Solving COVID
June 29, 2020

China is taking the fast track to approving a COVID-19 vaccine — and potentially putting lives in danger along the way.

China's Central Military Commission approved military use of an experimental coronavirus vaccine, Chinese vaccine developer CanSino Biologics announced Monday. It's unclear whether military members will be mandated to use the vaccine, but even an approval for optional use is worrisome considering the vaccine had only just been approved for human trial, Reuters reports.

CanSino's vaccine has already gone through two phases of experimentation, and had been deemed safe and showed some efficacy in humans, CanSino said. But it would have to undergo a third phase of widespread human testing to actually be deemed an effective and safe vaccine. It had just won approval to begin that third phase of trials both in China and abroad, with human trials scheduled to begin in Canada. But the Chinese military also moved to skip that necessary safety phase, allowing the use of the vaccine for the military for one year, CanSino said.

"The Ad5-nCoV is currently limited to military use only and its use cannot be expanded to a broader vaccination range without the approval of the Logistics Support Department," CanSino told Reuters, citing the department that okayed the military use in the first place. The vaccine is one of eight under development in China that were approved for human trial, and was developed jointly with China's Academy of Military Science. Kathryn Krawczyk

July 2, 2020

When COVID-19 cases started surging across the Sun Belt, Texas closed the bars. A few hours later, Florida followed suit, then California, then a day later, Arizona. "If I could go back and redo anything, it probably would have been to slow down the opening of bars, now seeing in the aftermath of how quickly the coronavirus spread in the bar setting," Texas Gov. Greg Abbott (R) said last Friday. The "bar setting, in reality, just doesn't work with a pandemic." This isn't puritanism, it's science. Bars are especially dangerous vectors of coronavirus transmission.

Public health experts say if people are going to leave their homes during the pandemic, they should maintain a distance of six feet from others, wear a mask to contain the saliva droplets and aerosolized breath that spread the virus, and stay outside as much as possible. Bars, one study in the journal Emerging Infectious Diseases put it, promote "heavy breathing in close proximity."

Bars are "the opposite of social distancing," Dr. David Hamer at Boston University School of Medicine tells The Associated Press. "Can you do social distancing at a bar? Can you wear a mask while drinking?" Drinking alcohol also lowers inhibitions and makes people more likely to flout safety precautions, especially the younger people who go to flirt and socialize at bars, added Natalie Dean, an infectious diseases expert at the University of Florida. "Young people have less severe illness, so they may be infected and able to infect others inadvertently."

Arizona epidemiologist Saskia Popescu tells AP it can be hard for public health agencies to trace outbreaks to any individual location when they are overwhelmed by spiking cases, but when the dust settles, bars will likely figure prominently in the hot spots.

"You can make a cocktail at home," Popescu suggests. In many states, bars can (more or less) safely sell you the ingredients. Peter Weber

July 1, 2020

The first clinical data on the vaccine candidate produced by pharmaceutical giant Pfizer in partnership with German biotech firm BioNTech showed some positive results, although there were side effects, Stat News reports.

The study randomly assigned 45 patients one of three doses of the vaccine — which relies on experimental messenger-RNA technology — or a placebo. The bad news is half of the patients who received the highest dose of the vaccine developed fevers, so they weren't given a second injection, but those who received the two lower doses did receive a second dose. After the follow-up shot, more than 50 percent of the volunteers reported some kind of adverse effect, including fevers and sleep disturbances. That's troublesome, but none of the side effects were considered life-threatening or resulted in hospitalization or disability.

Now, for the good news. The vaccine generated neutralizing antibodies that prevent the coronavirus from functioning, and the levels of those neutralizing antibodies were 1.8 to 2.8-times the levels found in recovered COVID-19 patients.

No one knows if antibodies lead to immunity, and Pfizer, like every manufacturer with a potential vaccine candidate, will have to conduct larger studies to figure that out. Despite the uncertainty and the side effects, the initial findings represent a promising first step. "We still have a ways to go and we're testing other candidates, as well," said Philip Dormitzer, the chief scientific officer for viral vaccines at Pfizer. "However, what we can say at this point is there is a viable vaccine candidate based on immunogenicity and early tolerability safety data." Read more at Stat News. Tim O'Donnell

July 1, 2020

If you're going to make your own coronavirus mask, you should probably use cotton, Gizmodo reports.

A new study published last week in ACS Nano involving researchers from the National Institute of Standards and Technology and the Smithsonian Institution's Conservation Institute eased some concerns that nothing but medical-grade masks can filter coronavirus particles. While N95 masks are still clearly the most effective, cloth masks can help, the study found.

Cotton, in particular, made strong showing, though Gizmodo notes that more tightly-woven types of cotton fabrics, like the kind used in flannel, did better than others.

Layering, while perhaps not incredibly enticing on a comfort level, seems to be key for homemade masks, as well. The best single-layer cotton blocked about 20 percent of the coronavirus-sized particles used in the study, which is useful, but a far cry from the 95 percent filtered by N95 masks.

All told, homemade masks won't provide complete protection, but they appear to at least mitigate the chance of being infected, a nice bonus to the fact they can also help prevent the wearer from spreading the virus to others. Read more at Gizmodo. Tim O'Donnell

June 30, 2020

The Food and Drug Administration has received some criticism amid the coronavirus pandemic for rushing approval on some medications, but the agency is expected to assure everyone Tuesday that it "will not reduce its standards or cut corners in its review to approve a vaccine" despite moving at unprecedented speed to do so, The Wall Street Journal reports.

