China Allows Some Volunteers to Receive Covid-19 Vaccines After Only Phase 2 Trials

(p. B1) The offer to employees at the state-owned oil giant was compelling: Be among the first in China to take a coronavirus vaccine.

The employees at PetroChina could use one of two vaccines “for emergency use” to protect themselves when working overseas as part of China’s ambitious infrastructure program, according to a copy of the notice, which was reviewed by The New York Times.

. . .

(p. B6) Such “emergency use” is rare, and the taking of unapproved vaccines is typically reserved for health care professionals. Although the government has stressed that taking the vaccine is voluntary, the state-owned workers and soldiers could feel pressure to participate.

. . .

Along with the testing at the oil company, Sinopharm, which has completed Phase 2 trials for two products, has injected the vaccine into its chairman and other senior officials, according to the State-owned Assets Supervision and Administration Commission, or SASAC, the government agency managing all employees at state-backed companies. The Chinese government has allowed the CanSino-military vaccine to be given to its armed forces, a first for the military of any country.

. . .

“If you are a regulatory body, if you play by the rules, if you are hard-nosed about it, you say this is very wrong,” said Ray Yip, the former head of the Gates Foundation in China.

Dr. Yip added that it would be useful for company executives to know that they had given the dose to “a couple of thousand people, but no one has dropped dead, so that’s pretty good.”

Dr. Yip said the people taking the vaccines should read up on reports of the safety data and make an informed decision. He said he would be willing to take it.

“If you offer that to me saying it’s safe and there’s an 85 percent chance that it works, would I take it today?” he said. “You know what, I probably will. Because then I don’t have to worry.”

In a post on its official WeChat account, a government agency reported that the “vaccine pretest” on Sinopharm employees showed that antibody levels were high enough in subjects to combat the coronavirus, indicating that it was safe and effective.

. . .

In June [2020], Sinopharm began the third phase of clinical trials in Beijing, Wuhan and Abu Dhabi, becoming the first company to enter the final regulatory stage. China’s Sinovac Biotech is teaming up with Instituto Butantan in Brazil, which has the world’s second-highest case count after the United States.

. . .

Dimas Tadeu Covas, the director of Butantan, said that he was impressed with Sinovac’s preliminary results and that the vaccine “has the greatest potential for success.” He cited results from Sinovac’s Phase 1 trials that showed no adverse effects and Phase 2 trials that showed 90 percent protection against Sars-Cov2.

“I know vaccines, and I am betting a lot on this one,” Dr. Covas said.

For the full story, see:

Sui-Lee Wee and Mariana Simões. “China Skirts Convention For Vaccines.” The New York Times (Friday, July 17, 2020): B1 & B6.

(Note: ellipses added.)

(Note: the online version of the story was updated June 17, 2020, and has the title “In Coronavirus Vaccine Race, China Strays From the Official Paths.”)

Blacks in Detroit Have Public Transit to Die For

(p. A1) DETROIT — Paris Banks sprayed the seat with Lysol before sliding into the last row on the right. Rochell Brown put out her cigarette, tucked herself behind the steering wheel and slapped the doors shut.

It was 8:37 a.m., and the No. 17 bus began chugging westward across Detroit.

. . .

This hardscrabble city, where nearly 80 percent of residents are black, has become a national hot spot with more than 7,000 infections and more than 400 deaths. One reason for the rapid spread, experts say, is that the city has a large working-class population that does not have the luxury of living in isolation. Their jobs cannot be performed from a laptop in a living room. They do not have vehicles to safely get them to the grocery store.

(p. A12) And so they end up on a bus. Just like the No. 17 — a reluctant yet essential gathering place, and also a potential accelerant for a pandemic that has engulfed Detroit.

For the full story, see:

John Eligon. “No Choice but Shoulder to Shoulder on the Bus.” The New York Times (Thursday, April 16, 2020): A1 & A12-A13.

(Note: ellipsis added.)

(Note: the online version of the story was updated April 16, 2020, and has the title “Rolling Through the Pandemic.”)

Citron Research Alleged That DNA Vaccine Firm Inovio Is “the COVID-19 Version of Theranos”

(p. A10) Not long after researchers completed their work with mice, guinea pigs, ferrets and monkeys, Human Subject 8, an art director for a software company in Missouri, received an injection. Four days later, her sister, a schoolteacher, became Subject 14.

Together, the sisters make up about 5 percent of the first ever clinical trial of a DNA vaccine for the novel coronavirus. How they respond to it will help determine the future of the vaccine. If it proves safe in this trial and effective in future trials, it could become not only one of the first coronavirus vaccines, but also the first DNA vaccine ever approved for commercial use against a human disease.

