Category: Covid-19

First of 300 Million Vaccine Doses Are Hoped to Be Ready by October

(p. A7) Expanding its pursuit of an inoculation against the coronavirus, the U.S. Department of Health and Human Services said on Thursday it would provide “up to $1.2 billion” to the drug company AstraZeneca to develop a potential vaccine from a laboratory at Oxford University.

The deal with AstraZeneca is the fourth and by far the largest vaccine research agreement that the department has disclosed. The money will pay for a Phase 3 clinical trial of a potential vaccine in the United States this summer with about 30,000 volunteers.

The H.H.S. statement said the agency and AstraZeneca “are collaborating to make available at least 300 million doses,” and projected that the first doses could be available as early as October [2020].

. . .

In a separate statement, AstraZeneca said it had reached agreements with several governments and other organizations to produce at least 400 million doses, had “secured manufacturing capacity for one billion doses,” and will begin its first deliveries in September [2020].

For the full story, see:

David D. Kirkpatrick. “Drugmaker Gets $1.2 Billion Grant From the U.S. to Develop a Vaccine.” The New York Times (Friday, May 22, 2020): A7.

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

(Note: the online version of the story was updated June 3 [sic], 2020 and has the title “$1.2 Billion From U.S. to Drugmaker to Pursue Coronavirus Vaccine.” The online version says that the title of the New York print version was “U.S. Gives Drugmaker $1.2 Billion Grant.” The title of my National print version was “Drugmaker Gets $1.2 Billion Grant From the U.S. to Develop a Vaccine.”)

Poll Says Two-Thirds of Voters Wear Mask When Outside the House

(p. A4) . . . an overwhelming majority, 80%, feel that the country is spiraling out of control, according to a new Wall Street Journal/NBC News poll.

. . .

Roughly two-thirds of voters said they always wear a mask when they leave the house, compared with 21% who sometimes wear one and 15% who said they rarely or never do.

. . .

The Journal/NBC News poll surveyed 1,000 registered voters from May 28 through June 2. The margin of error was plus or minus 3.1 percentage points.

For the full story, see:

Michael C. Bender. “Nation Deeply Worried, Poll Finds.” The Wall Street Journal (Monday, June 8, 2020): A4.

(Note: ellipses added.)

(Note: the online version of the story has the date June 7, 2020, and has the title “Americans Are More Troubled by Police Actions in Killing of George Floyd Than by Violence at Protests, Poll Finds.” The last two sentences quoted above appear in the online, but not the print, version.)

Vaccine Progress Gives Hope That Pandemic Will Begin to End in September

(p. A1) In a medical research project nearly unrivaled in its ambition and scope, volunteers worldwide are rolling up their sleeves to receive experimental vaccines against the coronavirus — only months after the virus was identified.

Companies like Inovio and Pfizer have begun early tests of candidates in people to determine whether their vaccines are safe. Researchers at the University of Oxford in England are testing vaccines in human subjects, too, and say they could have one ready for emergency use as soon as September.

. . .

(p. A11) The coronavirus itself has turned out to be clumsy prey, a stable pathogen unlikely to mutate significantly and dodge a vaccine.

“It’s an easier target, which is terrific news,” said Michael Farzan, a virologist at Scripps Research in Jupiter, Fla.

An effective vaccine will be crucial to ending the pandemic, which has sickened at least 4.7 million worldwide and killed at least 324,000. Widespread immunity would reopen the door to lives without social distancing and face masks.

For the full story, see:

Carl Zimmer, Knvul Sheikh and Noah Weiland. “Tests Fuel Hope That Vaccine Is Months, Not Years, Away.” The New York Times (Thursday, May 21, 2020): A1 & A11.

(Note: ellipses added.)

(Note: the online version of the story was updated June [sic] 10, 2020 and has the title “A New Entry in the Race for a Coronavirus Vaccine: Hope.” The online versions says that the title of the New York print version is “Labs Step Up Race to Be First, Or Even 4th, to Find a Vaccine.” the title of my National print version was “Tests Fuel Hope That Vaccine Is Months, Not Years, Away.”)

Anti-Hydroxychloroquine Lancet Study Retracted by Authors

(p. A7) Two major studies casting doubt on the ability of antimalaria drugs to treat Covid-19 patients based on data from a little-known Chicago company, Surgisphere Corp., were retracted Thursday [June 4, 2020].

