Following weeks of delay, the White House on Tuesday approved tough new rules for coronavirus vaccine developers that will make it unlikely that a vaccine will be approved before Election Day. The approval came only after the U.S. Food and Drug Administration published the updated guidelines on its website as part of briefing materials for outside vaccine advisers, the Washington Post reported. The standards, which would be applied to an emergency-use authorization for a vaccine, are similar to the standards for a traditional approval. But the White House has worried that the criteria would delay authorization of a vaccine beyond Nov. 3 and sat on the guidance, the Post reported. The delayed clearance by the White House came only after White House Chief of Staff Mark Meadows demanded detailed justification from the agency about the tougher criteria, the Post reported. The FDA provided the White House with additional data, but nothing happened, according to a senior administration official who spoke on the condition of anonymity, the Post reported. On Tuesday, the FDA circumvented the White House and published the criteria online as part of a briefing package for a meeting with its vaccine advisory committee that is scheduled for Oct. 22. Shortly after the standards were published, the White House approved the new vaccine guidance, the Post reported. The guidelines recommend that participants in late-stage…  read on >

After being treated for COVID-19 at Walter Reed National Military Medical Center for three days, President Donald Trump returned to the White House on Monday evening. Once he was discharged from the hospital, Trump flew in the Marine One helicopter to the White House lawn. He then climbed the steps to the White House entrance, removed his face mask and gave a thumbs up to reporters. Public health experts immediately reacted with outrage to the removal of his face mask while he is still contagious. “I am struggling for words — this is crazy,” Harald Schmidt, an assistant professor of medical ethics and health policy at the University of Pennsylvania in Philadelphia, told The New York Times. “It is just utterly irresponsible.” Dr. William Schaffner, an infectious disease specialist at Vanderbilt University Medical School in Tennessee, told the newspaper that the president’s decision to remove his mask was “dangerous” because it encourages Americans to ignore social distancing guidelines to keep themselves safe. “It will lead to more casual behavior, which will lead to more transmission of the virus, which will lead to more illness, and more illness will lead to more deaths,” Schaffner said. Earlier Monday, Trump’s medical team delivered an update on his condition, saying he would receive his fifth and final dose of the antiviral drug remdesivir at the White House on Tuesday.…  read on >

President Donald Trump’s doctors delivered an update of his condition on Sunday that suggested he might have more than just a mild case of COVID-19. Based on the doctors’ accounts, Trump’s symptoms quickly escalated after he announced early Friday morning that he had tested positive for the coronavirus, The New York Times reported. He was taken to Walter Reed National Military Medical Center Friday evening. Trump experienced a “high fever” on Friday, and there were two occasions when his blood oxygen levels dropped, on Friday and again on Saturday, the Times reported. Trump’s oxygen saturation level was 93% at one point, his doctors said. Ninety-five percent is considered the lower limit of the normal range. Many medical experts consider patients to have severe COVID-19 if their oxygen levels drop below 94%, the Times reported. The president’s physicians said he was given supplemental oxygen at the White House on Friday; they were not clear about whether it was administered again on Saturday, or whether his blood oxygen levels had fallen below 90% at some point, the Times reported. In addition to being given an experimental antibody cocktail on Friday, Dr. Sean Conley said Trump was also given the steroid dexamethasone on Saturday and is being treated with remdesivir, an antiviral drug. Dexamethasone has been shown to help patients who are severely ill with COVID-19, but it…  read on >

SATURDAY, Oct. 3, 2020 (HealthDay News) — President Donald Trump was being treated for coronavirus infection at Walter Reed National Military Medical Center on Saturday, after announcing that he had tested positive for COVID-19 early Friday morning. Trump is struggling with a fever, a cough and nasal congestion, among other symptoms, two officials familiar with his condition told the Washington Post. “President Trump remains in good spirits, has mild symptoms, and has been working throughout the day,” press secretary Kayleigh McEnany said Friday. “Out of an abundance of caution, and at the recommendation of his physician and medical experts, the President will be working from the presidential offices at Walter Reed for the next few days.” On Friday, an experimental antibody cocktail made by Regeneron Pharmaceuticals Inc. was given to Trump, the Associated Press reported. The company agreed to supply a single dose, given via IV, for Trump at the request of his physician, Dr. Sean Conley, under “compassionate use” provisions, the AP reported. Conley said late Friday that Trump had also been given the antiviral drug remdesivir at the hospital, the AP reported. The Gilead Sciences drug has been shown to help some COVID-19 patients recover more quickly. Trump was also taking zinc, vitamin D, an antacid called famotidine, melatonin and aspirin, Conley said. On Friday, Vice President Mike Pence and his wife, Karen,…  read on >