. . .

In many of these studies, the vaccine recipe isn’t the only thing on trial. Gene-based vaccines — and at least 20 coronavirus vaccines in development fall into this category — have yet to make it to market. Should one end up in doctors’ offices amid the rush to shield billions from Covid-19, it would represent a new chapter for vaccine development.

And though vaccine research has never moved this quickly — potentially meaning enhanced risks for volunteers — it has never been easier to recruit subjects, according to Dr. John E. Ervin, who is overseeing the DNA vaccine trial at the Center for Pharmaceutical Research in Kansas City, Mo., in which the sisters are involved. For the Phase 1 trial of the vaccine, which was developed by Inovio Pharmaceuticals, 90 people applied for the 20 slots in Kansas City.

“We probably could charge people to let them in and still fill it up,” he said. (In fact, the participants were paid per visit.)

. . .

Inovio researchers engineered the vaccine in just three hours, according to Kate Broderick, the company’s senior vice president for research and development. Or, rather, their computer algorithm did: On Jan. 10 [2020], when Chinese researchers released the genetic code of the novel coronavirus, the team ran the sequence through its software, which popped out a formula.

This timeline struck some in the financial sector as too good to be true. Citron Research, which advises investors on companies to bet on, called Inovio “the Covid-19 version of Theranos,” referring to the blood-testing device company that imploded as its supposedly revolutionary product was revealed to be a hoax.

“Much like Theranos, Inovio claims to have a ‘secret sauce’ that, miraculously, no pharma giant has been able to figure out,” Citron Research wrote. “This is the same ‘secret sauce’ that supposedly developed a vaccine for Covid-19 in just three hours.”

For the full story, see:

Heather Murphy. “Fight Against Coronavirus Could Produce a First: A DNA Vaccine.” The New York Times (Friday, June 19, 2020): A10.

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

(Note: the online version of the story was updated June 22 [sic], 2020, and has the title “Guaranteed Ingredient in Any Coronavirus Vaccine? Thousands of Volunteers.”)

More Blacks Die of Covid-19 Partly Due to Greater Use of Public Transit

(p. A7) African-Americans may be dying at higher rates than white people from Covid-19, the disease caused by the novel coronavirus, in part because of black people’s heavier reliance on public transportation for commuting, two new studies by economists suggest.

One of the studies, by University of Virginia economist John McLaren, found that the racial discrepancy remained even after controlling for income or insurance rates. Instead, Mr. McLaren found the gap was due in part to the fact that black workers are more likely to get to work via public transit, including subways and buses.

About 10.4% of black commuters take public transit, versus 3.4% of white commuters, according to the Census. After controlling for the use of public transit, Mr. McLaren finds the racial disparity in Covid-19 deaths is less pronounced.

. . .

The other study, by Christopher Knittel and Bora Ozaltun, both of the Massachusetts Institute of Technology, found that a 10% increase in the share of a county’s residents who use public transit versus those who telecommute raised Covid-19 death rates by 1.21 per 1,000 people when looking at counties around the U.S.—or by 0.48 per 1,000 people when focusing only on counties within individual states. In their analysis, the researchers controlled for race, income, age, climate and other characteristics.

For the full story, see:

David Harrison. “Virus Deaths Linked to Transit.” The Wall Street Journal (Monday, June 29, 2020): A7.

(Note: ellipsis added.)

(Note: the online version of the story has the date June 28, 2020, and has the title “Public Transit Use Is Associated With Higher Coronavirus Death Rates, Researchers Find.”)

The first academic study mentioned above, is:

McLaren, John. “Racial Disparity in Covid-19 Deaths: Seeking Economic Roots with Census Data.” National Bureau of Economic Research, NBER Working Paper #27407, June 2020.

The second academic study mentioned above, is:

Knittel, Christopher R., and Bora Ozaltun. “What Does and Does Not Correlate with Covid-19 Death Rates.” National Bureau of Economic Research, NBER Working Paper #27391, June 2020.

Fauci Tries to Explain Shifting Position on Face Masks

(p. A9) . . . Dr. Fauci grew testy when Representative David B. McKinley, Republican of West Virginia, asked him if he thought the news media had treated Mr. Trump unfairly — Dr. Fauci declined to answer — and whether he regretted not advising people more forcefully to wear masks earlier in the pandemic.

“OK, we’re going to play that game,” Dr. Fauci said, seemingly irked. Mr. McKinley said it was a yes-or-no question.