The Lancet first pulled a study published late last month that found antimalarials provided no benefit as a treatment for Covid-19 infections while increasing the risk of heart problems and death. The New England Journal of Medicine then retracted a separate article, published in early May, that examined the impact of cardiovascular and blood-pressure drugs in Covid-19 patients.

. . .

Three of the Lancet paper’s authors said they decided to retract the paper after Surgisphere refused to share the full data set as part of a review triggered by concerns raised by outside researchers. The Lancet published a correction to the study on May 29.

“We always aspire to perform our research in accordance with the highest ethical and professional guidelines,” the authors, Drs. Mehra, Patel and Frank Ruschitzka said in a statement. “We can never forget the responsibility we have as researchers to scrupulously ensure that we rely on data sources that adhere to our high standards. Based on this development, we can no longer vouch for the veracity of the primary data sources.”

. . .

Following the study, the World Health Organization paused enrolling patients in clinical trials of hydroxychloroquine, although this week the organization said it resumed the trials.

In the days following publication of the study, however, other researchers began to raise questions about the Surgisphere data, first on social media and in emails, then in an open letter to The Lancet and the study’s authors. More than 100 researchers signed on to the letter.

For the full story, see:

Jared S. Hopkins and Russell Gold. “Antimalaria Drug Studies Are Retracted.” The Wall Street Journal (Friday, June 5, 2020): A7.

(Note: ellipses, and bracketed date, added. In the passages quoted above, where the online version differs from the print version, the quoted passages follow the online version.)

(Note: the online version of the story was updated June 5, 2020, and has the title “Hydroxychloroquine Studies Tied to Data Firm Surgisphere Retracted.”)

Ridley Quotes Petrovsky: “We Can’t Exclude the Possibility That This Came From a Laboratory Experiment”

(p. C3) What about the controversial claim that the virus may have originated in a laboratory? Both Ralph Baric’s team at the University of North Carolina at Chapel Hill and Shi Zhengli’s team at the Wuhan Institute of Virology have been working on SARS-like coronaviruses and testing their ability to infect human cells. They have for some years reported successful experiments in which they created new strains of the virus by manipulating the spike proteins that are now the focus of discovering the origin of SARS-CoV-2, and their research has included inserting furin cleavage sites.

The two teams made these so-called chimeric viruses in order to understand what makes viruses more or less dangerous and in the hope of being ready to protect people against a future SARS epidemic. In 2015 they published a joint experiment in which they combined parts of one mouse-adapted SARS-like coronavirus with a spike gene from a SARS-like coronavirus derived from Chinese bats.

In reporting their results, they expressed caution about continuing such risky experiments: “On the basis of these findings, scientific review panels may deem similar studies building chimeric viruses based on circulating strains too risky to pursue, as increased pathogenicity in mammalian models cannot be excluded.” They added: “The potential to prepare for and mitigate future outbreaks must be weighed against the risk of creating more dangerous pathogens.”

Nikolai Petrovsky and colleagues at Flinders University in Australia have found that SARS-CoV-2 has a higher affinity for human receptors than for any other animal species they tested, including pangolins and horseshoe bats. He suggests that this could have happened if the virus was being cultured in human cells, adding that “We can’t exclude the possibility that this came from a laboratory experiment.”

For the full commentary, see:

Matt Ridley. “So Where Did the Virus Come From?” The Wall Street Journal (Saturday, May 30, 2020): C3.

(Note: I corrected a misspelling of Petrovsky’s name.)

(Note: the online version of the commentary was the date May 29, 2020 and has the same title as the print version.)

The manuscript co-authored by Petrovsky, and mentioned above, is reported in:

Sakshi Piplani, Puneet Kumar Singh, David A. Winkler, Nikolai Petrovsky. “In Silico Comparison of Spike Protein-Ace2 Binding Affinities across Species; Significance for the Possible Origin of the Sars-Cov-2 Virus.” May 13, 2020.

Rigid Merged Health Systems Cause Slow Covid-19 Testing

(p. A1) When a stay-at-home order in March all but closed the revered labs of the gene-editing pioneer Jennifer Doudna, her team at the University of California, Berkeley dropped everything and started testing for the coronavirus.

They expected their institute to be inundated with samples since it was offering the service for free, with support from philanthropies. But there were few takers.