SATURDAY, Oct. 3, 2020 (HealthDay News) — President Donald Trump was being treated for coronavirus infection at Walter Reed National Military Medical Center on Saturday, after announcing that he had tested positive for COVID-19 early Friday morning. Trump is struggling with a fever, a cough and nasal congestion, among other symptoms, two officials familiar with his condition told the Washington Post. “President Trump remains in good spirits, has mild symptoms, and has been working throughout the day,” press secretary Kayleigh McEnany said Friday. “Out of an abundance of caution, and at the recommendation of his physician and medical experts, the President will be working from the presidential offices at Walter Reed for the next few days.” On Friday, an experimental antibody cocktail made by Regeneron Pharmaceuticals Inc. was given to Trump, the Associated Press reported. The company agreed to supply a single dose, given via IV, for Trump at the request of his physician, Dr. Sean Conley, under “compassionate use” provisions, the AP reported. Conley said late Friday that Trump had also been given the antiviral drug remdesivir at the hospital, the AP reported. The Gilead Sciences drug has been shown to help some COVID-19 patients recover more quickly. Trump was also taking zinc, vitamin D, an antacid called famotidine, melatonin and aspirin, Conley said. On Friday, Vice President Mike Pence and his wife, Karen,…  read on >

Ordinary conversation releases airborne droplets that can spread widely through indoor spaces, a finding with big implications for transmission of the new coronavirus, researchers say. Their experiments showed that everyday talk can expel droplets farther than the typical “social distancing” limit of 6 feet. “People should recognize that they have an effect around them,” said Howard Stone, a professor of mechanical and aerospace engineering at Princeton University in New Jersey. “It’s not just around your head, it is at the scale of meters.” One meter equals just over 3 feet. How COVID-19 spreads is not fully understood, but it’s believed that people without symptoms could infect others through tiny droplets created when they speak, sing or laugh. “Lots of people have written about coughs and sneezes and the kinds of things you worry about with the flu,” Stone said in a university news release. “But those features are associated with visible symptoms, and with this disease we are seeing a lot of spread by people without symptoms.” Stone and his colleagues conducted tests to determine how far and fast exhaled droplets from normal speaking could spread in an interior space without good ventilation. In such settings, normal conversation can spread droplets at least as far as, and even beyond, social distancing guidelines recommended by U.S. officials (6.5 feet) and the World Health Organization (3.2 feet),…  read on >

FRIDAY, Oct. 2, 2020 (HealthDay News) — President Donald Trump announced early Friday morning that he and his wife, Melania Trump, have tested positive for the coronavirus. In a tweet sent out at 1 a.m., Trump said they will both quarantine in the White House for an unspecified period of time, The New York Times reported. The diagnosis forces him to temporarily withdraw from the campaign trail just 32 days before the election on Nov. 3. The White House did not say whether the 74-year-old or his wife were experiencing symptoms. The president’s physician, Dr. Sean Conley, said Trump could carry out his duties “without disruption” from the Executive Mansion, the Times reported. On Friday, Vice President Mike Pence and wife Karen, along with Secretary of State Mike Pompeo, all announced that they had tested negative for the new coronavirus. While Trump’s age and weight automatically put him in a high-risk category, Conley pronounced Trump to be “in very good health” last year after his last full medical checkup. And, unlike many of those who have succumbed to the virus, Trump will have the best medical care available, the Times said. On Thursday, reports swirled that Trump’s close advisor, Hope Hicks, had tested positive for COVID-19, the Times said. She had traveled with him several times recently. There was no immediate word on how far…  read on >

A life support technique called ECMO has saved the lives of many critically ill COVID-19 patients, a new study shows. The ECMO (extracorporeal membrane oxygenation) machine takes over the function of the lungs and heart. Blood is pumped from the body into equipment that adds oxygen to the blood before it’s returned to the body. This technique has saved lives in previous epidemics of lung-damaging viruses, but small studies published early in the coronavirus pandemic questioned its effectiveness. This international study included 1,035 COVID-19 patients at high risk of death because ventilators and other types of care couldn’t support their lungs. After being placed on ECMO, the death rate among these patients was less than 40%, according to the study authors. “These results from hospitals experienced in providing ECMO are similar to past reports of ECMO-supported patients, with other forms of acute respiratory distress syndrome or viral pneumonia,” said co-author Dr. Ryan Barbaro, of the University of Michigan. “The results support recommendations to consider ECMO in COVID-19 if the ventilator is failing. We hope these findings help hospitals make decisions about this resource-intensive option,” Barbaro said in a university news release. Most centers in this study did not need to use ECMO for COVID-19 very often, said study co-author Graeme MacLaren, of the National University Health System in Singapore. “By bringing data from over 200…  read on >