Pfizer received full approval on Thursday for its COVID-19 pill Paxlovid that’s been the go-to treatment against the coronavirus.
More than 11 million prescriptions for Paxlovid have been dispensed since the Food and Drug Administration allowed emergency use in late 2021. The emergency status was based on early studies and was intended to be temporary pending follow-up research.
The FDA granted full approval for adults with COVID-19 who face high risks of severe disease, which can lead to hospitalization or death. That group typically includes older adults and those with common medical conditions like diabetes, asthma and obesity.
The decision allows Pfizer’s drug to remain on the market indefinitely and to be marketed similarly to other drugs.
The pill is still available for children ages 12 to 17 under a separate emergency authorization.
The U.S. government has stockpiled millions of doses of Paxlovid and patients will continue to receive it at no charge, the FDA said in a statement. More than 14,000 new COVID-19 cases were reported each week last month, although most U.S. cases are no longer reported to health authorities.
Paxlovid is the fourth drug for COVID-19 to receive full FDA approval and the first one that is a pill. The previously approved therapies are IV or injectable drugs, typically given at clinics or hospitals.
Pfizer originally studied Paxlovid in the highest-risk COVID-19 patients: unvaccinated adults with other health problems and no evidence of prior coronavirus infection. In that group, the FDA said the drug lowered the risk of hospitalization or death by 86% when given shortly after symptoms emerged.
But that doesn’t reflect the U.S. population today, where more than 95% of people have protection from at least one vaccine dose, a prior infection or both.
In more recent studies of people who have had COVID-19, Paxlovid still significantly decreased the chance of hospitalization or death by more than 85%.
As Paxlovid became widely used in 2021, doctors and patients reported cases of COVID-19 symptoms returning several days after treatment with the drug. But the FDA said Thursday “there is not a clear association,” between Pfizer’s drug and rebound cases.
That conclusion was backed by an independent panel of FDA advisers, who voted to recommend the drug’s full approval at a meeting earlier this year.
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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.
Singapore Prime Minister Lee Hsien Loong said Monday he tested positive for COVID-19 for the first time after returning home from work trips in Africa and Asia.
Due to his age, the 71-year-old said he was prescribed the Paxlovid antiviral medication.
“I tested positive for COVID-19 for the first time this morning,” Lee said on Facebook, where he posted a photo of a positive antigen rapid test. “I am generally feeling ok, but my doctors have advised me to self-isolate until I am asymptomatic.”
Lee was on an official visit to South Africa from May 14 to 16, and Kenya from May 17 to 19. He also attended the Association of Southeast Asian Nations summit in Indonesia from May 10 to 11.
Lee said his last COVID-19 vaccine booster was in November. He urged Singaporeans to keep their vaccinations up to date to reduce the risk of severe illness.
Health Minister Ong Ye Kung was reported by local media as saying recently in Parliament that fewer seniors were keeping up with their COVID-19 shots. He warned this could weaken the population’s resistance against COVID-19 over time and make the nation vulnerable to the virus again.
The justice, a 55-year-old conservative who was President Donald Trump’s first Supreme Court nominee, called emergency measures taken during the COVID-19 crisis that killed more than 1 million Americans perhaps “the greatest intrusions on civil liberties in the peacetime history of this country.”
He pointed to orders closing schools, restricting church services, mandating vaccines and prohibiting evictions. His broadside was aimed at local, state and federal officials — even his colleagues.
“Executive officials across the country issued emergency decrees on a breathtaking scale,” Gorsuch wrote in an eight-page statement Thursday that accompanied an expected Supreme Court order formally dismissing a case involving the use of the Title 42 policy to prevent asylum seekers from entering the United States.
The policy was ended last week with the expiration of the public health emergency first declared more than three years ago because of the coronavirus pandemic.
From the start of his Supreme Court tenure in 2017, Gorsuch, a Colorado native who loves to ski and bicycle, has been more willing than most justices to part company with his colleagues, both left and right.
But he has charted a different course on some issues, writing the court’s 2020 opinion that extended federal protections against workplace discrimination to LGBTQ people. He also has joined with the liberal justices in support of Native American rights.
When the omicron variant surged in late 2021 and early 2022, Gorsuch was the lone justice to appear in the courtroom unmasked even as his seatmate, Justice Sonia Sotomayor, who has diabetes, reportedly did not feel safe in close quarters with people who were not wearing masks.
So Sotomayor, who continues to wear a mask in public, did not take the bench with the other justices in January 2022. The two justices denied reports they were at odds over the issue.
The emergency orders about which Gorsuch complained were first announced in the early days of the pandemic, when Trump was president, and months before the virus was well understood and a vaccine was developed.
The thrust of his complaint is not new. He has written before in individual cases that came to the court during the pandemic, sometimes dissenting from orders that left emergency decrees in place.
The justices intervened in several COVID-related cases.
With Gorsuch and five other conservatives in the majority, they ended the eviction moratorium and blocked a Biden administration plan to require workers at larger companies to be vaccinated or wear a mask and submit to regular testing. Once Amy Coney Barrett joined the court, after Ruth Bader Ginsburg died, they ended restrictions on religious services in some areas.
By a 5-4 vote from which Gorsuch and three conservative colleagues dissented, the court allowed the administration to require many health care workers to be vaccinated.
But on Thursday, Gorsuch gathered his complaints in one place, writing about lessons he hoped might be learned from the past three years.
“One lesson might be this: Fear and the desire for safety are powerful forces. They can lead to a clamor for action —almost any action — as long as someone does something to address a perceived threat. A leader or an expert who claims he can fix everything, if only we do exactly as he says, can prove an irresistible force,” he wrote.
Another possible lesson, he wrote: “The concentration of power in the hands of so few may be efficient and sometimes popular. But it does not tend toward sound government.”