Instead, the scientists learned, many local hospitals and doctors’ offices continued sending samples to national laboratory companies — like LabCorp and Quest Diagnostics — even though, early on, patients had to wait a week or more for results. The bureaucratic hurdles of quickly switching to a new lab were just too high.

. . .

(p. A5) In normal times, scientists at the Innovative Genomics Institute at Berkeley spend their time advancing the gene-editing technology called Crispr that the lab’s founder, Dr. Doudna, is known for.

But after the pandemic shut down the institute’s research in March, Dr. Doudna called for volunteers to redirect most of the labs’ work to coronavirus testing. The country was clamoring for more tests, after all, and her lab was full of researchers with the technical skills to make it happen.

Unlike many other major research institutions, Berkeley does not have a medical school or run its own hospital. So Dr. Urnov reached out to others in the area, who were still ordering from LabCorp and Quest, despite lengthy delays in processing results at the time.

“We would come to these entities and say, ‘Hi, we hear you have problems,’” Dr. Urnov recalled. “And they said, ‘Well, you have to basically work with our EHR,’” the acronym for electronic health records.

For the full story, see:

Katie Thomas. “In Testing Chaos, Some Labs Drowned While Others Sat Idle.” The New York Times (Friday, May 22, 2020): A1 & A5.

(Note: ellipsis added.)

(Note: the online version of the story has the date May 21, 2020 and has the title “These Labs Rushed to Test for Coronavirus. They Had Few Takers.”)

YouTube, Vimeo, and Twitter Censor Firm Working on Ultraviolet Covid-19 Cure

(p. A15) Early in the Covid-19 pandemic, Aytu BioScience made a commitment to find ways to help. One of those ways came through our newly formed relationship with a prominent Los Angeles hospital.

On April 20 [2020] we put out a press release titled “Aytu BioScience Signs Exclusive Global License with Cedars-Sinai for Potential Coronavirus Treatment.” The treatment is called Healight, and it was developed by research physicians at the hospital’s Medically Associated Science and Technology Program. The technology, which has been in development since 2016, uses ultraviolet light as an antimicrobial and is a promising potential treatment for Covid-19.

Aytu and Cedars-Sinai have engaged with the Food and Drug Administration to pursue a rapid path to human use through an Emergency Use Authorization. But hardly anyone noticed—until Thursday, when President Trump mused, “. . . supposing you brought the light inside the body . . .”

My team and I knew the president’s comments could trigger a backlash against the idea of UV light as a treatment, which might hinder our ability to get the word out. We decided to create a YouTube account, upload a video animation we had created, and tweet it out. It received some 50,000 views in 24 hours.

Then YouTube took it down. So did Vimeo. Twitter suspended our account. The narrative changed from whether UV light can be used to treat Covid-19 to “Aytu is being censored.”

For the full commentary, see:

Josh Disbrow. “Ultraviolet Light Takes Political Heat.” The Wall Street Journal (Tuesday, April 28, 2020): A15.

(Note: bracketed year added, ellipses in original.)

(Note: the online version of the commentary has the date April 27, 2020, and the title “An Experimental Ultraviolet Light Treatment for Covid-19 Takes Political Heat.”)

Seeking Cure for Covid-19, Scientist in Elite Group Identifies the FDA as “the Problem Here”

(p. A1) A dozen of America’s top scientists and a collection of billionaires and industry titans say they have the answer to the coronavirus pandemic, and they found a backdoor to deliver their plan to the White House.

The eclectic group is led by a 33-year-old physician-turned-venture capitalist, Tom Cahill, who lives far from the public eye in a one-bedroom rental near Boston’s Fenway Park. He owns just one suit, but he has enough lofty connections to influence government decisions in the war against Covid-19.

. . .

(p. A6) Brian Sheth, co-founder of private-equity firm Vista Equity Partners, and a Democrat, had been watching the effort gather steam from his home in Austin, Texas. He was an early investor in Dr. Cahill’s fund and had been on the first call. His expertise was technology, though, not immunology.

He had become friendly with Thomas Hicks Jr., the Dallas businessman and co-chairman of the Republican National Committee. Mr. Sheth introduced Mr. Hicks to Dr. Cahill’s group.

The connection cinched ties between a group of mostly liberal scientists from left-leaning institutions with a Republican stalwart who hunts birds with Donald Trump Jr.

In his first chat with the group, Mr. Hicks said, “I’m not a scientist. Make it clear enough for me, and then tell me where the red tape is.”

