Solving COVID
June 23, 2020

Imperial College London has "reached a significant milestone" after delivering a small dose of its coronavirus vaccine candidate to the first healthy volunteer in its trial. So far, all has gone according to plan. The clinical team is closely monitoring the participant's health, which remains in good condition, and there are no safety concerns.

Developing a vaccine for the COVID-19 virus is crucial during the pandemic, and it's worth keeping an eye on every effort. But Imperial College's candidate stands out because it's based on a new self-amplifying RNA technology, which has never before been involved in human trials. If it proves safe and effective, Imperial College believes it could revolutionize — and reduce the cost of — vaccine development, allowing scientists to take on emerging diseases like COVID-19 much more quickly in the future.

The initial volunteer will receive a booster shot in four weeks, and several other volunteers will enter the trial to further assess the vaccine's safety and find the right dosage. Then, in the next few weeks, Imperial College will administer doses to 300 healthy volunteers. If that goes well, larger trials will take place throughout the year. Read more about Imperial College's vaccine development here. Tim O'Donnell

5:56 p.m.

The results from the first phase of Moderna's coronavirus vaccine trial are out, and the promising findings are in line with some early data from the study released in May.

The study, published Tuesday in The New England Journal of Medicine, found the experimental mRNA vaccine — which requires two doses a month apart — induced coronavirus immune responses in all 45 participants, just as scientists had hoped. There were some mild side effects, including fatigue, chills, and fevers, but The Associated Press notes those aren't uncommon with other vaccines, and there have been no major safety concerns.

Moderna will begin its final step at the end of July, a 30,000-person study to prove if the shots are strong enough to protect people from the virus. While the first phase does indicate the vaccine produces antibodies geared toward fighting off the virus, it's less clear if the levels of antibodies are enough to actually fend off infection. Read the full results of the study at The New England Journal of Medicine, as well as more context at The Associated Press. Tim O'Donnell

July 13, 2020

As the debate about reopening American schools in the fall rages on, a new study conducted by the Dresden University Hospital in Germany could shed some light on the matter.

The study, the largest of its kind in Germany, tested more than 2,000 students and teachers at 13 schools in three different districts in Saxony, the only German state to reopen schools with full class sizes in May. The results showed only 12 participants tested positive for COVID-19 antibodies, five of whom had previously tested positive for the active virus, suggesting the schools did not play a major role in spreading the virus. Indeed, they may have even helped curb transmission.

"Children act more as a brake on infection," said Prof. Reinhard Berner, the head of pediatric medicine at Dresden University Hospital and leader of the study. "Not every infection that reaches them is passed on."

There are several caveats, however. For starters, Saxony has had a lower infection rate overall than other parts of Germany during the pandemic, so it's natural the rate would be lower among subgroups, as well. Still, even if areas with larger epidemics are more cautious, the study could be useful for other places with fewer cases.

Another complication is the fact that while Saxony allowed for full classrooms, parents won the right to keep their children home, so it's unclear if schools were really operating at full capacity.

Finally, a new study out of the United Kingdom suggests immunity to the novel virus wanes within months, so while that research warrants its own skepticism, it's possible more students in the German study were at one point infected but no longer produce antibodies. Read more at The Guardian and Yahoo News. Tim O'Donnell

July 13, 2020

Early this year, reports of people in South Korea testing positive for the coronavirus again after apparently recovering set off alarm bells. The concern largely subsided, however, when the Korean Centers for Disease Control and Prevention determined the positive tests weren't reinfections.

Now, though, a new study from King's College in London suggests people may lose their COVID-19 immunity within months. The study analyzed the immune response of more than 90 patients and health-care workers, with blood tests revealing 60 percent developed a strong antibody response during their infections, but only 17 percent retained the same potency three months later. In some cases, antibody levels weren't detectable.

Along those lines, Vox reported a case in which a patient tested positive for the virus three months after their initial infection. While the doctor in the case noted it's possible a single infection lasted that long, he's doubtful. Plus, other coronaviruses that cause common colds don't lead to long-term immunity, so some experts think the novel virus is headed down that path.

The results of the study indicate it could be challenging to develop herd immunity or a one-and-done vaccine, but there are several important pieces of information to process. The King's College participants haven't been reinfected, so it's not a sure thing it can even happen. Similarly, the Vox anecdote is a may not be representative, and there haven't been similar reports out of countries hit by the virus earlier than the U.S.

Secondly, Prof. Robin Shattock of Imperial College London said even if reinfection is possible, subsequent cases would likely "be less severe" because people "will still retain immune memory."

Lastly, this wouldn't mean there's no hope for a vaccine, but rather, like the flu, an annual coronavirus booster shot may be necessary for "sustained levels of protective antibodies." Read more at The Guardian. Tim O'Donnell

July 11, 2020

In Israel, public health officials mandated entire schools should close whenever a single student or staff member tests positive for the coronavirus, but another strategy adopted by Germany may be the model a lot of countries use going forward as they try to get students back in the classroom, The Washington Post reports.

Instead of shuttering schools because of an infection or trying to enforce social distancing in the classroom, Germany is employing "class bubbles." In other words, when a student tested positive, the entire class had to quarantine for two weeks, while the rest of the school went on with business as usual. England is planning on utilizing the strategy in September — elementary schools will be in bubbles of up to 30 students, and high school students will be grouped into a bubble of up to 240 peers.

Schools in the Canadian province of Quebec will take it a step even further when they start again in the fall; students will be in groups of up to six who don't have to social distance, while keeping one meter away from other bubbles and two meters from students.

