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U.S. Awaits F.D.A.’s Green Light for Johnson & Johnson’s Vaccine

https://www.nytimes.com/live/2021/02/27/world/covid-19-coronavirus

Doses of Johnson & Johnson’s vaccine in a refrigerator at a hospital in Klerksdorp, South Africa.
Credit…Phill Magakoe/Agence France-Presse — Getty Images

The Food and Drug Administration is expected to formally approve Johnson & Johnson’s Covid-19 vaccine on Saturday, making a third shot available in the United States.

The vaccine will be the first of the approved vaccines to require one dose instead of two. Shipments are expected to start within days, adding to the effort already underway to administer millions of doses of the Pfizer-BioNTech and Moderna vaccines.

“We’re going to use every conceivable way to expand manufacturing of the vaccine — the third vaccine — to make even more rapid progress at getting shots in people’s arms,” President Biden said on Friday in Houston, where he had traveled to showcase the government’s latest mass vaccination site.

The shots can’t come fast enough.

As Saturday dawned, the United States had recorded about 28.5 million coronavirus cases — representing more than 8 percent of the population — and a staggering 510,373 deaths. And it will be many weeks before vaccinations make a dent in the pandemic. Meanwhile, the virus has been mutating, creating variants that may partly sidestep the immune system.

Daily case numbers are about where they were in October, far below the single-day record of about 300,000 infections set in early January. And daily vaccination numbers have started to increase again after a decline brought on by severe weather.

Yet federal health officials warned impatient governors against relaxing pandemic control measures, saying that the recent steep drop in cases and deaths could be leveling off.

The seven-day average for new cases — 69,483 as of early Saturday — has been ticking up. Progress has largely stalled in New York City, where the latest coronavirus variant was discovered only this week. And another concerning version of the virus is spreading at a rapid pace through California.

“Things are tenuous,” Dr. Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said on Friday. “Now is not the time to relax restrictions.”

More than 68 million shots have been given since vaccinations began in December. The country is averaging about 1.5 million reported vaccinations a day.

The Johnson & Johnson shot, which was unanimously endorsed on Friday by a panel of experts advising the F.D.A., had an overall efficacy rate in clinical trials of 72 percent in the United States and 64 percent in South Africa, where a concerning variant emerged in the fall. It also showed 86 percent efficacy against severe Covid-19 in the United States, and 82 percent in South Africa.

Those are strong numbers, albeit lower than the roughly 95 percent efficacy rates of Pfizer-BioNTech and Moderna’s vaccines against mild, moderate and severe cases of Covid.

Trials are underway to determine if a second dose of the Johnson & Johnson shot would increase its protective effects — as scientists found it did during early clinical trials — although results will not be available until July at the earliest.

“The big question mark still is, how long does protection last?” said Dr. Johan Van Hoof, the global head of vaccine research and development at Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson.

Mr. Van Hoof said it would be important to track trial volunteers who receive a single dose to see if their immunity changes.

In Houston on Friday, Mr. Biden described the federal government’s mass inoculation drive as “the most difficult operational challenge this nation has ever faced logistically.” He said he expected challenges in reaching people in remote areas, and in persuading others who are “hesitant to take the shots.”

“We all know there’s a history in this country of subjugating certain communities to terrible medical and scientific abuse,” Mr. Biden said. “But if there’s one message that needs to cut through all this: The vaccines are safe. I promise you.”


United States › United StatesOn Feb. 26 14-day change
New cases 78,262 –29%
New deaths 2,266 –20%

World › WorldOn Feb. 26 14-day change
New cases 410,857 –5%
New deaths 9,468 –23%

U.S. vaccinations ›

Where states are reporting vaccines given

Military personnel at Fort Bragg going through a medical screening process before vaccinations on Wednesday. 
Credit…Kenny Holston for The New York Times

Americans who go into the military understand the loss of personal liberty. Many of their daily activities are prescribed, as are their hairstyles, attire and personal conduct.

So when it comes to taking a coronavirus vaccine, many troops — especially younger enlisted personnel as opposed to their officers — see a rare opportunity to exercise free will.

“The Army tells me what, how and when to do almost everything,” said Sgt. Tracey Carroll, who is based at Fort Sill, an Army post in Oklahoma. “They finally asked me to do something and I actually have a choice, so I said no.”