He also had strong words for the Republican-led states that tried to keep the Title 42 policy in place, and the five conservatives justices whose votes extended the policy five months beyond when it would have otherwise ended in late December.
“At the very least, one can hope that the Judiciary will not soon again allow itself to be part of the problem by permitting litigants to manipulate our docket to perpetuate a decree designed for one emergency to address another,” Gorsuch wrote.
In the final paragraph of his statement, Gorsuch acknowledged, but only grudgingly, that emergency orders sometimes are necessary. “Make no mistake — decisive executive action is sometimes necessary and appropriate. But if emergency decrees promise to solve some problems, they threaten to generate others,” he wrote.
AdventHealth Winter Park and Seminole State College are getting results when it comes to preparing nursing students for a career in health care.
In the last year, AdventHealth Winter Park and Seminole State College partnered up to form a Dedicated Education Unit.
Chief Nursing Officer for AdventHealth Winter Park Nicole Ayoub said the hospital’s DEU helps build a solid foundation for nursing students as they enter the workforce.
Initially, nursing students are paired with an experienced nurse and work together one-on-one. Eventually, the experienced nurse will assess the student’s skills and give them more independence on the unit.
“It allows for our experienced nurses to know the new nurses, be able to share their knowledge with them so that as they become part of our workforce. That (way) there is less (of a) learning curve and everyone’s more comfortable with each other,” Ayoub said.
In March 2022, the American Nurses’ Foundation and American Nurses’ Association released the results of its “Impacts of COVID-19″ survey. It found that 52% of nurses said they were considering leaving their positions and that 60% of acute care nurses reported feeling burnt out.
Seminole State College’s Dean of Nursing Nancy Gasper said she hopes the program will reduce attrition.
“So, in the past, students would come into the workforce and their eyes were open,” Gasper said. “They were shocked, especially with our complex system of health care right now. So, students who go through the DEU, you tend to be more competent and confident. They also know their team members. They’re better able to transition into their new roles. We find patients are safer and our new graduates, our new nurses, are happier, more satisfied.”
Recent Seminole State College Nursing graduate and new AdventHealth Winter Park nurse Kelly Andrews said the program has helped her find ways to prevent burnout.
“So, I know there’s more opportunities out there if I were to feel that way,” Andrews said. “And I feel with this program, it definitely gave me a lot of skills and opportunities that I wouldn’t have elsewhere to kind of prevent me from burnout. And like I said before, just being comfortable with the floor I’m on and already kind of knowing people has really helped prevent that.”
Andrews was offered a job at AdventHealth Winter Park on the same unit she trained on as a student. She said the program helped her gain confidence.
“I think I would have been a lot less confident without the program, and I think I would have been very nervous, you know, on every shift,” Andrews said. “But I feel like I’m already just two weeks out of training and I already feel very confident in what I’m doing.”
Andrews said she remembers the day she received her offer letter from AdventHealth, and it was exactly what she wanted.
“It made me feel very excited,” Andrews said. “And to know that I didn’t have to go and interview elsewhere, that I could just stay where I was comfortable, was very nice.”
AdventHealth has several DEUs across Central Florida. Here’s the full list:
AdventHealth Waterman with Lake-Sumter State CollegeAdventHealth Orlando with AdventHealth UniversityAdventHealth Winter Park with Seminole State CollegeAdventHealth Palm Coast with Jacksonville University
AdventHealth said the hospital will be adding more dedicated education units this fall.
Total Doses Distributed = 984,444,295. Total Doses Administered = 676,728,782. Number of People Receiving 1 or More Doses = 270,227,181. Number of People Fully Vaccinated = 230,637,348.
Dr. Rochelle Walensky, the head of the Centers for Disease Control and Prevention, submitted her resignation Friday, saying the waning of the COVID-19 pandemic was a good time to make a transition.
Walensky’s last day will be June 30, CDC officials said, and an interim director wasn’t immediately named. She sent a resignation letter to President Joe Biden and announced the decision at a CDC staff meeting.
Walensky, 54, has been the agency’s director for a little over two years. In her letter to Biden, she expressed “mixed feelings” about the decision and didn’t say exactly why she was stepping down, but said the nation is at a moment of transition as emergency declarations come to an end.
“I have never been prouder of anything I have done in my professional career,” she wrote.
The World Health Organization said Friday that COVID-19 no longer qualifies as a global emergency, and the U.S. public health emergency declaration will expire next week. Deaths in the U.S. are at their lowest point since the earliest days of the coronavirus outbreak in early 2020.
The CDC, with a $12 billion budget and more than 12,000 employees. is an Atlanta-based federal agency charged with protecting Americans from disease outbreaks and other public health threats.
Walensky, previously an infectious-diseases specialist at Harvard Medical School and Massachusetts General Hospital, had no experience running a government health agency when she was sworn in on the first day of the Biden administration.
She came with a reputation as a prominent voice on the pandemic, sometimes criticizing certain aspects of how the government was responding. She was brought in to raise morale at the CDC, to rebuild public trust in the agency and to improve its sometimes-bumbling response to the pandemic.
She started a center for forecasting and outbreak analytics, took steps to modernize data and improve the public health work force. Last year, she began a reorganization designed to make the agency more nimble and to improve its communications with the public.
In the spring of 2021, Walensky said fully vaccinated people could stop wearing masks in many settings, only to reverse course as the then-new delta variant spread. And in December 2021, the agency’s decision to shorten isolation and quarantine caught many by surprise and caused confusion.
In a statement, White House Chief of Staff Jeff Zients praised her performance.
“Her creativity, skill and expertise, and pure grit were essential to our effective response and an historic recovery that made life better for Americans across the country,” Zients said.
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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.
