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COVID-19 Vaccination Data Updates
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Two years ago, Pfizer was the envy of the pharmaceutical world, with more than $100 billion in annual sales from its COVID-19 vaccine and antiviral Paxlovid.
Today, CEO Albert Bourla is trying to turn the page from that success story, which has turned into more of a financial headache for the global drugmaker.
Lofty expectations for continuing sales of vaccines and antivirals have fallen short, sending Pfizer’s stock price tumbling to about half of its peak during the pandemic. Bourla has responded with a $3.5 billion cost-cutting effort, including layoffs, and new investments in drugs for cancer and obesity.
The transition hasn’t been easy. Company shares dropped again in December when Pfizer said it would abandon its twice-a-day formulation of an obesity pill due to an unacceptably high rate of side effects. The company continues to study a once-a-day version.
Bourla spoke to The Associated Press about the company’s COVID-19 business and his efforts to move beyond it. The transcript has been edited for length and clarity.
Q: How important are COVID-19 vaccines and Paxlovid to Pfizer’s future?
I think the two products you mentioned will continue to be very important products for Pfizer because COVID-19 will continue to be important. And those products will continue offering the best solution, in the minds of most people.
They’re not going to be as big as we thought last year when we gave an expectation of approximately $20 billion revenue. The reality was that they were closer to $10 billion. But that difference was not because we miscalculated the COVID-19 epidemiology, actually it came out exactly as we thought. But what has happened is that a lot of the contracts that governments had with us, they decided to challenge them. And although they didn’t have any legal merit, we felt that it was not the right thing to take governments to court. So we decided to settle with that.
Q: What is Pfizer getting from its $43 billion purchase of cancer drugmaker Seagen?
Seagen is the leading company in a new technology that is called ADC, antibody-drug conjugate. Let me try to use military terms to describe them. Cancer is the enemy. And in the past, we were fighting this disease with methods like those used in the Second World War. So the Allies would bomb the entire place, hoping that they will hit the most important targets.
This is how chemotherapy was working. We release chemotherapy into the body and it is attacking the cancer cells but at the same time is also attacking the healthy cells. The ADCs are more like modern warfare, with GPS-guided missiles. They have a system, which is the antibody, that is programed to identify the cancer cells among the billions of cells in our body and attach to them. It just goes to them and the drug is like the warhead on the tip of the missile.
With Seagen, we were able to get not one, but four products, that are already in the market; 13 programs in clinical trials that will hopefully become products; a set of patents and intellectual properties and, of course, a group of thousands of extremely skilled scientists.
Q. Where does Pfizer’s pill version of popular obesity injections fit into the marketplace?
Of course, everybody wants to lose weight, but if they have an option, a lot of people would choose the option of a pill. It remains to be seen, but in the data that we have seen in our Phase 2 studies, we believe we’ll have good tolerability and good efficacy. It’s important to note that danuglipron has been studied in more than 1,400 patients globally, so we know a lot about the molecule. And now we are looking to develop the once-a-day pill.
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Bleeding and in pain, Kyleigh Thurman didn’t know her doomed pregnancy could kill her.
Emergency room doctors at Ascension Seton Williamson in Texas handed her a pamphlet on miscarriage and told her to “let nature take its course” before discharging her without treatment for her ectopic pregnancy.
When the 25-year-old returned three days later, still bleeding, doctors finally agreed to give her an injection intended to end the pregnancy. But it was too late. The fertilized egg growing on Thurman’s fallopian tube would rupture it, destroying part of her reproductive system.
That’s according to a complaint Thurman and the Center for Reproductive Rights filed last week asking the government to investigate whether the hospital violated a federal law when staff failed to treat her initially in February 2023.
“I was left to flail,” Thurman said. “It was nothing short of being misled.”
Even as the Biden administration has publicly warned hospitals to treat pregnant patients in emergencies, facilities continue to violate the federal law.
More than 100 pregnant women in medical distress who sought help from emergency rooms were turned away or negligently treated since 2022, an Associated Press analysis of federal hospital investigations has found.
Two women – one in Florida and one in Texas – were left to miscarry in public restrooms. In Arkansas, a woman went into septic shock and her fetus died after an emergency room sent her home. At least four other women with ectopic pregnancies had trouble getting any treatment, including one California woman who needed a blood transfusion after she sat for nine hours in an emergency waiting room.
The White House says hospitals must offer abortions when needed to save a woman’s health, despite state bans. Texas is challenging that guidance and, earlier this summer, the Supreme Court declined to resolve the issue.
Abortion bans complicate risky pregnancy care
In Texas, where doctors face up to 99 years of prison if convicted of performing an illegal abortion, medical and legal experts say the law is complicating decision-making around emergency pregnancy care.
Although the state law says termination of ectopic pregnancies is not considered abortion, the draconian penalties scare Texas doctors from treating those patients, the Center for Reproductive Rights argues.
