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 Veteran 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 COVID-19 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, 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 physicians 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% 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 this 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.
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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.
Deaths of pregnant women in the U.S. fell in 2022, dropping significantly from a six-decade high during the pandemic, new data suggests.
More than 1,200 U.S. women died in 2021 during pregnancy or shortly after childbirth, according to a final tally released Thursday by the Centers for Disease Control and Prevention. In 2022, there were 733 maternal deaths, according to preliminary agency data, though the final number is likely to be higher.
Officials say the 2022 maternal death rate is on track to get close to pre-pandemic levels. But that’s not great: The rate before COVID-19 was the highest it had been in decades.
“From the worst to the near worst? I wouldn’t exactly call that an accomplishment,” said Omari Maynard, a New Yorker whose partner died after childbirth in 2019.
The CDC counts women who die while pregnant, during childbirth and up to 42 days after birth. Excessive bleeding, blood vessel blockages and infections are leading causes.
COVID-19 can be particularly dangerous to pregnant women, and experts believe it was the main reason for the 2021 spike. Burned out physicians may have added to the risk by ignoring pregnant women’s worries, some advocates said.
In 2021, there were about 33 maternal deaths for every 100,000 live births. The last time the government recorded a rate that high was 1964.
What happened “isn’t that hard to explain,” said Eugene Declercq, a long-time maternal mortality researcher at Boston University. “The surge was COVID-related.”
Previous government analyses concluded that one quarter of maternal deaths in 2020 and 2021 were COVID-related — meaning that the entire increase in maternal deaths was due to coronavirus infections or the pandemic’s wider impact on health care. Pregnant women infected with the coronavirus were nearly 8 times as likely to die as their uninfected peers, according to a recent study published by BMJ Global Health.
The bodies of pregnant women are already under strain, their heart forced to pump harder. Other health problems can make their condition more fragile. And then on top of that, “COVID is going to make all that much worse,” said Dr. Elizabeth Cherot, chief medical and health officer for the March of Dimes.
It didn’t help that vaccination rates among pregnant women were disappointingly low in 2021 — particularly among Black women. Part of that was related to limited vaccine availability, and that the CDC did not fully recommend shots for pregnant women until August 2021.
“Initially there was a lot of mistrust of the vaccine in Black communities,” said Samantha Griffin, who owns a doula service that mainly serves families of color in the Washington, D.C., area.
But there’s to more to it than that, she and others added. The 2021 maternal mortality rate for Black women was nearly three times higher than it was for white women. And the maternal death rate for Hispanic American women that year rose 54% compared with 2020, also surpassing the death rate for white moms.
More than a year into the pandemic, a lot of doctors and nurses were feeling burned out and they were getting less in-person time with patients.
Providers at the time “were needing to make snap decisions and maybe not listening to their patients as much,” Griffin said. “Women were saying that they thought something was wrong and they weren’t being heard.”
Maynard, who is 41 and lives in Brooklyn, said he and his partner experienced that in 2019.
Shamony Gibson, a healthy 30-year-old, was set to have their second child. The pregnancy was smooth until her contractions stopped progressing and she underwent a cesarean section.
The operation was more involved than expected but their son Khari was born in September. A few days later, Shamony began complaining of chest pains and shortness of breath, Maynard said. Doctors told her she just needed to relax and let her body rest from the pregnancy, he said.
More than a week after giving birth, her health worsened and she begged to go to the hospital. Then her heart stopped, and loved ones called for help. The initial focus for paramedics and firefighters was whether Gibson was taking illicit drugs, Maynard said, adding that she didn’t.
She was hospitalized and died the next day of a blood clot in the lungs. Her son was 13 days old.
“She wasn’t being heard at all,” said Maynard, an artist who now does speaking engagements as a maternal health advocate.
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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.
Residents are complaining about burning eyes and breathing problems. Dead fish have washed up on beaches. A beachside festival has been canceled, even though it wasn’t scheduled for another month.
Florida’s southwest coast experienced a flare-up of the toxic red tide algae this week, setting off concerns that it could continue to stick around for a while. The current bloom started in October.
The annual BeachFest in Indian Rocks Beach, Florida, sponsored by a homeowners’ association, was canceled after it determined, with help from the city and the Pinellas County Health Department, that red tide likely would continue through the middle of next month when the festival was scheduled.
“Red Tide is currently present on the beach and is forecasted to remain in the area in the weeks to come,” the Indian Rocks Beach Homeowners Association said in a letter to the public. “It is unfortunate that it had to be canceled but it is the best decision in the interest of public health.”
