UNITED STATES NEWS

Rare cases of COVID returning pose questions for Pfizer pill

May 9, 2022, 11:20 AM

WASHINGTON (AP) — As more doctors prescribe Pfizer’s powerful COVID-19 pill, new questions are emerging about its performance, including why a small number of patients appear to relapse after taking the drug.

Paxlovid has become the go-to option against COVID-19 because of its at-home convenience and impressive results in heading off severe disease. The U.S. government has spent more than $10 billion to purchase enough pills to treat 20 million people.

But experts say there is still much to be learned about the drug, which was authorized in December for adults at high risk of severe COVID-19 based on a study in which 1,000 adults received the medication.

WHY DO SOME PATIENTS SEEM TO RELAPSE?

Doctors have started reporting rare cases of patients whose symptoms return several days after completing Paxlovid’s five-day regimen of pills. That’s prompted questions about whether those patients are still contagious and should receive a second course of Paxlovid.

Last week, the Food and Drug Administration weighed in. It advised against a second round because there’s little risk of severe disease or hospitalization among patients who relapse.

Dr. Michael Charness reported last month on a 71-year-old vaccinated patient who saw his symptoms subside but then return, along with a spike in virus levels nine days into his illness.

Charness says Paxlovid remains a highly effective drug, but he wonders if it might be less potent against the current omicron variant. The $500 drug treatment was tested and OK’d based on its performance against the delta version of the coronavirus.

“The ability to clear the virus after it’s suppressed may be different from omicron to delta, especially for vaccinated people,” said Charness, who works for Boston’s VA health system.

Could some people just be susceptible to a relapse? Both the FDA and Pfizer point out that 1% to 2% of people in Pfizer’s original study saw their virus levels rebound after 10 days. The rate was about the same among people taking the drug or dummy pills, “so it is unclear at this point that this is related to drug treatment,” the FDA stated.

Some experts point to another possibility: The Paxlovid dose isn’t strong enough to fully suppress the virus. Andy Pekosz of Johns Hopkins University worries that could spur mutations that are resistant to the drug.

“We should really make sure we’re dosing Paxlovid appropriately because I would hate to lose it right now,” said Pekosz, a virologist. “This is one of the essential tools we have to help us turn the corner on the pandemic.”

HOW WELL DOES PAXLOVID WORK IN VACCINATED PEOPLE?

Pfizer tested Paxlovid in the highest-risk patients: unvaccinated adults with no prior COVID-19 infection and other health problems, such as heart disease and diabetes. The drug reduced their risk of hospitalization and death from 7% to 1%.

But that doesn’t reflect the vast majority of Americans today, where 89% of adults have had at least one shot. And roughly 60% of Americans have been infected with the virus at some point.

“That’s the population I care about in 2022 because that’s who we’re seeing — vaccinated people with COVID — so do they benefit?” asked Dr. David Boulware, a University of Minnesota researcher and physician.

There’s no clear answer yet for vaccinated Americans, who already have a hospitalization rate far below 1%.

That may come from a large, ongoing Pfizer study that includes high-risk vaccinated people. No results have been published; the study is expected to wrap up in the fall.

Pfizer said last year that initial results showed Paxlovid failed to meet the study’s goals of significantly resolving symptoms and reducing hospitalizations. It recently stopped enrolling anyone who’s received a vaccination or booster in the past year, a change Boulware says suggests those patients aren’t benefitting.

At a minimum, the preliminary data should be released to federal officials, Boulware said. “If the U.S. government is spending billions of dollars on this medicine, what’s the obligation to release that data so that they can formulate a good policy?”

CAN PAXLOVID BE USED TO HELP PREVENT COVID-19 INFECTION?

Pfizer recently reported that proactively giving Paxlovid to family members of people infected with COVID-19 didn’t significantly reduce their chances of catching it. But that’s not the end of the story. Pfizer is studying several other potential benefits of early use, including whether Paxlovid reduces the length and severity of COVID-19 among households.

“It’s a high bar to protect against infection but I’d love to see data on how Paxlovid did against severe disease because it may be more effective there,” said Pekosz.

___

Follow Matthew Perrone on Twitter: @AP_FDAwriter

___

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.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

United States News

Associated Press

Video shows California deputy slamming 16-year-old girl to the ground outside football game

VICTORVILLE, Calif. (AP) — A viral video shows a Southern California sheriff’s deputy slamming a teenage girl to the ground during a fight outside a Friday night high school football game, a use of force her mother says sent the 16-year-old to the hospital with injuries to her head and spine. The altercation prompted a […]

12 minutes ago

Associated Press

Canadian auto workers to target General Motors after deal with Ford is ratified

DETROIT (AP) — Canadian auto workers say General Motors will be their next target after members ratified a new three-year labor contract with Ford. Unifor, which represents about 4,300 workers at three GM facilities in Canada, said Monday it reached a strong deal with Ford and now will try to negotiate a pattern agreement with […]

22 minutes ago

Associated Press

Firefighter’s 3-year-old son struck and killed as memorial walk for slain firefighters was to begin

WILMINGTON, Del. (AP) — The 3-year-old son of a firefighter was struck and killed in Delaware over the weekend shortly before a memorial walk was to begin to honor three firefighters killed in an a blaze seven years ago, authorities said. The Wilmington fire chief’s office said a group of off-duty Wilmington firefighters, family members […]

48 minutes ago

Associated Press

Editorial Roundup: United States

Excerpts from recent editorials in the United States and abroad: Sept. 23 The Washington Post on the U.S. feeding children in 2023 The children’s names rarely make the news. They are the millions of kids in Somalia, Libya, Mali, Haiti, Afghanistan, Yemen and other poor nations who don’t have enough to eat. They were born […]

49 minutes ago

Associated Press

US military captures key Islamic State militant during helicopter raid in Syria

WASHINGTON (AP) — The U.S. military said Monday it had captured an operator for the Islamic State extremist group during a helicopter raid in northern Syria. The operator, Abu Halil al-Fad’ani, “was assessed to have relationships throughout the ISIS network in the region,” U.S. Central Command said in a statement. His capture on Saturday increases […]

1 hour ago

Associated Press

Manslaughter charges thrown out in Michigan prisoner’s death

MUNISING, Mich. (AP) — A judge dismissed charges Monday against six people in the death of a Michigan prisoner who lost 50 pounds over two weeks and died of dehydration while being restrained in 2019. There was evidence of a lack of proper care for Jonathan Lancaster but not enough to send two former prison […]

1 hour ago

Sponsored Articles

Sanderson Ford...

Sanderson Ford

Sanderson Ford congratulates D-backs’ on drive to great first half of 2023

The Arizona Diamondbacks just completed a red-hot first half of the major league season, and Sanderson Ford wants to send its congratulations to the ballclub.

...

re:vitalize

When most diets fail, re:vitalize makes a difference that shows

Staying healthy and losing weight are things many people in Arizona are conscious of, especially during the summer.

...

Ability360

At Ability360, every day is Independence Day

With 100 different programs and services, more than 1,500 non-medically based home care staff, a world-renowned Sports & Fitness Center and over 15,000 people with disabilities served annually, across all ages and demographics, Ability360 is a nationwide leader in the disability community.

Rare cases of COVID returning pose questions for Pfizer pill