Sergeant Carroll, 24, represents a broad swath of members of the military — a largely young, healthy set of Americans from every corner of the nation — who are declining to get the shot, which for now is optional among personnel. They cite an array of political and health-related concerns.

But this reluctance among younger troops is a warning to civilian health officials about the potential hole in the broad-scale immunity that medical professionals say is needed for Americans to reclaim their collective lives.

“At the end of the day, our military is our society,” said Dr. Michael S. Weiner, the former chief medical officer for the Defense Department, who now serves in the same role for Maximus, a government contractor and technology company. “They have the same social media, the same families, the same issues that society at large has.”

Roughly one-third of troops on active duty or in the National Guard have declined to take the vaccine, military officials recently told Congress. In some places, such as Fort Bragg, N.C., the nation’s largest military installation, acceptance rates are below 50 percent.

Members of the Kansas State University marching band maintained social distance as they played before a college football game in October 2020.
Credit…Charlie Riedel/Associated Press

Colleges and universities across the country are pledging to reopen more fully in the fall, with some administrators worried that students won’t return to campus if normality, or some semblance of it, isn’t restored by September.

Schools from large state institutions to small private ones have announced they are laying plans to bring students back to dormitories, deploy professors to teach most (if not all) classes in person and restart extracurricular activities, in stark contrast to the past academic year of largely virtual courses and limited social contact. The announcements of these changes coincide with the sending of acceptance letters to the class of 2025.

Some schools have taken a financial hit because of deferred admissions or lost room-and-board fees.

Bradley University, in Peoria, Ill., which has 5,600 undergraduate and graduate students, said earlier this month that it would return to “traditional residential education” in the fall, with in-person classes and activities on campus.

Kansas State University announced on Wednesday that it too is planning a “more normal” fall semester, with largely in-person classes, events and activities. Ohio State announced on Thursday that it plans to offer “robust” in-person activities and classes, allowing students to live in residence halls and fans to attend football games.

Katherine Fleming, New York University’s provost, told colleagues in an email on Tuesday of plans to have “all faculty teaching their classes in-person, in the classroom, in the fall 2021.” She conceded, however, that this would depend in part on whether enough professors were vaccinated by then.

Indeed, most school officials said that whether they can deliver on these promises hinges on factors like how much the virus can be suppressed, the availability of the vaccine — which is still in scarce supply, even for those who are eligible — and guidance from government authorities.

Despite their hopefulness about the fall, schools have struggled with keeping the virus in check. Positivity rates rose among college students, as among the general population, over the holidays, when people traveled. Administrators have put out many stern warnings that small parties and gatherings have been a source of infection. Many have noted, however, that the classroom itself has not proven to be a vector of infection, as long as students and teachers follow safety guidelines like wearing masks and social distancing.

More than 120,000 coronavirus cases have been linked to American colleges and universities since Jan. 1, and more than 530,000 cases have been reported since the beginning of the pandemic, according to a New York Times survey. The Times has identified more than 100 deaths, but the vast majority involved employees, not students.

Speaker Nancy Pelosi heading to the House chamber to vote for President Biden’s relief package.
Credit…Oliver Contreras for The New York Times

The House passed President Biden’s $1.9 trillion stimulus plan early Saturday in a nearly party-line vote, advancing a sweeping pandemic aid package that would provide billions of dollars for unemployed Americans, struggling families and businesses, schools and the distribution of coronavirus vaccines.

The vote was 219 to 212, with Democrats pushing the measure over unanimous Republican opposition. The legislation, which has broad bipartisan support among voters, now heads to the Senate, where it is expected to be amended and then sent back to the House for a final vote.

As passed by the House, the plan, Mr. Biden’s first significant legislative initiative, offer the following benefits:

  • Provide $1,400 direct payments to individuals earning up to $75,000 a year and to couples earning up to $150,000

  • Expand a weekly federal unemployment benefit that is set to lapse in mid-March, increasing the payments to $400 a week from $300 and extending them through the end of August

  • Increase the child tax credit

  • Provide more than $50 billion for vaccine distribution, testing and tracing

  • Allocate nearly $200 billion to primary and secondary schools and $350 billion to state, local and tribal governments

“We believe this is something that meets the moment,” said Representative John Yarmuth, Democrat of Kentucky and the chairman of the Budget Committee.