A major concern of the scientists was the FDA. The scientists had in their research identified monoclonal antibody drugs that latch onto virus cells as the most promising treatment. But to make the medicine in sufficient quantities, one drugmaker, Regeneron Pharmaceuticals Inc., would have to shift some of its existing manufacturing to Ireland. FDA rules required a monthslong wait for approval.

Mr. Scolnick, who had tussled with bureaucracy during the AIDS epidemic, tried reaching the FDA. The call ended poorly after the bureaucrats told the group they already had the pandemic under control. In a group call afterward, one of the scientists said, of the FDA: “They’re the problem here.”

Dr. Cahill got in touch with Mr. Ayers. Once the group briefed the vice president’s aide on the bottleneck, Mr. Ayers said he knew who to call. That evening, March 27, Regeneron received a call from the FDA. They had permission, starting immediately, to shift production to Dublin.

For the full story, see:

Rob Copeland. “Scientists, Billionaires Mount Manhattan Project for Covid-19.” The Wall Street Journal (Tuesday, April 28, 2020): A1 & A6.

(Note: ellipsis added.)

(Note: the online version of the article has the date April 27, 2020, and the title “The Secret Group of Scientists and Billionaires Pushing a Manhattan Project for Covid-19.”)

“For Every Scientist Employed by the F.D.A., There Are Three Lawyers”

(p. 5) Imagine that the fateful day arrives. Scientists have created a successful vaccine. They’ve manufactured huge quantities of it. People are dying. The economy is crumbling. It’s time to start injecting people.

But first, the federal government wants to take a peek.

That might seem like a bureaucratic nightmare, a rubber stamp that could cost lives. There’s even a common gripe among researchers: For every scientist employed by the F.D.A., there are three lawyers. And all they care about is liability.

For the full commentary, see:

Stuart A. Thompson. “How Long Will a Vaccine Really Take?” The New York Times, SundayReview Section (Sunday, May 3, 2020): 4-5.

(Note: the online version of the commentary was updated April 30, 2020 and has the same title as the print version.)

Hydroxychloroquine Clinical Trials Suspended on Basis of Lancet Article Containing “Major Inconsistencies”

(p. A11) A group of scientists who raised questions last week about a study in The Lancet about the use of antimalarial drugs in coronavirus patients have now objected to another paper about blood pressure medicines in the New England Journal of Medicine, which was published by some of the same authors and relied on the same data registry.

Moments after their open letter was posted online Tuesday morning [June 2, 2020], the editors of the N.E.J.M. posted an “expression of concern” about the paper, and said they had asked the paper’s authors to provide evidence that the data are reliable.

The Lancet followed later in the day with a statement about its own concerns regarding the malarial drugs paper, saying that the editors have commissioned an independent audit of the data.

. . .

In their letter to the N.E.J.M., critics of the work wrote: “Serious, and as yet unanswered, concerns have been raised about the integrity and provenance of these data.”

The letter points out “major inconsistencies” between the number of coronavirus cases recorded in some countries during the study period and the number of patient outcomes reported by the researchers over the same period.

. . .

Many of the scientists who first raised concerns about the database are involved in clinical trials of chloroquine and hydroxychloroquine, and they were forced to pause the studies for safety reviews after The Lancet study was published.

James Watson, a senior scientist with MORU Tropical Health Network, said his unit had to immediately suspend work on a large randomized clinical trial to see if chloroquine or hydroxychloroquine can protect health care workers exposed on the job to the coronavirus from infection.

“I saw very quickly this paper didn’t hold up to much scrutiny at all,” he said. “We started wondering, ‘Who’s been collecting this data, and where did it come from?’ We were quite surprised to see a global study with only four authors listed and no acknowledgment of anyone else.”

. . .

David Glidden, a professor of biostatistics at University of California, San Francisco, who reads all new publications about Covid-19 antiviral therapies as a member of a National Institutes of Health clinical guidelines panel, said he was immediately struck by the vagueness of the descriptions in both papers.

For the full story, see:

Roni Caryn Rabin. “Scientists Question Medical Data From Single Company Used in Two Studies.” The New York Times (Wednesday, June 3, 2020): A11.

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

(Note: the online version of the article was updated June 2, 2020, and had the title “Scientists Question Medical Data Used in Second Coronavirus Study.”)