FDA Limits Monoclonal Antibodies Therapy

Following the authorization of REGEN-COV monoclonal antibody therapy by the U.S. Food and Drug Administration (FDA)  for the prevention of COVID in adults and pediatric individuals (12 years of age and older) who are at high risk for progression to severe COVID-19, federal regulators are now considering limiting the authorization of specific monoclonal antibody treatments.

Those monoclonal antibody treatments, including antibody treatments produced by Eli Lilly and Regeneron, posed to be limited have proved non-effective against Omicron or ineffective in their efforts to neutralize the Omicron variant. 

Others have, on the other side, have stated that treatments work on Omicron patients; however sufficient evidence has not been proven to back up these claims.

What Is Monoclonal Antibody Therapy?

With monoclonal antibody therapy, it was said that severe symptoms of COVID are prevented from developing in those who are at high risk.

Houston Methodist Leading Medicine reports that ”Monoclonal antibodies are mass-produced in a laboratory and are designed to recognize a specific component of this virus — the spike protein on its outer shell. Antibodies that are similar to the ones your body would naturally make in response to infection.”

“By targeting the spike protein, these specific antibodies interfere with the virus’s ability to attach and gain entry into human cells. They give the immune system a leg up until it can mount its response.”

NIH pointed out those who are suitable for this monoclonal antibody therapy: 

• An immunocompromising condition or immunosuppressive treatment
• Being overweight (BMI 25–30) as the sole risk factor 
• Chronic kidney disease
• Pregnancy
• Sickle cell disease 
• Neurodevelopmental disorders (e.g., cerebral palsy) or other conditions that confer medical complexity (e.g., genetic or metabolic syndromes and severe congenital anomalies)
• Medical-related technological dependence (e.g., tracheostomy, gastrostomy, or positive pressure ventilation that is not related to COVID-19)
• Infants aged <1 year (for the antibody drugs bamlanivimab plus etesevimab only)

Monoclonal Antibodies Became A Cornerstone Of COVID Responses

In the past, up until now, many have made monoclonal antibodies a cornerstone of their COVID response and have pushed this treatment more vigorously than vaccines. 

According to the FDA, REGEN-COV was only to be used as post-exposure prophylaxis for adults and pediatric individuals (12 years of age and older weighing) who are:

• At high risk for progression to severe COVID-19, including hospitalization or death
• Not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications)
• Have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)
• Who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)

Up until now, these treatments have remained popular among some governors and health experts. 

Further to this, states have already distributed nearly 110,000 doses of the Lily and Regeneron treatments. 

Still, although a recent public statement made by Regeneron that its monoclonal antibody treatment is not effective against the Omicron variant, some governors continue to push this form of treatment. Adding to this are the adverse side effects experienced by patients.

Concerns Over Adverse Side Effects From Monoclonal Antibodies

There are also concerns that widespread use of the treatments could put people at unnecessary risk for the adverse effects of receiving monoclonal antibodies. According to the National Institutes of Health, some patients have reported rashes, diarrhea, nausea, and dizziness after treatment. A small percentage of patients had severe allergic reactions.

Not only has the Biden administration urged states to pivot away from the monoclonal antibody treatments, but the National Institutes of Health (NIH) has recently updated its guidelines to advise clinics against using these treatments on patients with mild to moderate COVID.

With Omicron sending stats rising, NIH also urged clinics against using these treatments, with Omicron now accounting for nearly all positive cases.

A Pivot To Alternative Treatments That Boast Greater Effectiveness

The Biden administration has pushed states to pivot to other treatments that have demonstrated greater effectiveness against the Omicron variant. These include: 

• Merck and Pfizer antiviral pills 
• GlaxoSmithKline’s monoclonal antibody
• AstraZeneca’s pre-exposure prophylaxis
• antiviral, commercially available, Remdesivir

It is recommended that doctors must make treatment decisions only when fully knowing which strand of the virus the patient is infected with. 

It is further recommended to the public to get vaccinated. As the FDA confirms, “Vaccines have proven to be the best defense available against COVID-19.”