Live Updates: Paxlovid and Molnupiravir Availability Tracker for Healthcare Providers
Key takeaways:
The oral antiviral medications Paxlovid (nirmatrelvir and ritonavir) and molnupiravir were granted emergency use authorization in December 2021.
Both medications help treat mild to moderate COVID-19 in those at risk of more severe disease.
These medications are in short supply, and many states have their own protocols for determining patient eligibility.
The FDA recently granted emergency use authorization (EUA) to Paxlovid (nirmatrelvir and ritonavir) and molnupiravir, which are used to treat mild to moderate COVID-19 infection. However, these oral antiviral drugs are in short supply, and many states have their own protocols for determining patients’ eligibility for the medications.
Our tracker below monitors the supply of Paxlovid and molnupiravir across the U.S. using publicly available data from HealthData.gov. Search by location to get a sense of drug availability near you. Information is updated in real time as new numbers on quantity are released throughout each week.
Antiviral supply by area
Paxlovid overview
The oral antiviral medication Paxlovid (nirmatrelvir and ritonavir) is manufactured by Pfizer and was issued an EUA on December 22, 2021. Paxlovid combines two medications: 2 tablets of nirmatrelvir (150 mg) and 1 tablet of ritonavir (100 mg). The dose consists of all 3 tablets taken at the same time, twice a day, for 5 days.
Candidates for treatment with Paxlovid include patients age 12 and older who weigh at least 40 kg and have:
Mild to moderate COVID-19 infection
High risk of progression to severe COVID-19 infection
Increased risk of COVID-19 complications, including hospitalization or death
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Paxlovid should be started as soon as possible after a positive SARS-CoV-2 test, and ideally within the first 5 days of symptom onset. It is not authorized for pre- or post-exposure prophylaxis, and it is not indicated for those hospitalized due to severe COVID-19.
Paxlovid was studied in the Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) trial sponsored by Pfizer. The clinical trial ran from July 16, 2021, with a primary completion date of December 9, 2021. Data will continue to be evaluated through at least April 19, 2022.
The double-blind trial enrolled 2,246 participants randomized to receive Paxlovid or a placebo. Its primary outcome measure was to prevent hospitalization and death from COVID-19. Paxlovid was found to reduce hospitalization and death by 88% compared with the placebo.
Potential side effects of Paxlovid treatment include:
Diarrhea
High blood pressure
Altered sense of taste
Liver damage
Muscle aches
Paxlovid is an inhibitor of the CYP3A pathway, and is contraindicated with other medications that are also cleared through CYP3A. The FDA has published a fact sheet for healthcare providers that includes a complete list of drugs to avoid or evaluate if prescribing Paxlovid. Additionally, the Paxlovid dose must be reduced for patients with moderate renal impairment and avoided in severe renal and hepatic impairment.
Molnupiravir overview
Molnupiravir is an oral antiviral medication manufactured by Merck and Ridgeback Biotherapeutics. The drug was approved for EUA on December 23, 2021. Molnupiravir is administered in 4 capsules (200 mg) taken every 12 hours for 5 days.
Candidates for treatment with molnupiravir include people age 18 and older who have:
Mild to moderate COVID-19 infection
High risk of progression to severe COVID-19 infection
Increased risk of COVID-19 complications, including hospitalization or death
Molnupiravir should be started as soon as possible after a positive SARS-CoV-2 test, and ideally within the first 5 days of symptom onset. It is not authorized for pre- or post-exposure prophylaxis, and it is not indicated for those hospitalized because of severe COVID-19.
Molnupiravir was studied in the MOVe-OUT trial sponsored by Merck Sharp & Dohme. The clinical trial runs from October 19, 2020 through a primary estimated completion date of May 5, 2022.
The study enrolled 1,850 participants in a double-blind clinical trial. Participants were randomized to receive molnupiravir or a placebo.
In the preliminary results, study participants who received molnupiravir had a hospitalization or death rate of 6.8%, compared with 9.7% in the placebo group. Adverse events occurred in 30% of the recipients of molnupiravir and 33% of the placebo group.
Potential side effects of molnupiravir treatment include:
Diarrhea
Dizziness
Fetal harm in animal reproduction studies
Nausea
The FDA has published a fact sheet for healthcare providers that outlines specific prescribing information related to molnupiravir.
Addressing Paxlovid and molnupiravir shortages
Unfortunately, these new COVID-19 treatments are in short supply. Production and supply chain issues are impacting the availability of antiviral drugs. The U.S. has ordered a supply of Paxlovid to treat 20 million people, but the initial 10 million orders won’t be delivered until June 2022. Pfizer, the manufacturer of Paxlovid, is attempting to ramp up production.
While molnupiravir is easier to make and seems to have greater availability, its effectiveness is lower than Paxlovid. It also comes with a greater risk for birth defects. So federal guidelines currently list it as a last-choice option.
The U.S. Department of Health and Human Services (HHS) is overseeing the distribution of antiviral medications to the state and territorial health departments. Initial allocations were determined on a population basis. State and territorial health departments then allocate the medications to dispensing sites, which ship on to receiving sites such as:
Clinics
Healthcare provider offices
Hospitals
Local health departments
Pharmacies
Urgent care center
Supply of both drugs is expected to increase in the coming months, at which point additional medications will be made available.
HHS has prioritized a subset of Health Resources and Services Administration (HRSA)-funded health centers across the county to receive an allotment of medication during each distribution cycle. This effort is to ensure access to vulnerable communities and populations.
However, the recent surge of the Omicron variant has increased the demand for antiviral medications, and there are not enough to meet the demand. Critics of the current distribution method point out that population-based dispensing does not necessarily get medication to areas with surges.
When to treat
The National Institute for Health (NIH) released treatment guidelines to help healthcare providers (HCPs) determine the best treatment option. However, final treatment decisions are made by patients and HCPs and may depend on the availability of resources. Treatment guidelines continue to be evaluated and updated as new options like oral antiviral medications become available.
The CDC has also developed treatment guidelines and acknowledges that resource supply is a factor in prioritizing treatment options. Patient prioritization falls into these tiers:
Tier 1: This tier includes immunocompromised individuals and unvaccinated individuals with high risk of severe disease. It also includes persons ages 65 and up with additional risk factors.
Tier 2: This tier includes unvaccinated individuals with high risk for severe disease not included in Tier 1. It may include those under age 65 with risk factors.
Tier 3: This tier includes vaccinated individuals with high risk for severe disease. It includes persons ages 65 and up with additional risk factors.
Tier 4: This tier includes vaccinated individuals at risk of severe disease. And it includes those under age 65 who have risk factors. This tier also includes those who have not had a COVID-19 vaccine booster, yet are at higher risk.
Among the factors considered in determining risk are:
Age: Older persons are at higher risk than younger people.
Clinical factors: These include obesity, diabetes, and cardiovascular disease.
Immune status: The immunocompromised are at higher risk.
Vaccination status: The unvaccinated are at higher risk than the vaccinated.
Current treatment recommendations in order of preference for non-hospitalized patients at high risk of clinical progression include:
1) Oral Paxlovid
2) IV Sotrovimab
3) IV Remdesivir
4) Oral Molnupiravir
Clinicians must consider treatment availability, feasibility of administering a parenteral instead of an oral medication, and the potential for drug interactions when choosing a treatment option.
The bottom line
Paxlovid and molnupiravir are new weapons in our fight against COVID-19. However, manufacturing and supply chain issues will continue to impact their availability for several months. Use the guidance supplied by the NIH and CDC in determining treatment options in various patient groups.
While demand continues to exceed supply, prioritize the patients most at risk.
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