FDA Commissioner Stephen Hahn is expected to discuss the agency's guidance for vaccine approval in Congressional testimony Tuesday. Per the Journal, the FDA won't give a candidate the green light unless the manufacturer "clearly" demonstrates its safety and effectiveness through a clinical study, and the production of antibodies in patients' bloodstream alone won't lead to approval since it's still unknown what levels of antibodies provide protection.

The Journal's report doesn't contain much more detail beyond about what warrants approval, but it does reveal the FDA's watch won't end after a vaccine hits the market. Instead, vaccine makers will reportedly be required to monitor recipients for a year after treatment since "post-market studies" may be necessary to "further assess known or potential serious risks." Read more at The Wall Street Journal. Tim O'Donnell

June 30, 2020

TC BioPharm, a Scottish biotech firm, has won approval to test an experimental T-cell injection therapy to fight COVID-19 by boosting the immune system early in a coronavirus infection, the Financial Times reports. The six-month trial in Edinburgh will involve harvesting T-cells from healthy people, cultivating a large number of the cells in a lab, then injecting the donor cells into hospitalized patients. A large enough infusion could head off the infection before the patient needs to move to intensive care, and even prevent cytokine storms that ravage patients whose body mounts an overly aggressive immune response.

"We have got some evidence that if you kill the virus effectively early on, then [there] should be no reason for the host to have this overwhelming response," Dr. Nik HiraniNik Hirani at Edinburgh University's Center for Inflammation Research tells FT. TC BioPharm founder and CEO Mike Leek said the trial will focus on gamma delta T-cells, the "bully boys" of the immune system. "They circulate in surveillance mode looking for a fight and are in particular attracted to cells that are stressed either by cancer or viral infection, for which they are our first line of defense," he said.

T-cells decrease in number as people get older, so the injections might be especially helpful for elderly patients. Peter Weber

June 29, 2020

"Wyatt Earp, the gunslinger who helped tame the American West, once said, 'fast is fine but accuracy is final,'" Sharyn Alfonsi reported on Sunday's 60 Minutes. "The same thing could be said about testing for COVID-19." On March 16, as the new coronavirus was spreading in parts of the U.S. and there were few working diagnostic tests, "the Food and Drug Administration took the unprecedented step of allowing COVID antibody tests to flood the market without review."

"The promise of a new serology, or antibody blood test, that could determine if a person had been exposed to COVID-19 and developed 'protective' antibodies was being heralded as the next best thing" to diagnostic testing, 60 Minutes reported. But federal officials knew pretty quickly that this "'game-changer' that could get Americans back to work" wouldn't work, because many of the tests were seriously flawed, Anfonsi reported, citing a three-month investigation. They "continued to allow them to be sold anyway."

The FDA said it allowed these flawed tests to remain on the market for 50 days after a "careful balancing of risks and benefits." But Rep. Raja Krishnamoorthi (D-Ill.), who is investigating that decision, told 60 Minutes "we've never seen anything like this in terms of a policy which is basically an anything goes, Wild West type of approach to regulating a health care market." In late May, the FDA started pulling tests — 50 so far — "but by then it was too late," 60 Minutes reports. "The flawed antibody tests are still being used and the bad data collected from them is guiding critical decisions about when to reopen communities."

If you still want to get a serology test, Alfonsi said you should get checked two or three times using different tests to lower the risk of false positives — and even if you do turn out to have antibodies, there's no guarantee you have immunity from the coronavirus. Peter Weber

June 28, 2020

Former Food and Drug Administration Commissioner Scott Gottlieb, who was early in sounding the alarm bells about the coronavirus, began Sunday with a dash of optimism. While he is anticipating 2020 remaining a very challenging year in the United States, he appears quite confident that, within six months, some technological development — whether in the form of a vaccine or a treatment — will end the epidemic and turn COVID-19 into a more manageable threat.

Gottlieb said available data suggests a vaccine will come onto the scene in early 2021, echoing recent comments from Dr. Anthony Fauci, but he also added that therapeutic antibodies should be ready to go by the fall and produced at scale by the end of the year.

But it's precisely because he expects scientific developments to turn the tide by early next year that Gottlieb wants Americans to buckle down, work together, and — especially — wear masks to slow the virus' spread and preserve as many lives as possible for the time being. Read more from Gottlieb here. Tim O'Donnell

June 27, 2020

New research from Italy published in Pathogens and Global Health found the mortality rate of patients hospitalized with COVID-19 declined from 24 percent in March to just 2 percent in May at a hospital in Milan. In even more positive news, there wasn't a significant change in the patients' age.

One reason is likely that doctors have improved at treating the novel and confounding disease over time. The study mentions that treatments specifically targeting issues associated with COVID-19 like hyper-inflammation and microvascular thrombosis may have played a big role. Another explanation is that Italy's lockdown measures were effective at curbing the spread of the virus, which subsequently helped lessen the strain on the health-care system.

The study also proposes that co-infections of other respiratory viruses like the flu and air pollution have both decreased in the timeframe, leading to fewer severe cases. Finally, there's a small chance that a viral mutation is a factor, although scientists have largely dismissed the notion that the virus has been or will be significantly altered enough to result in a change in lethality for better or worse anytime soon.

As always, it's important to remember this is just one study and not a definitive statement, but it's worth following especially as the United States continues to grapple with the pandemic. Read the full study here. Tim O'Donnell

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