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.
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.
Total Doses Distributed = 732,209,015. Total Doses Administered = 579,030,245. Number of People Receiving 1 or More Doses = 258,132,925. Number of People Fully Vaccinated = 220,138,061.
Last summer, Julio Carmona started the process of weaning himself off a fully remote work schedule by showing up to the office once a week.
The new hybrid schedule at his job at a state agency in Stratford, Connecticut, still enabled him to spend time cooking dinner for his family and taking his teenage daughter to basketball.
But in the next few months, he’s facing the likelihood of more mandatory days in the office. And that’s creating stress for the father of three.
Carmona, 37, whose father died from COVD-19 last year, worries about contracting the virus but he also ticks off a list of other anxieties: increased costs for lunch and gas, day care costs for his newborn baby, and his struggle to maintain a healthy work-life balance.
“Working from home has been a lot less stressful when it comes to work-life balance,” said Carmona, who works in finance at Connecticut’s Department of Children and Families. “You are more productive because there are a lot less distractions.”
As more companies mandate a return to the office, workers must readjust to pre-pandemic rituals like long commutes, juggling child care and physically interacting with colleagues. But such routines have become more difficult two years later. Spending more time with your colleagues could increase exposure to the coronavirus, for example, while inflation has increased costs for lunch and commuting.
Among workers who were remote and have gone back at least one day a week in-person, more say things in general have gotten better than worse and that they’ve been more productive rather than less, an April poll from The Associated Press-NORC Center for Public Affairs Research shows. But the level of stress for these workers is elevated.
Overall, among employed adults, the April AP-NORC poll shows 16% say they work remotely, 13% work both remotely and in-person and 72% say they work only in-person.
Thirty-nine percent of employees who had worked at home but have returned to the office say the way things are going generally has gotten better since returning in-person at the workplace, while 23% say things have gotten worse; 38% say things have stayed the same. Forty-five percent say the amount of work getting done has improved, while 18% say it’s worsened.
But 41% of returned workers say the amount of stress they experience has worsened; 22% say it’s gotten better and 37% say it hasn’t changed.
Even workers who have been in person throughout the pandemic are more negative than positive about the way the pandemic has impacted their work lives. Thirty-five percent say the way things are going in general has gotten worse, while 20% say it’s gotten better. Fifty percent say their stress has worsened, while just 11% say it’s gotten better; 39% say there’s no difference.
At least half of in-person workers say balancing responsibilities, potential COVID exposure at work, their commute and social interaction are sources of stress. But fewer than a third call these “major” sources of stress.
People with children were more likely to report their return was having an adverse effect, some of it stemming from concerns about keeping their families safe from COVID and maintaining a better work-life balance. Most said it could help alleviate stress if their employer provided more flexible work options and workplace safety precautions from the virus. But for some workers, a physical return — in any form — will be hard to navigate.
“A lot of people have gotten accustomed to working from home. It’s been two years,” said Jessica Edwards, national director of strategic alliances and development at the National Alliance on Mental Illness, a U.S.-based advocacy group. “For companies, it’s all about prioritizing mental health and being communicative about it. They should not be afraid of asking their employees how are they really doing.”
Companies like Vanguard are now expanding virtual wellness workshops that started in the early days of the pandemic or before. They’re also expanding benefits to include meditation apps and virtual therapy. Meanwhile, Target, which hasn’t set a mandatory return, is giving teams the flexibility of adjusting meeting times to earlier or later in the day to accommodate employees’ schedules.
A lot is at stake. Estimates show that untreated mental illness may cost companies up to $300 billion annually, largely due to impacts on productivity, absenteeism, and increases in medical and disability expenses, according to the National Alliance on Mental Illness.
Russ Glass, CEO of online mental health and wellbeing platform Headspace Health, said he has seen a fourfold spike in the use of behavioral health coaching and a fivefold spike in clinical services like therapy and psychiatric help during the pandemic compared to pre-pandemic days. With apps like Ginger and Headspace, the company serves more than 100 million people and 3,500 companies. Among the top worries: anxiety over contracting COVID-19, and struggles with work-life balance.
“We haven’t seen it abate. That level of care has just stayed high,” Glass said.
The constant wave of new virus surges hasn’t helped.
