FDA Simplifies Vaccination Schedule, Issues New Emergency Use Authorization For Patients On Mechanical Ventilation or Life Support, And More
FDA Simplifies Vaccination Schedule For Bivalent Vaccines1
The FDA has amended their emergency use authorization of both the Moderna and Pfizer-BioNTech COVID-19 mRNA vaccines, allowing for a simpler vaccination schedule for most adults with the hope that this will encourage future vaccination.
“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider staying current with vaccination, including with a bivalent COVID-19 vaccine,” said Peter Marks, PhD, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “The available data continue to demonstrate that vaccines prevent the most serious outcomes of COVID-19, which are severe illness, hospitalization, and death.”
The FDA’s amendment includes the authorization of the current bivalent vaccines—original and omicron BA.4/BA.5 strains—to use for all doses administered to individuals 6 months of age and older. And this includes an additional dose or doses for certain populations.
Further, the monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized in the United States.
FDA Authorizes New COVID-19 Treatment2
The FDA has issued an emergency use authorization for the use of vilobelimab to treat a part of the immune system that may play a role in the inflammation that progresses the COVID-19 virus.
A recommended dosage of 800 mg is administered by intravenous infusion after dilution and given up to six times over the individual’s treatment period. The treatment is approved to be given to adults hospitalized with COVID-19 who are receiving invasive mechanical ventilation or artificial life support.
“Today's authorization offers another potentially life-saving treatment option for the sickest COVID-19 patients,” said Center Director Patrizia Cavazzoni, MD, in a press release.
A few of the most common adverse reactions to treatment were pneumonia, sepsis, delirium, pulmonary embolism, hypertension, pneumothorax, deep vein thrombosis, and more.
Asthma Diagnoses Decline Among Pediatric Patients3
After conducting a retrospective cohort study, a group of researchers found that new diagnoses of childhood asthma declined during the first year of the COVID-19 pandemic.
The researchers used a large US commercial claims database where they analyzed data from children aged 18 years and younger without a prior diagnosis of asthma. A combination of diagnosis codes, location services, and medication dispensing were used to define incident asthma. The researchers calculated the crude quarterly rates of asthma diagnosis per 1000 children.
When compared with the 3 years before the pandemic, the researchers found that the “crude incident diagnosis rates of asthma decreased by 52% across the first four quarters” of the pandemic.3
“These findings raise important questions whether pandemic-related changes in infectious or other triggers truly altered the incidence of childhood asthma beyond the well-described disruptions in healthcare access,” the researchers concluded.
Fluvoxamine, Inhaled Budesonide Reduces COVID-19 Incidence in Outpatients4
Researchers determined that the use of oral fluvoxamine combined with inhaled budesonide reduces the incidence of severe COVID-19 among high-risk outpatients, according to a recent study.
In total, 1476 patients with a confirmed case of COVID-19 were enrolled in the randomized, placebo-controlled, adaptive platform trial. Patients received either fluvoxamine plus inhaled budesonide (n = 738) or placebo (n = 738).
The researchers found that the proportion of patients observed in an emergency setting for COVID-19 for more than 6 hours or hospitalized due to the disease was lower in the group treated with fluvoxamine and inhaled budesonide when compared with the placebo group.
Although the researchers found more adverse events in the in the treated group of patients, but “no important differences between the groups were detected,” the researchers wrote.
One limitation noted in the study was the low overall event rate, which was consistent with contemporary trials in vaccinated populations.
- Coronavirus (COVID-19) update: FDA authorizes changes to simplify use of bivalent mRNA COVID-19 vaccines. News release. US Food and Drug Administration; April 18, 2023. Accessed May 16, 2023. www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-changes-simplify-use-bivalent-mrna-covid-19-vaccines
- FDA authorizes Gohibic (vilovelimab) injection for the treatment of COVID-19. News release. US Food and Drug Administration; April 4, 2023. Accessed May 17, 2023. www.fda.gov/drugs/drug-safety-and-availability/fda-authorizes-gohibic-vilobelimab-injection-treatment-covid-19
- Horton DB, Neikirk AL, Yang Y, et al. Childhood asthma diagnoses declined during the COVID-19 pandemic in the United States. Respir Res. Publishe online March 10, 2023. doi:10.1186/s12931-023-0237-7
- Reis G, dos Santos Moreira Silva EA, Medeiros Silva DC, et al. Oral fluvocamine with inhaled budesonide for treatment of early-onset COVID-19. Ann Intern Med. 2023;176(5):667-675. doi:10.7326/M22-3305