The Food and Drug Administration on Wednesday authorized emergency use of a Pfizer pill that staved off hospitalization and death from COVID-19 in clinical trials, adding a major tool to America’s effort against the virus.
Federal officials said the pill, known as Paxlovid, will be a vital tool in treating people who test positive, develop symptoms and are at higher risk of a bad outcome, though they warned that quantity might be limited due to the complex chemistry involved in making the pills.
President Biden said he ordered 10 million courses that will be available through the first half of the year, including a quarter-million treatments by January.
“With today’s action, we add the first-ever oral treatment to our nation’s medicine cabinet and take a significant step forward in our path out of the pandemic,” Mr. Biden said.
“Recognizing that this pill takes time to make given the complex scientific process, production will ramp up in the months ahead. We will have over 250,000 treatment courses available to us in January and we will be working with states to ensure those are being distributed equitably and fairly and that our hardest-hit communities are reached,” he said.
The Pfizer drug reduced the risk of hospitalization or death by 89% compared to a placebo group in a clinical study involving over 2,200 participants.
Other treatments, including monoclonal antibodies, are effective but often require infusions and are harder to administer than a course of pills. Some of the monoclonals also aren’t effective against the omicron variant.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
Paxlovid is authorized for emergency use in adults, particularly those who are at high risk of a bad outcome from COVID-19, and children who are at least 12 years old and weigh at least 88 pounds.
The FDA authorized the drug as the world grapples with an omicron-fueled surge in the virus. High-profile politicians are testing positive, even if they are vaccinated and boosted, and the surge is producing long lines at testing centers, where Americans hope to screen themselves before Christmas gatherings.
“Due to omicron we expect a significant rise in cases,” said White House COVID-19 Coordinator Jeffrey Zients.
While “we will see fully vaccinated people get COVID,” he added, “they’ll likely be asymptomatic or feel under the weather for a few days.”
The Pfizer drug will be given by prescription only and should be initiated as soon as possible after a diagnosis of COVID-19, within five days of symptom onset.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said people should “stay tuned” for federal guidance on how patients should be prioritized, given the limited supply of the pills.
The administration also preordered 3 million courses of a Merck pill that is pending authorization but did not perform as well as Pfizer’s in clinical trials.
White House press secretary Jen Psaki tempered expectations about the supply of oral antivirals, saying they are hard to manufacture.
“We of course want to ensure that we are bringing to market and making available as many as we can. But that is a reality in the production of these, as well, that we want people to be aware of,” she said of the production complexity.
Likewise, experts toggled between hailing the authorization as a pivotal moment while warning that supply will be a thorny issue.
“Paxlovid just cleared by FDA! Will be available in days. Just not enough of it to go around and that needs to be fixed ASAP,” tweeted Eric Topol, a professor of molecular medicine and executive vice president at Scripps Research.
Paxlovid consists of nirmatrelvir, which helps to stop the virus from replicating, and ritonavir, which helps to keep the nirmatrelvir in the body for a longer period at higher concentrations.
It is given as three tablets — two tablets of nirmatrelvir and one tablet of ritonavir — taken together orally twice daily for five days, or a total of 30 tablets.
Pfizer said it is working with over 100 countries and projects it can produce 80 million to 120 million courses of treatment by the end of 2022.
“Everyone agrees this is a very promising antiviral and therefore we want to make sure that production is ramped up as quickly as possible,” Mr. Zients said. “Now the pill is authorized, we will have a discussion to explore how we can help them improve their manufacturing capacity even further.”
Mr. Zients said two of the three monoclonal antibody treatments being used in the U.S. are not effective against omicron. However, GlaxoSmithKline’s version is effective and the administration is moving to double its supply. It ordered 1 million new courses, including 300,000 that will be available in January.
Mr. Zients also highlighted an AstraZeneca treatment that protected immunocompromised people who don’t benefit from a vaccine alone. The U.S. will have 500,000 courses of it on hand in January.
For more information, visit The Washington Times COVID-19 resource page.
• Tom Howell Jr. can be reached at thowell@washingtontimes.com.
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