Please ensure Javascript is enabled for purposes of website accessibility
Pfizer Says COVID-19 Pill Cut Hospital, Death Risk by 90%
gvw_ap_news
By Associated Press
Published 3 years ago on
November 5, 2021

Share

WASHINGTON — Pfizer Inc. said Friday that its experimental antiviral pill for COVID-19 cut rates of hospitalization and death by nearly 90% in high-risk adults, as the drugmaker joined the race for an easy-to-use medication to treat the coronavirus.

Currently most COVID-19 treatments require an IV or injection. Competitor Merck’s COVID-19 pill is already under review at the Food and Drug Administration after showing strong initial results, and on Thursday the United Kingdom became the first country to OK it.

Pfizer Seeking Regulatory Approval

Pfizer said it will ask the FDA and international regulators to authorize its pill as soon as possible, after independent experts recommended halting the company’s study based on the strength of its results. Once Pfizer applies, the FDA could make a decision within weeks or months.

Since the beginning of the pandemic last year, researchers worldwide have been racing to find a pill to treat COVID-19 that can be taken at home to ease symptoms, speed recovery and keep people out of the hospital.

Having pills to treat early COVID-19 “would be a very important advance,” said Dr. John Mellors, chief of infectious diseases at the University of Pittsburgh, who was not involved in the Pfizer study.

“If someone developed symptoms and tested positive we could call in a prescription to the local pharmacy as we do for many, many infectious diseases,” he said.

On Friday, Pfizer released preliminary results of its study of 775 adults. Patients who received the company’s drug along with another antiviral shortly after showing COVID-19 symptoms had an 89% reduction in their combined rate of hospitalization or death after a month, compared to patients taking a dummy pill. Fewer than 1% of patients taking the drug needed to be hospitalized and no one died. In the comparison group, 7% were hospitalized and there were seven deaths.

“We were hoping that we had something extraordinary, but it’s rare that you see great drugs come through with almost 90% efficacy and 100% protection for death,” said Dr. Mikael Dolsten, Pfizer’s chief scientific officer, in an interview.

Study Participants Were Unvaccinated

Study participants were unvaccinated, with mild-to-moderate COVID-19, and were considered high risk for hospitalization due to health problems like obesity, diabetes or heart disease. Treatment began within three to five days of initial symptoms, and lasted for five days. Patients who received the drug earlier showed slightly better results, underscoring the need for speedy testing and treatment.

Pfizer reported few details on side effects but said rates of problems were similar between the groups at about 20%.

An independent group of medical experts monitoring the trial recommended stopping it early, standard procedure when interim results show such a clear benefit. The data have not yet been published for outside review, the normal process for vetting new medical research.

Top U.S. health officials continue to stress that vaccination will remain the best way to protect against infection. But with tens of millions of adults still unvaccinated — and many more globally — effective, easy-to-use treatments will be critical to curbing future waves of infections.

The FDA has set a public meeting later this month to review Merck’s pill, known as molnupiravir. The company reported in September that its drug cut rates of hospitalization and death by 50%. Experts warned against comparing preliminary results because of differences in the studies, including where they were conducted and what types of variants were circulating.

“It’s too early to say who won the hundred meter dash,” Mellors said. “There’s a big difference between 50% and 90% but we need to make sure the populations were comparable.”

Although Merck’s pill is further along in the U.S. regulatory process, Pfizer’s drug could benefit from a safety profile that is more familiar to regulators with fewer red flags. While pregnant women were excluded from the Merck trial due to a potential risk of birth defects, Pfizer’s drug did not have any similar restrictions. The Merck drug works by interfering with the coronavirus’ genetic code, a novel approach to disrupting the virus.

Similar Drug Used to Treat HIV and Hepatitis C

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 which viruses need to multiply in the human body.

The drug was first identified during the SARS outbreak originating in Asia during 2003. Last year, company researchers decided to revive the medication and study it for COVID-19, given the similarities between the two coronaviruses.

The U.S. has approved one other antiviral drug for COVID-19, remdesivir, and authorized three antibody therapies that help the immune system fight the virus. But they have to be given by IV or injection at hospitals or clinics, and limited supplies were strained by the last surge of the delta variant.

