Novavax’s Covid Jab Wins FDA Backing For People 65 And Older, Those At Risk

AP: FDA Approves Novavax COVID-19 Shot But With Unusual Restrictions
The Food and Drug Administration has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now it had emergency authorization from FDA for use in anyone 12 and older. But late Friday, the FDA granted the company full approval for its vaccine for use only in adults 65 and older – or those 12 to 64 who have at least one health problem that puts them at increased risk from COVID-19. (Neergaard, 5/18)

The New York Times: When A Vaccine Safety Trial Becomes Unethical
The Department of Health and Human Services last week announced a new standard for testing the safety of vaccines, a “radical departure from past practices.” All new vaccines will be evaluated against a placebo, an inert look-alike that serves as a point of comparison, the department said. Health Secretary Robert F. Kennedy Jr., as well as many anti-vaccine groups, has long argued that placebo-controlled trials were the only way to fully understand vaccine side effects. (Rosenbluth, 5/16)

Stat: Inside The Rise Of Tracy Beth Høeg, The Covid Contrarian Shaping FDA Vaccine Policy
The Covid-19 pandemic was a turning point for Tracy Beth Høeg. Before March 2020, Høeg was a sports medicine physician focused on ultramarathon runners. Then, she rose to prominence by challenging school closures, mask mandates, and the approval of booster shots for children. Now, she’s been tapped for a top role at the Food and Drug Administration, working closely with two fellow Covid contrarians — Marty Makary, the agency’s commissioner, and Vinay Prasad, the head of a key center — and advising on vaccines. (Lawrence, 5/19)

More on covid —

The Washington Post: Long Covid Patients Are Desperate For Treatments. These Trials May Help. 
Five years since the pandemic began, millions of people are still grappling with long covid, even as new patients are joining their ranks. “Considering how far along we are and how tens of millions of people are suffering, we’ve done very little,” said Eric Topol, a professor of translational medicine and the executive vice president of Scripps Research. (Sima, 5/16)

AP: WHO Opens Annual Assembly As UN Health Agency Faces 'Existential Crisis' In Wake Of US Funding Cuts
The World Health Organization on Monday opened its annual meeting of government ministers and other top envoys facing one of the most serious crises of its 77-year history in the wake of Trump administration funding cuts and plans to withdraw the United States. The U.N. health agency this year has seen a plunge in its ability to carry out its sweeping mandate to do everything from recommend reductions in sugar levels in soft drinks to head the global response to pandemics like COVID-19 or outbreaks like polio or Ebola. (Keaten, 5/19)

On bird flu, influenza, measles, and mpox —

AP: The US Hasn't Seen A Human Bird Flu Case In 3 Months. Experts Are Wondering Why
Health officials are making a renewed call for vigilance against bird flu, but some experts are puzzling over why reports of new human cases have stopped. Has the search for cases been weakened by government cuts? Are immigrant farm workers, who have accounted for many of the U.S. cases, more afraid to come forward for testing amid the Trump administration’s deportation push? Is it just a natural ebb in infections? “We just don’t know why there haven’t been cases,” said Jennifer Nuzzo, director of the Pandemic Center at Brown University. (Stobbe and Aleccia, 5/19)

CIDRAP: Flu Activity In The US Has Reached Low Levels
US flu activity is low and declining further, according to the latest FluView update today from the Centers for Disease Control and Prevention (CDC). The percentage of outpatient visits for influenza-like illness (ILI), or respiratory illness, dropped slightly from 2.1% the previous week to 1.9% last week (see CDC graph at left). The number of patients hospitalized for flu dropped from 2,336 to 2,008. As with the previous week, no state reported moderate, high, or very high ILI activity. (Wappes, 5/16)

CIDRAP: US Measles Outbreak Grows To 1,024 Cases
The US measles picture grew by 23 cases this week, according to today's update from the Centers for Disease Control and Prevention (CDC). A total of 1,024 confirmed measle cases have been reported from 31 jurisdictions, with 14 outbreaks (defined as 3 or more related cases). Ninety-two percent of confirmed cases are outbreak-associated. (Dall, 5/16)

CIDRAP: Researchers Report Mpox DNA, Live Virus On Surfaces And In Air From Patients' Rooms
A study conducted in UK hospitals found mpox virus (MPXV) clade 1b DNA in 73% of surface samples and 7% of air samples from infected patients' rooms, as well as live virus in 19% of surface samples that underwent viral isolation. Scientists at the UK Health Security Agency sampled the rooms and anterooms of seven of the first eight mpox clade 1b patients admitted for clinical observation at centers dedicated to airborne high-consequence infectious diseases from October 2024 through January 2025. (Van Beusekom, 5/16)