On the Site:

CORONAVIRUS

Pfizer says COVID-19 pill cut hospital, death risk by 90%

Nov 5, 2021, 5:23 AM | Updated: 5:36 am

FILE PHOTO (Photo by Dan Kitwood - WPA Pool/Getty Images)...

FILE PHOTO (Photo by Dan Kitwood - WPA Pool/Getty Images)

(Photo by Dan Kitwood - WPA Pool/Getty Images)

WASHINGTON (AP) — 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 joins the race to bring the first easy-to-use medication against the coronavirus to the U.S. market.

Currently all COVID-19 treatments used in the U.S. 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 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.

Researchers worldwide have been racing to find a pill against COVID-19 that can be taken at home to ease symptoms, speed recovery and reduce the crushing burden on hospitals and doctors.

Pfizer released preliminary results Friday of its study of 775 adults. Patients taking the company’s drug along with another antiviral 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, 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.

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 warn against comparing preliminary results because of differences in studies.

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.

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, which has not yet been named, 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.

Shares of Pfizer spiked more than 9% before the opening bell Friday.

___

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.

KSL 5 TV Live

Coronavirus

FILE - The Supreme Court is seen on Capitol Hill in Washington, March 4, 2024. (AP Photo/J. Scott A...

Associated Press

Supreme Court rejects COVID-19 vaccine appeals from nonprofit founded by Robert F. Kennedy Jr.

The Supreme Court has rejected two appeals related to COVID-19 vaccines from Children’s Health Defense, the anti-vaccine nonprofit founded by independent presidential candidate Robert F. Kennedy Jr.

23 days ago

FILE - Comirnaty, a new Pfizer/BioNTech vaccination booster for COVID-19, is displayed at a pharmac...

Jen Christensen, CNN

The FDA tells COVID-19 vaccine makers to update shot to target newest variant

The US Food and Drug Administration announced Friday that it had advised the makers of the Covid-19 vaccines to formulate their new shots to be a better match for the JN.1 lineage of the coronavirus.

1 month ago

(FILE) A test dummy getting hit by an air bag during a crash test....

Matt Gephardt and Sloan Schrage, KSL TV

Thousands of cars equipped with faulty airbags on Utah roads as automakers issues ‘Do Not Drive’ warnings

Auto manufacturers have recalled over millions of Takata airbags because of their potential to explode and shoot out sharp metal fragments. And there are still thousands of those in cars across Utah.

1 month ago

WASHINGTON, DC - JUNE 03: Dr. Anthony Fauci, former Director of the National Institute of Allergy a...

Lauran Neergaard, AP Medical Writer

Fauci testifies publicly before House panel on COVID origins, controversies

Dr. Anthony Fauci is facing heated questioning from Republican lawmakers about the origins of the COVID-19 pandemic.

1 month ago

A sign reminding Copper Hills High School students and staff to keep their hands clean during the c...

Lindsay Aerts

Utah school districts working to prioritize what stays when COVID relief money runs dry

Utah's school districts are working to figure out how they will continue to pay for programs propped up by COVID-19 relief funds.

2 months ago

FILE: Former Utah Jazz John Stockton reacts during a 76-70 Wichita State win over the Gonzaga Bulld...

Michael Houck

Former Utah Jazz star John Stockton sues Washington medical director about COVID misinformation policy

Former Utah Jazz superstar John Stockton has filed a federal lawsuit against Washington officials on First Amendment violations, arguing the state's policy of COVID-19 misinformation is unconstitutional.

4 months ago

Sponsored Articles

young male technician is repairing a printer at office...

Les Olson

Unraveling the dilemma between leasing and buying office technology

Carefully weigh these pros and cons to make an informed decision that best suits your business growth and day-to-day operation. 

A kitchen in a modern farmhouse....

Lighting Design

A room-by-room lighting guide for your home

Bookmark this room-by-room lighting guide whenever you decide to upgrade your lighting or style a new home.

Photo courtesy of Artists of Ballet West...

Ballet West

The rising demand for ballet tickets: why they’re harder to get

Ballet West’s box office is experiencing demand they’ve never seen before, leaving many interested patrons unable to secure tickets they want.

Electrician repairing ceiling fan with lamps indoors...

Lighting Design

Stay cool this summer with ceiling fans

When used correctly, ceiling fans help circulate cool and warm air. They can also help you save on utilities.

Side view at diverse group of children sitting in row at school classroom and using laptops...

PC Laptops

5 internet safety tips for kids

Read these tips about internet safety for kids so that your children can use this tool for learning and discovery in positive ways.

Women hold card for scanning key card to access Photocopier Security system concept...

Les Olson

Why printer security should be top of mind for your business

Connected printers have vulnerable endpoints that are an easy target for cyber thieves. Protect your business with these tips.

Pfizer says COVID-19 pill cut hospital, death risk by 90%