“Operation Warp Speed, . . . , Is More Imaginative Than the Bureaucratic Norm”

(p. 11) . . . the blundering of the Trump administration, while real and deadly, may not be responsible for the bulk of America’s coronavirus fatalities.

. . .

. . . : the absence of challenge trials for vaccines (in which young, healthy participants agree to be vaccinated and then infected with the virus), the predictable expert resistance to at-home testing. But the most important one was the straightforward bureaucratic calamity at the C.D.C. that delayed effective testing for a fateful month.

An effective president might have addressed some of these problems. (Although Operation Warp Speed, the White House’s vaccine initiative, is more imaginative than the bureaucratic norm.) But overall they are problems with structures and habits rather than personalities — an institutional decadence that predated Trump and will persist when he is gone.

. . .

. . . the third thing you see when you look beyond Trump [is] the fact that so many countries in Western Europe, to say nothing of our neighbors in the Americas, have had death rates similar to ours.

This reality speaks not of exceptionalism but of convergence — and the possibility that the trends of the early 21st century have left us sharing more in common not only with France and Spain but also with Mexico and Brazil than most Americans might expect.

This, too, may matter long after Trump is gone. Where there are crises, in this dispensation, they are likely to be general rather than just American. Where there is decadence, it is the shared experience of late modernity. And if renewal comes to an exhausted West, it will not necessarily come through America alone.

For the full commentary, see:

Ross Douthat. “What Isn’t Trump’s Fault.” The New York Times, SundayReview Section (Sunday, September 13, 2020): 11.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sept. 12, 2020, and has the same title as the print version.)

“An Active Regulatory State Is a Playground for the Privileged Class”

(p. A17) . . . the poor would suffer most under Mr. Biden’s platform. Dividing U.S. households into five income groups, I have estimated the regulatory costs of each quintile and expressed them as a percentage of each quintile’s average income. The costs to the bottom group amount to 15.3% of its total income—representing a burden equal to all the taxes they currently pay. This group would experience part of the cost as lower wages, but the biggest bite would come in diminished purchasing power due to higher prices for energy, cars and other consumer goods.

The top quintile, by contrast, would suffer the least from regulatory restoration, with labor, energy and other consumer rules amounting to only a 2.2% implicit tax on the highest earners.

This estimate includes not only regulations Mr. Biden has explicitly said he would revive, but also many of those that would be necessary to meet the goals outlined in his platform.

. . .

An active regulatory state is a playground for the privileged class to indulge its own preferences at the expense of ordinary Americans.

For the full commentary, see:

Casey B. Mulligan. “The Real Cost of Biden’s Plans.” The Wall Street Journal (Thursday, September 17, 2020): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sep. 16, 2020, and has the same title as the print version.)

Former FDA Commissioners Urge Early “Emergency Use Authorization” for Covid-19 Vaccine

(p. A17) As former FDA commissioners, we are confident in the FDA’s career scientists to oversee vaccine development rigorously.

If a Covid vaccine clears this process, it could be made available initially to specific groups of people through an Emergency Use Authorization. This emergency authority enables the FDA to make products available before a full application is approved by the agency. Congress created the emergency-use pathway as part of the Project BioShield Act of 2004, which provided for the development of medical countermeasures against chemical, biological, radiological and nuclear threats. Following 9/11 and anthrax, lawmakers expected an urgent need for such defenses.

After the 2009 swine flu, Congress expanded this pathway in the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, a bipartisan measure aimed at preparing the country to weather a pandemic. The law streamlined the application process for emergency use, expanded the classes of drugs eligible, and broadened the testing the FDA could require.

. . .

This authority enables the staged entry of a vaccine. It’s unlikely that a Covid-19 vaccine will receive full approval and broad distribution right away. Instead, the FDA will probably authorize vaccines for use in targeted groups of people at high risk from Covid and most likely to benefit from the vaccine. For them, it may make sense to provide access to the vaccine before long-term follow-up studies that address very remote risks.

This might include health-care providers or first responders, who face greater exposure, or older people, who are more prone to severe complications if infected.

. . .

This process exists precisely to deal with public-health emergencies like Covid-19. It isn’t a lower standard for FDA approval. It’s a more tailored, flexible standard that helps protect those who need it most while developing the evidence needed to make the public confident about getting a Covid-19 vaccine.

For the full commentary, see:

Mark McClellan, and Scott Gottlieb. “How ‘Emergency Use’ Can Help Roll Out a Covid Vaccine.” The Wall Street Journal (Monday, September 15, 2020): A17.

