AMARILLO, Texas (KAMR/KCIT) — As the pandemic approaches its third year, scientists and various entities have developed different ways to treat COVID-19, ranging from vaccines to various monoclonal antibody treatments.
At the end of 2021, the United States Food and Drug Administration (FDA) issued an emergency use authorization for three additional COVID-19 treatments that provide additional protection from COVID-19 or can help to prevent individuals who contract COVID-19 from progressing to severe disease, hospitalization or death.
COVID-19 Evusheld Treatment
In early December 2021, the U.S. FDA issued an emergency use authorization for Evusheld, a monoclonal antibody treatment from AstraZeneca, combining two antibodies for a layer of additional protection for immunocompromised individuals against COVID-19.
According to a news release from the U.S. FDA at the time, the treatment combines tixagevimab and cilgavimab and can be given to individuals 12 years of age and older who are not infected with COVID-19. However, the authorization requires that the individuals who receive this treatment have “moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination” or “a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines.”
In a statement given to MyHighPlains.com from the Texas Department of State Health Services (DSHS), officials said the treatment is aimed to give additional protection from COVID-19 for those patients who are “not likely to make a high level of antibodies in response to the vaccine.” Officials said the treatment gives individuals additional protection for around six months.
“It isn’t used in place of the vaccine but it adds to the antibodies created in response to the vaccine,” the statement reads, “It can also be used with patients who had a severe allergic reaction to one of the COVID vaccines or a component of one of the COVID vaccines. Unlike the other monoclonal antibody treatments, Evusheld is given to patients who are not currently sick with COVID.”
Officials from the Texas DSHS said that the state received 47,160 courses of Evusheld, giving providers the ability to request a supply from the Texas DSHS directly. As of Monday, Texas Oncology – Amarillo Cancer Center is the only provider in the Amarillo area offering Evusheld to patients.
Tucker Osteen, a hematologist and medical oncologist at Texas Oncology – Amarillo Cancer Center, told MyHighPlains.com that the center requested Evusheld from the Texas DSHS and started receiving the treatment in late 2021 and early 2022. Since then, the center has given out the treatment around 35 times.
“The reason we were chosen to get this medication is because a lot of our patients qualify for the treatment because of either their cancer or their cancer treatment,” he said. “It’s really nice to have the option to give this. A lot of our patients are immunocompromised. They just don’t make antibodies in response to the vaccine as well as the general public. There’s just a lot of concern about getting a COVID infection among that population and we just haven’t had a lot to offer them until now. To be able to give them antibodies designed to prevent them from catching COVID is just (a) real life changer for them. It gives them a lot of protection and it’s really rewarding.”
Osteen said in the population the center serves, individuals have either immune diseases or are taking medications that make them immunosuppressed, including chemotherapy treatments. The center is offering the treatment to patients that the Texas Oncology – Amarillo Cancer Center serves, as well as other members of the community who may be eligible.
“The overall reaction has been favorable,” he said. “There’s a lot of people that just don’t want to get COVID and having this extra layer of protection, especially in this population of patients who, during the whole pandemic, have been on edge because their immune system is just not optimal… I think it’ll just reduce a layer of uncertainty about your activities, be able to resume more normal activities and feel protected, right, if you are an immunocompromised patient.”
However, area medical professionals said the therapy may not be as effective against the Omicron variant.
“The unique thing is that this therapy has been modified so that the antibodies last for up to a year,” Todd Bell, an associate professor from the Texas Tech University Health Sciences Center in Amarillo, told MyHighPlains.com in a statement. “The downside is that no studies have been done against the Omicron variant. Other antibodies that worked against delta, alpha, etc failed against omicron due to mutation. If or when the therapy becomes available, it will likely go through health care provider channels and not the health department.”
Overall, Osteen said that Evusheld is an exciting opportunity for extra protection for those immunocompromised individuals in the Amarillo community.
“It’s an exciting treatment to be able to offer protection to our patients who are dealing with other illnesses and don’t get the protection the regular community gets from the vaccine,” he said. “It’s designed to be given before they’re exposed to COVID and blocks the virus from going into the body. So, it’s a real important treatment for our clinic.”
As of Friday, around 65 doses of the treatment remain at the Texas Oncology – Amarillo Cancer Center. For more information about the COVID-19 Evusheld Treatment, visit the HeatlhData.Gov website or the center’s website.
Oral COVID-19 Antiviral Treatments
Along with the Evusheld treatment, two oral COVID-19 antiviral treatments are also available for Texas Panhandle residents. This comes after both Paxlovid and Molnupiravir were issued an emergency use authorization by the FDA.
According to a news release, Paxlovid, an antiviral treatment from Pfizer, is aimed to be used for the treatment of mild-to-moderate COVID-19 in individuals 12 years of age and older. This medication is mainly for individuals who are at high risk of progression to severe disease, hospitalization, or death.
At the time, officials from the FDA called the authorization of this treatment “a major step forward in the fight against this global pandemic.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in the release.
According to the release, the medication is administered as three tablets, taken together orally, twice daily for five days. Paxlovid is available by prescription only and should be initiated as soon as possible after a diagnosis of COVID-19, specifically within five days of symptom onset.
Molnupiravir, an additional antiviral treatment from Merck, is also aimed at the treatment of individuals who have mild-to-moderate COVID-19 who are also at high risk of progression to severe disease, hospitalization, or death. Unlike Paxlovid, Molnupiravir is not authorized for patients younger than 18 years of age with the potential to impact bone and cartilage growth.
“Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Cavazzoni said in an additional release. “As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness.”
According to the release, Molnupiravir helps introduce errors into the virus’s genetic code, preventing further replication. It is administered as four capsules taken every 12 hours for five days. It is available by prescription only and should be initiated as soon as possible after a diagnosis of COVID-19, specifically within five days of symptom onset.
Both oral COVID-19 antiviral treatments are available through local entities, including the city of Amarillo’s Public Health Department as well as other pharmacies. More information can be found through HealthData.Gov.
Even with the availability of the COVID-19 therapeutics, officials with the U.S. FDA continue to stress that none of the therapeutics are a substitute for”individuals for whom COVID-19 vaccination and a booster dose are recommended.”
“The FDA has approved one vaccine and authorized others to prevent COVDI-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death,” the release from the FDA read.
As of Monday, officials with the Texas DSHS are reporting that 63.93% of the state’s population ages 5 and over are reported as fully vaccinated. In Potter County, 47.48% of the county’s population ages 5 and over are reported as fully vaccinated. In Randall County, 47.32% of the county’s population ages 5 and over are reported as fully vaccinated