WASHINGTON D.C. — Health regulators have officially authorized the first pill against COVID-19 that Americans can take at home.
The milestone comes as cases, hospitalizations and deaths are rising at rapid speeds, with the omicron variant also spreading rapidly.
The drug Paxlovid, created by Pfizer, will have limited supplies initially, but is expected to be a faster and cheaper way to treat early COVID-19 infections.
A pill from Merck is also expected to be authorized soon, but Pfizer’s pill has mild side effects and includes a 90 percent reduction in hospitalizations and deaths among patients.
“The efficacy is high, the side effects are low and it’s oral,” Mayo Clinic’s Dr. Gregory Poland said. “It checks all the boxes. You’re looking at a 90 percent decreased risk of hospitalization and death in a high-risk group, that’s stunning.”
The FDA authorized the drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risk of hospitalization. This includes older people and those with conditions like obesity and heart disease. Eligible children must weigh at least 88 pounds.
The pill is expected to be effective against the omicron variant because it doesn’t target the spike protein where most of the variant’s worrisome mutations are.
Pfizer has approximately 180,000 treatment courses available globally, with between 60,000 and 70,000 allocated to the U.S. The early shipments are expected to be rationed to the hardest hit areas of the country, but manufacturing time is currently taking about nine months.
The U.S. agreed to purchase enough Paxlovid to treat 10 million people and Pfizer said it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other countries.
We all know how to protect ourselves against COVID-19 as we enter our third calendar year of dealing with this virus. We have incredible tools in the form of life-saving vaccines and new pills. Take action to keep yourself safe. – Governor Gretchen Whitmer
The U.S. is now reporting more than 140,000 new cases daily and health experts expect the omicron variant to send cases soaring as it has already become the dominant strain.
Patients will need to have a positive COVID-19 test in order to get a prescription for the drug and it has only proven effective if given within five days of symptoms appearing, so experts worry that it may be unrealistic for patients to self-diagnose, get tested, see a physician and pick up a prescription in such a narrow time frame.
The FDA decision was based on results from a 2,250-patient trial that showed the drug cut hospitalizations and deaths by 89 percent when given to people with mild-to-moderate cases within three days of experiencing symptoms. Less than 1 percent of patients taking the pill were hospitalized and none died at the end of the 30-day study.
The drug is part of a decades-old family of antiviral drugs known as protease inhibitors that block a key enzyme viruses need to multiply in the body. This same type of drug has been used in treatments of HIV and Hepatitis C.
The U.S. will pay approximately $500 for each course of the treatment, which consists of three pills taken twice a day for five days. Two of the pills are Paxlovid and the third is a different antiviral that helps boost levels of the main drug in the body.
Governor Whitmer said that this is a “powerful new tool in our arsenal.”
“With it, we will be able to help high-risk Michiganders who test positive for COVID-19 recover effectively at home without requiring hospitalization, alleviating the burden on our hospitals and health care workers,” she said. “Michigan also welcomes the federal emergency response team headed our way that will backstop our health care system to ensure hospitals remain operational. In January, the federal government will also set up a website where you can request free, at-home rapid tests to be mailed to you.”
Whitmer also said that getting vaccinated is the best option to protect against the virus.
“There are steps every Michigander can take to protect themselves,” she said. “First, get vaccinated and if you are eligible, get your booster. Early data indicates that booster offers greater protection against the Omicron variant and will help keep you out of the hospital. If you plan on traveling for the holidays or attending an indoor gathering, please get tested beforehand and stay home if you’re sick. If you test positive, especially if you are in a high-risk group, contact a medical professional and find out if the new Pfizer pill is right for you, or if you qualify for monoclonal antibody treatments. We are facing a difficult surge, but I know we can get through it if we all do our part. We all know how to protect ourselves against COVID-19 as we enter our third calendar year of dealing with this virus. We have incredible tools in the form of life-saving vaccines and new pills. Take action to keep yourself safe.”