(Note: ellipses added.)

(Note: the online version of the commentary has the date Sep. 13, 2020, and has the same title as the print version.)

Russia Approves Covid-19 Vaccine Before Completing Phase 3 Clinical Trial

(p. A6) MOSCOW — Russia has become the first country in the world to approve a vaccine for the coronavirus, President Vladimir V. Putin announced on Tuesday, though global health authorities say the vaccine has yet to complete critical, late-stage clinical trials to determine its safety and effectiveness.

Mr. Putin, who told a cabinet meeting on Tuesday [Aug. 11, 2020] morning that the vaccine “works effectively enough,” said that his own daughter had taken it. And in a congratulatory note to the nation, he thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.”

. . .

If Russian scientists have taken an unorthodox route to the coronavirus vaccine, it would not be the first time. Back in the 1950s, a team of researchers tested a promising, and ultimately successful, polio vaccine on their own children.

For the full story, see:

Andrew E. Kramer. “Putin Says Russia Is First to Approve Vaccine, but Skepticism Abounds.” The New York Times (Wednesday, August 12, 2020): A6.

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

(Note: the online version of the story was updated Aug. 11, 2020, and has the title “Russia Approves Coronavirus Vaccine Before Completing Tests.”)

Shanghai Immunologist Says Phase 1 and Phase 2 Tests Show Chinese Vaccine Is Safe and “Highly Likely” to Protect Against Covid-19

(p. A8) The United Arab Emirates has become the first country outside China to approve emergency usage of a Chinese Covid-19 vaccine candidate, in a vote of confidence for a state-backed drugmaker racing global rivals to stop the spread of the coronavirus.

. . .

Tao Lina, a former immunologist with the Shanghai CDC, said in an interview that it makes sense for authorities to approve the usage of Chinese vaccines that have proved safe during the first two phases of clinical trials, given the scale of the Covid-19 crisis. Unlike medical drug treatments, vaccines work by triggering a person’s own immunity, he said. “I’m not at all worried about the safety of the vaccines,” Mr. Tao said.

While the level of efficacy of the Chinese vaccines being used including those of Sinopharm isn’t yet clear, Mr. Tao said the Chinese vaccines’ ability to induce the body to produce antibodies during previous clinical trials meant that they were highly likely to confer some degree of protection from the virus.

For the full story, see:

Chao Deng, and Rory Jones. “U.A.E. Approves Use of China-Made Covid-19 Vaccine.” The Wall Street Journal (Wednesday, September 16, 2020): A8.

(Note: ellipsis added.)

(Note: the online version of the story was updated Sep. 15, 2020, and has the title “In Global Covid-19 Vaccine Race, Chinese Shot Receives First Foreign Approval.”)

China’s “Emergency-Use” Rule Allows Vaccinating Hundreds of Thousands Against Covid-19

(p. A1) A Chinese pharmaceutical company has injected hundreds of thousands of people with experimental Covid-19 vaccines, as its Western counterparts warn against administering mass vaccinations before rigorous scientific studies are complete.

China National Biotec Group Co., a subsidiary of state-owned Sinopharm, has given two experimental vaccine candidates to hundreds of thousands of people under an emergency-use condition approved by Beijing in July [2020], the company said this week.

For the full story, see:

Chao Deng. “China Tests Vaccines on Hundreds of Thousands.” The Wall Street Journal (Saturday, September 12, 2020): A1 & A8.

(Note: bracketed year added.)

(Note: the online version of the story was updated September 12, 2020, and has the title “China Injects Hundreds of Thousands With Experimental Covid-19 Vaccines.”)

Asymptomatic Transmission of Covid-19 Reduces Value of Fever Checks

(p. A4) . . . while health officials have endorsed masks and social distancing as effective measures for curbing the spread of the coronavirus, some experts scoff at fever checks. Taking temperatures at entry points is nothing more than theater, they say, a gesture that is unlikely to screen out many infected individuals, and one that offers little more than the illusion of safety.

. . .

. . . a growing body of evidence suggests that many of those who are driving transmission are so-called silent carriers — people who have been infected but feel fine, and don’t have a fever or any other symptoms.

. . .

“We now have a better understanding of Covid-19 transmission that indicates symptom-based screening has limited effectiveness because people with Covid-19 may have no symptoms or fever at the time of screening, or only mild symptoms,” the C.D.C. said in a statement.

