While she was raised Catholic, Madonna has run into trouble with the church several times in her career. Now, it appears that she wants absolution.
On Wednesday, the Queen of Pop tweeted at Pope Francis — yes, he has a Twitter account — “Hello @Pontifex Francis —I’m a good Catholic. I Swear! I mean I don’t Swear! It’s been a few decades since my last confession. Would it be possible to meet up one day to discuss some important matters ?”
She added, “I’ve been ex communicated 3 times. It doesn’t seem fair. Sincerely Madonna.”
It’s not clear if Madonna has truly been excommunicated, but she’s certainly drawn condemnation from the Vatican and the previous Pope over the years for her videos and live performances. For example, her video for “Like a Prayer,” in which she kisses a Black saint, dances in front of burning crosses and displays stigmata, was condemned by the Vatican, and Pope John Paul II encouraged people to boycott Madonna when she toured Italy.
In 1990, she responded to calls from Italian Catholic organizations to ban her concerts in Rome and Turin by saying, “If you are sure that I am a sinner, then let he who has not sinned cast the first stone.”
And in 2006, during her Confessions tour, religious leaders accused Madonna of blasphemy and condemned her because she performed the song “Live to Tell” while hanging on a cross and wearing a crown of thorns.
They may be called ARMY, but BTS fans don’t want to see their boys go into the army for real. In South Korea, all able-bodied men are required to serve in the military for about two years, but now, a government minister is proposing that BTS should be exempt from that rule.
As Yonhap News Agency reports, South Korea’s Culture, Sports and Tourism Minister Hwang Hee is proposing that, just like South Korea’s elite athletes and classical musicians, K-pop stars like BTS should also be allowed to substitute their mandatory active military service for some kind of alternative service.
Hwang said at a press conference, “There is no reason the popular art-culture field should be excluded from this,” adding, “I thought somebody should be a responsible voice at a time when there are conflicting pros and cons ahead of the enlistment of some of the BTS members.”
He explained that if huge stars like BTS are forced to put their careers on hold for military service, there would be a great loss, not only to the country, but to the world.
Hwang urged parliament to approve a bill granting the exemption as soon as possible.
The oldest member of BTS, Jin, is due to enlist in December. Since 2018, there’s been a law in place — sometimes called the BTS Law — which allows K-pop stars to ask to delay their military service until they turn 30.
A day after Dave Chappelle was tackled on stage while playing the Netflix Is a Joke festival at the Hollywood Bowl in Los Angeles Tuesday night, the comedian and Netflix both issued statements regarding the incident.
“Dave Chappelle celebrated four nights of comedy and music, setting record-breaking sales for a comedian at the Hollywood Bowl,” a Chappelle spokesperson said in a statement on Wednesday. “This run ties Chappelle with Monty Python for the most headlined shows by any comedian at the Hollywood Bowl, reaching 70k fans of diverse backgrounds during the first Netflix Is a Joke: The Festival, and he refuses to allow last night’s incident to overshadow the magic of this historic moment.”
“As unfortunate and unsettling as the incident was, Chappelle went on with the show,” the statement continued. Jamie Foxx and Chris Rock helped calm the crowd with humor before Chappelle introduced the last and featured musical guests for the evening, hip-hop artists yasiin bey and Talib Kweli, a.k.a. Black Star, who performed music from their new album — the first in nearly 24 years -– which was released on Luminary. Other special comedic guests last night included Earthquake, Leslie Jones, Jeff Ross, Sebastian, Jon Stewart and Michelle Wolf.”
In a separate statement, a Netflix spokesperson said, “We care deeply about the safety of creators and we strongly defend the right of stand-up comedians to perform on stage without fear of violence.”
The attack suspect, identified as 23-year-old Isaiah Lee, allegedly rushed the stage when Chappelle was performing and shoved Dave to stage floor, where the comic tussled with the unknown assailant. The suspect, who was brandishing a knife shaped like a gun, was apprehended and taken to the hospital.
Netflix says it’s actively discussing the security protocols for future events.
(NEW YORK) — The leak of a draft opinion showing the Supreme Court’s conservative majority of justices is poised to overturn abortion rights established by Roe v. Wade has led to a sharp increase in donations to abortion funds, grassroots organizations that help people access abortion care.
The National Network of Abortion Funds, a network of more than 90 funds across the country, said it has received more than $1.5 million in donations since the draft ruling was published by Politico Monday night.
