Solving COVID
September 11, 2020

China on Wednesday approved Phase 1 human testing of a COVID-19 nasal spray vaccine being developed by researchers at Xiamen University, Hong Kong University, and vaccine maker Beijing Wantai Biological Pharmacy Enterprise Co. Children and some adults already get a nasal spray vaccine for the flu, and recent research from Washington University School of Medicine suggested a nasal vaccine was actually more effective than an injection at protecting mice against COVID-19 infections.

This is the first nasal spray vaccine candidate for COVID-19 to be tested in humans, and preliminary studies showed it can significantly reduce lung damage in infected mice and hamsters, according to Science and Technology Daily, a newspaper linked to China's Ministry of Science and Technology, Bloomberg News reports. The intranasal vaccine aims to promote a natural immune response to the coronavirus by combining the new virus' spike proteins with a weakened flu virus.

China now has 10 vaccines in human trials, including four in Phase 3 trials. The U.S. has three Phase 3 trials underway, although AstraZeneca and Oxford University paused their final-stage trial in the U.S. and elsewhere this week to investigate a spinal cord illness in one of its vaccine subjects. "Chinese drugmakers have taken their research abroad because the outbreak at home has been under control for months," The New York Times reports, but Beijing is also effectively using the promise of priority access to a vaccine and loans "in a charm offensive aimed at repairing damaged ties and bringing friends closer in regions China deems vital to its interests." Peter Weber

September 28, 2020

Low- and middle-income countries should expect a boost in coronavirus testing soon, The Guardian reports.

Rapid and affordable coronavirus antigen tests from two different companies — SD BioSensor in South Korea and Abbott in the U.S. — will soon be distributed across the world as part of the global Access to Covid Tools initiative, which was launched in March by the World Health Organization, the European commission, the Gates Foundation, and the French government. The WHO has granted BioSensor's test emergency approval and is expected to do so for Abbott's in the near future, with 20 percent of their production going to lower income countries.

The WHO's Dr. Maria Van Kerkhove explained Monday that the tests are crucial because of their turnaround time, which is just 15 to 30 minutes, and the fact that they don't need to be taken to labs to determine a result. Faster testing will likely play a significant role in helping countries, especially those that currently have less access to reliable diagnostic tools, combat all aspects of the pandemic.

Antigen tests aren't always accurate, but they should pick up most cases, especially during the right timeframe, and their ease of use allows for more regular testing, which lowers the risk of a false result. Read more at The Guardian. Tim O'Donnell

September 28, 2020

The coronavirus appears to have "one big trick," Shane Crotty, a professor in the Center for Infectious Disease and Vaccine Research at the La Jolla Institute for Immunology, told Bloomberg.

That trick — avoiding the human body's "initial innate immune response for a significant period of time," and, particularly, the response of a substance called interferon that typically helps orchestrate the defense against viral pathogens — is linked to more severe cases. Indeed, new studies published last week in Science found that an insufficient amount of interferon, the production of which may sometimes be inhibited in people with previously "silent" gene mutations and other times is actually disabled by a person's immune response, could signal a more dangerous infection.

The good news is that, because scientists are catching on to the virus' strategy, they have a better idea of how to prevent it from causing severe infections. Writes Bloomberg, the work highlights the potential for interferon-based therapies, which are typically used in in the early stages of a viral infection when it's easier to avoid life-threatening respiratory failure. Now, dozens of studies focusing on interferon treatments are recruiting COVID-19 patients. Read more at Bloomberg. Tim O'Donnell

September 26, 2020

Johnson & Johnson announced the start of phase three of its coronavirus vaccine trial this week, citing "positive interim results" from earlier stages of its study. Those were published Friday, and they were indeed promising.

The pharmaceutical giant reported that 99 percent of the participants between the ages of 18 and 55 in early-to-mid stage clinical trials developed neutralizing antibodies against the novel virus. The analysis also found that most of the side effects associated with the vaccine were mild and resolved within a matter of days.

It wasn't clear, however, whether participants over 65 were well-protected since immune response results were available for only 15 people in that demographic. Additionally, Reuters reports, the rate of adverse reactions — like fatigue and muscle aches — to the vaccine in that age group was just 36 percent, far lower than those seen in 64 percent of the younger participants. That might sound like good news, but it actually suggests the immune response in older people may be weaker.

One of the key aspects of Johnson & Johnson's trial is that just a single dose produced a strong immune response in participants. Other companies developing vaccines like Moderna and Pfizer are using a two-dose approach. If Johnson & Johnson's phase three trial, in which 60,000 volunteers will enroll across three continents, eventually proves the single dose is safe and effective, it could simplify distribution of the vaccine. Read more at Reuters and CNN. Tim O'Donnell

September 24, 2020

Helsinki Airport has started making use of dogs to detect COVID-19.

The airport in Finland is deploying trained sniffer dogs as part of a new trial after researchers said that in preliminary tests, dogs could "identify the virus with nearly 100 percent accuracy," including "days before before a patient developed symptoms," The Guardian reports. They can reportedly detect it in 10 seconds or less.

"It's very promising," University of Helsinki researcher Anna Hielm-Björkman, who is overseeing the trial, told The Guardian. "If it works, it could prove a good screening method in other places."

The trial reportedly involves having passengers use a wipe to dab their necks, which one of the dogs then sniffs, and if it detects the coronavirus, the passenger can then take a polymerase chain reaction test. Participation in the trial is voluntary, The New York Times reports.

Hielm-Bjorkman told the Times that it's not entirely clear what the dogs are actually detecting, explaining that "we know how dogs detect it — by smell — but we have no clue what they detect yet." But she added, "If we find this out, we can train thousands of dogs across the world." Airport Director Ulla Lettijeff in a statement said "we are pleased" with the start of the trial, adding, "This might be an additional step forward on the way to beating COVID-19." Brendan Morrow

September 24, 2020

The British government is on the verge of approving and funding the first clinical trials of COVID-19 vaccines in which healthy volunteers are deliberately infected with live coronavirus, the Financial Times reports. Such "challenge trials" are not new — they have been conducted since the 1790s — but they are more dangerous than double-blind placebo studies and therefore more rare. Still, 2,000 people have signed up to participate in the proposed trials in east London, FT reports, and Britain could green-light the research as soon as next week.

The volunteer subjects will be young, healthy, and deemed at low risk of being harmed by exposure to the new coronavirus. They will first be given a dose of the experimental vaccine and then later get a "challenge" dose of the coronavirus, to see if the vaccine works, FT reports. Imperial College London will reportedly be the academic lead on the trials. It's not clear which vaccines will be tested at the proposed new London quarantine facility, but AstraZeneca and Sanofi both told Reuters they are not involved. Peter Weber

September 23, 2020

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

September 23, 2020

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

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