. . .

Evidence of asymptomatic spread dates back to early in the pandemic, but has been mounting ever since. A recent study from South Korea published in JAMA Internal Medicine in August offered even more proof, finding that infected individuals who don’t feel ill may carry just as much virus in their nose, throat and lungs as those with symptoms — and for almost as long.

. . .

A. David Paltiel, a professor of health policy and management at Yale School of Public Health, says these individuals are the “silent spreaders” who are driving transmission and sparking superspreading events.

“You are maximally infectious before you exhibit symptoms, if you exhibit any symptoms at all,” Dr. Paltiel said. “You can be exposed and incubating the virus, and be beginning to shed massive amounts of transmissible virus and be a superspreader, without actually exhibiting any symptoms like a fever.”

For the full story, see:

Roni Caryn Rabin. “Fever Checks Are on the Rise, but Are They Effective Gatekeepers?” The New York Times (Monday, September 14, 2020): A4.

(Note: ellipses added.)

(Note: the online version of the story was updated September 14, 2020, and has the title “Fever Checks Are No Safeguard Against Covid-19.”)

The paper in JAMA Internal Medicine discussed above is:

Lee, Seungjae, Tark Kim, Eunjung Lee, Cheolgu Lee, Hojung Kim, Heejeong Rhee, Se Yoon Park, Hyo-Ju Son, Shinae Yu, Jung Wan Park, Eun Ju Choo, Suyeon Park, Mark Loeb, and Tae Hyong Kim. “Clinical Course and Molecular Viral Shedding among Asymptomatic and Symptomatic Patients with Sars-Cov-2 Infection in a Community Treatment Center in the Republic of Korea.” JAMA Internal Medicine (published online in advance of print Aug. 6, 2020). Doi:10.1001/jamainternmed.2020.3862

Plastic Bag Bans Are Reversed Because Covid-19 Clings to Reusable Bags

(p. 8A) PORTLAND, Ore. (AP) — Just weeks ago, cities and even states across the U.S. were busy banning straws, limiting takeout containers and mandating that shoppers bring reusable bags or pay a small fee as the movement to eliminate single-use plastics took hold in mainstream America.

What a difference a pandemic makes.

In a matter of weeks, hard-won bans to reduce the use of plastics — and particularly plastic shopping sacks — across the U.S. have come under fire amid worries about the virus clinging to reusable bags, cups and straws.

Governors in Massachusetts and Illinois have banned or strongly discouraged the use of reusable grocery bags. Oregon suspended its brand-new ban on plastic bags this week, and cities from Bellingham, Washington, to Albuquerque, New Mexico, have announced a hiatus on plastic bag bans as the coronavirus rages.

For the full story, see:

AP. “Virus Deals a Blow to Bans on Plastic Bags.” Omaha World-Herald (Monday, April 20, 2020): 8A.

More Work-Life Balance for Some Workers Means Less Work-Life Balance for Other Workers

(p. 3) I work for a successful, fast-growing technology company. There are times when some corporate “crisis” requires that a number of us lean in more in terms of office hours. My married, straight co-workers with children can easily bow out — while as a gay, single and child-free person, I get left with extra work because I am seen as not having responsibilities at home. I’m not unsympathetic to the difficulties my co-workers have in balancing work and life, but why does it have to be balanced on my back?

— Anonymous

. . .

You have every right to push back when you are imposed upon like this. Either everyone is responsible for extra work, or no one is. Your co-workers do not get to categorically decide that you have the time to handle the company’s crises because your life is arranged differently than theirs.

For the full story, see:

Roxane Gay. “A Great Work-Life Balance, Thanks to Me.” The New York Times, SundayBusiness Section (Sunday, August 23, 2020): 3.

(Note: ellipsis added.)

(Note: the online version of the story has the date Aug. 21, 2020, and has the title “My Colleagues Have Great Work-Life Balance (Thanks to Childless Me).”)

How “Blind” Is a Double-Blind Trial When Volunteers Know the Side-Effects of the Vaccine?

(p. A8) George Washington University had vaccinated 129 people since its share of the trials started. I would be No. 130. Altogether, Moderna planned to enroll 30,000 people in its trial. Half would be given the actual vaccine and half would get the placebo. The protocol called for two shots spaced a month apart.

Finally, it was time for my injection, which is when things got a little weird.

“We have to leave you now, because this is a double-blind study and we are blinded,” Dr. Malkin said. “You’ve been randomized.”