Republicans argued that the measure was too costly and too broad in scope. Democrats, with slim margins of control in both chambers, are pushing the legislation through Congress using a fast-track budget process, known as reconciliation, that allows it to pass on a simple majority vote in the Senate.

However, the bill could change during Senate consideration. While it included a marquee progressive proposal to raise the federal minimum wage to $15 per hour by 2025, that measure has been ruled out of order by a top Senate official. Senate Democrats were exploring alternatives that would allow them to maintain a version of the wage increase without imperiling the broader stimulus package.

At a news conference before the measure passed, Speaker Nancy Pelosi of California said that House Democrats had preserved the wage increase in their bill to send a message about its importance, even if it ultimately had to be removed from the final legislation.

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Decline in Coronavirus Cases ‘May Be Stalling,’ C.D.C. Director Warns

Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said on Friday that a recent decline in coronavirus cases across the U.S. “may be stalling” and urged governors not to relax restrictions.

Over the last few weeks, cases in hospital admissions in the United States have been coming down since early January and deaths have been declining in the past week. But the latest data suggest that these declines may be stalling, potentially leveling off at still a very high number. We at C.D.C. consider this a very concerning shift in the trajectory. We are watching these concerning data very closely to see where they will go over the next few days. But it’s important to remember where we are in the pandemic. Things are tenuous. Now is not the time to relax restrictions. Although we’ve been experiencing large declines in cases and admissions over the past six weeks, these declines follow the highest peak we have experienced in the pandemic. We may be done with the virus, but clearly, the virus is not done with us. We cannot get comfortable or give in to a false sense of security that the worst of the pandemic is behind us. Not now, not when mass vaccination is so very close.

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Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, said on Friday that a recent decline in coronavirus cases across the U.S. “may be stalling” and urged governors not to relax restrictions.CreditCredit…Josh Bell/The Sun News, via Associated Press

The federal government warned impatient governors against relaxing pandemic control measures on Friday, saying that a recent steep drop in U.S. coronavirus cases and deaths “may be stalling” and “potentially leveling off at still a very high number” — a worrisome development that comes as more cases of concerning new variants have been found and could suggest that a return to normalcy is not yet quite as near as many Americans had hoped.

“Things are tenuous,” Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said at a White House briefing on the pandemic. “Now is not the time to relax restrictions.”

Her warning was bolstered by Dr. Anthony S. Fauci, the government’s top epidemiologist, as the Biden administration scrambled to stay ahead of any new wave. President Biden himself flew to Houston to showcase the government’s latest mass vaccine site.

According to a New York Times database, virus cases across the United States appear to be leveling off from the steep decline that began in January, with figures comparable to those reported in late October. Cases have slightly increased week over week in recent days, though severe weather limited testing and reporting in Texas and other states the previous week, and not all states reported complete data on the Presidents Day holiday. The seven-day average of new cases was 77,800 as of Thursday.

While deaths tend to fluctuate more than cases and hospital admissions, Dr. Walensky said at the briefing on Friday, the most recent seven-day average is slightly higher than the average earlier in the week. The seven-day average of newly reported deaths was 2,165, as of Thursday.

“We at C.D.C. consider this a very concerning shift in the trajectory,” she said, adding, “I want to be clear: cases, hospital admissions and deaths — all remain very high and the recent shift in the pandemic must be taken extremely seriously.”

Dr. Walensky said some of the rise may be attributable to new variants of the coronavirus that spread more efficiently and quickly. The so-called B.1.1.7 variant, which first emerged in Britain, now accounts for approximately 10 percent of all cases in the United States, up from one to four percent a few weeks ago, she said. The U.S. ability to track variants is much less robust than Britain’s.

“I know people are tired; they want to get back to life, to normal,” she said. “But we’re not there yet.”

As cases had declined, some governors around the United States have begun to relax pandemic restrictions. States with Republican governors appeared to be more eager to make rollbacks, though New York, which has a Democrat as governor, has also been easing restrictions on a variety of activities.

On Friday, Gov. Henry McMaster of South Carolina, a Republican, announced that on Monday, restaurants would be able to serve alcohol past 11 p.m., and residents would not need to get approval from the state to hold events with 250 people or more. To try to limit the spread of the virus, the state last year ordered bars to stop serving alcohol after 11 p.m., which is three hours earlier than the late-night bar crowd was used to.

