Outcomes Associated With Nirmatrelvir or Monupiravir, FDA Authorizes Use of Novavax Vaccines, and More
Severe Outcomes Associated With Nirmatrelvir, Molnupiravir in Patients Treated for Omicron Subvarients1
A team of researchers investigated the outcomes associated with the use of nirmatrelvir or molnupiravir—ritonavir-boosted medications—in nonhospitalized patients with COVID-19 omicron subvariants, particularly BQ.1.1 and XBB.1.5.
The cohort study consisted of 68,867 patients who received a diagnosis of COVID-19 and who were at risk of the disease progressing to a severe state. Follow-up occurred 90 days after diagnosis. Thirty of 22,594 patients were treated with nirmatrelvir, 27 of 5311 patients were treated with molnupiravir, and 588 of 40,962 patients who did not receive either treatment died within 90 days of omicron infection.
“These findings suggest that the use of either nirmatrelvir or molnupiravir is associated with reductions in mortality and hospitalization in patients infected with omicron…” the researchers concluded. “Both drugs can, therefore, be used to treat nonhospitalized patients who are at high risk of progressing to severe COVID-19.”
FDA Authorizes Novavax Vaccine for Emergency Use to Protect Against Variants2
The FDA issued an amendment to the emergency use authorization of the Novavax COVID-19 vaccine for use in individuals aged 12 years and older.
Those who are eligible to receive the vaccine can receive either two doses if not previously vaccinated or one if they have received a recently updated mRNA COVID-19 vaccine.
The updated vaccine formula offers better protection against currently circulating variants that may cause serious complications of COVID-19, including hospitalization and death. The FDA reviewed manufacturing data and “non-clinical immune response data” to support the change to the 2023-2024 formula while showing the vaccine provides protection. Further, the FDA relied on its evaluation of efficacy and safety data from clinical trials of the vaccine.
NIH Treatment Guidelines Panel’s Review of Vilobelimab for the Treatment of COVID-193
In April 2023, the FDA authorized vilobelimab for emergency use for the treatment of COVID-19. The anti-C5a monoclonal antibody was approved for hospitalized adults with COVID-19 within 48 hours of “mechanical ventilation or extracorporeal membrane oxygenation.”
Despite the FDA’s authorization, the COVID-19 Treatment Guidelines Panel stated that there was insufficient evidence to recommend for or against the use of vilobelimab for the treatment of COVID-19 in adults.
The recommendation follows the review of the PANAMO study that was used to support the FDA’s emergency use authorization. According to the Panel, the “prespecified analysis that stratified by the study site showed that 28-day mortality among participants who received” treatment with vilobelimab was not different from 28-day mortality among those who received placebo.
Overall, the Panel stated that the results from the PANAMO study were insufficient, prompting them to make their recommendation regarding the use of vilobelimab for the treatment of COVID-19.
Prevalence of Emergency Department Admissions for Eating Disorders Among Adolescents, Adults4
A team of researchers investigated emergency department admission trends for eating disorders among adolescents and adults during the COVID-19 pandemic.
Researchers conducted a population-based, repeated cross-sectional study that compared the prepandemic rates of emergency department (ED) visits for eating disorders to ED visits during the pandemic. In their analysis, the researchers found that ED visits for eating disorders increased during the pandemic among adolescents aged 10 to 17 years, young adults aged 18-26, and older adults aged 41-105 years.
Further, hospital admissions for eating disorders increased during the pandemic for adolescents. All other age groups saw a decrease, especially older adults aged 41 to 105 years.
“We observed a differential impact of the pandemic on use of acute care services for eating disorders by age after onset of the COVID-19 pandemic,” the researchers concluded. “Presentations to emergency departments and hospital admissions increased above expected levels among adolescents. Emergency department visits also increased above expected levels for both young (ages 18–26 [years]) and older (ages 41–105 [years]) adults.”
- Lin DY, Fadel FA, Huang S, et al. Nirmatrelvir or molnupiravir use and severe outcomes from omicron infections. JAMA Netw Open. Published online September 21, 2023. doi:10.1001/jamanetworkopen.2023.35077
- FDA authorizes updated Novavax COVID-19 vaccine formulated to better protect against currently circulating variants. News release. US Food and Drug Administration; October 3, 2023. Accessed November 16, 2023. www.fda.gov/news-events/press-announcements/fda-authorizes-updated-novavax-covid-19-vaccine-formulated-better-protect-against-currently
- Vilobelimab. NIH COVID-19 Treatment Guidelines. National Institutes of Health; October 10, 2023. Accessed November 20, 2023. www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/vilobelimab/
- Toulany A, Saunders NR, Kurdyak P, et al. Acute presentations of eating disorders among adolescents and adults before and during the COVID-19 pandemic in Ontario, Canada. Can Med Assoc. Published online October 3, 2023. doi:10.1503/cmaj.221318