When can you get a COVID pill? What to know about the two authorized by FDA
Two at-home pill treatments for COVID-19 have been authorized by the Food and Drug Administration for patients who test positive for the coronavirus. An antiviral pill treatment from Pfizer was authorized Dec. 22, and another from Merck was approved the following day.
Both treatments have been given emergency use authorization by the FDA during the spread of the highly transmissible omicron variant. The pill treatments do not prevent COVID-19 infection, according to the FDA, which encourages all in the U.S. to get a COVID-19 vaccine or booster as the best way to reduce chances of infection, hospitalization and death.
Bob Wachter, chair of the University of California San Francisco’s department of medicine, called the authorization of antiviral pills — especially Pfizer’s Paxlovid — a “true game-changer.”
Pfizer’s treatment, although available at first in smaller quantities, has been touted as the more effective course of treatment, and should be used when available over the Merck option, the FDA said.
President Biden said Pfizer’s treatment “will significantly reduce hospitalization and death as we battle the more transmissible omicron variant.”
When will these pills be available for patients?
They will be available by prescription only to those who have tested positive for coronavirus, according to the FDA.
President Joe Biden said in a statement that 10 million treatment courses for Pfizer’s Paxlovid had already been pre-purchased.
The treatment — of which 65,000 courses should arrive by “the end of December” — will be limited at first, but its roll-out will “ramp up” in coming months, the U.S. Department of Health and Human Services said.
The U.S. plans to have 200,000 more of those treatments available in January, and will distribute them to states on a proportional basis. Biden said the pills will also be targeted toward “our hardest-hit communities.”
For example, of the initial 65,000 Pfizer treatment courses, California will receive 6,180 treatments in the first week, while Kentucky will get 720.
Three million treatments of Merck’s molnupiravir — with use encouraged in instances when other FDA-approved treatments are unavailable — have been ordered by the U.S. government.
Merck said on Dec. 23 it plans to begin shipping out treatments within the coming days. An initial 300,000 treatments will be available in the U.S. by the end of December.
Like Pfizer’s treatment, the Merck drug will also be provided to states on a proportional basis. Week one will see California receive 28,920 treatments, for example, and Kentucky will get 3,300.
While current COVID-19 monoclonal antibody treatments don’t appear to be working against the omicron variant, early research suggests the pills from Pfizer and Merck may work against the omicron variant that has been sweeping across the world, because the pills do not target the part of the virus that has been shown to mutate the most.
Who gets which pill, and when?
Although the United States will have more quantities of Merck’s treatment early on, Pfizer’s Paxlovid is authorized to be used in more patients.
The FDA stresses that Merck’s pill should be used in cases when no other options, like Pfizer’s treatment, are available while Merck also said it should only be used when no other treatment options are “clinically appropriate.”
Pfizer’s treatment boasted a nearly 90% efficacy rate in preventing hospitalizations and deaths, while Merck’s saw about a 30% reduction in hospitalizations and deaths during clinical trials. These numbers came before the omicron variant.
But it will likely be up to doctors to determine who gets which treatment.
“It almost certainly will be a physician writing a prescription for someone who within the first three days of notable symptoms of COVID and is in a high-risk group to get it,” Anthony Fauci, Biden’s chief medical adviser, said Dec. 22. “ It is a — obviously, a very difficult situation when you have a limited supply.”
Paxlovid is available to adults and to those at least 12 years old who have been diagnosed with coronavirus. The FDA advises the pills be used as soon as the patient tests positive for COVID-19, and within five days of the start of symptoms. People who are at high risk for COVID-19 complications, hospitalizations and death are also encouraged to take the pills.
The treatment involves three tablets — two tablets of nirmatrelvir and one tablet of ritonavir — taken together twice a day for five days.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said.
Merck’s molnupiravir antiviral pill is only authorized for adults over the age of 18 who are at high risk of developing COVID-19 complications, and is to be used in much rarer cases, the FDA said.
However, Merck’s option “will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Cavazzoni said in a statement.
Four capsules of the Merck pill are instructed to be taken every 12 hours for five days.
The molnupiravir pill is not authorized for use in children because it may affect bone growth and cartilage.
Eric Topol, a cardiologist and founder of the Scripps Research Translational Institute, wrote that the new antiviral pills, especially Pfizer’s, came “just in time.”
“Paxlovid is a breakthrough, and I don’t use that term lightly. It not only provides a new layer of defense, but a unique one that is not dependent on our immune system and not affected by Omicron or other variants,” he said. “It is the first drug specifically designed for SARS-CoV-2, not a repurposed molecule, and its efficacy supports that specific effort.”
This story was originally published December 23, 2021 at 12:25 PM with the headline "When can you get a COVID pill? What to know about the two authorized by FDA."