Brian Symmes, a spokesman for Mr. McMaster, said the governor “appreciates perspectives that differ from his own” but “respectfully disagrees” with Dr. Walensky’s assessment.

In Arkansas, Gov. Asa Hutchinson announced Friday that he’d be lifting restrictions around capacity limits for bars, restaurants, gyms and large venues, but extending the state’s emergency order and mask mandate until March 31. The current emergency order was set to expire February 27.

On Thursday, Gov. Greg Abbott of Texas said he was considering lifting a statewide mask mandate in place since July.

In Mississippi, Gov. Tate Reeves said he was also considering pulling back some restrictions, particularly mask mandates for people who have been fully vaccinated. As of Friday, 13 percent of the state’s population has received at least one shot, and 6.2 percent have received two, according to a Times database.

Dr. Fauci echoed Dr. Walensky’s warnings that more rollbacks at state or local levels would be unwise, noting that case levels remained at a “very precarious position.”

“We don’t want to be people always looking at the dark side of things, but you want to be realistic,” he said. “So we have to carefully look at what happens over the next week or so with those numbers before you start making the understandable need to relax on certain restrictions.”

In Oregon, Gov. Kate Brown extended the state’s emergency order until May 2. The state recorded a sharp decreases in daily cases, hospitalizations and deaths this week, but citing the new variants Ms. Brown said that “now is not the time to let up our guard.”

Eileen Sullivan Remy Tumin, Nicholas Bogel-Burroughs and Mitch Smith contributed reporting.

Ohio’s Dayton Arena last March. The N.C.A.A. received $270 million in insurance payments after the 2020 basketball tournament was canceled.
Credit…Aaron Doster/Associated Press

The money came in wire transfers, each one a boon for a beleaguered N.C.A.A.

In March, the coronavirus pandemic had eviscerated the Division I men’s basketball tournament, which had been poised to bring in more than $800 million. But by the end of June, N.C.A.A. executives knew that a crucial lifeline, one burrowed in the black-and-white language of five insurance policies, would soon come through: $270 million in cash — among the largest pandemic-related payouts in all of sports.

“It was one of the simpler claims processes,” Brad Robinson, the N.C.A.A. official who coordinates insurance matters, said in an interview in early February, soon after the association acknowledged that insurance proceeds tied to event cancellations accounted for more than half of its revenues during its 2020 fiscal year.

The specialized insurance policies, which cover cancellations because of communicable disease outbreaks, have historically been scarcely noticed but have proved crucial for parts of the sports world to weather the pandemic. Ordinarily, products purchased to guard against the financial fallout of terrorism, severe weather and other unexpected setbacks, have helped salvage the balance sheets of events as small as local road races to competitions as wealthy and mighty as the sprawling N.C.A.A. tournament.

Now, insurers are bracing to see whether the Tokyo Olympics, already postponed from 2020, will happen, and industry experts said a cancellation would fuel several billions of dollars in losses across a number of organizations.

But pandemic policies are now largely unavailable or extraordinarily expensive when they can be found because few, if any, new policies are being written to accommodate potential future claims related to the virus.

John Q. Doyle, the president and chief executive of Marsh, a global insurance brokerage firm, warned Congress in November that the industry was “seeing exclusions for communicable diseases coverage going forward” with event cancellation policies after “considerable losses on these policies related to Covid-19.” Brokers said that future policies could include deductibles, which have been rare in the past.

This means events that did not already have coverage for 2021 may be at risk of financial collapse if they cannot be held.

“If you have a $20 million event, you may only be able to get $1 or $2 million” of it covered for infectious disease, said John Beam, executive vice president for the sports and entertainment practice at the risk management firm Willis Towers Watson and a broker whose clients have included the N.C.A.A., Major League Baseball and the College Football Playoff. “That doesn’t really address what we want.”

What We Learned

Covax stickers being put on an arriving shipment of AstraZeneca’s Covid-19 vaccine at the airport in Abidjan, Ivory Coast, on Friday.
Credit…Sia Kambou/Agence France-Presse — Getty Images

The United States recorded its 500,000th coronavirus-related death.

