HEALTH

Pfizer pill becomes 1st US-authorized home COVID treatment

Dec 22, 2021, 11:45 AM
new COVID pills...
Two new antiviral pills have been authorized for treatment of COVID-19. This image provided by Pfizer in October 2021 shows the company's COVID-19 Paxlovid pills. U.S. health regulators on Wednesday, Dec. 22, 2021 authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus. Photo: Pfizer via AP

WASHINGTON (AP) — U.S. health regulators on Wednesday authorized the first pill against COVID-19, a Pfizer drug that Americans will be able to take at home to head off the worst effects of the virus.

The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals.

The drug, Paxlovid, is a faster, cheaper way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.

An antiviral pill from Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”

The Food and Drug Administration authorized Pfizer’s drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. That includes older people and those with conditions like obesity and heart disease. Children eligible for the drug must weigh at least 88 pounds (40 kilograms).

The pills from both Pfizer and Merck are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.

Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the U.S. Federal health officials are expected to ration early shipments to the hardest hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year.

The U.S. government has agreed to purchase enough Paxlovid to treat 10 million people. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia, and other nations.

Health experts agree that vaccination remains the best way to protect against COVID-19. But with roughly 40 million American adults still unvaccinated, effective drugs will be critical to blunting the current and future waves of infection.

The U.S. is now reporting more than 140,000 new infections daily and federal officials warn that the omicron variant could send case counts soaring. Omicron has already whipped across the country to become the dominant strain, federal officials confirmed earlier this week.
Against that backdrop, experts warn that Paxlovid’s initial impact could be limited.

For more than a year, biotech-engineered antibody drugs have been the go-to treatments for COVID-19. But they are expensive, hard to produce and require an injection or infusion, typically given at a hospital or clinic. Also, laboratory testing suggests the two leading antibody drugs used in the U.S. aren’t effective against omicron.

Pfizer’s pill comes with its own challenges.

Patients will need a positive COVID-19 test to get a prescription. And Paxlovid has only proven effective if given within five days of symptoms appearing. With testing supplies stretched, experts worry it may be unrealistic for patients to self-diagnose, get tested, see a physician and pick up a prescription within that narrow window.
“If you go outside that window of time I fully expect the effectiveness of this drug is going to fall,” said Andrew Pekosz, a Johns Hopkins University virologist.

The FDA based its decision on company results from a 2,250-patient trial that showed the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate COVID-19 within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the group getting a dummy pill, which included nine deaths.

Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme that viruses need to multiply in the human body.

The U.S. will pay about $500 for each course of Pfizer’s 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.
___
Associated Press writer Tom Murphy contributed to this report. The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

Health

Dogs and cats cannot get the avian flu...
Aimee Cobabe

Avian flu in Utah causes worry in pet owners

A Utah veterinarian explained there is no reason to worry about your cats or dogs getting the avian flu. He encouraged pet vaccinations.
2 months ago
FILE: A Boeing 737-932ER operated by Delta Airlines takes off from JFK Airport on August 24, 2019 i...
Pete Muntean, CNN

Three US airlines extend olive branch to passengers banned for mask violations

The move comes after two dizzying days of rulings and countermoves on the federal mask mandate for public transportation.
2 months ago
Mask mandate...
MICHAEL BALSAMO and ZEKE MILLER Associated Press

Justice Dept. to appeal order voiding travel mask mandate

WASHINGTON (AP) — The Justice Department is filing an appeal seeking to overturn a judge’s order that voided the federal mask mandate on planes and trains and in travel hubs, officials said Wednesday. The notice came minutes after the Centers for Disease Control and Prevention asked the Justice Department to appeal the decision handed down […]
2 months ago
Utah national parks no longer have a mask mandate...
Chandler Holt

Masks no longer required in national parks

Since a federal judge struck down the CDC's transportation mask mandate, guests in national parks can choose if they'd like to wear a mask or not.
2 months ago
New eligibility rules for pandemic-EBT program...
Waverly Golden

New eligibility guidelines for Pandemic-EBT

Utah households will have to apply for free or reduced-price meal benefits with their local school by May 6 to possibly receive Pandemic-EBT.
2 months ago
Intermountain Healthcare facilities upgrade landscaping...
Waverly Golden

Intermountain Healthcare landscaping gets a new look

Landscaping at Intermountain Healthcare facilities is getting a new look to help save water as Utah still experiences a bad drought.
2 months ago

Sponsored Articles

Prescription opioid...
Know Your Script

Prescription opioid misuse | How to protect your family from the opioid epidemic

Studies have shown that prescription opioid misuse has increased since COVID-19. So what do you need to know about these opioids?
...

Tax Tuesday: The Most Common Mistakes People Make When Filing Their Taxes

Fortunately, for most average earners, they will not end up owing overpayments received for the Child Tax Credit in 2021.
...

Tax Tuesday: How will last year’s child tax credits affect you?

Fortunately, for most average earners, they will not end up owing overpayments received for the Child Tax Credit in 2021.
...

Tax Tuesday: Key Information Before the Filing Deadline

Businesses can receive a credit of up to $5,000 per employee in 2020 and up to $21,000 per employee in 2021.
national heart month...
Intermountain Healthcare

National Heart Month: 5 Lifestyle Changes to Make Today to Keep You Heart Healthy

Heart disease is the leading cause of death for both men and women. One person dies every 36 seconds in the United States from cardiovascular disease
Joseph Smith Memorial Building...
Temple Square

The Joseph Smith Memorial Building is an icon of Salt Lake City | Why hosting an event at this beautiful location will make you a hero this year

Here's why hosting an event at the iconic Joseph Smith Memorial Building in downtown Salt Lake City will make you a hero this year.
Pfizer pill becomes 1st US-authorized home COVID treatment