Before I could ask her to translate what she had just said, she was gone, and two nurses arrived with my vaccine. The first nurse left, and the second nurse, Linda Witkin, asked whether I was right-handed or left-handed, then proceeded to inject my right arm.

“Which one are you giving me, the vaccine or the placebo?” I asked. She gave me a look, clearly not pleased with my questioning.

. . .

With the Moderna trial, the side effects reported so far have been typical: fever, chills, muscle and joint soreness.

. . .

The night after my shot, I took my temperature: 97.5. I felt under my arms for glandular swelling and felt only mild joint pain.

. . .

“You all gave me the placebo, didn’t you?” I demanded of Dr. Diemert on Wednesday, during my one-week checkup. “I cannot believe I went through all of this and got the placebo.”

He told me that the actual vaccine shot was more “viscous” than the placebo, which was why neither he nor Dr. Malkin could be in the room when I got it, because they would have been able to easily determine. And so he really couldn’t answer because the double-blind program is meant to protect doctors like him from patients like me. He said I wasn’t to badger Ms. Witkin, if I ever even saw her again. He also said that most people reacted more to the second shot than the first one.

I texted the peanut gallery, “I feel no different.”

For the full story, see:

Helene Cooper. “From Reporting on Ebola to Being a Volunteer in a Covid-19 Vaccine Trial.” The New York Times (Saturday, September 12, 2020): A8.

(Note: ellipses added.)

(Note: the online version of the story has the date Sep. 11, 2020, and has the title “Covering Ebola Didn’t Prepare Me for This: I Volunteered for the Covid-19 Vaccine Trial.”)

Quick, Less Precise, but Repeated, Covid-19 Tests Can Be Better Than Slow Precise Tests

(p. A1) Public health experts are increasingly calling for a shift in thinking about Covid-19 testing: It is better to get fast, frequent results that are reasonably accurate than more precise results after dayslong delays.

. . .

Covid-19 tests that don’t require a lab tend to be less sensitive than “gold standard” laboratory-based tests, meaning they are likely to miss more cases. But many public health experts now say that repeat testing can make up for the loss of sensitivity, and such testing could quickly identify the most infectious people and help bring transmission to heel as workplaces and schools resume in-person operations and as influenza season looms.

. . .

(p. A6) “When we looked ahead, we realized we needed a paradigm shift from the still-needed diagnostic tests to the screening tests,” said Jonathan Quick, managing director for pandemic response, preparedness and prevention at the Rockefeller Foundation, which released a report in July [2020] calling for a massive scale-up in quick, cheap tests for Covid-19 screening. “As a practical matter, that meant making much more of a new kind of test,” Dr. Quick said.

Most Covid-19 diagnostic testing in the U.S. is processed in laboratories and uses a technique called rt-PCR that searches for the virus’s genetic material and amplifies it. The tests are incredibly sensitive but expensive to run, and the process often requires shipping samples from a test site to a lab.

. . .

“I think there’s a sense of desperation that we need to do something else,” Ashish Jha, dean of Brown University’s School of Public Health, said at a media briefing in August [2020].

. . .

Antigen tests are better at identifying cases when people have more virus in their system—meaning they will likely find people when they are most infectious, said Michael Mina, an epidemiologist at the Harvard T.H. Chan School of Public Health and an advocate of low-cost, widely available at-home testing that can be done on a paper strip.

. . .

The FDA also has said that rapid tests should have comparable accuracy to PCR diagnostic tests—a requirement that some public health specialists and companies say is overly stringent for surveillance testing.

An FDA official noted sensitivity rates lower than PCR might be acceptable, depending on how the test results are used. The agency has allowed for antigen tests with a sensitivity rate of 80% or better, the official said. “You can even have lower than 80% sensitivity” if it is a recurring or serial test.

For the full story, see:

Brianna Abbott, and Thomas M. Burton. “Speed Over Precision Favored in Covid Tests.” The Wall Street Journal (Wednesday, September 9, 2020): A1 & A6.

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

(Note: the online version of the story has the date Sep. 8, 2020, and has the title “Public Health Officials Pursue Covid-19 Tests That Trade Precision for Speed.” Where there are differences between the print and online versions, the passages above follow the online version.)

The report by The Rockefeller Foundation mentioned above is:

The Rockefeller Foundation. “National Covid-19 Testing & Tracing Action Plan.” Thurs., July 16, 2020.