Scientists reported a concerning new virus variant in New York that could weaken the effects of vaccines.

And health officials and experts warned governors against loosening restrictions in their states, saying the sharp decline in new coronavirus cases “may be stalling.” They worry that Americans, with the finish line to the pandemic seemingly in sight, might once again underestimate the virus, triggering a fourth wave.

But there was a big piece of good news this week: The single-shot Johnson & Johnson vaccine was endorsed on Friday by a panel of experts advising the Food and Drug Administration, clearing the way for the emergency authorization of a third Covid-19 vaccine in the United States.

Here’s what else we learned this week:

  • Covax, a global program designed to improve vaccine access for poorer countries, launched on Wednesday when hundreds of thousands of doses arrived in Ghana. But the initiative is hitting some road blocks. Trying to secure more vaccines for themselves, rich countries are undermining Covax and prolonging the pandemic, the head of the World Health Organization said on Tuesday.

  • A large nationwide U.S. study has found two major ways children can become seriously ill from the coronavirus. A key finding in the study was that Black or Hispanic kids were more likely to suffer from an inflammatory syndrome that has erupted in some children weeks after they have had a typically mild initial infection. Experts say the disparity most likely reflects socioeconomic and other factors that have disproportionately exposed some communities to the virus.

  • Canada approved use of the AstraZeneca vaccine on Friday. The addition of a third vaccine, in addition to the offerings from Moderna and Pfizer-BioNTech, may help Canada alleviate a growing dissatisfaction about the sluggish pace of vaccination in the country.

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Carl Zimmer is a science columnist for The Times who has been covering the coronavirus pandemic. The Sunday Review adapted this essay from his forthcoming book “Life’s Edge: The Search for What It Means to Be Alive.”

Last spring, coyotes strolled down the streets of San Francisco in broad daylight. Pods of rarely seen pink dolphins cavorted in the waters around Hong Kong. In Tel Aviv, jackals wandered a city park, a herd of mountain goats took over a town in Wales, and porcupines ambled through Rome’s ancient ruins. As the canals in Venice turned strangely clear, cormorants started diving for fish, and Canada geese escorted their goslings down the middle of Las Vegas Boulevard, passing empty shops displaying Montblanc pens and Fendi handbags.

Nature was expanding as billions of people were retreating from the Covid-19 pandemic. The change was so swift, so striking that scientists needed a new name for it: the anthropause.

But the anthropause did more than reconfigure the animal kingdom. It also altered the planet’s chemistry. As factories grew quiet and traffic dropped, ozone levels fell by 7 percent across the Northern Hemisphere. As air pollution across India dropped by a third, mountain snowpacks in the Indus Basin grew brighter. With less haze in the atmosphere, the sky let more sunlight through. The planet’s temperature temporarily jumped between a fifth and half of a degree.

At the same time, the pandemic etched a scar across humanity that will endure for decades. More than 2.4 million people have died so far from Covid-19, and millions more have suffered severe illness. In the United States, life expectancy fell by a full year in the first six months of 2020; for Black Americans, the drop was 2.7 years. The International Monetary Fund predicts that the global economy will lose over $22 trillion between 2020 and 2025. UNICEF is warning that the pandemic could produce a “lost generation.”

At the center of these vast shocks is an oily bubble of genes just about 100 nanometers in diameter. Coronaviruses are so small that 10 trillion of them weigh less than a raindrop.

Since the discovery of SARS-CoV-2 last January, the scientific world has scrutinized it to figure out how something so small could wreak so much havoc. They have mapped the spike proteins the coronavirus uses to latch onto cells. They have uncovered the tricks it plays on our immune system. They have reconstructed how an infected cell creates millions of coronaviruses.

That frenzy of research has revealed a lot about SARS-CoV-2, but huge questions remain. Looming over them is the biggest question of all: Is the coronavirus alive?

Tap through to read the full article by Carl Zimmer.

The C.D.C. is urging communities to reopen schools as quickly as possible, but parents and teachers have raised questions about the quality of ventilation available in public school classrooms to protect against the coronavirus.

We worked with a leading engineering firm and experts specializing in buildings systems to better understand the simple steps schools can take to reduce exposure in the classroom.

These simulations offer examples based on specific inputs, but they show how ventilation and filtration can work alongside other precautions like masking and social distancing.

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