Francine Yoon, a 24-year-old food scientist at Ajinomoto Health and Nutrition North America, in Itasca, Illinois, has been working mostly in person since the pandemic, including at her current job that she started last fall. Yoon said her company has helped to ease anxiety by doing things like creating huddle rooms and empty offices to create more distance for those experiencing any form of anxiety about being in close proximity to colleagues.
But moving in last year with her older parents, both in their early 60s, has led to some heightened level of anxiety because she’s worried about passing on the virus to them. She said every surge of new cases creates some anxiety.
“When cases are low, I feel comfortable and confident that I am OK and that I will be OK,” she said. ‘When surges occur, I can’t help but become cautious.”
As for Carmona, he’s trying to lower his stress and is considering participating in his office’s online meditation sessions. He’s also thinking of carpooling to reduce gas costs.
“I am one of those people that take it day by day,” he said. “You have to try to keep your stress level balanced because you will run your brain into the ground thinking about things that could go haywire.”
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The AP-NORC poll of 1,085 adults was conducted April 14-18 using a sample drawn from NORC’s probability-based AmeriSpeak Panel, which is designed to be representative of the U.S. population. The margin of sampling error for all respondents is plus or minus 3.9 percentage points.
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AP staff writer Haleluya Hadero in New York contributed to this report.
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Follow Anne D’Innocenzio: http://twitter.com/ADInnocenzio
They crawled to the surface as the coronavirus pandemic roiled New York City, scurrying out of subterranean nests into the open air, feasting on a smorgasbord of scraps in streets, parks and mounds of curbside garbage. As diners shunned the indoors for outdoor dining, so did the city’s rats.
Now city data suggests that sightings are more frequent than they’ve been in a decade.
Through April, people have called in some 7,400 rat sightings to the city’s 311 service request line. That’s up from about 6,150 during the same period last year, and up by more than 60% from roughly the first four months of 2019, the last pre-pandemic year.
In each of the first four months of 2022, the number of sightings was the highest recorded since at least 2010, the first year online records are available. By comparison, there were about 10,500 sightings in all of 2010 and 25,000 such reports in all of last year (sightings are most frequent during warm months).
Whether the rat population has increased is up for debate, but the pandemic might have made the situation more visible.
With more people spending time outdoors as temperatures grow warmer, will rat sightings further surge?
“That depends on how much food is available to them and where,” said Matt Frye, a pest management specialist for the state of New York, who is based at Cornell University.
While a return to pre-pandemic routines “is exciting after two years of COVID-imposed lifestyle changes,” Frye said in an email, “it also means business as usual for rat problems that are directly tied to human behavior.”
Rats have been a problem in New York City since its founding. Every new generation of leaders has tried to find a better way of controlling the rodent population, and struggled to show results.
When Mayor Eric Adams was borough president of Brooklyn, he annoyed animal rights activists — and upset the stomachs of some journalists — by demonstrating a trap that used a bucket filled with a vinegary, toxic soup to drown rats lured by the scent of food.
Former Mayor Bill de Blasio spent tens of millions of dollars on efforts to reduce the rat population in targeted neighborhoods through more frequent trash pickup, more aggressive housing inspections, and replacing dirt basement floors in some apartment buildings with ones made of concrete.
The city also launched a program to use dry ice to suffocate rats in their burrows, once demonstrating the technique for reporters at an event where workers chased — but never caught — one of the fleeing critters.
During a recent news conference in Times Square, Adams announced the city’s latest effort: padlocked curbside trash bins intended to reduce the big piles of garbage bags that turn into a buffet for rodents.
“You’re tired of the rodents, you’re tired of the smell, you’re tired of seeing food, waste and spillage,” the mayor said.
Rats not only strike fear among the easily squeamish, they can also be a public health concern.
Last year, at least 13 people were hospitalized — one died — because of leptospirosis, a condition that attacks the kidneys and liver. Most human infections are associated with rats.
As some cities consider making outdoor dining permanent — an option born of necessity during the pandemic — they are mindful of a further swelling of the rat population. Even before the pandemic, experts noticed a rise in rat populations in some of the country’s largest cities.
Rats can survive on less than an ounce of food a day and rarely travel more than a city block to find food, according to rat scholars.
