For COVID-19 therapies, there is limited supply and high demand, meaning it is difficult for most to access new antiviral pills and monoclonal antibodies.
Prescription-only antiviral drugs Paxlovid, by Pfizer, and Merck’s Molnupiravir are for people who have mild to moderate COVID-19 but are at high risk of their illness progressing to severe disease. They are to be taken within five days of symptom onset.
The window is a bit longer, 5 to 10 days, for monoclonal antibodies, more readily available. These are laboratory-produced molecules acting as substitute antibodies and distributed intravenously or subcutaneously, meaning by injection, at hospitals and medical and infusion centers and sometimes, in homes.
They too are used to treat mild to moderate cases, and are effective at preventing hospitalization and death in high-risk patients, doctors say. However, the rise of the omicron variant has rendered two of the three approved products ineffective, further straining supply.
Criteria for the therapeutics is to be adjusted and reevaluated with time and as supply changes.
Here are the eligibility requirements and specifics related to each treatment:
Paxlovid
Criteria for Paxlovid, shown in clinical trials to be the most effective of the two pills at preventing the worst COVID outcomes, expanded this week. It was to be allocated, beginning Tuesday, to selected pharmacies in all of Michigan’s eight healthcare preparedness regions. Approved in December for emergency use, it was previously available only in 10 Meijer pharmacies, according to the Michigan Department of Health and Human Services.
Paxlovid is for people 12 and older assuming they meet a certain weight threshold, and consists of three tablets, a combination of two drugs, taken twice a day for five days.
It might have potentially significant interactions with other medications so determining candidates is tricky, Dr. Bruce Muma, president and CEO of the Henry Ford Physician Network and director of the health system’s monoclonal antibodies program said early this month. “Candidates may actually not be candidates if they’re on drugs that we can’t stop or that we can’t modify.”
Those who are eligible for Paxlovid include, according to the state health department:
- People, regardless of vaccine status, who are moderately to severely immunocompromised, including patients undergoing cancer treatment for tumors or blood, with untreated or advanced HIV, immunodeficiency syndromes or taking drugs that may suppress immune response; or those who have received organ or stem cell transplants.
- Those 75 years old and older who are not up to date on COVID-19 vaccines, meaning they are entirely unvaccinated or they are past due for booster shots months after their primary doses
- People 65 to 74 who are not up to date on their vaccines and have priority risk factors, including obesity, defined as a body-mass index at or greater than 35; chronic respiratory disease, such as chronic obstructive pulmonary disease, moderate or severe asthma requiring daily inhaled corticosteroid, or bronchiectasis, a condition characterized by damage to the lungs’ airways; chronic kidney disease; cardiovascular disease; or diabetes.
- With caution, pregnant people who are not up to date on their vaccines.
Molnupiravir
Unlike Paxlovid, Molnupiravir is only to be used when other alternative and federally approved treatment options are not accessible or clinically appropriate, but it is more widely available.
It works by introducing errors into the SARS-CoV-2 virus’ genetic code. “There is a theoretical risk that molnupiravir will be metabolized by the human host cell and incorporated into the host DNA, leading to mutations. For these, and other reasons, the FDA and MDHHS, have limited the use of this medication,” MDHHS reports.
Molnupiravir is available at all Meijer pharmacies, based on supply, and selected retail pharmacies in areas not served by Meijer, also based on supply, according to the Department of Health and Human Services.
Merck’s pill is authorized only for adults because it may affect bone and cartilage growth, and it should not be given to pregnant patients. It could cause fetal harm, according the the U.S. Food and Drug Administration.
Four Molnupiravir capsules are to be taken orally every 12 hours for five days.
Those eligible for this alternative therapy include those eligible for Paxlovid, minus women who are pregnant, plus:
- People 65 to 74 who are not up to date on vaccines; those younger than 65 who are both not up to date on vaccines and have above listed priority risk factors.
Monoclonal antibodies
Monoclonal antibodies or mAb treatment, distributed statewide, are preferred over Molnupiravir whenever the mAb courses are available, according to the state health department.
The antibodies, said to reduce chances of hospitalization and death by 70%, should be considered for patients who are in eligible lower risk tiers.
Included here are:
- First, people 65 to 74 who are not up to date on vaccines; those younger than 65 who are both not up to date on vaccines and have above listed priority risk factors.
- Next in line are those older than 75 who are up to date on vaccines; those who are vaccinated, age 65 to 74, and have priority risk factors, such as substance abuse disorder, a history of cigarette use or a body-mass index of 25 or greater.
