These potential side effects explain why the antibody treatment is often restricted to certain individuals.
Who Is This Treatment Approved For?
The COVID-19 antibody treatment is recommended for persons who are having mild to moderate symptoms from the disease. It’s not to be given to anyone who needs to be hospitalized for the consistent administration of oxygen. Other qualifying criteria include:
- having a body mass index (BMI) that is equal to or greater than 35.
- having chronic kidney disease, diabetes, or an immunosuppressive condition.
- being older than 65 years of age.
- being older than 55 years and having chronic illnesses such as cardiovascular disease, hypertension, chronic obstructive pulmonary disease, or another chronic respiratory disease.
- being between the ages of 12–17 years and having a BMI equal to or greater than the 85th percentile for one’s age and sex. Additionally having sickle cell disease, heart disease, a neurodevelopmental disorder,
- medical-related technological dependence, asthma, or another chronic respiratory disease that requires daily medication.
Why Did It Need Emergency Authorization?
As the pandemic continues, it’s essential to explore viable treatment programs quickly. That means the FDA is using its emergency authorization protocols more often than persons are used to.
Does that mean that the treatment isn’t safe? No, it only means that it has been fast-tracked through the system.
The typical authorization process for drugs and medical devices has multiple steps and can take some time to reach completion.
Recognizing that this won’t work for all situations, the FDA has always had an emergency authorization process that moves faster while still ensuring that the products are safe for use by the public.
The process also includes thorough reporting and recall procedures so the products can be withdrawn quickly if there’s a need.
So far the FDA has approved two COVID-19 antibody treatments but it’s likely that others will be submitted for approval as well.
Not only would additional treatments provide choices for persons who have been infected with the virus, but they may also extend the criteria of those who can accept the treatment.