‘So far, so good’: The view from inside a coronavirus vaccine trial (Horizon)

Horizon: ‘So far, so good’: The view from inside a coronavirus vaccine trial. “Dr Lidia Oostvogels is feeling the pressure. After nearly two decades of working in vaccine development, seeing the subject of her work – coronavirus – in the news every single day is a first for her ‘It’s very exciting and very motivational, but there is a lot of pressure,’ she said. Dr Oostvogels is steering the human trials of a coronavirus vaccine for German biopharmaceutical firm CureVac, where she is head of their infectious diseases programme and leads its development of vaccines and therapies.”

New York Times: Call Me the Joan of Arc of Coronavirus Vaccine Trials

New York Times: Call Me the Joan of Arc of Coronavirus Vaccine Trials. “I am Patient 1133. I’ve never been in a medical trial before and I never wanted to be. As someone who suffers from pretty significant anxiety about my health, I am, in theory, the last person who should ever do any medical trial at all, and, on the way, up to the hospital, this thought occurred to me numerous times. But on Tuesday, Sept. 8, I did it anyway. I drove up to Yale New Haven Hospital to get my first of two doses of the experimental Pfizer coronavirus vaccine.”

Covering Ebola Didn’t Prepare Me for This: I Volunteered for the Covid-19 Vaccine Trial (New York Times)

New York Times: Covering Ebola Didn’t Prepare Me for This: I Volunteered for the Covid-19 Vaccine Trial. “I hadn’t thought of the placebo part of the vaccine trial when I signed up. I am a Type 1 diabetic — a chronic autoimmune disorder I have had since I was 15, with asthma to boot, so I am firmly in the high-risk category. That had been made clear to me by Dr. Fauci himself in early March when I ran into him in the green room for NBC’s ‘Meet the Press.’ ‘What happens if I get Covid?’ I had asked him. ‘I’m not saying you’re a dead duck,’ he replied, ‘but I cannot stress enough that you really need to not get it.'”

CNBC: Eli Lilly reports a reduced rate of hospitalization for coronavirus patients using its antibody treatment

CNBC: Eli Lilly reports a reduced rate of hospitalization for coronavirus patients using its antibody treatment. “Eli Lilly said Wednesday its antibody-based drug appears to have reduced the rate of hospitalization for coronavirus patients recently diagnosed with mild-to-moderate symptoms. The U.S. drugmaker said it tested three different doses of LY-CoV555 against a placebo in a trial enrolling roughly 450 patients. The middle dose of 2,800 mg met the trial’s target of significantly reducing the presence of SARS-CoV-2 after 11 days.”

STAT News: AstraZeneca resumes Covid-19 vaccine trials in the U.K.

STAT News: AstraZeneca resumes Covid-19 vaccine trials in the U.K.. “A large, United Kingdom-based Phase 2/3 study testing a Covid-19 vaccine being developed by AstraZeneca has been restarted, according to a statement from the company. News that the trial is resuming comes four days after the disclosure that it had been paused because of a suspected serious adverse reaction in a participant.”

STAT News: AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.

STAT News: AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.. “A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.” Apparently the issue has been addressed and the trial will resume shortly.

MIT Technology Review: New standards for AI clinical trials will help spot snake oil and hype

MIT Technology Review: New standards for AI clinical trials will help spot snake oil and hype. “An international consortium of medical experts has introduced the first official standards for clinical trials that involve artificial intelligence. The move comes at a time when hype around medical AI is at a peak, with inflated and unverified claims about the effectiveness of certain tools threatening to undermine people’s trust in AI overall.”

Washington Post: Two coronavirus vaccines begin the last phase of testing: 30,000-person trials

Washington Post: Two coronavirus vaccines begin the last phase of testing: 30,000-person trials. “At 6:45 a.m. Monday, a volunteer in Savannah, Ga., received a shot in the arm and became the first participant in a massive human experiment that will test the effectiveness of an experimental coronavirus vaccine candidate. The vaccine is being developed by the biotechnology company Moderna in collaboration with the National Institutes of Health.”

Houston Chronicle: J&J vaccine protects monkeys from Covid with single shot

Houston Chronicle: J&J vaccine protects monkeys from Covid with single shot. “Johnson & Johnson’s experimental coronavirus vaccine protected a group of macaques with a single shot in an early study, prompting the U.S. drugmaker to start trials in humans this month. All of the animals that were exposed to the pandemic-causing pathogen six weeks after the injection were immune except one, who showed low levels of the virus, according to a study published in the medical journal Nature. The health-care behemoth kick-started human trials on July 22 in Belgium and in the U.S. earlier this week.”

CNBC: Johnson & Johnson hopes to begin late-stage coronavirus vaccine trial ahead of schedule in September

CNBC: Johnson & Johnson hopes to begin late-stage coronavirus vaccine trial ahead of schedule in September. “The company is in talks with the National Institutes of Health to move up the timeline for the trial, J&J’s Chief Scientific Officer Dr. Paul Stoffels said during an earnings call with investors Thursday. The company announced earlier in the day that it plans to enter a phase one human trial next week, which will include more than 1,000 participants.”

Gulf Business: UAE to begin Covid-19 vaccine trials with 15,000 volunteers

Gulf Business: UAE to begin Covid-19 vaccine trials with 15,000 volunteers. “The UAE government has confirmed that it is set to begin Covid-19 vaccine trials in 15,000 volunteers imminently. The trials have been approved by the Ethics Committee Scientific research in Abu Dhabi, Dr. Abdul Rahman bin Mohammad bin Nasser Al Owais, Minister of Health and Prevention (MoHAP) said on Monday. Al Owais said that this Phase III stage includes testing two possible vaccines and added that the best scientific standards will be adopted when conducting the trials.”

CNN: Here’s how to volunteer for a Covid-19 vaccine trial

CNN: Here’s how to volunteer for a Covid-19 vaccine trial. “Wednesday, a new website… went live allowing people in the United States to register to take part in clinical trials for vaccines. The website will handle registration for the four large vaccine studies that are expected to start this summer and fall, and any others that follow.”

New York Times: Researchers Debate Infecting People on Purpose to Test Coronavirus Vaccines

New York Times: Researchers Debate Infecting People on Purpose to Test Coronavirus Vaccines. “Challenge trials have been used to test vaccines for typhoid, cholera, malaria and other diseases. For malaria, volunteers have stuck their arms into chambers full of mosquitoes to be bitten and infected. But there were so-called rescue medicines to cure those who got sick. There is no cure for Covid-19. For both ethical and practical reasons, the idea of challenge trials for a coronavirus vaccine has provoked fierce debate.”

Immuno-Oncology News: FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials

Immuno-Oncology News: FDA’s New ‘Project Patient Voice’ to Share Symptoms Data From Cancer Trials. “The U.S. Food and Drug Administration (FDA) has launched an initiative called Project Patient Voice to create a publicly available information bank describing patient-reported symptoms from cancer trials for marketed treatments. The initiative is a part of the FDA’s Oncology Center of Excellence (OCE), which is designed to advance the development and regulation of oncology products for all types of cancers.”

Columbia University: COVID-19 Trial Finder Provides Simplified Search Process For COVID-Related Clinical Trials

Columbia University: COVID-19 Trial Finder Provides Simplified Search Process For COVID-Related Clinical Trials. “Researchers at Columbia University have developed COVID-19 Trial Finder, a simplified method for patients, clinicians and healthy volunteers to search for appropriate COVID-related clinical trials in their general location. This system also allows potential candidates to pre-screen their eligibility for such trials through a set of short medical questions.”