Solving COVID
July 7, 2020

Regeneron Pharmaceuticals is still conducting trials on its double-antibody cocktail for COVID-19, but the company will have a head start on distribution should the Food and Drug Administration grant an emergency use authorization for the potential treatment.

Regeneron on Tuesday said the U.S. government signed a $450 million dollar contract with the company to make and supply the cocktail — which consists of two human antibodies binding "non-competitively to the receptor binding domain of the virus' spike protein" hindering its ability "to escape treatment" — as part of "Operation Warp Speed," the initiative aimed at accelerating the development of and access to coronavirus vaccines and treatments during the pandemic.

Pending FDA approval, Regeneron said it expects somewhere between 70,000 and 300,000 treatment doses or 420,000 to 1.3 million prevention doses, with the initial batch ready to go as early as the end of the summer. If that's the case, the government has reportedly committed to making the doses available to Americans at no cost and would be responsible for their distribution. Read more at CNBC. Tim O'Donnell

July 7, 2020

Novavax is set to receive more than a billion dollars in federal funding for its COVID-19 vaccine candidate.

The company on Tuesday morning announced it's getting $1.6 billion from the Trump administration's Operation Warp Speed, and this money will help it to "complete late-stage clinical development," "establish large-scale manufacturing," and "deliver 100 million doses" of its potential vaccine "as early as late 2020."

The Trump administration's Operation Warp Speed aims to speed up the development of a vaccine for COVID-19, and the $1.6 billion for Novavax is the largest deal the administration has made as part of this program so far, The New York Times reports. Novavax has "never brought a product to market," the Times notes.

"We are grateful to the U.S. government for its confidence in our technology platform, and are working tirelessly to develop and produce a vaccine for this global health crisis," Novavax CEO Stanley C. Erck said.

U.S. Health and Human Services Secretary Alex Azar also said in a statement that backing Novavax's vaccine candidate "increases the odds that we will have a safe, effective vaccine as soon as the end of this year." Novavax says it's planning to begin its phase three clinical trial with up to 30,000 subjects in the fall. Brendan Morrow

July 7, 2020

The Food and Drug Administration has granted emergency use approval for Becton Dickinson's COVID-19 antigen test, the New Jersey company said Monday. The test can be used by people with little laboratory training on a portable device about the size of a smartphone that returns results within 15 minutes, Becton Dickinson said in a statement.

The tests can be run on the company's Veritor Plus System, which is already in use at about 25,000 U.S. health-care facilities, at a cost of about $20 per test, not counting the $250 to $300 price for the platform itself. "People keep saying 'For that, I want to buy one for my house,'" Becton Dickinson chief executive Tom Polen told Bloomberg News. (The FDA approved the test only for specific facilities, not home use.) In comparison, an antigen test by Quidel Corp. approved by the FDA in May can cost as little as $5 to administer, while Abbott Laboratories' rapid ID NOW system costs thousands of dollars.

Antigen tests are a relatively new form of diagnostic test that scan for proteins on or inside a virus, Reuters explains. Becton Dickinson suggested its test could be used in retail pharmacies, urgent care clinics, and doctor's offices, and set a goal of producing 2 million tests a week by the end of September. The downside of antigen tests is that they "may not detect all active infections," the FDA said in May. "This means that positive results from antigen tests are highly accurate, but there is a higher chance of false negatives, so negative results do not rule out infection." Peter Weber

July 6, 2020

The U.S. government is planning to fund three 30,000-subject phase 3 COVID-19 vaccine trials starting this month, and Pfizer is recruiting for its own similarly large vaccine trial. "Quickly lining up all the subjects for so many studies at the same time poses several challenges," The Wall Street Journal reports. "We not only have to find the number of volunteers," National Institutes of Health Director Francis Collins explained, "but they need to be in an area where the virus is currently spreading, otherwise you learn nothing about the effectiveness of the vaccine."

The volunteers also need to be healthy and include sufficient high-risk groups that regulators can be sure the vaccines will be safe and effective in the broader population. That means COVID-19 hotspots are seen as fertile ground for recruiting, the Journal reports:

Among the areas being targeted in the U.S. and outside the country, industry officials say, are places where people generally aren't following preventive measures like social distancing or wearing masks. Some testing sites for Pfizer's vaccine trial will be in states that have seen recent increases in infections, such as Florida, Arizona, and Texas, Pfizer Chief Executive Albert Bourla said during a recent online event hosted by the Milken Institute. [The Wall Street Journal]

The need to quickly procure volunteers that meet these criteria has effectively created competition between vaccine trials. Vaccine developers and recruitment organizations are using novel techniques to find such volunteers, including working with churches and community groups, trawling testing centers and pharmacies, using algorithms, and asking employees to reach out to friends and family.

There are about 150 COVID-19 vaccines under development, and the three large late-stage trials being funded by the U.S. government this summer are for Moderna's vaccine candidate, the U.S. trial of a drug developed by Oxford University and AstraZeneca that's already being tested in Britain, and Johnson & Johnson's vaccine effort. Peter Weber

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

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