Walensky steps down: Centers for Disease Control and Prevention Director Rochelle Walensky will leave her position on June 30, according to statements from the CDC and President Joe Biden. Walensky, who led the CDC for the majority of the COVID-19 pandemic, said in a letter to Biden that the agency “saved and improved lives and protected the country and the world from the greatest infectious disease threat we have seen in over 100 years.”
The CDC also announced that it will stop tracking community transmission levels of COVID-19 and the percentage of reported positive tests, in addition to reducing the amount of data that hospitals are required to report. The agency will continue to track hospitalizations and intensive care unit admissions. The changes come amid multiple strategy shifts as the United States transitions out of its COVID-19 public health emergency declaration this week.
WHO’s COVID-19 emergency ends: The World Health Organization said that it no longer considers the COVID-19 pandemic a public health emergency of international concern, more than three years after it made the declaration. WHO Director General Tedros Adhanom Ghebreyesus said that the move “does not mean that COVID-19 is over as a global health threat,” citing the fact that the virus has still recently killed someone every three minutes.
U.S. pandemic strategy shifts: The Biden administration plans to end COVID-19 vaccination requirements for federal workers and contractors, health care workers, most international travelers and Head Start educators on Thursday, when the nation’s coronavirus pandemic public health emergency declaration ends. The requirements, which were ordered by Biden in late 2021, have been challenged in court and criticized by Republicans — and more recently public health experts and Democrats — for being unnecessary.
Meanwhile, U.S. COVID-19-related deaths declined by 47% between 2021 and 2022, but the illness still killed more than 500 people a day, according to preliminary data from the CDC. COVID-19 was the country’s fourth leading cause of death last year (186,702), following heart disease (699,659), cancer (607,790) and “unintentional injury” (218,064), which includes drug overdoses.
FDA advisers will meet on June 15 to make recommendations on which strains should be included in the new round of COVID-19 vaccines this fall, shortly after the agency authorized that people 65 or older or who are immunocompromised can get a second dose of Pfizer Inc.’s or Moderna Inc.’s omicron-specific booster shots.
Eli Lilly’s Alzheimer’s drug: Eli Lilly’s Alzheimer’s treatment donanemab slowed memory decline by 35% and reduced the likelihood of disease progression by 39% for people who received the antibody infusion, according to clinical trial data from an 18-month study. However, three patients who participated in the study died from brain swelling and bleeding, known side effects of the treatment.
Califf praised Eli Lilly’s results, saying the agency will “have to look at the data when it comes in before making a judgment, but if the data look as good as the press release — this is really, really exciting.” The company’s positive data could put pressure on the Centers for Medicare and Medicaid Services to change its strict Medicare coverage requirements for the class of anti-amyloid Alzheimer’s treatments, restrictions that pharmaceutical groups, patient advocates and lawmakers have questioned.
Finally, a bipartisan group of attorneys general from 23 states, the District of Columbia, Puerto Rico and the Northern Mariana Islands have asked for CMS to provide full coverage of antibody treatments for Alzheimer’s disease. The letter, which was sent to Health and Human Services Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure, is the latest move in an ongoing fight for the federal government to expand coverage for new, costly treatments.
The first RSV vaccine: The FDA approved GSK PLC’s RSV vaccine for people 60 and older, the first approval of a vaccine for the virus after decades of failed attempts. The agency could issue a second approval later this month for a competing vaccine from Pfizer, though an advisory committee raised more safety concerns for Pfizer’s shot than GSK’s.
HELP needs help: After what appeared to be bipartisan cooperation to increase oversight of pharmacy benefit managers, the Senate HELP Committee’s hearing last week to markup the legislation was abruptly adjourned due to partisan infighting. Ranking Republican Bill Cassidy (La.) criticized Chair Bernie Sanders (I-Vt.) for accepting last-minute changes to a group of bills the two had agreed on and for not sharing feedback on the package from the FDA and congressional budget experts.
