Solving COVID
October 1, 2020

Moderna won't be able to seek emergency use authorization for its COVID-19 vaccine candidate earlier than late November, and the vaccine would likely not be available to the general public prior to March, its CEO says.

Moderna CEO Stéphane Bancel told the Financial Times on Wednesday that the company wouldn't have enough data to seek emergency use authorization from the Food and Drug Administration for its coronavirus vaccine candidate before Nov. 25 at the earliest. He also told the Financial Times that the company wouldn't be able to file for approval to get the vaccine to the entire population until late January at the earliest, meaning that "late [first quarter], early [second quarter]" of 2021 is a "reasonable timeline" for approval.

This, CBS News writes, was both a "setback for Moderna" as well as a "blow to claims by" President Trump that a coronavirus vaccine could be ready prior to Election Day. Trump has repeatedly touted such a possibility, and he contradicted experts in his administration during the first 2020 presidential debate on Tuesday while claiming that "we're weeks away from a vaccine."

But Robert Redfield, director of the Centers for Disease Control and Prevention, told Congress last month that in terms of when a vaccine might be "generally available to the American public so we can begin to take advantage" of it to "get back to our regular life, I think we're probably looking at ... late second quarter, third quarter 2021."

Given the Moderna CEO's comments, the Financial Times writes that the "most realistic hope of a pre-election vaccine" would be from Pfizer, as that company's CEO says it should know whether its vaccine works by the end of October. But The New York Times writes that "the idea that it will be ready in October is far-fetched." Brendan Morrow

7:44 a.m.

The U.S. National Institutes of Health on Monday ended one clinical trial of Eli Lilly's experimental COVID-19 antibody treatment after finding that the drug, "bamlanivimab, is unlikely to help hospitalized COVID-19 patients recover from this advanced stage of their disease." The trial was suspended Oct. 13 out of "an abundance of caution," but the NIH said Monday it had found no significant safety issue with the monoclonal antibody treatment.

Eli Lilly said it will continue testing bamlanivimab with the NIH on mild or moderately ill COVID-19 patients to see if it reduces hospitalizations and severe symptoms. Eli Lilly is also conducting its own separate trials.

Human bodies make antibodies to fight off infections, and Eli Lilly's experimental drug, like a similar treatment from Regeneron, features concentrated copies of one or two antibodies found to be effective at fighting of COVID-19. President Trump was given Regeneron's version when he was hospitalized with COVID-19, and public health experts have high hopes for monoclonal antibody treatments. Eli Lilly and Regeneron are both seeking emergency use authorization from the Food and Drug Administration. Peter Weber

October 26, 2020

Another potential coronavirus vaccine is moving along, with especially good news for the elderly.

AstraZeneca announced Monday that its COVID-19 vaccine in development with the University of Oxford has produced a similar immune response in both younger and older adults. The vaccine also results in low adverse responses among older people, the pharmaceutical giant said. That's a standout response considering COVID-19 tends to be more severe in older patients.

Several dozen coronavirus vaccines are in the works around the globe, with AstraZeneca's one of many undergoing clinical testing. It's unclear when AstraZeneca will publish the results of its large ongoing trial that will help determine its vaccine's safety, but it is expected to be one of the first vaccine candidates to seek regulatory approval, Reuters reports. This vaccine is expected to protect people from the coronavirus for about a year. Kathryn Krawczyk

October 24, 2020

Coronavirus vaccine trials conducted by AstraZeneca and Johnson & Johnson are preparing to resume, the pharmaceutical companies said Friday.

Both studies were put on hold after two volunteers who enrolled in AstraZeneca's vaccine trial developed a possible neurological side effect, and another person enrolled in J&J's study reportedly suffered a stroke. AstraZeneca, which had already restarted its trial in other parts of the world, including the United Kingdom, South Africa, and Brazil, said independent monitoring committees and international regulators agreed it was safe to resume the trial in the U.S, as well. The Food and Drug Administration reportedly did not find the vaccine candidate to be responsible for the neurological symptoms, but the agency was also unable to definitively rule out a link.

Similarly, investigators concluded the J&J volunteer's illness did not appear to be related to the vaccine candidate, although there was "no clear cause" of the incident. Paul Stoffels, the chief scientific officer at J&J, told Stat News the company could begin enrolling patients for the vaccine study — the only major one to test just a single dose — again early next week. Read more at The Washington Post and The Wall Street Journal. Tim O'Donnell

October 23, 2020

Reopening schools doesn't seem to be a major contributor to coronavirus community spread, data from random testing in the U.S. and Britain reveals. That's especially true of elementary schools, the data shows.

Children, even young ones, can and have been infected with COVID-19 and can transmit the virus to adults. But even as coronavirus surges once again across the U.S. and Britain, random testing data shows young children aren't the ones causing coronavirus spikes, experts who've seen the data say. "The more and more data that I see, the more comfortable I am that children are not, in fact, driving transmission, especially in school settings,” Brooke Nichols, an infectious disease modeler at the Boston University School of Public Health, told The New York Times.

