Solving COVID
9:48 a.m.

Visby Medical, a startup in Silicon Valley, last week became the first company to receive an Emergency Use Authorization from the Food and Drug Administration for a portable PCR coronavirus test kit, Reuters reports.

PCR testing, considered one of the most accurate diagnostic tools for infectious diseases, usually requires a large, expensive machine to run results, but Visby's product can reportedly fit in a person's palm. The medical equipment company's founder and CEO Adam de la Zerda said he hasn't settled on a price for the kit — which Visby has been developing for the last seven years, initially for the purpose of diagnosing sexually transmitted diseases — but the goal is to make it affordable.

For now, the EUA will allow Visby's kit to be used in clinical labs, where it can process a nasal swab and detect COVID-19 in 30 minutes, but eventually Visby aims to sell it directly to consumers for in-home use, per Reuters.

Steven Chu, who has won the Nobel Prize for physics and invested in Visby, said he believes portable coronavirus test kits "can really transform things." The United States, of course, hopes to increase its testing capacity through affordable, efficient methods from any location, and Visby's kit seems to fit the bill. Read more at Reuters. Tim O'Donnell

8:13 a.m.

Johnson & Johnson is commencing phase three testing for a single-dose COVID-19 vaccine candidate.

The company announced on Wednesday the start of a phase three trial for its coronavirus vaccine candidate after "positive interim results" from previous clinical studies, and it said it will enroll up to 60,000 volunteers across three continents. This is the fourth COVID-19 vaccine candidate to enter phase three clinical trials in the United States but the first candidate hoping to provide protection with only one shot, The Washington Post reports.

"A single-shot vaccine, if it's safe and effective, will have substantial logistic advantages for global pandemic control," Dan Barouch, the director of Beth Israel Deaconess Medical Center's Center for Virology and Vaccine Research, told the Post. Judith Feinberg, West Virginia University vice chairwoman for research in medicine, also told The New York Times that a single-shot vaccine "would be fabulous" since "we've got to vaccinate a lot of people really quickly."

Johnson & Johnson CEO Alex Gorsky celebrated this as a "pivotal milestone" that "demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process." If the vaccine proves to be safe and effective, Johnson & Johnson is expecting that "the first batches" could be "available for emergency use authorization in early 2021," and it's "on track to meet its goal of providing one billion doses of a vaccine each year." Brendan Morrow

September 22, 2020

The Food and Drug Administration is poised to roll out new, rigorous standards for an emergency approval for a coronavirus vaccine, The Washington Post reports.

The standards, which appear to be an example of the agency's efforts to increase public trust amid the politicization of vaccine development, could be unveiled as soon as this week and are expected to be much tougher than what was used for the controversial emergency clearances of potential COVID-19 treatments hydroxychloroquine and convalescent plasma, per the Post. Manufacturers will be asked to follow vaccine trial participants for at least two months after they receive their second shot, two individuals familiar with situation told the Post on condition of anonymity. The agency will also reportedly be looking for at least five severe COVID-19 cases in the placebo group for each trial, as well as some cases of the disease in older people to see if the vaccine works.

Given the new standards, plus the time it will take companies developing vaccine candidates to apply for an emergency use authorization and for the FDA to review the data, "it's hard to imagine how an EUA could possibly occur before December," Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia and FDA vaccine advisory board member, told the Post.

That will likely allay at least some fears that the White House will try to push a vaccine out before the November election, although there are some people who think the FDA shouldn't grant an EUA for a vaccine at all since there'd still be less safety data required for approval than under normal circumstances. Read more at The Washington Post. Tim O'Donnell

September 21, 2020

The Centers for Disease Control and Prevention in a new guidance has acknowledged that COVID-19 can spread through the air, CNN reports.

The CDC's website as of Friday says that "airborne viruses, including COVID-19, are among the most contagious and easily spread" and that the coronavirus commonly spreads "through respiratory droplets or small particles, such as those in aerosols."

The CDC's latest guidance also says, "It is possible that COVID-19 may spread through the droplets and airborne particles that are formed when a person who has COVID-19 coughs, sneezes, sings, talks, or breathes. There is growing evidence that droplets and airborne particles can remain suspended in the air and be breathed in by others, and travel distances beyond 6 feet (for example, during choir practice, in restaurants, or in fitness classes)."

The guidance from the CDC, CNN notes, previously described COVID-19 as mainly spreading through "respiratory droplets produced when an infected person coughs, sneezes or talks" and within six feet. In the new guidance, when listing ways to protect oneself from COVID-19, in addition to steps such as social distancing and wearing a mask, the CDC also now says to "use air purifiers to help reduce airborne germs in indoor spaces."

The Washington Post notes that "scientists and public health experts have warned of mounting evidence that the novel coronavirus is airborne" for months, and University of Colorado at Boulder chemistry professor Jose-Luis Jimenez told the Post this acknowledgement from the CDC as a "major change."

"This is a good thing," Jimenez told the Post, "if we can reduce transmission because more people understand how it is spreading and know what to do to stop it."

Additionally, University of Maryland professor Donald Milton told CNN it's a "major improvement," adding, "I'm very encouraged to see that the CDC is paying attention and moving with the science. The evidence is accumulating." Brendan Morrow

September 18, 2020

The Trump administration's communications on a COVID-19 vaccine haven't exactly been seamless.

