FDA has decided to authorize a second dose of updated boosters for high-risk individuals, physicians are testing an experimental new procedure to help those with smell or taste disorders from long COVID, and more in this week's roundup of COVID-19 news.
- Children's National Hospital and the National Institute of Allergy and Infectious Diseases are currently investigating the potential impact of long COVID among children. So far, researchers have enrolled over 800 children in the study and hope to reach 1,000 participants by the summer. In addition to the study, Children's National has evaluated over 200 children through its Pediatric Post-COVID Program. Many of the children evaluated initially had mild COVID-19 infections. According to the researchers, around 5% and 10% of children likely have long COVID, and the average age of these patients is roughly 13 years old. On average, children with long COVID experience around 10 symptoms, with the most common being significant fatigue, shortness of breath, chest pain, muscle aches, and headaches. Children were less likely to develop lung problems with long COVID than adults. Overall, the researchers found that the majority of children with long COVID eventually recovered, although the timeline for recovery varies. "Our experience has been reassuring," said Roberta DeBiasi, chief of pediatric infectious diseases at Children's National and the study's leader. There are "very few children who have not gotten back to normal activities." (Rodriguez, USA Today, 4/5)
- FDA has authorized a new antibody treatment, vilobelimab, for emergency use in some hospitalized adult COVID-19 patients. According to FDA, vilobelimab "is a recombinant chimeric monoclonal IgG4 antibody that specifically binds to the soluble human complement split product C5a after cleavage from C5 to block its interaction with the C5a receptor, both of which are components of the complement system thought to contribute to inflammation and worsening of COVID-19." In its authorization, FDA said the treatment is intended to be used within 48 hours of a patient "receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support)." The authorization was based on PANAMO, a phase III study of critically ill COVID-19 patients at 46 hospitals in several countries. In the study, vilobelimab demonstrated a reduction in all-cause mortality at day 28 compared to those who received a placebo. "Today's authorization offers another potentially life-saving treatment option for the sickest COVID-19 patients," said Patrizia Cavazzoni, director of FDA's Center for Drug Evaluation and Research, in a statement. (Hein, MedPage Today, 4/4; Vinluan, MedCity News, 4/5; Twenter, Becker's Hospital Review, 4/5)
- FDA has decided to authorize a second omicron-specific booster dose for high-risk individuals, including people 65 and older or those who have weak immune systems. According to officials who spoke to the Washington Post under the condition of anonymity, FDA is expected to announce the move in the next few weeks, and CDC is likely to endorse it soon after. Those who are eligible for a second booster will be able to receive the dose if it's been at least four months since their first dose of the updated booster. So far, physicians and other experts have expressed mixed views about the necessity of a second booster. Although some say there is little evidence to justify another booster, others have argued that it would be beneficial for high-risk individuals who have reduced immunity. Separately, the Strategic Advisory Group of Experts on Immunization (SAGE), which advises the World Health Organization, said that countries no longer need to consider offering additional COVID-19 boosters to low- or medium-risk individuals. Although SAGE did not say that countries could not do so, they recommended the decision be made based on a country's health conditions and spending priorities. "The rationale there is that the benefit of these additional boosters is actually quite marginal, based on what we know of the immune status of these people," said committee chair Hanna Nohynek. Notably, SAGE said that the new recommendations should be considered "time limited," meaning that they only address current needs based on the existing epidemiological scenariao. (Branswell, STAT, 3/28; McGinley/Sun, Washington Post, 4/3)
- A common enzyme deficiency in certain groups of men was associated with an increased risk of severe COVID-19 outcomes, according to a new Veterans Affairs cohort study published in JAMA Network Open. For the study, researchers examined data from 4,811 patients in the Veterans Health Administration who had a positive COVID-19 test and had been tested for a glucose-6-phosphate dehydrogenase (G6PD) deficiency. This enzyme deficiency affects around 4% to 7% of the U.S. population, but rates are higher (10% to 14%) among Black men. Overall, the researchers found that Black men under 65 who had a G6PD deficiency had around a 1.5-fold higher risk of severe COVID-19, while white men 65 and over with a G6PD deficiency had a 3.6-fold increased risk. "This study is the first to present epidemiologic evidence that putatively link a biologic mechanism of impaired cellular responses in G6PD deficiency to increased COVID-19 severity," the researchers wrote. "Our analysis revealed a strong association between G6PD deficiency and COVID-19 severity, modified by race and age." According to the researchers, the findings highlight "the need to review and determine possible underlying inherent genetic risks, such as G6PD deficiency, prior to illness or early in treatment course as a strategy to mitigate negative outcomes." (Hein, MedPage Today, 3/29)
- Physicians are currently experimenting with a new numbing procedure to help restore or improve smell and taste disorders in individuals with long COVID. The procedure, which is called a stellate ganglion block, injects a temporary, local anesthetic into the stellate ganglion nerves on both sides of a person's neck. These nerves are part of the sympathetic nervous system, and while it's not clear how they affect smell, some physicians have reported improvement in long COVID patients with smell disorders. Christina Shin, a pain management physician at Cleveland Clinic, said that around half of the 30 long COVID patients she's treated with the block have reported between a 25% and 90% improvement in their sense of smell or taste. Similarly, Nyssa Farrell, an assistant professor of otolaryngology–head and neck surgery at Washington University School of Medicine in St. Louis, conducted a small study of the treatment in 20 patients, and half reported "slight to moderate" improvement after receiving the block. However, some experts are skeptical of the treatment, especially since there is currently a lack of scientific evidence on its efficacy. "Given the lack of data suggesting efficacy, it's really hard to advocate for this for patients who have a problem that typically resolves with time," said Justin Turner, an associate professor in the department of otolaryngology – head and neck surgery at Vanderbilt University Medical Center. (Taylor, Becker's Hospital Review, 4/3)