Regeneron Pharmaceuticals Inc. said Wednesday that it is seeking emergency approval from the U.S. Food and Drug Administration for an experimental antibody cocktail given to President Donald Trump shortly after he was diagnosed with COVID-19. Hours before the company made the announcement, Trump proclaimed in a video released by the White House that the drug had an “unbelievable” effect on his recovery from coronavirus infection, the Washington Post reported. “I think this was the key,” Trump said, after acknowledging that the antibody cocktail was one of several drugs he was prescribed by his medical team. While there is no hard evidence yet proving the drug’s effectiveness in humans, it has shown promise in treating mild cases of the new coronavirus, the Post reported. In his video, Trump said, “I have emergency-use authorization all set, and we’ve got to get it signed now.” However, an FDA spokeswoman told The New York Times Wednesday that the agency does not confirm or deny product applications. Regeneron said in its statement that it could initially produce doses of the antibody cocktail for 50,000 patients, and then ramp production up to doses for 300,000 patients in the next few months if granted emergency authorization. The antibody cocktail is now in late-stage testing. The company has granted fewer than 10 “compassionate use” requests allowing people not enrolled in its trials to…  read on >

Facebook chatter from the anti-vaccination movement now frames the issue as one of civil liberties, a new study finds. As a COVID-19 vaccine gets closer to becoming a reality, opposition from so-called anti-vaxxer groups could become a political movement, researchers warn. For the study, the investigators looked at more than 250,000 posts on 204 Facebook pages opposing vaccines between October 2009 and October 2019. Opposition has traditionally centered on medical safety and government conspiracy theories. But vaccine opponents have recast their objections, saying it is a civil right to refuse vaccination. The latest recent spike in the anti-vaxxer movement was a 2019 Facebook campaign with posts that included a U.S. state in their title, such as “Michigan for Vaccine Choice.” The posts cited vaccine safety concerns and alternative medicines, and encouraged opposition to vaccine mandates. “Starting in 2019, we saw a large increase in these state-level pages, especially in places considering vaccine-related legislation,” said study co-author Mark Dredze, an associate professor of computer science at Johns Hopkins University, in Baltimore. “These pages make it easy for vaccine opponents to know how to vote in their local elections to make it easier to opt out of vaccination,” Dredze added in a Hopkins news release. There were two prior events that also changed the online discourse, the study authors reported. The first event was a measles outbreak…  read on >

Black people who have a strong sense of psychological well-being may have better heart health, a new study indicates. It suggests that feelings of optimism and a sense of purpose and control — hallmarks of psychosocial resilience — are more important to heart health than where people live, researchers said. Lead researcher Tené Lewis, an associate professor at Emory University’s Rollins School of Public Health in Atlanta, noted that differences in heart health between Black and white Americans have been documented for decades. But individual factors affecting Black Americans have not been well understood. “Almost everything we know about Black Americans and their health focuses on deficits, yet we really need to begin to identify strengths,” she said. “Understanding which strengths matter most for Black Americans — and under which contexts — will allow us to develop the most appropriate and applicable public health interventions for this group.” For the study, the researchers recruited nearly 400 Black volunteers between the ages of 30 and 70. They investigated whether the American Heart Association’s Life’s Simple 7 metrics were linked to better heart health among them. The seven measures include smoking, physical activity, diet, weight, blood sugar, cholesterol and blood pressure. Participants also completed standard questionnaires gauging their psychosocial health. This information was then compared with neighborhood data on heart disease and stroke and death rates. In…  read on >

Everyone agrees about the good news — folks whose asthma is spurred on by allergies don’t appear to have an increased risk of life-threatening illness if they contract COVID-19. “Asthma has not risen as one of the top comorbid diseases for worse COVID-19 outcomes,” said Dr. Sandhya Khurana, director of the Mary Parkes Center for Asthma, Allergy and Pulmonary Care at the University of Rochester (N.Y.) Medical Center. “We always worry with asthma and viral infections, because they seem to trigger asthma exacerbation unreasonably. But what we’ve seen so far is reassuring.” But debate continues to swirl regarding the potential severity of COVID infection in people with non-allergic asthma. Some studies have suggested that people who have asthma caused by something other than allergies — exercise, stress, air pollution, weather conditions — might have an increased risk of severe COVID-19. For example, Harvard researchers found that having non-allergic asthma increased the risk of severe COVID-19 by as much as 48%. That conclusion was based on data from 65,000 asthma sufferers presented in the June issue of the Journal of Allergy and Clinical Immunology. “For those people, I think being more cautious would be good for them,” said senior researcher Liming Liang, an associate professor of statistical genetics at the Harvard T.H. Chan School of Public Health in Boston. “I think the next wave is coming.…  read on >

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 >