Russell Medical Now Offering Monoclonal Antibody Therapy to Fight COVID-19
As a majority of the U.S. continues to see the number of new cases of the delta variant coronavirus drop after a spike earlier in the year, health officials are continuing to endorse the efficacy of vaccinations to help keep the virus at bay. But for those who become infected, either because they’ve never been vaccinated or even if they have been vaccinated, but test positive for a breakthrough infection, there is still hope that they can lessen their chance of hospitalization or the severity of their COVID-19 symptoms.
As the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) to monoclonal antibody therapy late last year, early clinical data has shown that monoclonal antibodies can be effective in treating mild to moderate COVID-19 in adults and some pediatric patients, reducing the number of hospitalizations and/or emergency room visits for those who have tested positive and are at risk of progressing to severe COVID-19.
What are Monoclonal Antibodies?
Monoclonal antibodies are man-made antibodies that are similar to the ones naturally produced by the human body in response to an infection, but designed to target what’s known as the spike protein located on the outer shell of the virus, which helps to prevent the virus from attaching itself to human cells in order to gain entry.
Is Monoclonal Antibody Therapy Safe?
While the FDA has not yet officially approved the use of monoclonal antibodies, the EUA allows the use of medical countermeasures (much like the COVID-19 vaccines, initially) during public health emergencies. By granting an EUA for the use of monoclonal antibodies, for example, the FDA concludes that “the known and potential benefits outweigh the known and potential risks” of the treatment. As part of the EUA, certain FDA criteria must be met, in addition to the presence of evidence that patients have benefited from the treatment, and that there are no adequate alternatives, either available or approved.
Once the EUA was granted, FDA Commissioner, Stephen M. Hahn, M.D. said,
“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic. Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system… As part of our Coronavirus Treatment Acceleration Program, the FDA uses every possible pathway to make new treatments available to patients as quickly as possible while continuing to study the safety and effectiveness of these treatments.”
Do I Qualify for Treatment?
Monoclonal antibody infusion is generally available to individuals 12 years of age or older, weighing at least 88 lbs. who have recently tested positive for mild to moderate COVID-19 or shown symptoms for 10 days or less, but have not been hospitalized due to COVID-19, AND are at high risk of infection due to age (generally 65 or older) or other serious health conditions (heart, lungs, obesity, diabetes, immunodeficiency, etc.).
To find out if you’re eligible for monoclonal antibody therapy or to discuss the various guidelines regarding treatment eligibility, contact the medical specialists at Russell Medical to learn more about this revolutionary step in preventive health care.