Category: Covid-19

Slow FDA Feeds Skepticism of mRNA Covid-19 Vaccines

(p. A19) In December 2020, the F.D.A. approved the distribution of mRNA coronavirus vaccines made by Pfizer and Moderna under the agency’s emergency use authorization provision, which permits an accelerated approval process for medications and treatments during a public health emergency.

. . .

In theory, full approval should be imminent, since Pfizer applied for full approval in early May, and Moderna asked for full approval on June 1. This process is often long, requiring the agency to inspect manufacturing plants and review considerable amounts of documentation for vaccine production. But in this case, because of the urgency of the pandemic, the vaccine makers began to submit this material, called a biologics licensing application, in late 2020, and they’ve continued to submit more information. The F.D.A. has already reviewed some of the submissions and has provided feedback to the manufacturers. The emergency authorizations were granted more than six months ago. That’s more than ample time for the agency to conduct plant inspections and review the applications.

. . .

Fortunately, two doses of the mRNA vaccines appear to provide nearly full protection from Covid-related hospitalization and death, and the shots substantially reduce infections.

The lives and health of millions of Americans rest on the F.D.A.’s decision to fully license these vaccines.

For the full commentary see:

Eric J. Topol. “Vaccines Need Full Approval.” The New York Times (Monday, July 5, 2021): A19.

(Note: ellipses added.)

(Note: the online version of the commentary has the date June 1, 2021, and has the title “It’s Time for the F.D.A. to Fully Approve the mRNA Vaccines.”)

“Unemployment Rises Like a Rocket and Falls Like a Feather”

(p. B7) Robert Hall, an economics professor at Stanford University, says the job matching process has progressed in two stages. Last year, millions of people were called back to their jobs from temporary layoffs and the unemployment rate descended quickly from 14.8% to 6.7%. This year, the progress has slowed markedly; the jobless rate fell from 6.3% in January [2021] to 5.9% in June.

Mr. Hall and Marianna Kudlyak at the Federal Reserve Bank of San Francisco studied the past 10 recoveries and concluded that U.S. job recoveries have a common pattern. In normal times, they find, “unemployment rises like a rocket and falls like a feather.”

“The easy stuff has been accomplished,” Mr. Hall said in an interview. The rest of the job recovery, he concluded, is going to take some time.

For the full story, see:

Jon Hilsenrath and Sarah Chaney Cambon. “The Mismatch That Is Hammering Job Prospects.” The Wall Street Journal (Saturday, July 10, 2021): B1 & B6-B7.

(Note: bracketed year added.)

(Note: the online version of the story has the date July 9, 2021, and has the title “Why Aren’t Millions of Unemployed Americans Finding Jobs?”)

Auerbach Talked to Hikers, Skiers, and Divers to Advance Wilderness Medicine: “He Never Stopped”

(p. B10) Dr. Paul Auerbach, an emergency care physician who pioneered the field of wilderness medicine in the 1980s and then taught ways to heal people injured by the unpredictable, died on June 23 [2021] at his home in Los Altos, Calif.

. . .

Out in the wild, knowing how to treat a venomous snake bite or a gangrenous infection can mean the difference between life and death. In the 1970s, however, the specialized field of health care known as wilderness medicine was still in its infancy. Then Dr. Auerbach showed up.

A medical student at Duke University at the time, he went to work in 1975 with the Indian Health Service on a Native American reservation in Montana, and the experience was revelatory.

“We saw all kinds of cases that I would have never seen at Duke or frankly anywhere else except on the reservation,” Dr. Auerbach said in a recent interview given to Stanford University, where he worked for many years. “Snakebites. Drowning. Lightning strike.”

. . .

“I kept going back to literature to read, but there was no literature,” he said. “If I wanted to read about snake bites, I was all over the place. If I wanted to read about heat illness, I was all over the place. So I thought, ‘Huh, maybe I’ll do a book on wilderness medicine.’”

Dr. Auerbach started researching material for the book in 1978, when he began his medical residency at U.C.L.A., finding the time to do so despite grueling 12-hour hospital shifts. He collected information about how to treat burn wounds, hypothermia, frostbite and lightning injuries. He interviewed hikers, skiers and divers. And he assigned chapters to doctors who were passionate about the outdoors.

The resulting book, “Management of Wilderness and Environmental Emergencies,” which he edited with a colleague, Edward Geehr, was published in 1983 and is widely considered the definitive textbook in the field, with sections like “Protection From Blood-Feeding Arthropods” and “Aerospace Medicine: The Vertical Frontier.” Updated by Dr. Auerbach over 30 years, it is in its seventh edition and now titled “Auerbach’s Wilderness Medicine.”