- In the bottom two tiers are: People 65 and older who are up to date on vaccines and have general risk factors; those 65 and older who are up to date on vaccines and those younger than 65 who are vaccinated and have general risk factors.
There are three available monoclonal antibodies. However, two of them have been said to show low to no activity against the newly dominate omicron variant. It has been identified in a majority of Michigan counties and documentation lags spread, but the delta variant has not entirely disappeared, the latest data shows. In the latest week available, about 89% of specimens that underwent genomic sequencing were identified as the omicron variant, according to a Tuesday state report. About 11% were delta.
“At this time we are evaluating the prevalence of the omicron variant and determining ability to continue allocations,” a spokesperson for the state Department of Health and Human Services said this week.
One of the three, sotrovimab, is effective, but it is scarce. These patients receive priority consideration:
- People, regardless of vaccine status, with moderate to severe immunocompromise, including patients undergoing cancer treatment for tumors or blood, with untreated or advanced HIV, immunodeficiency syndromes or taking drugs that may suppress immune response; or those who have received organ or stem cell transplants.
- Those 75 years old and older who are not up to date on COVID-19 vaccines, meaning they are entirely unvaccinated or they are past due for booster shots months after their primary doses
- People 65 to 74 who are not up to date on their vaccines and have priority risk factors, including obesity, defined as a body-mass index at or greater than 35; chronic respiratory disease, such as chronic obstructive pulmonary disease, moderate or severe asthma requiring daily inhaled corticosteroid, or bronchiectasis, a condition characterized by damage to the lungs’ airways; chronic kidney disease; cardiovascular disease; or diabetes.
- Pregnant women who are not up-to-date on their vaccines.
When people in the above categories are treated in a timely manner, providers may consider:
- People 65 to 74 who are not up to date on vaccines; those younger than 65 who are both not up to date on vaccines and have above listed priority risk factors.
Remdesivir
IV remdesivir also can be used as a safe and effective treatment for COVID-19. It has been used in hospitals since it was authorized for emergency use in May 2020 and has since garnered full FDA approval. Recently, the National Institutes of Health added a three-day course of the drug, infused by vein, as an alternative treatment option for non-hospitalized, high-risk patients with mild to moderate COVID-19, according to the state health department.
With omicron dominant in the state and the shortage of Paxlovid and sotrovimab, this is off-label use is warranted, the state health department reported.
It is to be administered within seven days of symptoms and is available statewide at variable sites. Along with Molnupirvar, supply is greater. It is not federally allocated but ordered by the administering site.
The eligibility requirements are the same as with sotrovimab and are listed in order of highest tier to lowest:
- People, regardless of vaccine status, with moderate to severe immunocompromise, including patients undergoing cancer treatment for tumors or blood, with untreated or advanced HIV, immunodeficiency syndromes or taking drugs that may suppress immune response; or those who have received organ or stem cell transplants.
- Those 75 years old and older who are not up to date on COVID-19 vaccines, meaning they are entirely unvaccinated or they are past due for booster shots months after their primary doses
- People 65 to 74 who are not up to date on their vaccines and have priority risk factors, including obesity, defined as a body-mass index at or greater than 35; chronic respiratory disease, such as chronic obstructive pulmonary disease, moderate or severe asthma requiring daily inhaled corticosteroid, or bronchiectasis, a condition characterized by damage to the lungs’ airways; chronic kidney disease; cardiovascular disease; or diabetes.
- Pregnant women, with caution, who are not up to date on vaccines.
- People 65 to 74 who are not up to date on vaccines; those younger than 65 who are both not up to date on vaccines and have above listed priority risk factors.
COVID-19 vaccines
COVID-19 vaccines, easily accessible all across Michigan and the United States, remain the best option to prevent hospitalization and death, doctors say. There is plenty of vaccine supply and shots are administered at pharmacies, health departments, doctor’s offices and health centers.
“Our patients shouldn’t be counting on monoclonal antibodies,” Dr. Gordana Simeunovic, an infectious disease physician and head of Grand Rapids-based Spectrum Health’s mAbs program, said earlier this month.
“The only way to protect yourself and to protect everybody else is to get vaccinated.”
Protection afforded by vaccines is “infinitely better” than the protection afforded by monoclonal antibodies, Dr. David Gordon, an oncology physician at Munson Healthcare, based in Traverse City, said at a press conference this week. “They aren’t even in the same category.”