“There is more than a yes or no, by the tone of your question,” Dr. Fauci shot back. “I do not regret that. Let me explain to you what happened. At that time, there was a paucity of equipment that our health care providers needed who put themselves daily in harm’s way of taking care of people who are ill.”

For the full story, see:

Sheryl Gay Stolberg and Noah Weiland. “Experts Sketch Gloomy Picture Of Virus Spread.” The New York Times (Wednesday, June 24, 2020): A1 & A9.

(Note: ellipsis added.)

(Note: the online version of the story has the date June 23, 2020, and has the title “Fauci, Citing ‘Disturbing Surge,’ Tells Congress the Virus Is Not Under Control.”)

If Aerosols Transmit Covid-19, It Is Even More Prudent to Wear Masks

(p. A1) The coronavirus is finding new victims worldwide, in bars and restaurants, offices, markets and casinos, giving rise to frightening clusters of infection that increasingly confirm what many scientists have been saying for months: The virus lingers in the air indoors, infecting those nearby.

If airborne transmission is a significant factor in the pandemic, especially in crowded spaces with poor ventilation, the consequences for containment will be significant. Masks may be needed indoors, even in socially-distant settings. Health care workers may need N95 masks that filter out even the smallest respiratory droplets as they care for coronavirus patients.

Ventilation systems in schools, nursing homes, residences and businesses may need to minimize recirculating air and add powerful new filters. Ultraviolet lights may be needed to kill viral particles floating in tiny droplets indoors.

The World Health Organization has long held that the coronavirus is spread primarily by large respiratory droplets that, once expelled by infected people in coughs and sneezes, fall quickly to the floor.

But in an open letter to the W.H.O., 239 scientists in 32 countries have outlined the evidence showing that smaller particles can infect people, and are calling for the agency to revise its recommendations. The researchers plan to publish their letter in a (p. A5) scientific journal this week.

. . .

Dr. Benedetta Allegranzi, the W.H.O.’s technical lead on infection control, said the evidence for the virus spreading by air was unconvincing.

. . .

But interviews with nearly 20 scientists — including a dozen W.H.O. consultants and several members of the committee that crafted the guidance — and internal emails paint a picture of an organization that, despite good intentions, is out of step with science.

Whether carried aloft by large droplets that zoom through the air after a sneeze, or by much smaller exhaled droplets that may glide the length of a room, these experts said, the coronavirus is borne through air and can infect people when inhaled. Continue reading “If Aerosols Transmit Covid-19, It Is Even More Prudent to Wear Masks”

Many Men “in the West” View Mask-Wearing to Be “a Sign of Weakness”

(p. A4) As countries begin to reopen their economies, face masks, an essential tool for slowing the spread of coronavirus, are struggling to gain acceptance in the West. One culprit: Governments and their scientific advisers.

Researchers and politicians who advocate simple cloth or paper masks as cheap and effective protection against the spread of Covid-19, say the early cacophony in official advice over their use—as well as deeper cultural factors—has hampered masks’ general adoption.

There is widespread scientific and medical consensus that face masks are a key part of the public policy response for tackling the pandemic. While only medical-grade N95 masks can filter tiny viral particles and prevent catching the virus, medical experts say even handmade or cheap surgical masks can block the droplets emitted by speaking, coughing and sneezing, making it harder for an infected wearer to spread the virus.

. . .

Male vanity . . . appears to be a powerful factor in rejecting masks. A study by Middlesex University London, U.K., and the Mathematical Sciences Research Institute in Berkeley, Calif., found that more men than women agreed that wearing a mask is “shameful, not cool, a sign of weakness, and a stigma.”

For the full story, see:

Bojan Pancevski, Jason Douglas. “Mask-Wearing Still Meets Resistance.” The Wall Street Journal (Monday, June 29, 2020): A4.

(Note: ellipses added.)

(Note: the online version of the story was updated June 29, 2020, and has the title “Masks Could Help Stop Coronavirus. So Why Are They Still Controversial?”)

“All You Need Is a Pair of Eyes”

(p. 1) MUNICH — Dr. Camilla Rothe was about to leave for dinner when the government laboratory called with the surprising test result. Positive. It was Jan. 27 [2020]. She had just discovered Germany’s first case of the new coronavirus.

But the diagnosis made no sense. Her patient, a businessman from a nearby auto parts company, could have been infected by only one person: a colleague visiting from China. And that colleague should not have been contagious.

The visitor had seemed perfectly healthy during her stay in Germany. No coughing or sneezing, no signs of fatigue or fever during two days of long meetings. She told colleagues that she had started feeling ill after the flight back to China. Days later, she tested positive for the coronavirus.

. . .

