First COVID-19 prevention therapy has finally been authorized by FDA

The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization for AstraZeneca’s Evusheld in early December. This prevention therapy is the only non-vaccine authorized for use as a pre-exposure prophylaxis against COVID-19. While vaccination remains the recommended way to prevent severe COVID-19-related illness and death, some people are not able to receive the vaccination or may be unable to complete a vaccination series.

More than 200 million people in the U.S. are fully vaccinated. This number includes about 87 percent of nursing home residents and roughly 83 percent of nursing home workers according to the week ending Jan. 16. Evusheld is currently being studied and is recommended only for certain high-risk individuals and can help protect them from COVID-19 before they are exposed to the virus. According to AstraZeneca, a six-month follow-up of its prevention therapy trial “showed 83% reduced risk of symptomatic COVID-19, with no severe disease or deaths.”

What is prevention therapy?

Evusheld for prevention therapy is a combination of two long-acting monoclonal antibodies (mAbs), tixagevimab and cilgavimab. Our bodies naturally make antibodies to fight infection. However, some people may not have antibodies that recognize a new virus like COVID-19. Monoclonal antibodies are made in a laboratory to fight a particular infection. The mAbs are usually given via an infusion or injections. The treatment gives the person the antibodies their body needs to defend itself. This helps prevent an infected person from becoming more ill and developing life-threatening symptoms such as pneumonia.

Evusheld is given in one injection of tixagevimab and one injection of cilgavimab, immediately given one after another into a muscle. Tixagevimab and cilgavimab may cause side effects, including tiredness or weakness, swelling in the ankles or lower legs, headache and coughing. After receiving the injections, recipients should continue to isolate as directed by their doctor and follow public health practices such as wearing a mask, social distancing and frequent hand washing.

Who is eligible for prevention therapy?

Evusheld may only be prescribed by physicians, advanced practice registered nurses and physician assistants that are licensed or authorized under state law to prescribe drugs in the anti-infective therapeutic class. Currently, the U.S. Department of Health and Human Services is tasked with allocating Evusheld to communities across the nation.

Not everyone is eligible for Evusheld. It is not to be used in unvaccinated individuals for whom COVID-19 vaccination is recommended. It’s authorized for people ages 12 and older who weigh at least 88 pounds. They also can’t be currently infected with COVID-19 or have a known recent exposure to the virus. Additionally, potential oral prevention therapy recipients need to meet one of the following criteria:

  • Moderately to severely immunocompromised and have a condition that likely won’t allow their body to develop a strong enough response to the COVID-19 vaccine. (ex: active treatment for cancer, active treatment with high-dose corticosteroids, advanced or untreated HIV infection and organ or stem cell transplant recipient taking immunosuppression therapy)
  • Not able to be fully vaccinated with any available COVID-19 vaccines due to a documented history of serious adverse reactions to a COVID-19 vaccine or any of the ingredients.
  • Have been vaccinated, have not received a booster shot, and are at high risk of severe disease. Anyone aged >75 years or anyone aged >65 years with clinical risk factors (ex: age, cancer, cardiovascular disease, chronic kidney disease, chronic lung disease, diabetes, BMI >30, pregnancy or sickle cell disease).
  • Have been vaccinated and are at risk of severe disease (anyone aged >65 years or anyone <65 with clinical risk factors)

Patients should talk to their health care provider to determine whether, based on individual circumstances, they are eligible to receive Evusheld, and when it should be administered.

First pills for COVID-19 infection

In December, the FDA also granted authorization to the first oral medications for treating mild to moderate COVID-19 infections. Molnupiravir is an antiviral pill made by Merck and Ridgeback Biotherapeutics. Paxlovid is an oral antiviral made by Pfizer. The pills are hoped to make COVID-19 treatment cheaper and more accessible.

Both pills prevent the virus from replicating. When the virus enters cells, it copies itself over and over to spread around its host’s body and potentially be transmitted to others. The virus will cause an immune response to combat the infection. However, sometimes the infection may be difficult for some people’s immune systems to fight. This can lead to a more severe infection or death. Disrupting virus replication and transmission allows more time for a person’s immune system to fight the infection before it becomes more severe.

According to a Merck study, molnupiravir reduces the chance of hospitalization and death in at-risk adults with COVID-19 by 30 percent when the pills are started within five days of symptom onset. In their study, Pfizer found that Paxlovid reduced the risks of hospitalizations and deaths by 89 percent when patients were treated within three days of symptom onset. 

Who is eligible for COVID-19 pills?

According to the FDA, molnupiravir can be used to treat adults with mild to moderate COVID-19 “who are at high risk for progressing to severe COVID-19, including hospitalization or death, and for whom alternative treatment options authorized by the FDA are not accessible or clinically appropriate.”  Paxlovid  is authorized to treat adults and children with mild to moderate COVID-19 infections. Patients must be 12 years of age and older, weigh at least 40 kg (88.2 pounds) and at high risk for progression to severe COVID-19.

How can we help?

In addition to our pharmacy offering various antibody and antiviral treatments, Turenne is also a COVID-19 vaccination provider. We have trained, immunization-certified pharmacists and nurses that can administer the vaccines at healthcare facilities. During the on-site clinics, we will vaccinate residents and staff. Click here to learn more about our vaccination service in Alabama and to complete a vaccine clinic request form. For convenience, a consent form for vaccine recipients and vaccine fact sheets from the FDA are available for download on our website. To request a clinic in Tennessee, call 1-866-710-7626.

Cecilia Hughes, PharmD candidate at Auburn University, contributed to this article.