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

5:08 p.m.

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

October 20, 2020

Stéphane Bancel, chief executive of Moderna Inc., said Monday that the federal government could grant emergency use authorization for its COVID-19 vaccine in December, assuming the company gets promising data from its Phase 3 trial in November. Moderna started its final-phase trial with 30,000 volunteers in July, and in order to apply for emergency authorization, 53 of the subjects have to become infected with the new coronavirus, and the cases have to be significantly higher in the half of the trial that received a placebo.

That first analysis will likely happen in November, Bancel said at a Wall Street Journal conference, but "it's hard to predict exactly which week because it depends on the cases, the number of people getting sick." If the results don't show sufficient efficacy, Moderna will try again when 106 trial participants contract symptomatic COVID-19, likely delaying authorization until early next year. Under Food and Drug Administration guidelines, drugmakers also have to show that their vaccine is safe for at least two months after vaccination, a benchmark Bancel said Moderna should hit in late November.

Moderna is testing one of four viable COVID-19 vaccines, and its timeline is closest to Pfizer, which said last week it expects to seek emergency use authorization of its vaccine in late November. The trials of vaccine candidates from Johnson & Johnson and AstraZeneca are on pause while the companies look into unexplained health issues among participants. Moderna says it plans to produce 20 million does of its vaccine this year and 500 million next year. Peter Weber

October 16, 2020

Pfizer could apply for emergency use authorization for its potential COVID-19 vaccine next month, its CEO says.

Pfizer CEO Albert Bourla on Friday provided an update on when the company may potentially seek emergency use authorization from the Food and Drug Administration for its coronavirus vaccine candidate, should it prove to be safe and effective.

"In the instance of emergency use authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine," Bourla explained. "Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November."

Bourla added that "assuming positive data, Pfizer will apply for emergency authorization use in the U.S. soon after the safety milestone is achieved in the third week of November."

With this announcement, The New York Times noted that Pfizer was "ruling out President Trump's assertion that a vaccine would be ready before Election Day." The CEO of Moderna, another company that has a potential COVID-19 vaccine in development, recently told the Financial Times it would likely not have enough data to seek FDA emergency use authorization until at least Nov. 25. At the time of those comments, the Financial Times wrote that this meant that Trump's "most realistic hope of a pre-election vaccine" would be from Pfizer.

Bourla also reiterated on Friday that Pfizer may know whether its vaccine is effective by the end of October, although the data required to make this determination "may come earlier or later based on changes in the infection rates." Brendan Morrow

October 16, 2020

A Defense Department study released Thursday concluded that passengers faced little risk of catching the coronavirus on a packed commercial flight. Researchers concluded that a passenger wearing a surgical mask continuously would have to sit next to an infectious passenger for 54 hours to get a dangerous level of exposure through the air. The threat of infection is greatly reduced because of the way air is circulated and filtered on airliners.

The study used a mannequin expelling simulated virus particles, and researchers conceded that this method of measuring the threat of aerosol exposure had its limitations. Still, Vice Adm Dee Mewbourne said, "the results showed an overall low exposure risk from aerosolized pathogens like COVID-19 on these aircraft." Harold Maass

October 15, 2020

Scientists at Britain's Oxford University have developed a "simple, extremely rapid, and cost-effective" antigen test that accurately identifies COVID-19 in less than five minutes, Oxford physics professor Achilles Kapanidis said Thursday. Oxford said it hopes to start developing the test for commercial use in early 2021, with expected approval six months later. A quick and accurate COVID-19 test could allow for bulk testing at places like airports, colleges, and businesses.

Public health officials expect at least one COVID-19 vaccine to be widely available by next summer. But the coronavirus will likely remain a public health concern for at least another year, and having an rapid test that "can reliably distinguish between different viruses in clinical samples" should offer "a crucial advantage in the next phase of the pandemic," said Dr Nicole Robb at Warwick Medical School, especially in winter months when COVID-19 is mixed in "with other seasonal respiratory viruses." Peter Weber

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