FDA has paused emergency use authorization (EUA) for Eli Lilly's monoclonal antibody treatment, bebtelovimab, the Biden administration is considering ending the monkeypox public health emergency, and more in this week's roundup of monkeypox and Covid-19 news.
- The World Health Organization (WHO) on Monday announced that it is renaming monkeypox as mpox over concerns that the original name could be racist or stigmatizing. "WHO will adopt the term mpox in its communications, and encourages others to follow these recommendations, to minimize any ongoing negative impact of the current name and from adoption of the new name," the organization said in a press release. Over the next year, WHO will use both monkeypox and mpox synonymously as it gradually phases out the term monkeypox. According to WHO, the one-year transition period will help "mitigate the concerns raised by experts about confusion" and allow for "time to complete the ICD update process and to update WHO publications." In a press release, HHS Secretary Xavier Becerra expressed support for the name change, saying, "We welcome the change by the World Health Organization. We must do all we can to break down barriers to public health, and reducing stigma associated with disease is one critical step in our work to end mpox." (Saric, Axios, 11/28; Hein, MedPage Today, 11/28; Branswell, STAT, 11/28)
- The Biden administration is considering winding down the public health emergency declaration for monkeypox, according to two people familiar with the situation. If HHS issues a 60-day notice to end monkeypox's public health emergency declaration this week, the emergency will likely officially end by Jan. 31. CDC data shows that the seven-day moving average for new cases as of Nov. 30 was seven cases a day—a significant decline from the more than 400 average daily cases during the outbreak's peak. With average daily case counts relatively low, health officials are reevaluating whether an emergency declaration is still needed. So far, the decision to end the public health emergency for monkeypox has not been finalized and could still change, but health officials said ending the emergency would not significantly impact the current response to the virus. (Cancryn, Politico, 11/30)
- FDA on Wednesday paused the EUA for Eli Lilly's Covid-19 monoclonal antibody treatment bebtelovimab since it is not likely to be effective against the omicron subvariants BQ.1 and BQ.1.1, which together currently account for 57.3% of all new Covid-19 cases in the United States. "Lilly and the FDA agree that it is not medically appropriate, at this time, to treat high-risk patients with mild-to-moderate Covid-19 with bebtelovimab in the U.S.," Eli Lilly said. FDA said Eli Lilly and its distributors have paused distribution of the drug. Going forward, the agency advised that health care providers choose other "appropriate" Covid-19 treatments for their patients, including antivirals like Pfizer's Paxlovid and Gilead Sciences' Veklury, in the place of bebtelovimab. However, FDA also recommended that providers keep their remaining supplies of bebtelovimab in case a Covid-19 variant that is susceptible to the drug emerges in the future. (Choi, The Hill, 11/30; Loftus, Wall Street Journal, 11/30)
- Screening for Covid-19 symptoms and exposure at hospital entrances turned away fewer than 0.1% of patients, visitors, and health workers, according to a new study published in JAMA Internal Medicine. For the study, researchers at Yale New Haven Hospital analyzed 951,033 individuals who were screened at the hospital's entrances between March 2020 and May 2021. A positive screen, which meant a person was turned away, included a body temperature of 100.4°F or higher, exposure to or symptoms of Covid-19, a positive Covid-19 test in the last two weeks, or recent travel to a high-risk area. In total, 631 patients and visitors (0.066%) were turned away due to a positive screen. Of the positive screens, nearly half occurred during the first wave of the pandemic before declining during subsequent waves. According to the researchers, the cost of having 24-hour staffing for screening surveillance at the hospital's 10 entrances equaled $1,288,560 in total annual salaries for 29.5 full-time staff members at a minimum wage of $15 an hour. When including the workers' benefits, the estimated cost to identify one positive screening was $233.58 during the first wave of the pandemic and $2350.96 over the entire study period. Because of the high cost of screening, the researchers suggest that it "might not have been worth it" when so few people were turned away over potential Covid-19 risks. (Hein, MedPage Today, 11/28)
- Covid-19 hospitalizations have increased across the country over the last few weeks, according to data tracked by the New York Times. As of Nov. 29, the number of daily Covid-19 hospitalization in the United States averaged 31,125, a 12% increase over the previous two weeks. Overall, 32 states, the District of Columbia, and Puerto Rico have seen an increase in hospitalizations over the last 14 days. The state that saw the largest increase in hospitalization was Louisiana at 84%, while North Carolina had the lowest increase at 2%. This rise in hospitalizations nationwide has coincided with the highly transmissible omicron subvariants BQ.1 and BQ.1.1 becoming the dominant variants in the United States. According to health experts, a potential surge in cases this winter is likely to be driven by several different coronavirus variants rather than just one. However, any surge is likely to be less severe than those in past years. (Bean, Becker's Hospital Review, 11/30)
- Researchers from Stanford University are planning to test Paxlovid as a treatment for long Covid in a new clinical trial, Becker's Hospital Review reports. Currently, researchers are enrolling 200 participants in a Phase 2 study on Paxlovid and long Covid. Currently, HHS estimates that there are between 7.7 million and 23 million Americans who have long Covid, but no treatments have been approved for the condition. During the study, which is projected to run through November 2023, participants will either receive Paxlovid (nirmatrelvir and ritonavir) or a placebo and ritonaivir for 15 days, which is three times longer than Paxlovid's currently recommended use. The primary endpoint of the study is to see if severe symptoms of long Covid are reduced after Paxlovid treatment. In addition, a secondary endpoint will evaluate"the correlation of physical activity and biometric parameters" from Apple Watches and blood pressure monitors to determine symptom severity. (Twenter, Becker's Hospital Review, 11/22)