MHFV Blog New COVID Therapies
M Health Fairview is working to plan for equitable distribution of new COVID-19 therapies to patients who are at high risk of serious illness.

COVID 19, News and Events

Three new COVID-19 therapies approved for emergency use

The U.S. Food & Drug Administration (FDA) issued emergency use authorization for paxlovid, molnupiravir and Evusheld, three new options for preventing or treating COVID-19. M Health Fairview is planning for distribution of these new options to people at highest risk.

  • January 17, 2022
  • By Staff Writer

Three new COVID-19 therapies recently received emergency use authorization from the U.S. Food and Drug Administration (FDA).

Two of the new therapies are antiviral pills that could help people once they have been diagnosed with COVID-19. The third is a monoclonal antibody therapy designed to prevent illness in people who are immunocompromised, such as cancer or organ transplant patients. M Health Fairview is working closely with the Minnesota Department of Health and other health systems throughout the state to equitably distribute these new therapies to patients who are at high risk of serious illness and hospitalization from COVID-19.

While the COVID-19 vaccine with boosters is still the best protection against the virus, new prevention and treatment options are especially helpful for people with certain pre-existing conditions. Read on to learn more about how the new therapies work, who qualifies, and how to access them at M Health Fairview as supplies become available.

Paxlovid

What is it?

Paxlovid is an antiviral pill from Pfizer. It was approved for emergency use on Dec. 22 to help treat COVID-19 in people at high risk of severe illness from the virus. It has been approved to treat mild to moderate COVID-19 cases and is meant for use before hospitalization.

Clinical trials show Paxlovid can reduce the risk of hospitalization from COVID-19 bynearly 90 percent. Like Molnupiravir, another antiviral pill recently authorized by the FDA, Paxlovid treatment must be started within five days of showing symptoms.

Paxlovid is a protease inhibitor. It stops the COVID-19 virus from replicating inside a person’s body by blocking protease, an enzyme that the virus needs to multiply. Protease inhibitors have long been used to treat other viruses, including HIV and hepatitis C.

Paxlovid is currently approved for people 12 and older who weigh at least 88 pounds.

This is a potential alternative to the monoclonal antibody treatments through MNRAP with Sotrovimab. The infusion Sotrovimab continues to show effectiveness against the omicron variant.

How do I get it?

Paxlovid received emergency use authorization on Dec. 22. As with molnupiravir, there is currently a very limited supply of Paxlovid nationwide. We are collaborating closely with the Minnesota Department of Health and other health systems to create an equitable and convenient distribution plan for people throughout the state. Due to the limited supply, our care teams are reaching out to current M Health Fairview high-risk patients directly after they receive a positive COVID-19 test to offer them an appointment to discuss therapeutic options with one of our providers. High-risk patients include:

  • People older than 65
  • People 55+ who have chronic heart disease, chronic lung disease or pulmonary hypertension
  • People over age 18 who are immunocompromised, or have chronic kidney disease or diabetes, who overweight with BMI greater than 35, who are pregnant or who are BIPOC
  • People age 12-17 with high or highest risk per MDH guidance

We will continue to update this page and our COVID-19 Resource Hub with the latest information on how you can access these treatments through M Health Fairview.

How does it work against the omicron variant?

Paxlovid uses a different method to stop the COVID-19 virus compared to current monoclonal antibody treatments. Researchers believe Paxlovid and Molnupiravir treatments will continue to have some effectiveness against the omicron variant as we work to adapt therapies to this new strain.

As the virus continues to spread and mutate, the vaccine offers critical protection. These new therapies can supplement care for those who are immunocompromised or at higher risk from COVID-19.

News and Events, Health and Wellness

What you need to know about the COVID-19 vaccines

Molnupiravir

What is it?

In additional to Paxlovid, the FDA recently issued emergency use authorization for Molnupiravir. Molnupiravir is an oral pill from Merck. It dramatically changes the virus’ genetic code, causing it to mutate so much that it can’t replicate.

Recent studies show that Molnupiravir can reduce the risk of hospitalization from COVID-19 by 30 percent, according to M Health Fairview Chief Medical Informatics Officer Bryan Jarabek, MD, PhD. Patients take four pills every 12 hours for five days. They must start the treatment within five days of showing symptoms.

Molnupiravir is approved to treat mild-to-moderate cases of COVID-19 in adults who are at high risk for severe illness but have not yet been hospitalized. It’s only approved in cases where alternative more effective COVID-19 treatments approved by the FDA like Paxlovid or monoclonal antibodies like Sotrovimab aren’t appropriate. Molnupiravir is only approved for adults 18 and older. It’s not recommended for people who are pregnant or breastfeeding and contraception needs to be used until 4 days after treatment is completed. This is a potential alternative to Paxlovid and the monoclonal antibody treatments through MNRAP with Sotrovimab. The infusion Sotrovimab continues to show effectiveness against the omicron variant, according to M Health Fairview experts.

How do I get it?

Molnupiravir received emergency use authorization on Dec. 23, and there is currently a limited quantity. At this time, our care teams are reaching out directly to current high-risk patients who would be good candidates to receive this treatment. High-risk patients include:

  • People older than 65
  • People older than 55 with chronic heart disease, chronic lung disease or pulmonary hypertension
  • People over age 18 who are immunocompromised, or have chronic kidney disease or diabetes, are overweight with a BMI greater than 35, are pregnant, or are BIPOC

M Health Fairview is working with the Minnesota Department of Health and health systems throughout the state to plan for distribution as supplies become available.

We will continue to update this page and our COVID-19 Resource Hub with the latest information on how you can access this treatment through M Health Fairview.

How does it work against the omicron variant?

Like Paxlovid, Molnupiravir uses a different method to stop the COVID-19 virus from spreading compared to monoclonal antibody treatments. Because of this, researchers believe it will continue to have some effectiveness against the new variant.

Evusheld

What is it?

The FDA issued an emergency use authorization on Dec. 8 for Evusheld, a new monoclonal antibody treatment from AstraZeneca. Evusheld is a preventive therapy designed to protect people with compromised immune systems before exposure to COVID-19. These people receive less protection from the vaccine and are at higher risk of hospitalization and death if they get COVID-19. Evusheld may provide up to six months of protection against COVID-19. In clinical trials, it has been shown to reduce the risk of getting COVID-19 by nearly 80 percent.

Evusheld is not a COVID-19 treatment. It can’t be given to people who have the virus or were recently exposed to COVID-19.

How do I get it?

There is currently a very limited supply of Evusheld.

M Health Fairview will be able to provide Evusheld during pre-existing appointments to patients 12 and older with severely weakened immune systems who are at highest risk of severe illness from COVID-19. Eligible patients include those who have received:

  • Lung transplants
  • Small bowel transplants
  • Allogenic stem cell transplants (within 12 months), including lung or small bowel transplant recipients
  • Allogenic stem cell transplant patients (within 12 months)
  • Autologous stem cell transplant patients (within 6 months)
  • CAR-T therapy patients (within 6 months)
  • Patients on chemotherapy for lymphoma, multiple myeloma, Waldenstrom’s macroglobulinemia or acute leukemia

For those who are not immunocompromised, the COVID-19 vaccine is the best option for prevention and provides more protection than Evusheld. We will also be inviting high-risk patients based on provider evaluation.

How does it work against the omicron variant?

Early data suggests that current monoclonal antibody injections – including Evusheld – may be less effective against the new omicron variant but continues to show benefit.