“As fearful as hospitals and doctors are of running afoul of these state abortion bans, they also need to be concerned about running afoul of federal law,” said Marc Hearron, a center attorney. Hospitals face a federal investigation, hefty penalties and threats to their Medicare funding if they break the federal law.
The organization filed two complaints last week with the Centers for Medicare and Medicaid Service alleging that different Texas emergency rooms failed to treat two patients, including Thurman, with ectopic pregnancies.
Another complaint says Kelsie Norris-De La Cruz, 25, lost a fallopian tube and most of an ovary after an Arlington, Texas, hospital sent her home without treating her ectopic pregnancy, even after a doctor said discharge was “not in her best interest.”
“The doctors knew I needed an abortion, but these bans are making it nearly impossible to get basic emergency healthcare,” she said in a statement. “I’m filing this complaint because women like me deserve justice and accountability from those that hurt us.”
Conclusively diagnosing an ectopic pregnancy can be difficult. Doctors cannot always find the pregnancy’s location on an ultrasound, three separate doctors consulted for this article explained. Hormone levels, bleeding, a positive pregnancy test and ultrasound of an empty uterus all indicate an ectopic pregnancy.
“You can’t be 100% — that’s the tricky part,” said Kate Arnold, an OB-GYN in Washington. “They’re literally time bombs. It’s a pregnancy growing in this thing that can only grow so much.”
Texas Right to Life Director Dr. John Seago said the state law clearly protects doctors from prosecution if they terminate ectopic pregnancies, even if a doctor “makes a mistake” in diagnosing it.
“Sending a woman back home is completely unnecessary, completely dangerous,” Seago said.
But the state law has “absolutely” made doctors afraid of treating pregnant patients, said Hannah Gordon, an emergency medicine physician who worked in a Dallas hospital until last year.
“It’s going to force doctors to start creating questionable scenarios for patients, even if it’s very dangerous,” said Gordon. She left Texas hoping to become pregnant and worried about the care she’d get there.
Gordon recalled a pregnant patient at her Dallas emergency room who had signs of an ectopic pregnancy. Because OB-GYNs said they couldn’t definitively diagnose the problem, they waited to end the pregnancy until she came back the next day.
“It left a bad taste in my mouth,” Gordon said.
“Oh my God, I’m dying.”
In Thurman’s case, when she returned to Ascension Seton Williamson a third time, her OB-GYN told her she’d need surgery to remove the fallopian tube, which had ruptured. Thurman, still heavily bleeding, balked. Losing the tube would jeopardize her fertility.
But her doctor told her she risked death if she waited any longer.
“She came in and she’s like, you’re either going to have to have a blood transfusion, or you’re going to have to have surgery or you’re going to bleed out,” Thurman said, through tears. “That’s when I just kind of was like, “oh my God, I’m, I’m dying.”
Ascension Seton Williamson declined to comment on Thurman’s case, but said in a statement the hospital “is committed to providing high-quality care to all who seek our services.”
In Florida, a 15-week pregnant woman leaked amniotic fluid for an hour in Broward Health Coral Springs’ emergency wait room, according to federal documents. An ultrasound revealed the patient had no amniotic fluid surrounding the fetus, a dangerous situation that can cause serious infection.
The woman miscarried in a public bathroom that day, after the emergency room doctor listed her condition as “improved” and discharged her, without consulting the hospital’s OB-GYN.
Emergency crews rushed her to another hospital, where she was placed on a ventilator and discharged after six days.
Abortions after 15 weeks were banned in Florida at the time. Broward Health Coral Springs’ obstetrics medical director told an investigator that inducing labor for anyone who presents with pre-viable premature rupture of membranes is “the standard of care, has been a while, regardless of heartbeat, due to the risk to the mother.”
The hospital declined to comment or share its policies with the AP.
In another Florida case, a doctor admitted state law had complicated emergency pregnancy care.
“Because of the new laws … staff cannot intervene unless there is a danger to the patient’s health,” a doctor at Memorial Regional Hospital in Hollywood, Florida, told an investigator who was probing the hospital’s failure to offer an abortion to a pregnant woman whose water broke at 15 weeks, well before the fetus could survive.
Troubles extend beyond abortion ban states
Serious violations that jeopardized a mother or her fetus’ health occurred in states with and without abortion bans, the AP’s review found.
In interviews with investigators, two short-staffed hospitals – in Idaho and Washington – admitted to routinely directing pregnant patients to drive to other hospitals.
A pregnant patient at a Bakersfield, California, emergency room was quickly triaged, but staff failed to realize the urgency of her condition, a uterine rupture. The delay, an investigator concluded, may have contributed to the baby’s death.
Doctors at emergency rooms in California, Nebraska, Arkansas and South Carolina failed to check for fetal heartbeats or discharged patients who were in active labor, leaving them to deliver at home or in ambulances, according to the documents.