. . .

Last year, shortly before he received his cancer diagnosis, the coronavirus pandemic began to take hold, and Dr. Auerbach decided to act.

“The minute it all first happened, he started working on disaster response,” his wife said. “Hospitals were running out of PPE. He was calling this person and that person to learn as much as he could. He wanted to find out how to design better masks and better ventilators. He never stopped.”

For the full obituary, see:

Alex Vadukul. “Dr. Paul Auerbach, 70, Who Pioneered Treatment of Wilderness Emergencies.” The New York Times, First Section (Tuesday, July 20, 2021): B10.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the obituary has the date July 19, 2021, and has the title “Dr. Paul Auerbach, Father of Wilderness Medicine, Dies at 70.”)

The latest edition of Auerbach’s book is:

Auerbach, Paul S., Tracy A. Cushing, and N. Stuart Harris, eds. Auerbach’s Wilderness Medicine. 7th ed. 2 vols. Philadelphia, PA: Elsevier, 2017.

120 Million Added People Face Food Scarcity Due to Covid-19

(p. A1) An estimated 270 million people are expected to face potentially life-threatening food shortages this year — compared to 150 million before the pandemic — according to analysis from the World Food Program, the anti-hunger agency of the United Nations. The number of people on the brink of famine, the most severe phase of a hunger crisis, jumped to 41 million people currently from 34 million last year, the analysis showed.

The World Food Program sounded the alarm further last week in a joint report with the U.N.’s Food and Agriculture Organization, warning that “conflict, the economic repercussions of Covid-19 and the climate crisis are expected to drive higher levels of acute food insecurity in 23 hunger hot spots over the next four months,” mostly in Africa but also Central America, Afghanistan and North Korea.

The situation is particularly bleak in Africa, where new infections have surged. In recent months, aid organizations have raised alarms about Ethiopia — where the number of people affected by famine is higher than anywhere in the world — and (p. A5) southern Madagascar, where hundreds of thousands are nearing famine after an extraordinarily severe drought.

. . .

In South Africa, typically one of the most food-secure nations on the continent, hunger has rippled across the country.

. . .

An estimated three million South Africans lost their jobs and pushed the unemployment rate to 32.6 percent — a record high since the government began collecting quarterly data in 2008.

. . .

In Duncan Village, the sprawling township in Eastern Cape Province, the economic lifelines for tens of thousands of families have been destroyed.

Before the pandemic, the orange-and-teal sea of corrugated metal shacks and concrete houses buzzed every morning as workers boarded minibuses bound for the heart of nearby East London. An industrial hub for car assembly plants, textiles and processed food, the city offered stable jobs and steady incomes.

“We always had enough — we had plenty,” said Anelisa Langeni, 32, sitting at the kitchen table of the two-bedroom home she shared with her father and twin sister in Duncan Village.

For nearly 40 years, her father worked as a machine operator at the Mercedes-Benz plant. By the time he retired, he had saved enough to build two more single family homes on their plot — rental units he hoped would provide some financial stability for his children.

The pandemic upended those plans. Within weeks of the first lockdown, the tenants lost their jobs and could no longer pay rent. When Ms. Langeni was laid off from her waitressing job at a seafood restaurant and her sister lost her job at a popular pizza joint, they leaned on their father’s $120 monthly pension.

Then in July, he collapsed with a cough and fever and died of suspected Covid-19 en route to the hospital.

“I couldn’t breathe when they told me,” Ms. Langeni said. “My father and everything we had, everything, gone.”

For the full story, see:

Christina Goldbaum and Joao Silva. “No Job, No Food: Virus Deepens Global Hunger.” The New York Times (Friday, August 6, 2021): A1 & A5.

(Note: ellipses added.)

(Note: the online version of the story was updated Aug. 6, 2021, and has the title “No Work, No Food: Pandemic Deepens Global Hunger.”)

30% of U.S. Manufacturing Job Growth Is in Southwest

(p. A1) Companies producing everything from steel to electric cars are planning and building new plants in Southwest states, far from historical hubs of American industry in the Midwest and Southeast.  . . .

The Southwest, comprising Arizona, New Mexico, Texas and Oklahoma, increased its manufacturing output more than any other region in the U.S. in the four years through 2020, according to an analysis by The Wall Street Journal of data from the Bureau of Economic Analysis.

Those states plus Nevada added more than 100,000 manufacturing jobs from January 2017 to January 2020, representing 30% of U.S. job growth in that sector and at roughly triple the national growth rate, according to data from the Bureau of Labor Statistics.

. . .

