DEVELOPING Person on fire outside Trump's hush money trial rushed away on a stretcher
A person who was on fire in a park outside the New York courthouse where Donald Trump’s hush money trial is taking place has been rushed away on a stretcher.
Pfizer's COVID-19 pill Paxlovid won another vote of confidence from U.S. health advisers Thursday, clearing the way for its full regulatory approval by the Food and Drug Administration.
The medication has been used by millions of Americans since the FDA granted it emergency use authorization in late 2021. The agency has the final say on giving Pfizer's drug full approval and is expected to decide by May.
A panel of outside experts voted 16-1 that Paxlovid remains a safe and effective treatment for high-risk adults with COVID-19 who are more likely to face hospitalization and death due to the virus.
"We still have many groups that stand to benefit from Paxlovid, including unvaccinated persons, under-vaccinated persons, the elderly and the immuno-compromised," said Dr. Richard Murphy of the Department of Veterans Affairs.
The FDA said using Paxlovid in high-risk patients could prevent 1,500 COVID-19 deaths and 13,000 hospitalizations per week.
The panel's positive vote was widely expected, given that Paxlovid has been the go-to treatment against COVID-19, especially since an entire group of antibody drugs has been sidelined as the virus mutated.
The U.S. continues reporting about 4,000 deaths and 35,000 hospitalizations weekly, the FDA noted.
The agency asked its panel of independent medical experts to address several lingering questions involving Paxlovid, including which people currently benefit from treatment and whether the drug plays a role in cases of COVID-19 rebound.
The panel agreed with assessments by both the FDA and Pfizer that found no clear link between the use of Paxlovid and returning symptoms, but said more information is needed from studies and medical records data. High-profile cases drew attention to the issue last year, including President Joe Biden and first lady Jill Biden.
Between 10 per cent and 16 per cent of patients across multiple Pfizer studies had symptoms return, regardless of whether they'd received Paxlovid or a dummy pill. Such cases "likely reflect natural COVID-19 progression," the FDA concluded.
The federal government has purchased more than 20 million doses of Paxlovid and encouraged health professionals to prescribe it aggressively to help prevent severe COVID-19. But that's led to concerns of overprescribing and questions of whether some patients are needlessly getting the drug.
Pfizer originally studied Paxlovid in the highest-risk COVID-19 patients: unvaccinated adults with other health problems and no evidence of prior coronavirus infection. But that doesn't reflect the U.S. population today, where an estimated 95 per cent of people have protection from at least one vaccine dose, a prior infection or both.
The FDA reviewed Pfizer data showing Paxlovid made no meaningful difference in otherwise healthy adults, whether or not they'd been previously vaccinated.
But when FDA teased out data for high-risk adults -- regardless of their vaccination or infection history -- Paxlovid still showed a significant benefit, reducing the chance of hospitalization or death between 60 per cent and 85 per cent, depending on individual circumstances. Patients in that group included seniors and those with serious health problems, such as diabetes, obesity, lung disease and immune-system disorders.
With so many different factors, panellists said prescribing Paxlovid will remain a case-by-case decision.
Dr. Sankar Swaminathan of the University of Utah and other panellists stressed the importance of managing potentially dangerous drug interactions between Paxlovid and other commonly used medications.
------
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group. The AP is solely responsible for all content.
A person who was on fire in a park outside the New York courthouse where Donald Trump’s hush money trial is taking place has been rushed away on a stretcher.
Soulful gospel artist Mandisa, a Grammy-winning singer who got her start as a contestant on 'American Idol' in 2006, has died, according to a statement on her verified social media. She was 47.
Scottish comedian Samantha Hannah was working on a comedy show about finding a husband when Toby Hunter came into her life. What happened next surprised them both.
A Manitoba woman thought she found a miracle natural supplement, but said a hidden ingredient wreaked havoc on her health.
One day after a Montreal police officer fired gunshots at a suspect in a stolen vehicle, senior officers were telling parliamentarians that organized crime groups are recruiting people as young as 15 in the city to steal cars so that they can be shipped overseas.
Police in Sault Ste. Marie charged a 22-year-old man with animal cruelty following an attack on a dog Thursday morning.
The Senate legal affairs committee has rejected a motion calling for members to take a $50,000 field trip to the African Lion Safari in southern Ontario to see the zoo's elephant exhibit.
Ontario Provincial Police have landed a suspect following a fishy theft in Beachburg, Ont.
Group of Seven foreign ministers warned of new sanctions against Iran on Friday for its drone and missile attack on Israel, and urged both sides to avoid an escalation of the conflict.
At 6'8" and 350 pounds, there is nothing typical about UBC offensive lineman Giovanni Manu, who was born in Tonga and went to high school in Pitt Meadows.
Kevin the cat has been reunited with his family after enduring a harrowing three-day ordeal while lost at Toronto Pearson International Airport earlier this week.
Molly Knight, a grade four student in Nova Scotia, noticed her school library did not have many books on female athletes, so she started her own book drive in hopes of changing that.
Almost 7,000 bars of pure gold were stolen from Pearson International Airport exactly one year ago during an elaborate heist, but so far only a tiny fraction of that stolen loot has been found.
When Les Robertson was walking home from the gym in North Vancouver's Lower Lonsdale neighbourhood three weeks ago, he did a double take. Standing near a burrow it had dug in a vacant lot near East 1st Street and St. Georges Avenue was a yellow-bellied marmot.
A moulting seal who was relocated after drawing daily crowds of onlookers in Greater Victoria has made a surprise return, after what officials described as an 'astonishing' six-day journey.
Just steps from Parliament Hill is a barber shop that for the last 100 years has catered to everyone from prime ministers to tourists.
A high score on a Foo Fighters pinball machine has Edmonton player Dave Formenti on a high.
A compound used to treat sour gas that's been linked to fertility issues in cattle has been found throughout groundwater in the Prairies, according to a new study.