CDC Director Robert Redfield testified Wednesday that a vaccine won't be "fully available to the American public" until probably "late second quarter, third quarter 2021." That's consistent with estimates from National Institute of Allergy and Infectious Diseases chief Dr. Anthony Fauci, National Institutes of Health Director Francis Collins, and Moncef Slaoui, the chief scientist at Operation Warp Speed, the federal vaccine initiative.

President Trump said Redfield "made a mistake" with his timeframe and shared "incorrect information." He predicted there will be a vaccine before Election Day and up to 100 million doses delivered by the end of the year — more than double the CDC's most optimistic projection. White House Chief of Staff Mark Meadows said Thursday the goal is for 300 million doses by Jan. 1 and "we believe that we can get the vast majority of those at risk with a distribution model that would be available at the end of October."

Moderna, testing one of the most promising vaccine candidates in Phase 3 trials, said Thursday it may not even know if its vaccine works until next year. Stéphane Bancel, Moderna's CEO, said he anticipates massive vaccine shortages "in the first half of next year, at least maybe until Labor Day next year."

Assuming at least one of the half-dozen late-stage vaccines pans out and wins approval from an outside panel of experts, states will then have to overcome "a host of logistical and supply chain challenges" to get it distributed to the public, starting with health care and other essential workers, Politico reports. "State officials overseeing the largest and most complex vaccination campaign in history say the effort will require a level of careful coordination with the federal government that's been lacking during the pandemic."

"Many things could still go wrong," and "all the claims and counterclaims about when a vaccine will be ready and how safe it will be — some coming from Trump himself — have created a great deal of public hesitancy, beyond the regular anti-vaccination sentiments," Politico health editor Joanne Kenen writes. But "we've seen amazing science over the last eight or nine months," and "with each passing day, a vaccine is getting closer." Even if the first efforts "aren't as powerful as we'd like," she adds, it will help contain the virus. Peter Weber

September 17, 2020

Moderna is ramping up to have its coronavirus vaccine to the public early next year.

Stephane Bancel, CEO of the Cambridge, Massachusetts-based biotech company, told The Boston Globe that Moderna originally planned to determine its vaccine's effectiveness in October. But because infection rates are slowing, "which is great for the country," Bancel added, it's becoming "less and less probable" Moderna will have definitive results by then. "We've said November," Bancel said, but that timetable could stretch into December if infections slow even further.

Determining a vaccine's effectiveness requires there's a good amount of coronavirus infections out there, as a developer needs to know if the vaccine protects people from a virus better than a placebo. The Food and Drug Administration requires a vaccine to prevent at least 50 percent of infections to be considered effective. More than 25,000 people are currently enrolled in Moderna's phase three trial across the country.

If everything pans out, Bancel said Moderna will seek an emergency use authorization from the FDA to speed up the vaccine's approval process. And when that happens, Moderna can ship out the doses of the vaccine it has already produced to the federal government. The Department of Health and Human Services and the Department of Defense pledged $1.5 billion for 100 million doses of Moderna's vaccine, but Bancel said that many doses won't be ready until early 2021.

Moderna's vaccine is among several the government is helping fund in hopes of rolling out hundreds of millions of doses as soon as possible. Read more at The Boston Globe. Kathryn Krawczyk

September 17, 2020

Coronavirus testing may soon be much easier.

Computer vision startup Gauss and biotech company Cellex announced Thursday they've created the first at-home COVID-19 test that can actually be done fully at home, Axios reports. While existing at-home tests still require sending test samples to a lab for analysis, this one coordinates with an app to deliver results at home in just 15 minutes.

To take the test, people follow a video and swipe a nasal swab through both nostrils, then put it in a tube of solution. Drops of that solution head into a rapid test cassette, which delivers lines as a visible test result. People then take a picture of those lines and upload it to Gauss's app, and it uses AI to determine results in about 15 minutes, Axios describes. This is a big change from typical tests that require sending samples out for analysis, though those PCR tests tend to be a bit more accurate than rapid tests. Gauss/Cellex's collaboration produces a correct positive test result 90 percent of the time, and a correct negative test result 100 percent of the time, Cellex CEO James Li said.

The Food and Drug Administration still has to approve the test, though it could grant it an emergency use authorization, which would get it out into the world earlier by avoiding much of the typical approval process. Then comes distribution and pricing; Li told Axios "our goal is to make this assay as widely available as possible." Kathryn Krawczyk

September 16, 2020

Eli Lilly's monoclonal coronavirus antibody drug is off to a "good start" after the pharmaceutical giant completed a small clinical trial, Stat News reports.

Only about 450 patients were enrolled in the trial, so there's a long way to go before Lilly finds anything definitive, but Stat reports the medicine — a manufactured version of the naturally-occurring antibodies the body produces to fend off the virus — appeared to reduce patients' hospitalization odds. Only 1.7 percent of the patients who received the drug went to the emergency room or were hospitalized, compared to 6 percent who took a placebo.

Again, it's unclear if that will hold up with further study, but Daniel Skovronsky, Lilly's chief scientific officer, said the early data are "extremely exciting" and "should give us confidence that neutralizing antibodies are going to be an important part of the solution" to the pandemic. Skovonrsky said the company will discuss additional clinical trials with regulators, as well as options like an emergency use authorization.

On the latter point, Eric Topol, the director and founder of the Scripps Research Translational Institute, suggested pumping the brakes. Topol is encouraged by the initial results, but doesn't think the drug currently "would qualify to even consider" an EUA. Read more findings from the trial at Stat News. Tim O'Donnell

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