Oh, what a year it has been.
As we approach the year marker of COVID-19 shutting down the country, new hope for prevention and treatment is on the horizon. Even as the approval of new vaccines and treatments for the novel SARS-CoV-2 virus brings hope after a long and difficult year, it also raises several questions. Everyone from parents to teachers, senior citizens, and Gen Z alike are wondering if these treatments are safe.
Today, we aim to put some of those fears to rest. We’re going to dive into monoclonal treatments that have been approved for emergency use by the FDA and that we’ve recently started providing in our ERs. In explaining this treatment, Neighbors Emergency Center hopes to put you and your family at ease, should you ever find yourself in need of receiving it.
So what is the monoclonal treatment? Let’s start with what it’s not. It is not a vaccine. The monoclonal treatments granted an emergency use authorization (EUA) by the FDA will not prevent you from getting COVID-19. They can, however, prevent you from becoming severely ill should you contract the virus. While studies are ongoing, clinical trials have shown a decrease in hospitalizations and a decrease of the virus in the infected person’s blood.
There are currently three emergency use treatments approved:
- Bamlanivimab was approved in November of 2020 for the treatment of mild to moderate COVID-19.
- Casirivimab and imdevimab
- Also approved in November of 2020 for mild to moderate COVID-19. Carisivimab and imdevimab are to be administered together.
- Bamlanivimab and etesevimab
- The most recent treatment, a combination of bamlanivimab and etesevimab, received its emergency use approval in February of 2021.
These medications are known as antibody cocktails and are administered by IV infusion in an outpatient setting; an overnight hospital stay is not a requirement for receipt of treatment. They mimic the immune system’s ability to fight dangerous pathogens, like viruses. The treatments above were created for the specific purpose of treating COVID-19.
It is common for things like drug developments and approvals to take years, sometimes decades. It’s no doubt that some people might be wondering if these treatments are safe for them and their families. It’s a valid question, and we aim to answer it.
All treatments underwent a double-blind clinical trial. What that means is, neither the recipient nor the administrator knows if the treatment is the actual drug or the placebo. Double-blind trials are commonplace in studies such as these, they often help to prevent bias in the research results. Double-blind trials and studies are some of the most reliable forms of research because they eliminate the power of suggestion. It’s also important to note that while the development of these drugs and treatments happened quickly, researchers skipped no steps in the process. Instead of conducting every step one after the other, drug companies realized they could work certain steps simultaneously. This gave them the ability to speed up the production and testing process without having to sacrifice safety.
The FDA considers all monoclonal treatments safe. However, as with any drug, some side effects might occur. Commonly reported side effects for these monoclonal treatments were nausea, dizziness, diarrhea, itchiness, vomiting, pneumonia, and hyperglycemia. Generally speaking, the side effects of any drug administered by IV could include pain upon infusion site, bruising, bleeding, swelling, and soreness. You could also develop an infection at the infusion site. Reports of these side effects were few.
There have also been reports of allergic reactions to the treatment. These reports were also few and far between. For example, in the bamlanivimab and casirivimab/imdevimab trials involving nearly 3000 people, only two reported severe allergic reactions. Five trial participants reported serious reactions. All reported cases were treated and resolved without death or further injury.
Now that we know the methods used to develop the drugs and that they are safe, the question is, who is eligible for these treatments? As we stated above, these treatments do not prevent COVID-19, so they should only be given to you if you are already infected with the virus. Patients 65 years of age and older, who have mild to moderate COVID-19 are eligible for the treatments. Treatments have also been approved for patients 12 years of age and older and weighing at least 88 pounds who are high-risk with mild to moderate COVID-19. Patients hospitalized due to COVID-19 or for those who require oxygen therapy due to COVID-19, are not eligible for the treatments. Specific healthcare providers could also have certain criteria that need to be met. Do not hesitate to reach out and ask.
As of March 2021, all Neighbors Emergency Center locations are currently administering monoclonal antibody treatment in the E.R. for patients that test positive for COVID, are high risk, and meet the other criteria. This treatment is available for patients inside the E.R. who test positive and have mild to moderate symptoms. It is covered by the CARES Act and will be administered by a doctor.
The federal government is actively distributing monoclonal treatments to healthcare providers around the U.S. You can visit the FDA coronavirus update page for more information or visit the U.S. Department of Health and Human Services’ treatment locator to find a treatment center near you. You can also call your primary care provider to see if they are administering the infusions.
Vaccines and new treatments are exciting advancements in the fight against COVID-19, but there’s more we can do. Don’t forget to stay vigilant by washing your hands, wearing a mask, avoiding touching your eyes and face, and practicing social distancing whenever possible. If we do this together, we can stop the spread of COVID-19 and one day return to the life we all love. Never forget, you aren’t fighting this alone. Should you need us, Neighbors is just a short drive away.