COVID-19 Pill Paxlovid Moves Closer to Full FDA Approval

FILE - Doses of the anti-viral drug Paxlovid are displayed in New York, on Monday, Aug. 1, 2022. (AP Photo/Stephanie Nano, File)
FILE - Doses of the anti-viral drug Paxlovid are displayed in New York, on Monday, Aug. 1, 2022. (AP Photo/Stephanie Nano, File)
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COVID-19 Pill Paxlovid Moves Closer to Full FDA Approval

FILE - Doses of the anti-viral drug Paxlovid are displayed in New York, on Monday, Aug. 1, 2022. (AP Photo/Stephanie Nano, File)
FILE - Doses of the anti-viral drug Paxlovid are displayed in New York, on Monday, Aug. 1, 2022. (AP Photo/Stephanie Nano, File)

Pfizer’s COVID-19 pill Paxlovid won another vote of confidence from US 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, The Associated Press.

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 US 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% and 16% 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 US population today, where an estimated 95% 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% and 85%, 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, panelists said prescribing Paxlovid will remain a case-by-case decision.

Dr. Sankar Swaminathan of the University of Utah and other panelists stressed the importance of managing potentially dangerous drug interactions between Paxlovid and other commonly used medications.



6,101 Pieces of History: Brazilian Owns World’s Largest Shirt Collection

 Cassio Brandao, 41, holds a German shirt received by Pele during an exchange with player Beckenbauer at the end of a game, in a room filled with clothes racks that in April 2024 made him become a Guinness World Records title holder as the owner of the world's largest collection of soccer shirts, in Sao Paulo, Brazil June 24, 2024. (Reuters)
Cassio Brandao, 41, holds a German shirt received by Pele during an exchange with player Beckenbauer at the end of a game, in a room filled with clothes racks that in April 2024 made him become a Guinness World Records title holder as the owner of the world's largest collection of soccer shirts, in Sao Paulo, Brazil June 24, 2024. (Reuters)
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6,101 Pieces of History: Brazilian Owns World’s Largest Shirt Collection

 Cassio Brandao, 41, holds a German shirt received by Pele during an exchange with player Beckenbauer at the end of a game, in a room filled with clothes racks that in April 2024 made him become a Guinness World Records title holder as the owner of the world's largest collection of soccer shirts, in Sao Paulo, Brazil June 24, 2024. (Reuters)
Cassio Brandao, 41, holds a German shirt received by Pele during an exchange with player Beckenbauer at the end of a game, in a room filled with clothes racks that in April 2024 made him become a Guinness World Records title holder as the owner of the world's largest collection of soccer shirts, in Sao Paulo, Brazil June 24, 2024. (Reuters)

Brazilian Cassio Brandao walks through rooms filled with clothes racks that in April made him a Guinness World Records title holder as the owner of the world's largest collection of soccer shirts.

From rare Pele jerseys to a 1998 World Cup shirt signed by Ronaldo, the 41-year-old Google employee has amassed a total 6,101 shirts since he started collecting them in 2000.

"They are more than just 6,101 pieces of fabric; they are 6,101 stories that help us tell a bit of the history of soccer," Brandao told Reuters as, wearing white gloves, he took out some of his favorite items.

He keeps his shirts at the office of a collectors club he founded in Sao Paulo, "Alambrado Soccer & Culture," bringing together 60 people who trade stories and jerseys - some worth up to 40,000 reais ($7,400).

Brandao's collection includes the shirt worn by Pele when the Brazilian player nicknamed "The King" met Britain's Queen Elizabeth in 1968. She was the guest of honor at a match at Rio de Janeiro's monumental Maracana stadium during an official visit to Brazil.

Pele is the star of the Alambrado office, which is decorated with signed shirts and framed pictures of the late soccer great, who died in December 2022.

"Some shirts can go up to 40,000 reais, but a Pele shirt is priceless," Brandao said.

He also displays a 1994 Brazil jacket worn by seven times Formula One world champion Lewis Hamilton at last year's Sao Paulo Grand Prix, when the British driver - an honorary Brazilian citizen - asked to borrow the outfit.

A large part of Brandao's collection is dedicated to his favorite club, local side Corinthians, including jerseys from Ronaldo's spell at the club and shirts worn by his favorite player Socrates.

"Each shirt contains a story," Brandao said. "Stories of wins, losses, and overcoming. Stories that document a bit of the world's greatest sport."