“That is only what is being funneled through the National Network of Abortion Funds and we’ve heard from our local members that many people are also donating directly to abortion funds,” Debasri Ghosh, managing director of the National Network of Abortion Funds, told ABC News’ Good Morning America. “Given the groundswell of support … we wouldn’t be surprised if those numbers were pretty high as well.”
In North Dakota, the WIN Fund, which helps people access abortion care at the state’s sole abortion clinic and travel to other states for care, has also seen an “exponential” increase in donations since Monday, according to Destini Spaeth, one of the volunteers who runs the fund.
“There’s absolutely been an influx of donations,” Spaeth told GMA, adding that people from across the country had donated. “The only thing that I can compare it to on even some type of scale was the death of Justice Ruth Bader Ginsburg, when we also saw an influx of donations.”
Spaeth said that donations are the lifeline of WIN Fund, a 501(c)(3) organization that, like all abortion funds, relies purely on donations and does not receive any government funding.
“We pride ourselves on being able to say yes to every caller,” said Spaeth. “We believe that abortion is a human right and that nobody should be denied access because of financial barriers.”
Abortion funds like WIN Fund began to form over three decades ago in response to the Hyde Amendment, a provision that since 1976 has banned federal funding for most abortions, according to Ghosh.
“So many people who use government insurance, including Medicaid recipients in most states, cannot have their abortion covered by their insurance,” she said. “So we were seeing droves and droves of people trying to put together funding for this out-of-pocket health care expense.”
Abortion funds now exist at the local, state and regional levels, but they are primarily locally-based organizations that provide on-the-ground resources for people, from providing direct funding for abortions to offering transportation money, child care, lodging and doula support.
The average funding given to people supported by the WIN Fund, for example, is around $250, according to Spaeth.
“People are traveling great distances so travel assistance is something we see quite a bit of,” said Spaeth, who said the fund often works with college students and members of North Dakota’s rural and indigenous populations. “Many of the patients travel three to four hours from Western parts of the state and also from Minnesota and we see a lot of patients from South Dakota as well.”
In West Virginia, a team of mostly volunteers runs the Holler Health Justice Fund, an abortion fund that serves people across the Appalachian Region, from West Virginia to Kentucky and Tennessee.
The volunteers coordinate care for people in the region who come from rural communities and often lack funds to pay for abortion or to travel, according to Hayley McMahon, a member of the fund’s board of directors.
West Virginia currently has one abortion clinic in the state, where abortion is currently allowed up to 20 weeks of pregnancy.
McMahon said the fund has been “overwhelmed” with support since Monday, but said even more donations will be needed if Roe v. Wade is overturned and West Virginia and nearby states enact abortion bans.
Last year, the fund was able to help over 530 people get abortion care, averaging donations of around $260 per person, according to McMahon.
“A lot of our folks are going to need to leave the state to get care, which means it’s going to be harder to coordinate and more expensive,” she said. “We expect to see higher gestations which means higher costs for the procedure and greater transportation needs.”
It’s a concern echoed by abortion funds across the country as they brace for the impact of the Supreme Court’s final decision in the case of Mississippi, Dobbs v. Jackson Women’s Health, the source of the draft opinion that was leaked.
If the Court rules in Mississippi’s favor and fully overturns Roe v. Wade, more than half of the nation’s 50 states are prepared to ban abortion, according to the Guttmacher Institute, a reproductive rights organization.
Twenty-one states already have laws on the books that would immediately ban abortion if Roe were overturned. Five additional states are likely to ban abortion should Roe be overturned, the Guttmacher report said.
In response to potential bans, leaders of abortion funds say they plan to continue to do their work, but will need increased resources as they help more people who will likely need to travel further.
Because the states that plan to ban abortion are focused in specific geographic regions, including the South, an expected effect is that women will have to travel much longer distances, at a greater cost and inconvenience, to seek abortion care, according to the Guttmacher Institute.
“North Dakotans aren’t going to stop needing and wanting abortions just because abortion becomes illegal here, and the North Dakota WIN Fund won’t be going anywhere,” said Spaeth. “I know the sentiment is true for other abortion funds in abortion-hostile states as well.”
Spaeth said she and other abortion fund leaders are looking at the example set by funds in Texas, where a law went into effect last year that bans nearly all abortions after six weeks of pregnancy.