The risks among children in middle and high schools are less clear, experts acknowledge. But they believe "these schools may be able to contain the coronavirus, provided the community prevalence is low and the schools take abundant precautions," the Times reports. It all led Dr. David Rubin, a pediatrician and infectious disease expert at the University of Pennsylvania, to conclude it's worth at least reopening elementary schools in lower-risk areas. "I think there’s a pretty good base of evidence now that schools can open safely in the presence of strong safety plans, and even at higher levels of case incidence than we had suspected,” he said. Kathryn Krawczyk

October 22, 2020

The Food and Drug Administration has given final approval to remdesivir as a treatment for COVID-19, making it the first and only fully-approved treatment in the U.S. for the novel coronavirus, CNBC reports. The drug has been permitted in cases of emergency use authorization since May, and was one of the medications used to treat President Trump when he was hospitalized earlier this month.

Remdesivir (sold under the brand name Veklury) is administered via an IV, and is intended for "the treatment of COVID-19 requiring hospitalization," the drugmaker, Gilead Sciences, said in a statement. While it is approved or authorized for temporary use in around 50 countries, a World Health Organization study earlier this month of some 2,750 patients found that remdesivir had "little or no effect" on death rates.

In a separate study by Gilead Sciences of 1,060 patients, the drug was found to prevent people from "getting sicker" and "from going onto more oxygen support," though the drugmaker likewise "did not find a statistically significant reduction in death rates across the entirety of patients treated in the trial," CNBC writes. Jeva Lange

October 21, 2020

A pair of peer-reviewed studies suggest there has been a "sharp" drop in COVID-19 death rates among patients hospitalized with the coronavirus, NPR reports.

One of the two new studies, which will be published in the Journal of Hospital Medicine, looked at NYU Langone Health system hospitalizations and found "mortality has dropped among hospitalized patients by 18 percentage points," from 25.6 percent to 7.6 percent, since March, according to the report. Another study that will be published in Critical Care Medicine observed "an unadjusted drop in death rates among hospitalized patients of around 20 percentage points since the worst days of the pandemic" in England, NPR writes.

A number of factors may be contributing to this apparent decline, NPR reports, including doctors improving their ability to treat COVID-19 patients since the pandemic began. Leora Horwitz, one of the authors on the first study, also suggested that mask-wearing may help lessen the severity of coronavirus cases.

At the same time, Horwitz pointed out that even with this decline, the COVID-19 death rate is "still higher than many infectious diseases, including the flu," and while "I do think this is good news," it "does not make the coronavirus a benign illness." She added that COVID-19 "still has the potential to be very harmful in terms of long-term consequences for many people." But Bilal Mateen, who conducted research for the second study, told NPR, "I would classify this as a silver lining to what has been quite a hard time for many people." Read more at NPR. Brendan Morrow

October 21, 2020

Most people recover from COVID-19 within four weeks, but one in 20 patients is still ill after eight weeks and one in 40 continues to have symptoms after 12 weeks, a new study from Kings College London found, according to BBC News. The researchers pored over self-reported data in the COVID Symptoms Study app, looking for patterns that could predict if a patient who contracts the new coronavirus will have "long COVID" or recover more rapidly. They found several traits that appeared to increase the risk of longer-lasting COVID-19.

"Having more than five different symptoms in the first week was one of the key risk factors," Dr. Claire Steves at Kings College London told BBC News. Patients with a cough, diarrhea, loss of taste and smell, headaches, and fatigue would be at higher risk than somebody with just a cough, for example. People over 50 also had increased odds of long COVID, as did people with asthma or lung disease, and women.

"We've seen from the early data coming out that men were at much more risk of very severe disease and sadly of dying from COVID, it appears that women are more at risk of long COVID." Steves said. There are no set symptoms for long COVID, but fatigue is common, BBC News notes. You can find more examples in this new PSA on long COVID from Britain's Department of Health and Social Care. Peter Weber

October 20, 2020

Scientists will deliberately infect healthy volunteers with the coronavirus as part of the first COVID-19 human challenge trials.

Imperial College London scientists are leading the research, which will be funded by the British government, The Washington Post reports. Andrew Catchpole, chief science officer for the pharmaceutical company set to run the study, explained to the Post a key advantage is that "you get efficacy data so much sooner," as researchers won't have to wait for volunteers who are given vaccine candidates to become naturally exposed to COVID-19.

The first stage of the research, CNN explains, will be a "characterization study" in early 2021 that will involve exposing healthy volunteers to COVID-19 at Royal Free Hospital to determine what the minimum dose is that results in an infection. Researchers then plan to test potential COVID-19 vaccines. Lead researcher Dr. Chris Chiu said in a statement the goal is to "accelerate development of the many potential new COVID-19 treatments and vaccines."

Experts have debated the ethics of proceeding with such challenge trials for COVID-19, given the limited treatment options and potential long-term health consequences, but Imperial College London immunologist Peter Openshaw told the Post, "it is really vital that we move as fast as possible toward getting effective vaccines and other treatments for COVID-19." U.K. Business Secretary Alok Sharma in a statement said this announcement "marks an important next step in building on our understanding of the virus and accelerating the development of our most promising vaccines which will ultimately help in beginning our return to normal."

Regulators and an ethics committee will have to approve the challenge trials before they can begin next year, and an announcement said results are "expected by May 2021." Brendan Morrow

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