The FDA this week granted emergency use authorization to two separate at-home COVID treatments.
The two treatments share some similarities.
- Both are a series of pills a COVID-positive individual can take at home over a series of five days.
- The Pfizer and Merck medications are also both only available via prescription — they are not over-the-counter drugs.
- Each is specifically authorized to treat patients with mild-to-moderate COVID, who are at higher risk of experiencing severe complications (such as hospitalization or death).
- Neither are to be taken before getting COVID, nor are they authorized to treat patients already experiencing severe symptoms.
- Both should be taken "as soon as possible," the FDA says, after someone is diagnosed with COVID-19, and within five days of symptoms starting.
- Pfizer and Merck have both said data suggest their COVID pill regimen will be effective against the omicron variant.
The FDA has stressed these are not a substitute for getting vaccinated, if you are eligible for the vaccines and booster shot.
A Paxlovid treatment totals 30 pills: two tablets of nirmatrelvir and one tablet of ritonavir, taken together twice a day for five days. The molnupiravir series is four capsules taken every 12 hours, totaling 40 pills.
While Paxlovid is authorized for use in anyone 12 and up who weighs at least 88 pounds, molnupiravir is only authorized for adults at this stage. The FDA says Merck's drug "may affect bone and cartilage growth" in younger patients.
A lifeline for stressed hospitals?
The development and approval of at-home COVID treatments, such as Paxlovid and molnupiravir, could help ease a strained health care system.
Many hospitals have been operating near breaking point in recent months, while bracing for a dire situation to become worse due to the omicron variant. Health care officials are expressing optimism about the pills' ability to keep people out of the hospital — meaning these overstressed resources won't face higher demand.
Dr. Priya Sampathkumar, a Mayo Clinic infectious diseases specialist, called the pill "an important addition to our COVID-19 mitigation toolkit." She continued: "This oral pill means easier access for patients and less burden on the health care system. And unlike monoclonal antibodies, it should retain efficacy against variants."
Said Albert Shaw, MD, PhD, a Yale Medicine infectious diseases specialist, of Merck's drug: “It certainly has the potential to be a really important advance. Other COVID-19 treatments, such as remdesivir or monoclonal antibodies against the SARS-CoV-2 virus causing COVID-19, are given intravenously. This is a pill your physician could write a prescription for, that you could pick up in a drugstore.”
But supply chain issues could hamper things initially.
Paxlovid won't be widely available for a while. Dr. Anthony Fauci on Wednesday said the manufacturing process is "complicated and complex," meaning it takes a long time to produce the pills.
While the U.S. has ordered 10 million treatment courses, officials expect to have just 265,000 between now and the end of January.