“We’ve seen the amazing work that the Texas funds have done in getting their callers out of state and into surrounding states where they can have the abortions they want and need, so we can look to Texas and learn from them,” said Spaeth, who added that collaboration is also already happening between abortion funds in states where abortion access is limited and those where it is not.
Ghosh, of the National Network of Abortion Funds, said she hopes the current spotlight placed on abortion funds keeps the support coming for the long-term.
“I hope that individuals, that institutional philanthropy will really rethink the way that we connect and resource abortion funds, beyond this one-time, crisis moment,” she said, adding, “People shouldn’t have to privately fundraise and rely on private philanthropy to have a basic health care need met, but this is where we are, and we have an infrastructure to do it.”
HBO Max has renewed Julia, the comedy series inspired by the life and TV career of Julia Child, for a second season, the streaming service announced on Wednesday. The original series — while exploring the dawn of public television, the women’s movement and the nature of celebrity and America’s cultural growth — is first and foremost a portrait of a “loving marriage with an evolving and complicated power dynamic,” says the streamer. Happy Valley‘s Sarah Lancashire and Frasier‘s David Hyde Pierce star as Child and her husband, Paul. Bebe Neuwirth and Isabella Rossellini co-star…
Deadline reports Peacock has cancelled its Saved by the Bell reboot after two seasons. In the new iteration of the classic ‘90s high school sitcom Zack Morris — played by Mark-Paul Gosselaar, who returns in a recurring role — is now the governor of California, who, after getting into hot water for shutting down too many low-income high schools, proposes sending students from the affected schools to the highest-performing schools in the state, including his alma mater, Bayside High. The cast includes Haskiri Velazquez, Josie Totah, Alycia Pascual-Peña, Mitchell Hoog, Belmont Cameli, Dexter Darden and John Michael Higgins. Original cast members Elizabeth Berkley Lauren and Mario Lopez were also regulars…
A TV reboot of The Prince of Tides, the 1991 film starring Nick Nolte and Barbra Streisand, based on the novel by the late Pat Conroy, is in early development at Apple TV+, sources tell The Hollywood Reporter. The Help filmmaker Tate Taylor is reportedly attached to write the script for the Sony Pictures Television drama, which is already making offers to A-list talent ahead of a potential production start this summer. Insiders tell THR scripts are still being finalized. The original film, directed by Streisand, followed a man who falls in love with his sister’s psychiatrist as he works out the issues that stem from his troubled childhood. It was was nominated for seven Oscars, including best picture…
Oscar winner Ariana DeBose will host this year’s Tony Awards, live from New York’s Radio City Music Hall on Sunday, June 12 on CBS, organizers announced on Tuesday. “I’m coming home,” DeBose said in a statement. “I’m so honored to celebrate 75 years of excellence in theatre, but more importantly every member of this community who poured themselves into making sure the lights of Broadway have the opportunity to shine brightly once again. This is a dream come true, and I’m excited to see you all on June 12th.” DeBose took home the Best Supporting Actress Oscar this year for her performance as Anita in Steven Spielberg’s West Side Story. Her upcoming projects include Sony Pictures’ Kraven the Hunter, due out in 2023…
(NEW YORK) — Russian President Vladimir Putin’s “special military operation” into neighboring Ukraine began on Feb. 24, with Russian forces invading from Belarus, to the north, and Russia, to the east. Ukrainian troops have offered “stiff resistance,” according to U.S. officials.
The Russian military last month launched a full-scale ground offensive in eastern Ukraine’s disputed Donbas region, attempting to capture the strategic port city of Mariupol and to secure a coastal corridor to the Moscow-annexed Crimean Peninsula.
Here’s how the news is developing. All times Eastern:
May 05, 7:48 am
Ukrainian shelling of Russia’s Belgorod region damages homes, power line, governor claims
Ukrainian forces continued to shell villages in neighboring Russia’s Belgorod Oblast, the regional governor claimed Thursday.
In a statement via Telegram, Belgorod Oblast Gov. Vyacheslav Gladkov alleged that Ukrainian shelling had damaged at least five homes and a power line in the villages of Zhuravlevka and Nekhoteevka, which share a border with eastern Ukraine. There were no casualties reported among civilians in the area, according to Gladkov.
“We will start working within an hour to resume power supply,” Gladkov said, noting that the shelling had stopped for now. “We will also carry out the necessary measurements to restore every damaged house. No one will be left without help.”