Dr. Rothe and her colleagues were among the first to warn the world. But even as evidence accumulated from other scientists, leading health officials expressed unwavering confidence that symptomless spreading was not important.

In the days and weeks to come, politicians, public health officials and rival academics disparaged or ignored the Munich team. Some actively worked to undermine the warnings at a crucial moment, as the disease was spreading unnoticed in French churches, Italian soccer stadiums and Austrian ski bars. A cruise ship, the Diamond Princess, would become a deadly harbinger of symptomless spreading. Continue reading ““All You Need Is a Pair of Eyes””

“Can You Imagine Turning on Someone Who Saves Your Life?”

(p. A20) WASHINGTON — Alice Marie Johnson was watching the Super Bowl with two of her sisters on Sunday night [Feb. 2, 2020] when she saw her own face in an advertisement amid the commercials for Doritos and Audis.

Ms. Johnson was serving a life sentence in an Alabama prison for a nonviolent drug conviction when the president commuted her sentence in 2018. The reality television star Kim Kardashian West had discovered Ms. Johnson’s story on social media and personally appealed to him on her behalf.

And now the 64-year-old African-American woman was the star of the Trump campaign’s multimillion-dollar Super Bowl ad, . . .

. . .

“I’ve been such a source of pride for him,” she said. “Who doesn’t want to show something they’re proud of during an election year? That’s what all the candidates do. For him to highlight me, it makes me know he’s not only proud, he’s super proud.”

She described herself as “not an expert in politics” but someone fighting for “anything that advances my cause, anything that advances my cause of bringing people home.”

Ms. Johnson would not say whether she would vote for Mr. Trump if she could. “I can’t vote, and that’s part of what I’m fighting for,” she said. But as for criticizing Mr. Trump, she said that was simply out of the question for her.

“Can you imagine turning on someone who saves your life?” she said. “Just on a personal level, can you imagine?”

For the full story, see:

Annie Karni. “Life as the Face of Trump’s Super Bowl Ad.” The New York Times (Friday, Feb. 7, 2020): A20.

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

(Note: the online version of the story has the date Feb. 6, 2020, and the title “What It’s Like to Be the Face of Trump’s Super Bowl Ad.”)

Compared to 1918, Today a Death Delayed Is More Likely to Be a Life Saved

Harvard economics professor Robert Barro has a useful NBER working paper showing that lockdowns during the 1918 flu pandemic succeeded in delaying deaths by flattening the curve, but not in reducing the overall number of deaths. Some would use this paper to argue against the efficacy of the current lockdowns. But there is a key difference between now and 1918: Flattening the curve in 1918 resulted in the end in about the same deaths over the 3 year run of the virus. Flattening the curve now is likely to cut off the deaths in about a year when a vaccine comes on line. Now, a death delayed is more likely to be a life saved.

Non-pharmaceutical public-health interventions (NPIs) were measured by Markel, et al. (2007) for U.S. cities during the second wave of the Great Influenza Pandemic, September 1918-February 1919. The NPIs are in three categories: school closings, prohibitions on public gatherings, and quarantine/isolation. Although an increase in NPIs flattened the curve in the sense of reducing the ratio of peak to average deaths, the estimated effect on overall deaths is small and statistically insignificant. The likely reason that the NPIs were not more successful in curtailing mortality is that the interventions had an average duration of only around one month.

The above abstract is from the following Barro NBER working paper. (The link leads to the American Enterprise Institute version of the paper.):

Barro, Robert J. “Non-Pharmaceutical Interventions and Mortality in U.S. Cities During the Great Influenza Pandemic, 1918-1919.” National Bureau of Economic Research, Inc., Working Paper # 27049 (April 2020).

Mainstream Science, and Governments, Rejected Early Evidence of Symptomless Transmission

(p. 1) MUNICH — Dr. Camilla Rothe was about to leave for dinner when the government laboratory called with the surprising test result. Positive. It was Jan. 27 [2020]. She had just discovered Germany’s first case of the new coronavirus.

But the diagnosis made no sense. Her patient, a businessman from a nearby auto parts company, could have been infected by only one person: a colleague visiting from China. And that colleague should not have been contagious.

The visitor had seemed perfectly healthy during her stay in Germany. No coughing or sneezing, no signs of fatigue or fever during two days of long meetings. She told colleagues that she had started feeling ill after the flight back to China. Days later, she tested positive for the coronavirus.

. . .

Dr. Rothe and her colleagues were among the first to warn the world. But even as evidence accumulated from other scientists, leading health officials expressed unwavering confidence that symptomless spreading was not important.

