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New COVID-19 antibody therapy to be distributed to hospitals countywide
A new investigational monoclonal antibody treatment that may reduce hospitalization for people infected with COVID-19 will be distributed to hospitals and patients in skilled nursing facilities throughout San Bernardino County.
The federal government funded the distribution of 484 units of Bamlanivimab to the San Bernardino County Department of Public Health to provide the treatments to emergency rooms and skilled nursing facilities. The treatment from Eli Lilly is similar to the Regeneron treatment given to President Donald J. Trump during his hospitalization in October, but his was for more critically ill patients and does not have FDA Emergency Use Authorization.
“This medication will allow our county to treat a significant share of our high-risk patients who do not require hospitalization,” said Dr. Erin Gustafson, the County’s Acting Public Health Officer. “We are hopeful that this therapy will help residents who can take it to recover quickly from this virus.”
The therapy is used to treat COVID-19 in non-hospitalized adults and adolescents 12 years or older, typically those who arrive in emergency rooms and test positive for the virus with mild to moderate symptoms and who meet the following criteria:
– Have a body mass index (BMI) over 35
– Have chronic kidney disease
– Have diabetes
– Have immunosuppressive disease
– Are currently receiving immunosuppressive treatment
– Are older than 65 years of age
– Are older than 55 years of age AND have
-cardiovascular disease, OR
-chronic obstructive pulmonary disease/other chronic respiratory disease.
– Are 12 – 17 years of age AND have:
– BMI over 85th percentile for their age and gender based on CDC growth charts
– sickle cell disease, OR
– congenital or acquired heart disease, OR
– neurodevelopmental disorders, for example, cerebral palsy, OR
– a medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
– asthma, reactive airway or other chronic respiratory disease that requires daily medication for control.
Bamlanivimab is not authorized for use in patients:
– who are hospitalized due to COVID-19, OR
– who require oxygen therapy due to COVID-19, OR
– who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity
For instance, a person with diabetes who tests positive for COVID-19 in the emergency room and does not need to be admitted could receive the IV infusion and be sent home to recover, Gustafson said. Medical personnel will explain the risks and benefits to patients before administering the therapy.
Early results from a clinical trial showed that Bamlanivimab may reduce hospitalization for infected people if given early in infection. The Food and Drug Administration (FDA) has authorized the emergency use of Bamlanivimab for the treatment of COVID-19 under an Emergency Use Authorization (EUA). Bamlanivimab is investigational until evaluation of safety and efficacy of the therapy is complete.
The California Department of Public Health (CDPH) used the most recent hospital COVID-19 data reported to them to proportionately allocate Bamlanivimab to counties in the state. The County is using the data reported by hospitals to determine their COVID burden to provide an equitable allocation. The treatment regimen of Bamlanivimab is one vial per patient.
Allocations of Bamlanivimab will be provided by the state on a weekly basis until the supply from the federal government is exhausted. Additionally, future allocations are anticipated to benefit more patients on an ongoing basis.