(p. A8) Manufacturers in the Southwest have been relatively insulated from pandemic shutdowns and layoffs, and job growth there is expected to continue.

. . .

Some growth in the Southwest has come at the expense of California, classified in U.S. statistics as part of the Far West. In 2019, nearly 2,000 manufacturing workers in Texas and more than 1,300 in Arizona arrived from California, the most in a decade, the most recent Census Bureau data show. More than 2,700 manufacturing workers have come to Nevada from California in 2017 through 2019.

For the full story, see:

Ben Foldy and Austen Hufford. “Southwest Emerges As America’s New Factory Hub.” The Wall Street Journal (Weds., June 02, 2021): A1 & A8.

(Note: ellipses added.)

(Note: the online version of the story has the date June 1, 2021, and has the same title in search list, but on the article page has the title “The Southwest Is America’s New Factory Hub. ‘Cranes Everywhere.’”)

Choppin at Hughes Medical Institute Hired Good Scientists and Let Them Pursue Hunches and Serendipitous Insights

(p. A27) Purnell Choppin, whose research on how viruses multiply helped lay the foundation for today’s fight against the Covid-19 pandemic, died on July 3 [2021] at his home in Washington, one day shy of his 92nd birthday.

. . .

Dr. Choppin (pronounced show-PAN) focused on measles and influenza, but his research, and the methods he developed to conduct it, proved critical for later work on other viruses, including severe acute respiratory syndrome coronavirus 2, the virus behind the Covid-19 pandemic, said David Baltimore, an emeritus professor of biology at the California Institute of Technology and a winner of the 1975 Nobel Prize in Physiology or Medicine.

“The issue of how viruses infect cells was very much on his mind, and the mechanisms he worked out studying influenza were central to thinking about coronaviruses,” Dr. Baltimore said. “Thanks to his work and that of so many others, when the pandemic hit, we were able to formulate questions about the virus in quite precise terms.”

Dr. Choppin was equally well known as an administrator, first at Rockefeller and then at the Howard Hughes Medical Institute, which hired him in 1985 as its chief medical officer. He later ran the institute for 12 years, turning it from a modest-size research organization into a global research powerhouse.

. . .

With a calm, easygoing demeanor that disguised a fierce, visionary ambition, Dr. Choppin took an innovative approach to funding. Unlike other institutions, which provide grants for specific projects, he focused on identifying top researchers and then showering them with money and resources. Even better, he did not ask them to move to the institute, in Chevy Chase, Md. — they could stay where they were and let the Hughes largesse come to them.

. . .

While Dr. Choppin was sometimes criticized for making safe bets on established scientists who probably didn’t need his help, he made no apologies, and had the track record to prove the soundness of his approach: Dozens of Hughes researchers had gone on to become members of the National Academy of Sciences, and six won the Nobel Prize.

“We bet on people who look like they are going to be winners,” he told The Washington Post in 1988. “You look for originality. How they pick a problem and stick to it. Their instinct for the scientific jugular.”

For the full obituary, see:

Clay Risen. “Purnell Choppin, 91, Researcher Who Focused on Viruses.” The New York Times, First Section (Sunday, July 25, 2021): 27.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the obituary has the date July 23, 2021, and has the title “Purnell Choppin, 91, Dies; Researcher Laid Groundwork for Pandemic Fight.”)

Omaha’s “Boutique” Quarantine Unit Looked Backward to Ebola, Not Forward to Covid-19

(p. C1) Quarantine can be lifesaving; it can also be dangerous, an exercise of extraordinary power in the name of disease control, a presumption of guilt instead of innocence.

In “Until Proven Safe,” a new book about quarantine’s past and future, Geoff Manaugh and Nicola Twilley do an impressively judicious job of explaining exactly why fears of quarantine are understandable and historically justified, . . .

. . .

(p. C6) What becomes clear in “Until Proven Safe” is that it’s a lot easier to tell someone else to just shut up and submit to quarantine than to do it yourself. Any exercise of such formidable power also opens up the possibility of abuse. The book includes historical examples of disease control measures getting mapped onto existing prejudices. In 1900, a cordon sanitaire in San Francisco’s Chinatown zigzagged around white-owned businesses; . . .

. . .

Quarantine infrastructures tend to be tailored to the previous epidemic, instead of anticipating whatever is to come. A shiny new federal quarantine facility in Omaha — the first constructed in the United States in more than a century — was finished in January 2020, just in time to receive 15 American passengers from the coronavirus-infested Diamond Princess cruise ship. This National Quarantine Unit has a grand total of 20 beds. It offers a “boutique experience” ideally suited to managing one or two patients at a time after they have had potential exposure to, say, Ebola. The facility can’t do much to help contain a raging pandemic. As Manaugh and Twilley point out, the first American evacuation flight out of Wuhan alone carried 195 passengers.