May 05, 6:19 am
Mariupol men are being ‘forcibly detained’ in Russian ‘filtration camps,’ deputy mayor claims
The deputy mayor of embattled Mariupol claimed Thursday that some of the city’s residents are being “forcibly detained in appalling conditions” in Russian “filtration camps” in a nearby village.
“Filtration camps in the village of Bezymyanne have been turned into a real ghetto for Mariupol residents,” Mariupol Deputy Mayor Petro Andryushchenko said in a statement via Telegram. “This is the most horrible story that needs to be told to the whole world. Without exaggeration, this is a new page in Russia’s war crime that is happening right now.”
Andryushchenko alleged that, about a month ago, Russian forces took thousands of men from several Mariupol neighborhoods, confiscated their passports and placed them in filtration camps in Bezymianny, about 20 miles from Mariupol. As for the women who were left behind, they don’t leave their homes because they fear being raped by Russian troops who have settled in the area, according to the deputy mayor.
“All this once again shows the realities of the occupation,” he said.
Andryushchenko posted videos on Telegram alongside his statement, purportedly showing a school in Bezymianny that he alleged Russian force are using as a filtration camp. He claimed that the detainees are forced to sleep on the floor, don’t have access to medical care and can only wash themselves in a single sink with cold water. He alleged that all detainees, including the sick and those with disabilities, are forced to do landscaping work in the village. He also claimed that at least one man has died because he was refused medical assistance and another has been diagnosed with tuberculosis.
The deputy mayor alleged that the Russian military is planning to dress the detainees in the uniform of the Ukrainian military and parade them as “prisoners” during a celebration in Mariupol on Monday to coincide with Moscow’s Victory Day Parade, which celebrates Russia’s victory over Nazi Germany in World War II.
The Russian military claimed Wednesday to have taken complete control of Mariupol, a strategic port city in eastern Ukraine’s war-torn Donetsk Oblast that has been under heavy Russian bombardment since the start of the invasion on Feb. 24. Ukrainian fighters and civilians who remain in Mariupol are holed up inside the sprawling Azovstal Iron and Steel Works plant, which has a network of underground tunnels and bunkers.
ABC News recently spoke to Denys Prokopenko, a commander of the Azov Regiment, a far-right group now part of the Ukrainian military that was among the units defending Mariupol. Prokopenko is now trapped inside the Azovstal plant with others and said the fighters there have tried to initiate a cease-fire with Russian force to create conditions that would allow people to flee. But he said there are grave concerns about where those who choose to leave will end up because Russian authorities have said that all civilians will be allowed to choose to go to either Ukrainian- or Russian-controlled territory, but only after processing through Russian filtration camps.
“If our people are captured against their will and forcefully, forcibly relocated to the Russians, it’s unacceptable,” Prokopenko told ABC News.
May 05, 4:39 am
Russian shelling on residential areas of Kramatorsk injures 25, officials say
At least 25 civilians were injured by Russian shelling on residential areas and the central part of Kramatorsk on Wednesday night, according to the local city council.
Six of the wounded required hospitalization, and at least nine homes, a school as well as various civilian infrastructure sustained damaged, the Kramatorsk City Council said in a statement via Telegram.
Kramatorsk Mayor Oleksandr Honcharenko confirmed in a statement via Facebook that a kindergarten was seriously damaged.
Kramatorsk is a city in eastern Ukraine’s war-torn Donetsk Oblast.
May 05, 3:50 am
Over 300 civilians evacuated from Mariupol, surrounding areas
More than 300 civilians have been evacuated from the besieged Ukrainian port city of Mariupol and surrounding areas, officials said late Wednesday.
The International Committee of the Red Cross said it facilitated the safe passage of the civilians in coordination with the United Nations and both sides of the Russia-Ukraine conflict. The evacuees arrived Wednesday in Zaporizhzhia, a Ukrainian government-controlled city about 140 miles northwest of Mariupol.
“We are relieved that more lives have been spared,” Pascal Hundt, the ICRC’s head of delegation in Ukraine, said in a statement Wednesday night. “We welcome the renewed efforts of the parties with regards to safe passage operations. They remain crucial and urgent in light of the immense suffering of the civilians.”