RELATED TOPICS:

DON'T MISS

Wine Judging Explained: How Taste Buds and Palates Evolve

DON'T MISS

Clovis Unified Bond Measure Would Modernize 67-Year-Old School, Complete Brand-New Campus

DON'T MISS

Costa: It’s Time for Biden ‘to Pass the Torch’ and Drop Out of Race

DON'T MISS

How Do Former CEOs’ Guilty Pleas Impact Lawsuit Filed by Bitwise Employees?

DON'T MISS

People Close to Biden Say He Appears to Accept He May Have to Leave the Race

DON'T MISS

Founder of Fandango Dies After Plunge From Manhattan Hotel

DON'T MISS

New Study Shows Promise and Caution for Magic Mushrooms

DON'T MISS

Why Does Venezuela’s President Appear on the Ballot 13 Times?

DON'T MISS

JD Vance’s Public Venmo Reveals Ties to Elites, Project 2025

DON'T MISS

A Daily Pill to Prevent STIs? It May Work, Scientists Say

UP NEXT

California Sent a Mentally Ill Man to a State Hospital. Then It Charged Him $760,000

UP NEXT

US Army Honors Nisei Combat Unit That Helped Liberate Tuscany From Nazi-Fascist Forces in WWII

UP NEXT

US Journalist Masha Gessen Is Convicted in Absentia in Russia for Criticizing the Military

UP NEXT

A Trump Ally Is Training 75 Armed Citizens. Is That a Militia?

UP NEXT

You Might Have West Nile Virus in Fresno County and Not Know It

UP NEXT

Madera Health Clinic Takes Over Urgent Care for Saint Agnes

UP NEXT

The Plague Rarely Affects Humans, Though the US Sees About 7 Cases a Year. Here’s Why

UP NEXT

House Passes GOP Bill Requiring Proof of Citizenship to Vote, Boosting Election-Year Talking Point

UP NEXT

FDA Approves Second Drug to Modestly Slow Alzheimer’s Disease

UP NEXT

Air Pollution Costs Valley Residents Millions in’Preventable’ Medical Costs: Study

How Do Former CEOs’ Guilty Pleas Impact Lawsuit Filed by Bitwise Employees?

11 hours ago

People Close to Biden Say He Appears to Accept He May Have to Leave the Race

11 hours ago

Founder of Fandango Dies After Plunge From Manhattan Hotel

12 hours ago

New Study Shows Promise and Caution for Magic Mushrooms

12 hours ago

Why Does Venezuela’s President Appear on the Ballot 13 Times?

13 hours ago

JD Vance’s Public Venmo Reveals Ties to Elites, Project 2025

13 hours ago

A Daily Pill to Prevent STIs? It May Work, Scientists Say

13 hours ago

America’s Allies in Middle East See Some Advantages in Potential 2nd Trump Presidency

13 hours ago

Comedian Bob Newhart, Deadpan Master of Sitcoms and Telephone Monologues, Dies at 94

13 hours ago

CA Mom Pleads Guilty to Masterminding $8 Million Makeup Theft Ring From Her Mansion

14 hours ago

Wine Judging Explained: How Taste Buds and Palates Evolve

Have you ever wondered how the wine judges score wine? Tony Kirk, owner of Birdstone Winery, explains the process on how wine is judged. Rel...

8 hours ago

8 hours ago

Wine Judging Explained: How Taste Buds and Palates Evolve

8 hours ago

Clovis Unified Bond Measure Would Modernize 67-Year-Old School, Complete Brand-New Campus

10 hours ago

Costa: It’s Time for Biden ‘to Pass the Torch’ and Drop Out of Race

11 hours ago

How Do Former CEOs’ Guilty Pleas Impact Lawsuit Filed by Bitwise Employees?

11 hours ago

People Close to Biden Say He Appears to Accept He May Have to Leave the Race

12 hours ago

Founder of Fandango Dies After Plunge From Manhattan Hotel

12 hours ago

New Study Shows Promise and Caution for Magic Mushrooms

13 hours ago

Why Does Venezuela’s President Appear on the Ballot 13 Times?

MENU

CONNECT WITH US

Search

Send this to a friend