For the full review, see:

Jennifer Szalai. “BOOKS OF THE TIMES; You Can’t Leave Unless We Say So.” The New York Times (Tuesday, July 27, 2021): C1 & C6.

(Note: ellipses added.)

(Note: the online version of the review has the date July 26, 2021, and has the title “BOOKS OF THE TIMES; The Extraordinary History (and Likely Busy Future) of Quarantine.”)

The book under review is:

Twilley, Nicola, and Geoff Manaugh. Until Proven Safe: The History and Future of Quarantine. New York: Farrar, Strauss and Giroux, 2021.

Lack of Full FDA Vaccine Approval Discourages Use

(p. A12) Even as President Biden, the C.D.C. and virtually the entire scientific community are urging — pleading with, even — Americans to get vaccinated, the government has not formally approved any vaccine. The Food and Drug Administration has instead given only “emergency use authorization” to the shots from Moderna, Pfizer and Johnson & Johnson. That’s a temporary form of approval that allows people to receive shots while the agency continues to study their effectiveness and safety.

The difference between emergency authorization and full approval matters.

. . .

The situation also feeds uncertainty and skepticism among some Americans who have not yet gotten a shot. Those skeptics, as Matthew Yglesias of Substack wrote yesterday, are effectively taking the F.D.A. at its word. The F.D.A. leaders’ official position is that “they don’t have enough safety data yet,” Yglesias noted.

. . .

. . ., public health officials made highly technical statements about masks that many people interpreted as discouragement from wearing them. These statements ignored the many reasons to believe that masks could make a difference (like their longtime popularity in Asia to prevent the spread of viruses) and focused instead on the absence of studies showing that masks specifically prevented the spread of Covid.

Later, officials insisted that they were merely “following the data.” In truth, though, they were basing their advice on a narrow reading of the data — . . . .

. . .

Think of it this way: In the highly unlikely event that the evidence were to change radically — if, say, the vaccines began causing serious side effects about 18 months after people had received a shot — Americans would not react by feeling confident in the F.D.A. and grateful for its caution. They would be outraged that Woodcock and other top officials had urged people to get vaccinated.

The combination means that the F.D.A.’s lack of formal approval has few benefits and large costs: The agency has neither protected its reputation for extreme caution nor maximized the number of Americans who have been protected from Covid. “In my mind, it’s the No. 1 issue in American public health,” Topol told me. “If we got F.D.A. approval, we could get another 20 million vaccinated,” he estimated.

For the full commentary, see:

David Leonhardt. “Why, After Months of Shots, Are None Approved?.” The New York Times (Thursday, July 22, 2021): A12.

(Note: ellipses added.)

(Note: the online version of the commentary has the date July 21, 2021, and has the title “Why Aren’t the Vaccines Approved?”)

California Regulators Banned Angela Marsden’s Customers from Eating Outside, but Allowed Next Door “Essential” TV Comedy Workers to Eat Outside


The news report above was posted to YouTube by ABC channel 7 in Los Angeles on Dec. 5, 2020.

(p. 4) For more than a week, tensions have flared between Los Angeles restaurant owners and politicians over the county’s ban on outdoor dining, which health officials say is necessary to slow the surging pandemic — and restaurateurs say is destroying their livelihoods.

The controversy came to a head on Saturday when a restaurant owner shared a video on social media showing tents, tables and chairs set up as a catering station for a film crew — just feet away from her eatery’s similar outdoor dining space, which has sat empty since the restriction went into effect late last month.

“Tell me that this is dangerous, but right next to me — as a slap in my face — that’s safe?” Angela Marsden, who owns the restaurant, Pineapple Hill Saloon & Grill, said as the video panned from her outdoor dining space to the film crew’s catering site.

Ms. Marsden had already organized a protest against the outdoor dining ban before discovering the film tents. On Saturday, she and others gathered outside County Supervisor Sheila Kuehl’s house, saying the government’s uneven application of the rules was crushing small businesses.

. . .

The catering site was for a crew filming “Good Girls,” a comedy television show that airs on NBC, according to Philip Sokoloski, a spokesman for FilmLA, which helps Los Angeles manage film permits. Mr. Sokoloski said the catering site and the film location nearby were both authorized under a permit issued by the city.

. . .

California has declared entertainment industry workers essential, and in Los Angeles County they must follow strict guidelines such as eating in staggered shifts or in an area large enough to stay six feet apart.