Ukrainian Deputy Prime Minister Iryna Vereshchuk confirmed that 344 people were evacuated to Zaporizhzhia from the Mariupol area, Manhush, Berdyansk, Tokmak and Vasylivka.
The evacuation did not include civilians trapped inside the Azovstal Iron and Steel Works plant, the last pocket of Ukrainian resistance in Mariupol.
(DALLAS) — Jerry Jones, the owner of the Dallas Cowboys, was reportedly involved in a car crash in Dallas Wednesday night.
ABC News affiliate WFAA-TV, citing multiple sources, said Jones was involved in an accident just before 8:10 p.m. local time in the area of Wolf and Harry Hines Boulevard.
Jones, 79, reportedly suffered minor injuries. A source confirmed to ESPN that he was taken to a local hospital as a precaution.
Stephen Jones, Jerry’s son and the executive vice president of the Cowboys, told ESPN in a text message later that his father was back home and “all good.”
(NEW YORK) — When Laura Martin tested positive for COVID-19 last month during an extended stay in California, she was prescribed Paxlovid, the highly touted antiviral drug created by Pfizer.
Just one day after her diagnosis, she started her five-day course of pills, which have been shown to dramatically reduce the risk of hospitalization and death.
Martin, a 63-year-old Boston native who now resides in Canada, said she was thrilled when her symptoms began to subside.
“By the end of [the treatment], on Day 5, I was negative and feeling completely normal like without any symptoms, so I thought, ‘Wow, this is really great. What a great drug,’” Martin told ABC News.
Martin resumed her normal activities, but a week later, she began to feel ill again. When her symptoms worsened, she tested again.
“It came roaring back, and this round two has been much more severe than round one was,” Martin said. “This is like four days of much more significant symptoms than round one.”
Martin’s case is part of a seemingly rare, but increasingly reported phenomenon of COVID-19 symptom recurrence after being treated with Paxlovid. While it is largely unknown what is causing the reported viral resurgence, scientists say they are investigating.
Pfizer says that it is taking the reported incidences of recurrence “very seriously,” but that the rates mirror those who received a placebo in clinical trials. Experts urge that the benefits of the drug, in preventing hospitalization and death, outweigh the potential risk of a second positive test or symptom reemergence.
In additional analysis of the Paxlovid clinical trial data, the Food and Drug Administration (FDA) reported that most patients “did not have symptoms at the time of a positive PCR test after testing negative, and, most importantly, there was no increased occurrence of hospitalization or death or development of drug resistance.”
Company executives also reported, this week, that the use of Paxlovid continues to expand rapidly, particularly as infection rates across the country rise again. In the U.S., use of the treatment has increased by nearly ten-fold in recent weeks.
The number of locations in the U.S. with Paxlovid supply has grown to more than 33,000 sites now available, a four-fold increase since late-February. In addition, the company reported that there are now more than 2,200 Test to Treat locations now open.
‘Game-changer’
Long heralded as a “game-changer” in the fight against COVID-19, the push to make Paxlovid available to Americans has ramped up in recent weeks, with the White House looking to increase supply of the treatment.
The drug, which was granted emergency use authorization by the FDA in December 2021 for people with mild to moderate COVID-19 at high risk of disease progression, is also strongly recommended by the World Health Organization. It has been shown to be highly effective, estimated to provide an 89% reduction in virus-related hospitalizations and deaths.
However, in recent weeks, a number of patients, who have taken the treatment, have taken to social media to disclose what they say is a perplexing phenomenon of COVID-19 symptoms reemerging after they finished the prescribed five-day treatment course.
Some individuals claimed on Twitter that after their initial symptoms dissipated, leading to a negative test, they are once again testing positive.
“We’re seeing people get better on Paxlovid,” Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center, told ABC News. “But then, when they stop at the end of five days, we’re hearing stories of symptoms coming back and even, tests becoming either more positive, i.e. a darker line, or tests that had gone negative turning positive.”
Studies have found that a dark line can “indicates a strong positive with a high level of virus and is usually seen when people are at or near peak virus load.”
Reports of these “rebound symptoms” are largely anecdotal so far but with an increasing number of questions about the puzzling viral recurrence, scientists across the country are trying to assess what may be happening in new research.
Pfizer taking reports of viral rebounds ‘very seriously’
In February, a 71-year-old man in Massachusetts who had been vaccinated and boosted recovered after being treated for COVID-19 with Paxlovid, Dr. Michael Charness, chief of staff at the VA Boston Healthcare System, who has been researching the phenomenon and recently put out a preprint study last week, told ABC News.