Otto Helve, a pediatric infectious-disease expert from Finland, told the Post the strategy could work especially well in a place like the United States that still has a high infection rate and, subsequently, a higher chance of experiencing an outbreak at a school. Read more at The Washington Post. Tim O'Donnell

July 10, 2020

Data shows the drug remdesivir significantly reduced the risk of death in severely sick COVID-19 patients, biopharmaceutical company Gilead Sciences announced Friday.

Remdesivir reduced the risk of death by 62 percent when compared to normal care, Gilead claims its data shows. Gilead noted this is an "important finding that requires confirmation in prospective clinical trials." Shares of Gilead rose close to three percent before the market opened upon the news.

Gilead developed remdesivir as a potential treatment for Ebola and has been testing it on coronavirus patients for months. Late last month, Gilead said each dose of remdesivir will cost $520, totaling more than $3,000 over the course of a typical coronavirus treatment. The Trump administration has since bought up Gilead's remdesivir supply. Kathryn Krawczyk

July 10, 2020

The CEO of Pfizer is expressing confidence in the company's coronavirus vaccine candidate, which he says could potentially receive approval from the FDA this October.

Pfizer CEO Albert Bourla spoke with Time this week after the pharmaceutical company recently released the first clinical data on its COVID-19 candidate, which showed it generated neutralizing antibodies at levels 1.8 to 2.8-times the levels found in patients who recovered from COVID-19. There were, however, some side effects including fevers.

"What we learned is that this vaccine can neutralize the virus," Bourla told Time. "...For me, it was the moment when I saw the data, plus many other data that we haven't published yet, [that] made me say that until now I was thinking if we have a vaccine. Now I'm discussing when we're going to have a vaccine."

Bourla added that "we have a lot of indications that make me feel that really it should make it," noting that it won't be until "we have the final study" that it's clear whether the vaccine candidate works but saying that this answer should come around September.

"So for a potential approval in October, if we are lucky," he said. "It's feasible."

If that happens, Bourla says "we will have already manufactured doses that will be readily available" as soon as the FDA approval comes. In announcing its recent data, Pfizer said it's looking to "manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021." Brendan Morrow

July 10, 2020

Texas A&M College of Medicine is leading a consortium of research hospitals and medical schools in a Phase 4 trial to determine if the century-old tuberculosis vaccine can help blunt the damage from COVID-19, at least until a vaccine for the new coronavirus has been proven safe and effective.

"Scientists have known for decades that the tuberculosis vaccine, called bacille Calmette-Guerin, or BCG, improves immunity against some viruses," The Texas Tribune reported back in May, when the trial was just getting started. Jeffrey Cirillo, the Texas A&M microbial pathogenesis and immunology professor who is leading the trial, told Politico on Thursday that about 100 people have already been vaccinated, 200-300 more will get their shots over the next two weeks, and the goal is 1,800 subjects in the "randomized, blinded, placebo-controlled trial."

The TB vaccine has been used more than a billion times around the world, but it's not commonly used in the U.S., except to fight bladder cancer. The researchers at Texas A&M, Baylor College of Medicine, Harvard's School of Public Health, Cedars Sinai Medical Center, and the University of Texas MD Anderson Cancer Center are hoping the vaccine ramps up the immune system to fight off the disease, as it does the cancer cells. A similar trial is being conducted in the Netherlands.

The U.S. researchers will monitor the volunteers for six months, looking for statistically significant differences between those who get the BCG vaccine and the group that gets a placebo shot. "We're also doing a cognitive study in parallel to evaluate the cognitive effects of COVID-19," Cirillo told Politico's Myah Ward, using before-and-after MRIs and cognitive assessments to see if the vaccine reduces COVID-19's mental impairments. The vaccine is most effective in the first two to three years, he added, and if it is found to be effective, it could be used either as a stop-gap measure until a coronavirus vaccine arrives or in tandem with that vaccine to make it more effective. Peter Weber

July 10, 2020

The World Health Organization updated its findings Thursday on how COVID-19 is transmitted, and there are two important changes. First, the WHO acknowledged growing evidence the new coronavirus may spread through aerosols, tiny droplets of saliva that linger in the air for hours, especially in enclosed and poorly ventilated spaces. The second change involved the risk of transmission by people who don't have symptoms. Both issues have broad implications for how to contain the disease.

The WHO maintains that the main route of transmission involves infected people projecting saliva droplets into the eyes, mouth, or nose of people in close proximity, via coughing, sneezing, talking, or singing. The agency also said spread through infected surfaces, or formite transmission, is "likely" though not yet proven. Urine and feces have been shown to contain viable amount of the new coronavirus, too.

The virus can be spread by people who don't have COVID-19 symptoms, the WHO said, but there is an "important" distinction between people who never develop symptoms (asymptomatic) and those who have yet to develop symptoms (presymptomatic), and "the extent of truly asymptomatic infection in the community remains unknown." As a practical matter, Michael Barbaro noted on Thursday's The Daily podcast, the WHO is "making distinctions that don't mean all that much to people who are trying to decide whether to go to work, whether to go to a restaurant, whether to see friends."

The WHO has long dismissed aerosols as a means of transmission except during certain medical procedures, but it now says airborne spread "cannot be ruled out." There's evidence aerosols may have been responsible for "outbreaks of COVID-19 reported in some closed settings, such as restaurants, nightclubs, places of worship, or places of work where people may be shouting, talking, or singing," the WHO said, though larger droplets or contaminated surfaces might also have caused those outbreaks.

"Outdoors, any virus in small or large droplets may be diluted too quickly in the air to pose a risk," The New York Times reports. "But even a small possibility of airborne spread indoors has enormous implications for how people should protect themselves." The new brief mostly shows the WHO's experts interpret the data on aerosols differently, Oxford University's Dr. Trish Greenhalgh tells the Times. "The push-pull of that committee is palpable," she said. "As everyone knows, if you ask a committee to design a horse, you get a camel." Peter Weber

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