Ms. Marsden said in an interview that she saw two people eating without masks at the tables when she went to her restaurant on Friday to pick up paychecks for her employees and supplies for the protest.

. . .

She said she had worked hard to make her outdoor patio compliant with the previous guidelines for outdoor dining before it, too, was banned.

“You name it, we did it,” she said.

For the full story, see:

Giulia McDonnell Nieto del Rio and Nicholas Bogel-Burroughs. “Restaurant Owners See Cruel Disparity in Los Angeles’s Outdoor Dining Ban.” The New York Times, First Section (Sunday, December 6, 2020): 4.

(Note: ellipses added.)

(Note: the online version of the story was updated June 4, 2021 [sic], and has the title “She Couldn’t Open for Outdoor Dining. The Film Crew Next Door Could.”)

Small Firms Nimbly Pivoted to Face Masks

(p. R3) The humble face mask has proved to be a lifesaver not just by slowing Covid-19—but by helping small businesses.

Countless companies in dire straits during the lockdown have turned to masks to generate revenue. A lot of them have gotten into the niche from very diverse backgrounds. And, for some, mask sales haven’t only helped them survive but also driven their earnings higher than they were before Covid.

Here’s a look at some businesses that took a big gamble on masks—and saw it pay off.

. . .

Before the pandemic, custom-furniture maker David Halbout had a small but stable income and a waiting list stretching about four months. Within a week of the lockdown, though, his business came to a halt because he couldn’t meet customers to discuss the job or go to their home to work on projects. Almost all of his orders were canceled within days.

. . .

Facing that situation—and seeing the need that medical workers faced for protective equipment—the couple decided to turn their Red Bank, N.J., business to making masks. “We wanted to use our talents to help, so we started making fabric face masks with ties and elastic around the head,” says Mr. Halbout.

It turns out that the design was a hit for an unexpected niche. Because his products don’t interfere with hearing aids like traditional straps do, people who use the medical devices flocked to the masks, says Mr. Halbout. He estimates that his business, French Fix LLC, has sold 20,000 masks and donated another 3,000. Mr. Halbout says that he is making substantially more money from the masks, which start at $10.99 for children and $17.99 for adults, than he did from furniture.

. . .

Even so, “the core of my business stayed the same: I am still a creative person,” says Mr. Halbout. “I still design and I still work with my hands. I now work with fabric rather than wood.”

For the full story, see:

Elizabeth Garone. “The Lucrative Pivot to Making Face Masks.” The Wall Street Journal (Thursday, June 03, 2021): R3.

(Note: ellipses added.)

(Note: the online version of the story has the date June 2, 2021, and has the title “4 Entrepreneurs Who Found Big Money in Face Masks During Covid.”)

Leading American Scientists Endorsed False Soviet Denial of Anthrax Lab Leak

(p. A4) YEKATERINBURG, Russia — Patients with unexplained pneumonias started showing up at hospitals; within days, dozens were dead. The secret police seized doctors’ records and ordered them to keep silent. American spies picked up clues about a lab leak, but the local authorities had a more mundane explanation: contaminated meat.

It took more than a decade for the truth to come out.

In April and May 1979, at least 66 people died after airborne anthrax bacteria emerged from a military lab in the Soviet Union. But leading American scientists voiced confidence in the Soviets’ claim that the pathogen had jumped from animals to humans. Only after a full-fledged investigation in the 1990s did one of those scientists confirm the earlier suspicions: The accident in what is now the Russian Urals city of Yekaterinburg was a lab leak, one of the deadliest ever documented.

Nowadays, some of the victims’ graves appear abandoned, their names worn off their metal plates in the back of a cemetery on the outskirts of town, where they were buried in coffins with an agricultural disinfectant. But the story of the accident that took their lives, and the cover-up that hid it, has renewed relevance as scientists search for the origins of Covid-19.

It shows how an authoritarian government can successfully shape the narrative of a disease outbreak and how it can take years — and, perhaps, regime change — to get to the truth.

“Wild rumors do spread around every epidemic,” Joshua Lederberg, the Nobel-winning American biologist, wrote in a memo after a fact-finding trip to Moscow in 1986. “The current Soviet account is very likely to be true.”

Many scientists believe that the virus that caused the Covid-19 pandemic evolved in animals and jumped at some point to humans. But scientists are also calling for deeper investigation of the possibility of an accident at the Wuhan Institute of Virology.

There is also widespread concern that the Chinese government — which, like the Soviet government decades before it, dismisses the possibility of a lab leak — is not providing international investigators with access and data that could shed light on the pandemic’s origins. Continue reading “Leading American Scientists Endorsed False Soviet Denial of Anthrax Lab Leak”