Some New York City restaurants erected curbside sheds to allow COVID-wary diners to eat outside. But unfinished meals left at tables have sometimes drawn brazen four-legged leftover bandits — a la Pizza Rat, who gained fame in 2015 after a video went viral showing the rodent dragging a slice of pizza down a flight of subway stairs (debates raged at the time about whether the video was staged).
As fewer people used the subways, there were fewer morsels on which to feast in tunnels.
“What happened during the pandemic was that your restaurants shut down,” said Richard Reynolds, whose rat-hunting group for years periodically takes out teams of dogs to sniff out — and kill — vermin. “When outside dining came along, there was food again.”
In planter boxes outside dining sheds, rats lie in wait for any fallen crumb. They lurk in storm drains ready to lunge.
It’s the stuff of nightmares for Brooklyn resident Dylan Viner, who recently accidentally hit a dead rat with his bicycle. In recent months, he and friends have noticed a rise in the number of rats out in the open.
“I’ve always had a phobia of rats. I’m not squeamish about snakes or bugs — but rats, there’s something about them,” said Viner, a transplant from London, who likes to keep his distance from the vermin. “It’s OK seeing them around the subway tracks. It’s when you see one jump out in front of you and dash from a trash can to a dumpster or a restaurant … that’s when it makes you feel a bit squeamish.”
He recalled taking a recent walk in the West Village, where a stride landed on one of the creatures.
“I screamed and ran,” he recounted. The rat might have squealed, too.
“Mine was so loud,” he said, “that it’s hard to know if it was mine or the rat’s.”
Total Doses Distributed = 732,182,715. Total Doses Administered = 578,726,209. Number of People Receiving 1 or More Doses = 258,080,764. Number of People Fully Vaccinated = 220,093,855.
Thousands of high school students in China learned Friday that COVID-19 restrictions will prevent them from taking Advanced Placement exams that many prepared for to improve their chances of attending college in the U.S. or Europe.
Many students are unable to sit for the in-person, pen-and-paper tests given once a year in May because of the government’s “zero-COVID” lockdowns meant to curb the spread of the virus. The College Board, which administers the tests, previously offered an online option in response to pandemic school closures but said that was intended as a temporary solution.
“We regret the impact that this decision may have on students who have worked hard all year to prepare for this opportunity,” the College Board said in a written statement.
The decision to not provide an online option frustrated students who worry that missing test scores for the college-level AP courses will weaken their college applications. Students also risk losing out on the college credits that are a reward for high test scores, meaning they will have to enroll in — and pay for — classes they could have otherwise skipped.
Luke Penaloza, 16, a sophomore at Shanghai American School, is among millions of people restricted to the buildings and compounds where they live in China’s largest city, because of its COVID-19 outbreak. He was set to take the AP U.S. History exam this month.
“It was important that I take this test because it shows academic rigor in my transcripts and it gives me a solid representation of my skills in the U.S. History curriculum,” he said by email.
Some other admissions tests are still offered digitally in China, including the ACT. Administrators said students’ ability to take that test have not been affected by lockdowns.
Parents have accused the College Board of being indifferent to the affected students. Students worldwide were able to test via computer in 2020 and 2021, though with universal start times. In China, that meant middle-of-the night AP testing sessions.
“As a parent it is difficult to see your child work so hard for a full year and then not be allowed to sit for the exam,” said Angelique Schultz, who has two students in Shanghai American School.
College Board said it would not be able to offer makeup sessions beyond May. It said it would urge university admissions officers to be flexible.
“The lack of certainty about when large gatherings will be permitted, when testing locations and staff will be available, when schools may re-open for in-person learning, and when exam materials could be delivered without service disruptions and hold times make it impossible to plan a makeup exam administration,” it said.
Junghyok Park, 16, said he prepared all year for his AP U.S. History exam, even as it appeared increasingly unlikely that he and his classmates, many of whom are not allowed to leave their houses, would take the exams.
“Many have been studying half-heartedly in the prolonged wait for a definitive answer,” he said.
Although missing AP scores won’t directly prevent students from applying for U.S. colleges and universities, many schools in Europe and Asia demand scores for admission, said Marcel Gauthier, the head of Shanghai American School. Some students have flown to other countries to take the exams.
His students, he said, “have been working all year, driving towards one single exam .. and it’s a culminating event that they will not get to have.”