However, around nine days after his initial positive test, Charness said his patient developed cold symptoms and tested positive again for the virus.
Molecular testing soon revealed that the patient’s viral load had increased to an even higher point than when the diagnosis was first made, according to an analysis by Charness and his team.
“We were interested in whether this was a new infection or whether this was maybe an adaptation or mutation that somehow changed the variant,” Charness said, adding that gene sequencing demonstrated that this second positive test demonstrated a recurrence of the original infection in an individual who had no symptoms for a week.
“We just were very struck by that,” said Charness. “I heard from people all over the country and some from other parts of the world, who had had the same experience.”
Representatives from the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, told ABC News that teams of scientists are investigating the surprising relapse reports, and they will provide further recommendations, if appropriate.
“The phenomenon of recrudescence reiterates the importance of following CDC’s isolation guidance – anyone who develops symptoms of illness during or after isolation should remain isolated, masked, and seek out testing and clinical care,” a representative from the CDC told ABC News in a statement. “Anyone who is concerned about having been exposed or who for any other reason wants to determine their infection status should test for COVID-19.”
The FDA stressed that the reports “do not change the conclusions from the Paxlovid clinical trial which demonstrated a marked reduction in hospitalization and death.”
The viral recurrence had been observed and reported in Pfizer’s application to the FDA, last year, in which the company said several trial participants had appeared to “have a rebound” of COVID-19 around day 10 or day 14.
Pfizer executives said Tuesday that they are taking the reports “very seriously,” but they do not believe that it is related to the drug, given that the same rate of rebound was observed in people who took the placebo. Further, no connection was noted between the viral load increase and subsequent severe illness.
“We’ve taken a preliminary look at our high-risk data, and so we’ve seen for example, that we have about an incidence about 2% of that viral load rebound, but we also see the same, or close to the same, percent in the placebo arm. So it’s something that’s not particularly associated with Paxlovid itself, but may have something to do with the virus itself,” Dr. William Pao, Pfizer’s executive vice president and chief development officer, said during an investors call on Tuesday. “It’s preliminary data so far, we again take it very seriously. But it’s very current, and a very low incidence, and we continue to learn as we go.”
A representative from Pfizer told ABC News that although it is too early to determine the cause, initial indications suggest an increased viral load is both uncommon and not uniquely associated with the Paxlovid treatment.
“We remain very confident in its clinical effectiveness at preventing severe outcomes from COVID-19 in high-risk patients,” the representative said.
Reports uncommon but happening ‘frequently enough’
Although official reports of these relapses still appear to be rare, such occurrences are happening “frequently enough” in those treated with Paxlovid that Charness said that it should be studied further.
“I think the first step in studying something is to know that it exists,” he explained, adding that it is particularly important for clinicians to be informed about potential rebounds, and for the public to know, so that people do not become unduly alarmed.
Thus far, researchers know very little about the reason for the recurring symptoms.
Of critical importance in the investigations is whether an individual, in the midst of such a rebound, remains infectious, Charness said.
“We are sufficiently concerned about whether people can transmit, when they’re on day 12 and 13 and 15, that we are essentially recommending that when people have a recurrence, a rebound, that they restart their isolation, and isolate until their antigen test is negative,” Charness said. “We’re seeing people whose antigen test stays positive for a week after they rebound, which means that they’re well outside the CDC’s 10-day guidance.”
Should you experience a viral rebound, the FDA is now recommending that health care providers and patients refer to CDC guidance, wear a mask and isolate if they have any COVID-19 symptoms — regardless of whether or not they have been treated with an antiviral.
Charness and his team are also encouraging their patients to start their isolation period over again and stay away until their antigen test is negative.
“It’s important to exercise caution until you clear the virus the second time,” Charness said, further urging people to notify their provider.
In terms of further treatments, Charness noted it is still largely unclear what patients should do. While there are no limitations, within the authorized label, around additional usage of the drug for a subsequent COVID-19 infection, according to Pfizer, the FDA said “there is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”
Despite the reports of rebounding, health experts stress that Paxlovid is still largely achieving its original goal, to keep people out of the hospital, and severe disease at-bay.
