Along with administering FDA-approved vaccines to prevent or reduce the severity of COVID-19 infection, we will now be offering monoclonal antibody treatments for those who have already contracted the virus, are showing mild to moderate symptoms and are at higher risk for severe symptoms and/or hospitalization. This group includes those who are 65 or older or are between the ages of 12 and 65 with certain chronic medical conditions.
The monoclonal antibody treatment approved by the FDA is a combination of Casirivimab and Indevimab introduced directly into the bloodstream. While vaccines can take up to two weeks to generate enough antibodies to fight the virus effectively, monoclonal antibodies can start fighting infection immediately after the treatment is administered through intravenous infusion.
Our monoclonal antibody treatments are only given to those with mild to moderate symptoms. We will not offer this course of treatment once a patient is admitted to a hospital or given supplemental oxygen. Clinical studies have shown no benefit when treatments were given to those already experiencing more severe symptoms or needing additional oxygen.
Both Casirivimab and Indevimab are laboratory-made proteins that mimic the immune system’s ability to combat infectious diseases. In this case, both proteins have been created to attack the spike protein of COVID-19. The protection is provided by blocking the ability of the spike protein to attach to cells and provide entry for the virus.
The current approval for monoclonal antibodies is limited to emergency use authorization (EUA), which is different from standard FDA approval. Normal approval is given to drugs that typically are scrutinized against massive amounts of clinical data that are gathered through trials. It is not uncommon to take years to fully get through the approval process. In EUA, the drug is given approval with much less evidence to firmly establish both its efficacy and safety. Due to emergency conditions such as our current world wide pandemic, these drugs have been shown to be safe and effective, but in limited studies and with far fewer participants. In these cases, the limited amount of data needs to point towards more potential benefit than harm in order for a drug to even be considered for EUA. In clinical trials done with each vaccine and both monoclonal antibody proteins, all data indicated that each option had a greater likelihood of helping our population than causing further harm.
For both monoclonal antibodies, randomized tests were conducted with 799 non-hospitalized patients with mild to moderate symptoms. A third of participants received one dosage of the treatment. Another third of participants got three times the amount of antibodies as the first group. The final third of participants were given a placebo. Treatments were given to participants within three days of testing positive for COVID-19.
Results for the test were analyzed by looking at the change in viral load over time in reference to the baseline amount. Patients receiving the treatment showed a larger reduction in viral load than those in the placebo group. It was also found that only 3% of patients existing in the high risk groups were hospitalized or had to seek further medical attention. The high-risk patients having received the placebo were hospitalized 9% of the time, or three times as often as those with monoclonal antibodies.
Under provisions of EUA, fact sheets with important information regarding the use of monoclonal antibody treatment must be provided to all health care providers, patients and caregivers. These fact sheets include important information regarding instructions for use, possible drug interactions and side effects. The most common side effects for this course of treatment include: anaphylaxis and infusion-related reactions, fever, chills, hives, itching and flushing.
The EUA was issued to Regeneron Pharmaceuticals, Inc. by the United States Food and Drug Administration. In addition to safeguarding American lives and health through approval and regulations of medications, the agency also watches over our nation’s food supply, dietary aids and supplements, tobacco, cosmetics, and radioactive materials.
To learn more about monoclonal antibody treatments and discuss if it’s an option for you, schedule your appointment today by calling 773-897-5711.