In the days and weeks to come, politicians, public health officials and rival academics disparaged or ignored the Munich team. Some actively worked to undermine the warnings at a crucial moment, as the disease was spreading unnoticed in French churches, Italian soccer stadiums and Austrian ski bars. A cruise ship, the Diamond Princess, would become a deadly harbinger of symptomless spreading.

. . .

(p. 10) Though estimates vary, models using data from Hong Kong, Singapore and China suggest that 30 to 60 percent of spreading occurs when people have no symptoms.

. . .

After two lengthy phone calls with the woman, doctors at the Robert Koch Institute were convinced that she had simply failed to recognize her symptoms. They wrote to the editor of The New England Journal of Medicine, casting doubt on Dr. Rothe’s findings.

Editors there decided that the dispute amounted to hairsplitting. If it took a lengthy interview to identify symptoms, how could anyone be expected to do it in the real world?

“The question was whether she had something consistent with Covid-19 or that anyone would have recognized at the time was Covid-19,” said Dr. Eric Rubin, the journal’s editor.

“The answer seemed to be no.”

The journal did not publish the letter. But that would not be the end of it.

. . .

On Monday, Feb. 3, the journal Science published an article calling Dr. Rothe’s report “flawed.” Science reported that the Robert Koch Institute had written to the New England Journal to dispute her findings and correct an error.

. . .

Dr. Rothe’s report quickly became a symbol of rushed research. Scientists said she should have talked to the Chinese patient herself before publishing, and that the omission had undermined her team’s work. On Twitter, she and her colleagues were disparaged by scientists and armchair experts alike.

“It broke over us like a complete tsunami,” Dr. Hoelscher said.

. . .

If Dr. Rothe’s paper had implied that governments might need to do more against Covid-19, the pushback from the Robert Koch Institute was an implicit defense of the conventional thinking.

Sweden’s public health agency declared that Dr. Rothe’s report had contained major errors. The agency’s website said, unequivocally, that “there is no evidence that people are infectious during the incubation period” — an assertion that would remain online in some form for months.

French health officials, too, left no room for debate: “A person is contagious only when symptoms appear,” a government flyer read. “No symptoms = no risk of being contagious.”

. . .

(p. 11) Dr. Rothe, . . ., was shaken. She could not understand why much of the scientific establishment seemed eager to play down the risk.

“All you need is a pair of eyes,” she said. “You don’t need rocket-science virology.”

. . .

While public health officials hesitated, some doctors acted. At a conference in Seattle in mid-February, Jeffrey Shaman, a Columbia University professor, said his research suggested that Covid-19’s rapid spread could only be explained if there were infectious patients with unremarkable symptoms or no symptoms at all.

In the audience that day was Steven Chu, the Nobel-winning physicist and former U.S. energy secretary. “If left to its own devices, this disease will spread through the whole population,” he remembers Professor Shaman warning.

Afterward, Dr. Chu began insisting that healthy colleagues at his Stanford University laboratory wear masks. Doctors in Cambridge, England, concluded that asymptomatic transmission was a big source of infection and advised local health workers and patients to wear masks, well before the British government acknowledged the risk of silent spreaders.

The American authorities, faced with a shortage, actively discouraged the public from buying masks. “Seriously people — STOP BUYING MASKS!” Surgeon General Jerome M. Adams tweeted on Feb. 29.

. . .

By the end of the month [March 2020], the U.S. Centers for Disease Control announced it was rethinking its policy on masks. It concluded that up to 25 percent of patients might have no symptoms.

Since then, the C.D.C., governments around the world and, finally, the World Health Organization have recommended that people wear masks in public.

Still, the W.H.O. is sending confusing signals. Earlier this month, Dr. Van Kerkhove, the technical lead, repeated that transmission from asymptomatic patients was “very rare.” After an outcry from doctors, the agency said there had been a misunderstanding.

“In all honesty, we don’t have a clear picture on this yet,” Dr. Van Kerkhove said. She said she had been referring to a few studies showing limited transmission from asymptomatic patients.

Recent internet ads confused the matter even more. A Google search in mid-June for studies on asymptomatic transmission returned a W.H.O. advertisement titled: “People With No Symptoms — Rarely Spread Coronavirus.”

For the full story, see:

Matt Apuzzo, Selam Gebrekidan and David D. Kirkpatrick. “How the World Missed Covid’s Symptom-Free Carriers.” The New York Times, First Section (Sunday, June 28, 2020): 1 & 10-11.

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

(Note: the online version of the story was updated June 27, 2020 and has the title “How the World Missed Covid-19’s Silent Spread.”)