Nearly two tons of debris, mainly dead fish, were cleared from Pinellas County beaches and brought to the landfill, county spokesperson Tony Fabrizio told the Tampa Bay Times. About 1,000 pounds (454 kilograms) of fish have been cleared from beaches in St. Pete Beach since the start of the month, Mandy Edmunds, a parks supervisor with the city, told the newspaper.
Red tide, a toxic algae bloom that occurs naturally in the Gulf of Mexico, is worsened by the presence of nutrients such as nitrogen in the water. The Florida Fish and Wildlife Conservation Commission warns people to not swim in or around red tide waters over the possibility of skin irritation, rashes and burning and sore eyes. People with asthma or lung disease should avoid beaches affected by the toxic algae.
The Florida Fish and Wildlife Conservation Commission on Friday reported that it had found red tide in 157 samples along Florida’s Gulf Coast, with the strongest concentrations along Pinellas and Sarasota counties.
U.S. health agencies have sent a letter to Florida’s surgeon general, warning him that his claims about COVID-19 risks are harmful to the public.
The letter from the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention was sent Friday to Florida Surgeon General Joseph Ladapo.
Ladapo was appointed by Republican Gov. Ron DeSantis in 2021 and has attracted national scrutiny over his close alignment with the governor in opposing COVID-19 vaccine mandates and other health policies embraced by the federal government.
Ladapo last year released guidance recommending against COVID-19 vaccinations for healthy children, contradicting federal public health leaders whose advice says all kids should get the shots.
He also has recommended against men ages 18 to 39 getting the mRNA COVID-19 vaccines, claiming that an analysis by the Florida Department of Health showed an 84% increase in cardiac-related deaths.
In their letter, the federal agencies debunked the analysis’ conclusion, saying that cardiovascular experts who studied the concern had concluded that the risk of strokes and heart attacks was lower in people who had been vaccinated, not higher.
More than 13 billion doses of COVID-19 vaccines have been given around the world with little evidence of adverse effects, the federal health agencies said.
“It is the job of public health officials around the country to protect the lives of the populations they serve, particularly the vulnerable. Fueling vaccine hesitancy undermines this effort,” said the letter signed by FDA Commissioner Robert Califf and CDC Director Rochelle Walensky.
The Florida Department of Health on Saturday didn’t respond to an email inquiry about the letter.
A requirement that travelers to the U.S. from China present a negative COVID-19 test before boarding their flights expired Friday after more than two months as cases in China have fallen.
The restrictions were put in place Dec. 28 and took effect Jan. 5 amid a surge in infections in China after the nation sharply eased pandemic restrictions and as U.S. health officials expressed concerns that their Chinese counterparts were not being truthful to the world about the true number of infections and deaths. The requirement from the U.S. Centers for Disease Control and Prevention expired for flights leaving after 3 p.m. Eastern time Friday.
When the restriction was imposed, U.S. officials also said it was necessary to protect U.S. citizens and communities because there was a lack of transparency from the Chinese government about the size of the surge or the variants that were circulating within China.
The rules imposed in January require travelers to the U.S. from China, Hong Kong and Macau to take a COVID-19 test no more than two days before travel and provide a negative test before boarding their flight. The testing applies to anyone 2 years and older, including U.S. citizens.
China saw infections and deaths surge after it eased back from its “zero COVID” strategy in early December after rare public protests against a policy that confined millions of people to their homes and sparked protests and demands for President Xi Jinping to resign.
But as China eased its strict rules, infections and deaths surged, and parts of the country for weeks saw their hospitals overwhelmed by infected patients looking for help. Still, the Chinese government has been slow to release data on the number of deaths and infections.
The U.S. decision to lift restrictions comes at a moment when U.S.-China relations are strained. Biden ordered a Chinese spy balloon shot down last month after it traversed the continental United States. The Biden administration has also publicized U.S. intelligence findings that raise concern Beijing is weighing providing Russia weaponry for its ongoing war on Ukraine.
On the third anniversary of the COVID-19 pandemic, the virus is still spreading and the death toll is nearing 7 million worldwide. Yet most people have resumed their normal lives, thanks to a wall of immunity built from infections and vaccines.
The virus appears here to stay, along with the threat of a more dangerous version sweeping the planet.
“New variants emerging anywhere threaten us everywhere,” said virus researcher Thomas Friedrich of the University of Wisconsin-Madison. “Maybe that will help people to understand how connected we are.”
With information sources drying up, it has become harder to keep tabs on the pandemic. Johns Hopkins University on Friday shut down its trusted tracker, which it started soon after the virus emerged in China and spread worldwide.
Saturday marks three years since the World Health Organization first called the outbreak a pandemic on March 11, 2020, and the United Nation’s health organization says it’s not yet ready to say the emergency has ended.