“The bottom line is if it prevents hospitalization, if it keeps you from progressing to severe disease, hospitalization and death, the fact that you might have a recurrence of some of the symptoms and even the recurrence of a positive test is sort of secondary,” said Doron. “The main thing is Paxlovid is to prevent progression to severe disease [and] hospitalization, and it does. So, it’s still doing its job.”
(NEW YORK) — When Laura Martin tested positive for COVID-19 last month during an extended stay in California, she was prescribed Paxlovid, the highly touted antiviral drug created by Pfizer.
Just one day after her diagnosis, she started her five-day course of pills, which have been shown to dramatically reduce the risk of hospitalization and death.
Martin, a 63-year-old Boston native who now resides in Canada, said she was thrilled when her symptoms began to subside.
“By the end of [the treatment], on Day 5, I was negative and feeling completely normal like without any symptoms, so I thought, ‘Wow, this is really great. What a great drug,’” Martin told ABC News.
Martin resumed her normal activities, but a week later, she began to feel ill again. When her symptoms worsened, she tested again.
“It came roaring back, and this round two has been much more severe than round one was,” Martin said. “This is like four days of much more significant symptoms than round one.”
Martin’s case is part of a seemingly rare, but increasingly reported phenomenon of COVID-19 symptom recurrence after being treated with Paxlovid. While it is largely unknown what is causing the reported viral resurgence, scientists say they are investigating.
Pfizer says that it is taking the reported incidences of recurrence “very seriously,” but that the rates mirror those who received a placebo in clinical trials. Experts urge that the benefits of the drug, in preventing hospitalization and death, outweigh the potential risk of a second positive test or symptom reemergence.
In additional analysis of the Paxlovid clinical trial data, the Food and Drug Administration (FDA) reported that most patients “did not have symptoms at the time of a positive PCR test after testing negative, and, most importantly, there was no increased occurrence of hospitalization or death or development of drug resistance.”
Company executives also reported, this week, that the use of Paxlovid continues to expand rapidly, particularly as infection rates across the country rise again. In the U.S., use of the treatment has increased by nearly ten-fold in recent weeks.
The number of locations in the U.S. with Paxlovid supply has grown to more than 33,000 sites now available, a four-fold increase since late-February. In addition, the company reported that there are now more than 2,200 Test to Treat locations now open.
‘Game-changer’
Long heralded as a “game-changer” in the fight against COVID-19, the push to make Paxlovid available to Americans has ramped up in recent weeks, with the White House looking to increase supply of the treatment.
The drug, which was granted emergency use authorization by the FDA in December 2021 for people with mild to moderate COVID-19 at high risk of disease progression, is also strongly recommended by the World Health Organization. It has been shown to be highly effective, estimated to provide an 89% reduction in virus-related hospitalizations and deaths.
However, in recent weeks, a number of patients, who have taken the treatment, have taken to social media to disclose what they say is a perplexing phenomenon of COVID-19 symptoms reemerging after they finished the prescribed five-day treatment course.
Some individuals claimed on Twitter that after their initial symptoms dissipated, leading to a negative test, they are once again testing positive.
“We’re seeing people get better on Paxlovid,” Dr. Shira Doron, an infectious disease physician and hospital epidemiologist at Tufts Medical Center, told ABC News. “But then, when they stop at the end of five days, we’re hearing stories of symptoms coming back and even, tests becoming either more positive, i.e. a darker line, or tests that had gone negative turning positive.”
Studies have found that a dark line can “indicates a strong positive with a high level of virus and is usually seen when people are at or near peak virus load.”
Reports of these “rebound symptoms” are largely anecdotal so far but with an increasing number of questions about the puzzling viral recurrence, scientists across the country are trying to assess what may be happening in new research.
Pfizer taking reports of viral rebounds ‘very seriously’
In February, a 71-year-old man in Massachusetts who had been vaccinated and boosted recovered after being treated for COVID-19 with Paxlovid, Dr. Michael Charness, chief of staff at the VA Boston Healthcare System, who has been researching the phenomenon and recently put out a preprint study last week, told ABC News.
However, around nine days after his initial positive test, Charness said his patient developed cold symptoms and tested positive again for the virus.
Molecular testing soon revealed that the patient’s viral load had increased to an even higher point than when the diagnosis was first made, according to an analysis by Charness and his team.
