Bamlanivimab treatment. What is a monoclonal antibody?
The city will provide the new COVID-19 treatment Bamlanivimab, starting this week, to prevent hospitalizations.
El Paso was selected to provide this treatment developed by Eli Lilly due to the high COVID-19 positive cases and hospitalizations. El Paso has received a limited number of doses of this new infusion treatment.
“We are grateful to have been selected to pilot a noble treatment program aimed at preventing higher hospitalization numbers among our most vulnerable loved ones, thus improving their outcomes when infected with COVID-19,” City-County Local Health Authority Dr. Hector Ocaranza said in a news release.
The FDA has granted the emergency use of Bamlanivimab, a medication used for the treatment of COVID-19 in patients who meet the following criteria:
- COVID-19 positive
- Non-hospitalized adults and adolescents 12 years and older
- Mild to moderate symptoms
- Weigh 88 pounds or more
- Underlying health conditions
- High risk for developing severe COVID-19 symptoms
Bamlanivimab is not authorized for patients who are already hospitalized or require oxygen therapy because of COVID-19.
Patients who qualify for the treatment will receive a one-time intravenous (IV) dose that takes about 1 hour. Patients will be required to wait an additional hour to monitor the reaction to the treatment.
What is Bamlanivimab? What is a monoclonal antibody?
According to the FDA, Bamlanivimab is a monoclonal antibody, laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance or mimic the immune system’s attack on cells.
Bamlanivimab is designed to block viral attachment and entry into human cells, thus neutralizing the virus. It is designed to limit viral replication and may be effective for the treatment of COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.
When should Bamlanivimab be administered to a patient?
According to the FDA, it’s recommended that Bamlanivimab be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset. Bamlanivimab is administered as a single dose of 700 mg via IV infusion over 60 minutes.
Is Bamlanivimab approved by the FDA to treat COVID-19?
According to the FDA, Bamlanivimab is an investigational drug. It is not currently FDA-approved to treat any diseases or conditions, including COVID-19.
However, upon issuance of the Emergency Use Authorization (EUA), Bamlanivimab is authorized for emergency use for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
What is an Emergency Use Authorization (EUA)?
The FDA may authorize an unapproved product or unapproved uses of an approved product for emergency use. In issuing a EUA, the FDA must determine, among other things, that the product may be effective in diagnosing, treating, or preventing a serious or life-threatening disease or condition caused by a chemical, biological, radiological, or nuclear agent. Emergency use authorization is not the same as FDA approval or licensure.