A look at where we stand:
THE VIRUS ENDURES
With the pandemic still killing 900 to 1,000 people a day worldwide, the stealthy virus behind COVID-19 hasn’t lost its punch. It spreads easily from person to person, riding respiratory droplets in the air, killing some victims but leaving most to bounce back without much harm.
“Whatever the virus is doing today, it’s still working on finding another winning path,” said Dr. Eric Topol, head of Scripps Research Translational Institute in California.
We’ve become numb to the daily death toll, Topol says, but we should view it as too high. Consider that in the United States, daily hospitalizations and deaths, while lower than at the worst peaks, have not yet dropped to the low levels reached during summer 2021 before the delta variant wave.
At any moment, the virus could change to become more transmissible, more able to sidestep the immune system or more deadly. Topol said we’re not ready for that. Trust has eroded in public health agencies, furthering an exodus of public health workers. Resistance to stay-at-home orders and vaccine mandates may be the pandemic’s legacy.
“I wish we united against the enemy — the virus — instead of against each other,” Topol said.
FIGHTING BACK
There’s another way to look at it. Humans unlocked the virus’ genetic code and rapidly developed vaccines that work remarkably well. We built mathematical models to get ready for worst-case scenarios. We continue to monitor how the virus is changing by looking for it in wastewater.
“The pandemic really catalyzed some amazing science,” said Friedrich.
The achievements add up to a new normal where COVID-19 “doesn’t need to be at the forefront of people’s minds,” said Natalie Dean, an assistant professor of biostatistics at Emory University. “That, at least, is a victory.”
Dr. Stuart Campbell Ray, an infectious disease expert at Johns Hopkins, said the current omicron variants have about 100 genetic differences from the original coronavirus strain. That means about 1% of the virus’ genome is different from its starting point. Many of those changes have made it more contagious, but the worst is likely over because of population immunity.
Matthew Binnicker, an expert in viral infections at Mayo Clinic in Rochester, Minnesota, said the world is in “a very different situation today than we were three years ago — where there was, in essence, zero existing immunity to the original virus.”
That extreme vulnerability forced measures aimed at “flattening the curve.” Businesses and schools closed, weddings and funerals were postponed. Masks and “social distancing” later gave way to showing proof of vaccination. Now, such precautions are rare.
“We’re not likely to go back to where we were because there’s so much of the virus that our immune systems can recognize,” Ray said. Our immunity should protect us “from the worst of what we saw before.”
REAL-TIME DATA LACKING
On Friday, Johns Hopkins did its final update to its free coronavirus dashboard and hot-spot map with the death count standing at more than 6.8 million worldwide. Its government sources for real-time tallies had drastically declined. In the U.S., only New York, Arkansas and Puerto Rico still publish case and death counts daily.
“We rely so heavily on public data and it’s just not there,” said Beth Blauer, data lead for the project.
The U.S. Centers for Disease Control and Prevention still collects a variety of information from states, hospitals and testing labs, including cases, hospitalizations, deaths and what strains of the coronavirus are being detected. But for many counts, there’s less data available now and it’s been less timely.
“People have expected to receive data from us that we will no longer be able to produce,” said the CDC’s director, Dr. Rochelle Walensky.
Internationally, the WHO’s tracking of COVID-19 relies on individual countries reporting. Global health officials have been voicing concern that their numbers severely underestimate what’s actually happening and they do not have a true picture of the outbreak.
For more than year, CDC has been moving away from case counts and testing results, partly because of the rise in home tests that aren’t reported. The agency focuses on hospitalizations, which are still reported daily, although that may change. Death reporting continues, though it has become less reliant on daily reports and more on death certificates — which can take days or weeks to come in.
U.S. officials say they are adjusting to the circumstances, and trying to move to a tracking system somewhat akin to how CDC monitors the flu.
THEN AND NOW
“I wish we could go back to before COVID,” said Kelly Forrester, 52, of Shakopee, Minnesota, who lost her father to the disease in May 2020, survived her own bout in December and blames misinformation for ruining a longtime friendship. “I hate it. I actually hate it.”
The disease feels random to her. “You don’t know who will survive, who will have long COVID or a mild cold. And then other people, they’ll end up in the hospital dying.”
Forrester’s father, 80-year-old Virgil Michlitsch, a retired meat packer, deliveryman and elementary school custodian, died in a nursing home with his wife, daughters and granddaughters keeping vigil outside the building in lawn chairs.
Not being at his bedside “was the hardest thing,” Forrester said.
Inspired by the pandemic’s toll, her 24-year-old daughter is now getting a master’s in public health.
“My dad would have been really proud of her,” Forrester said. “I’m so glad that she believed in it, that she wanted to do that and make things better for people.”
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Associated Press writers Laura Ungar and Mike Stobbe contributed. ___
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.