“We were interested in whether this was a new infection or whether this was maybe an adaptation or mutation that somehow changed the variant,” Charness said, adding that gene sequencing demonstrated that this second positive test demonstrated a recurrence of the original infection in an individual who had no symptoms for a week.
“We just were very struck by that,” said Charness. “I heard from people all over the country and some from other parts of the world, who had had the same experience.”
Representatives from the FDA, the Centers for Disease Control and Prevention and the National Institutes of Health, told ABC News that teams of scientists are investigating the surprising relapse reports, and they will provide further recommendations, if appropriate.
“The phenomenon of recrudescence reiterates the importance of following CDC’s isolation guidance – anyone who develops symptoms of illness during or after isolation should remain isolated, masked, and seek out testing and clinical care,” a representative from the CDC told ABC News in a statement. “Anyone who is concerned about having been exposed or who for any other reason wants to determine their infection status should test for COVID-19.”
The FDA stressed that the reports “do not change the conclusions from the Paxlovid clinical trial which demonstrated a marked reduction in hospitalization and death.”
The viral recurrence had been observed and reported in Pfizer’s application to the FDA, last year, in which the company said several trial participants had appeared to “have a rebound” of COVID-19 around day 10 or day 14.
Pfizer executives said Tuesday that they are taking the reports “very seriously,” but they do not believe that it is related to the drug, given that the same rate of rebound was observed in people who took the placebo. Further, no connection was noted between the viral load increase and subsequent severe illness.
“We’ve taken a preliminary look at our high-risk data, and so we’ve seen for example, that we have about an incidence about 2% of that viral load rebound, but we also see the same, or close to the same, percent in the placebo arm. So it’s something that’s not particularly associated with Paxlovid itself, but may have something to do with the virus itself,” Dr. William Pao, Pfizer’s executive vice president and chief development officer, said during an investors call on Tuesday. “It’s preliminary data so far, we again take it very seriously. But it’s very current, and a very low incidence, and we continue to learn as we go.”
A representative from Pfizer told ABC News that although it is too early to determine the cause, initial indications suggest an increased viral load is both uncommon and not uniquely associated with the Paxlovid treatment.
“We remain very confident in its clinical effectiveness at preventing severe outcomes from COVID-19 in high-risk patients,” the representative said.
Reports uncommon but happening ‘frequently enough’
Although official reports of these relapses still appear to be rare, such occurrences are happening “frequently enough” in those treated with Paxlovid that Charness said that it should be studied further.
“I think the first step in studying something is to know that it exists,” he explained, adding that it is particularly important for clinicians to be informed about potential rebounds, and for the public to know, so that people do not become unduly alarmed.
Thus far, researchers know very little about the reason for the recurring symptoms.
Of critical importance in the investigations is whether an individual, in the midst of such a rebound, remains infectious, Charness said.
“We are sufficiently concerned about whether people can transmit, when they’re on day 12 and 13 and 15, that we are essentially recommending that when people have a recurrence, a rebound, that they restart their isolation, and isolate until their antigen test is negative,” Charness said. “We’re seeing people whose antigen test stays positive for a week after they rebound, which means that they’re well outside the CDC’s 10-day guidance.”
Should you experience a viral rebound, the FDA is now recommending that health care providers and patients refer to CDC guidance, wear a mask and isolate if they have any COVID-19 symptoms — regardless of whether or not they have been treated with an antiviral.
Charness and his team are also encouraging their patients to start their isolation period over again and stay away until their antigen test is negative.
“It’s important to exercise caution until you clear the virus the second time,” Charness said, further urging people to notify their provider.
In terms of further treatments, Charness noted it is still largely unclear what patients should do. While there are no limitations, within the authorized label, around additional usage of the drug for a subsequent COVID-19 infection, according to Pfizer, the FDA said “there is no evidence of benefit at this time for a longer course of treatment … or repeating a treatment course of Paxlovid in patients with recurrent COVID-19 symptoms following completion of a treatment course.”
Despite the reports of rebounding, health experts stress that Paxlovid is still largely achieving its original goal, to keep people out of the hospital, and severe disease at-bay.
“The bottom line is if it prevents hospitalization, if it keeps you from progressing to severe disease, hospitalization and death, the fact that you might have a recurrence of some of the symptoms and even the recurrence of a positive test is sort of secondary,” said Doron. “The main thing is Paxlovid is to prevent progression to severe disease [and] hospitalization, and it does. So, it’s still doing its job.”
