the University of Washington has designed and built from scratch a molecule that, when pitted against the coronavirus in the lab, can attack and sequester it at least as well as an antibody does.

The researchers call the molecule a “mini-binder” for its ability to stick to the coronavirus. When spritzed up the noses of mice and hamsters, it appears to protect the animals from becoming seriously sick.

Because of its engineering, the mini-binder can also withstand wide variations in temperature, making it extremely convenient, unlike antibodies that must be kept cold to preserve longevity.

The product is still in early stages of development, and will not be on the market any time soon. However, researchers said that it looked promising. Eventually, healthy people might be able to self-administer the mini-binders as a nasal spray, and potentially keep any inbound coronavirus particles at bay.

Researchers at Neoleukin, a biopharmaceutical company in Seattle, have also created a molecule that is a smaller, sturdier version of the human protein ACE-2 — one that has a far stronger grip on the virus, so the molecule could potentially serve as a decoy that prevents the pathogen from infecting human cells.

In a series of experiments described in a Neoleukin paper, the research team misted its ACE-2 decoy into the noses of hamsters, then exposed the animals to the coronavirus. The untreated hamsters fell dangerously ill, but animals that received the nasal spray fared far better.

The two machine-made molecules present a more affordable option to synthetic antibodies, which can cost thousands of dollars, said Lauren Carter, one of the researchers behind the University of Washington’s project.

Coronavirus cases are climbing quickly in Japan and South Korea, two countries that have managed to avoid the worst of the pandemic.

Japan has had its worst-ever jump in new cases, breaking records on four consecutive days, with at least 2,508 new cases on Sunday. Its previous worst spike dropped off after peaking at nearly 2,000 cases in early August.

On Saturday Prime Minister Yoshihide Suga announced that government-funded domestic travel stipends intended to help kick-start the economy would be suspended for some of the hardest hit areas of the country.

South Korea has had a smaller increase, with five straight days of more than 300 cases. Last week new restrictions were announced for Seoul and surrounding areas, including limiting the number of people in mass events such as concerts, conferences and festivals to 100.

South Korea was particularly hard hit at the beginning of the pandemic in February and March. On March 1 it peaked at more than 1,000 new cases. Since then the country has earned praise for bringing its outbreak under control, before enduring another surge in late August.

A South Korean health official warned that the latest surge could become the county’s worst if it is not quickly brought under control.

“We are at a crossroads as we experience a huge nationwide wave that may outclass the previous tides,” Lim Sook-young, a Korean Disease Control and Prevention Agency official, said Saturday, the Yonhap News Agency reported.

More than 500 people have died in the outbreak in South Korea this year.

Covid-19 Live Updates: Antibody Treatment Given to Trump Gets F.D.A. Emergency Approval

Written by Week 12