Evusheld for COVID-19 Prevention
The COVID-19 vaccine is still the best defense against COVID-19 infection, however there is additional medication available to help lower the risk of becoming infected.
The monoclonal antibody combination, tixagevimab and cilgavimab (Evusheld), is under Emergency Use Authorization from the FDA for patients who are moderately to severely immunocompromised and who have not been recently exposed to or currently have COVID-19. It has been shown to moderately reduce the likelihood of COVID-19 infection.
Evusheld can supplement the COVID vaccine for those who may not have had a full protective reaction. But, it is not a substitute for COVID vaccination, especially because Evusheld may not protect people against the Omicron variant as effectively as vaccines do.
Evusheld Distribution at Penn Medicine
We are starting to provide doses of Evusheld to prevent COVID-19 in patients who may not respond to COVID-19 vaccination.
At this time, the entire Evusheld supply for the United States is low — Penn Medicine has been allocated a very limited number of doses. We are providing doses to individuals at the highest risk of not responding the vaccine and allocating Evusheld in an equitable way.
If you are a Penn Medicine patient who is eligible to receive Evusheld, we may contact you. There may be other ways to receive the medication in the future. We will be sure to update you as more information becomes available.
Learn more about Evusheld in the FDA’s FACT SHEET or contact your care team.
COVID-19 Treatment for Patients Who are Not Hospitalized
Several new COVID-19 medications for outpatient use are now approved through Emergency Use Authorization by the Food Administration, although they are in limited supply.
Due to the limited availability of these antivirals, health care providers will need to determine the best course of treatment for their patients based on eligibility criteria. People with weakened immune systems have a harder time fighting infections and are especially vulnerable to viruses like COVID and may be prioritized.
About COVID Antivirals for Outpatients
At this time there are two oral antiviral pills nirmatrelvir-ritonavir (PaxlovidTM) (Pfizer) and molnupiravir (Merck) that have been approved for emergency use authorizations by the U.S. Food and Drug Administration. These pills are for the treatment of mild-moderate COVID-19 in outpatients with risk factors for progression to severe COVID-19. These pills can be prescribed only if your symptoms of COVID-19 started within the past 5 days. Both antiviral pills may only be prescribed for a patient by doctors, advance practice registered nurses, and physician’s assistants. Due to the limited availability of this medication, health care providers will need to determine the best course of treatment for their patients based on eligibility criteria and medication availability. Vaccination and taking measures to avoid getting COVID-19 are still your best methods of protection.
In addition to the pill, there is also an intravenous treatment called remdesivir. This medication is not FDA approved for outpatients, and it is available only for inpatients with moderate-severe COVID-19 at this time.
Antiviral medications help your body fight off viruses that cause disease, reduce the symptoms of an infection, and shorten the length of illness. It’s important to note that the pills are meant to be taken after you’ve experienced COVID-19 symptoms. They cannot be used to prevent COVID-19 or in people who test positive for COVID-19, but do not have symptoms. When the drugs enter your bloodstream, they block the ability of the SARS-CoV-2 virus to replicate it. In most cases, the virus clears up without these drugs, but when your infection is chronic or life-threatening, your doctor may want to treat you with the COVID antiviral medications.
Neither medication can be used in patients hospitalized due to COVID-19 so you are not able to get these medications if you have to come into the hospital. However, there are other treatments available for people who need to be hospitalized due to more severe COVID-19 symptoms.
Pfizer's Paxlovid and Merck's molnupiravir are both oral antiviral pills that can be taken at home to keep patients out of the hospital. They're meant to be taken within the first few days of having COVID-19, and they reduce the risk of hospitalization and death by up to 88% for Paxlovid and 30% for molnupiravir. Today these treatments are only for patients at the highest risk of developing severe COVID-19 illness.
Both medicines can reduce hospitalizations and deaths from COVID-19 when given within three days of symptom onset. In an interim analysis, Paxlovid reduced the risk of Covid-19-associated hospitalization or death by 88% in those who received treatment within five days of symptom onset. In its Phase II/III clinical trial, 1% of patients who received Paxlovid were hospitalized through day 28 compared to 6.7% of placebo participants. Ten deaths were reported among patients in the placebo arm, while none occurred among patients taking Paxlovid.
Molnupiravir reduced the risk of hospitalization or death by 30% in the final analysis of its Phase III trial. Nine deaths were reported in the placebo group, and one in the molnupiravir group. However, in the second half of the trial data when newer COVID-19 variants were present, there was no difference between molnupiravir in placebo. So it is possible that molnupiravir may be less effective against newer variants.
While these are effective treatments for people with COVID-19, they’re not meant to replace the COVID-19 vaccine.
The COVID antiviral treatments are available only to patients at highest risk of developing severe COVID-19 illness, including people older than 65 and those with other health conditions like heart disease, cancer, or diabetes, that make them more vulnerable to severe illness. Patients can be prescribed these medications only if symptoms developed in the past 5 days and they tested positive for COVID-19. Contact your healthcare provider and get tested as soon as possible if you develop symptoms.
These medications cannot be prescribed to prevent COVID-19. They are available only for patients who have an active infection. Vaccination and taking measures to avoid getting COVID-19 are still your best methods of protection.
The antiviral pills are not recommended for everyone who tests positive for COVID. The pills are intended for those who have symptoms from COVID-19 and who are not in the hospital, but who are more likely to become seriously ill. That includes older people and those with other health conditions like heart disease, cancer, or diabetes that make them more vulnerable. Both pills have been approved for adults and the Paxlovid is authorized for children ages 12 and older. These medications can be prescribed only if your symptoms of COVID-19 started with the past 5 days.
The safety of molnupiravir and Paxlovid was studied in clinical trials prior to their EUA designations. The following reservations for use were among the findings arising from these studies:
Molnupiravir is not authorized for children and teenagers younger than 18 years because it may affect bone and cartilage growth. The medication is not recommended for use during pregnancy because findings from animal reproduction studies showed that it may cause fetal harm when administered to pregnant individuals.
Paxlovid cannot be used in patients with severe liver and kidney disease. It also can have serious or life-threatening interactions with certain medications so you should always tell your healthcare provider other medications or supplements that you may be taking.
- These pills are available by prescription only. They are available only at select outpatient pharmacies.
- Both medications may be prescribed for a patient by doctors, advance practice registered nurses, and physician’s assistants.
- The medications can be prescribed only to patients at highest risk of developing severe COVID-19 illness, including people older than 65 and those with other health conditions like heart disease, cancer, or diabetes that make them more vulnerable to severe illness. Vaccination and taking measures to avoid getting COVID-19 are still your best methods of protection.