Nursing and doctor shortages that have plagued hospitals since the onset of COVID-19, trouble staffing ultrasounds around-the-clock, and new abortion laws are making the emergency room a dangerous place for pregnant women, warned Dara Kass, an emergency medicine doctor and former U.S. Health and Human Services official.
“It is increasingly less safe to be pregnant and seeking emergency care in an emergency department,” she said.
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Noah Lyles said he tested positive for COVID two days before he finished third in the 200-meter final at the Paris Olympics on Thursday night.
Here’s what we know about the timeline of Lyles’ illness:
When did Lyles know he had COVID?
Lyles says he quickly got into quarantine after he had tested positive Tuesday morning. He participated in the 200-meter semifinal on Wednesday, where he finished second. Lyles’ coach afterward said the sprinter was “fine.”
Lyles, who usually always takes an opportunity to talk, did not speak to reporters after the semifinal.
The 100-meter champion said he was feeling better as the 200 final approached. He estimated he was about 90-95 percent when the starting gun went off.
“I still wanted to run,” he said after Thursday night’s race. “They said it was possible.”
What happened in his 200-meter race?
Lyles was trailing 200-meter champion Botswana’s Letsile Tebogo as they headed into the homestretch, which is usually where the American puts on a trademark closing finish that has always been the best part of his race. Before this week, he hadn’t lost a 200 since his third-place finish in Tokyo three years ago.
This time, Lyles could not close. Only a desperate push to the line then a collapse onto the purple track.
“To be honest, I knew if I wanted to come out here and win, I had to give everything I had from the get-go,” he said. “I didn’t have any time to save energy. So that was kind of the strategy for today.”
After crossing the line third for the second straight Olympics, Lyles fell to his back and writhed on the ground trying to catch his breath. He got to one knee and stayed there for nearly 30 seconds before getting up, asking for water and getting to the wheelchair.
Why was he allowed to run?
The U.S. track federation released a statement saying it and the U.S. Olympic and Paralympic Committee adhered to all Olympic and Centers for Disease Control guidelines.
“After a thorough medical evaluation, Noah chose to compete tonight,” the statement said. “We respect his decision and will continue to monitor his condition closely.”
Three years ago, at the Tokyo Olympics, a positive COVID test would have put an athlete in immediate isolation, forcing them to a special hotel with no contact with other Olympic participants. Even in 2022 at the Winter Games in China, daily tests and strict isolation measures were automatic. COVID rules have been changed in much of society, including sports, school and work. The USATF says they followed current policies.
France, which once had tight COVID restrictions, no longer has rules for people with the virus, just recommendations to those who test positive to self-isolate.
The World Health Organization said Tuesday that 40 athletes at the Olympics had tested positive for the virus amid growing cases worldwide.
What races does Lyles have left?
Lyles was expected to run the anchor leg of the 4×100 on Friday in what many thought would be a quest for a third gold medal in Paris. He said he would talk to his relay teammates and come to a decision.
“I want to be very honest and transparent, and I’m going to let them make the decision,” Lyles said, describing himself as being at around 90 or 95%.
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AP Olympics: https://apnews.com/hub/2024-paris-olympic-games
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The medical-cannabis company Trulieve has contributed another $5 million to a campaign to allow recreational marijuana in Florida, according to a newly filed finance report.
The company made the contribution July 15 to the Smart & Safe Florida political committee, which is leading efforts to pass a recreational-marijuana initiative on the November ballot.
In all, Trulieve had contributed about $60.39 million to the committee as of July 19, according to a state Division of Elections database.
The committee had raised a total of $66.475 million in cash and nearly $129,000 in in-kind contributions. It had spent $53.963 million.
The initiative, which will appear on the ballot as Amendment 3, says, in part, that it would allow “adults 21 years or older to possess, purchase, or use marijuana products and marijuana accessories for non-medical personal consumption by smoking, ingestion, or otherwise.”
Voters in 2016 passed a constitutional amendment that allowed medical marijuana.
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President Joe Biden did not wear a face mask in public a couple of times after the White House announced he had tested positive for COVID-19. The White House said the Democratic incumbent was experiencing “mild” symptoms while the president’s physician said Biden would self-isolate “in accordance with CDC guidance for symptomatic individuals.”
What does the CDC guidance say? What does the White House say?
After the announcement on Wednesday, Biden emerged bare-faced from the motorcade after he arrived at the airport in Las Vegas, where he had made several appearances, and boarded Air Force One. He also was not wearing a mask, which medicals professionals have said can help slow the spread of disease, as he stepped off the plane hours later at Dover Air Force Base in Delaware. Biden was surrounded by Secret Service agents and aides on both ends of the trip.
White House press secretary Karine Jean-Pierre said in Wednesday’s announcement that Biden, 81, was experiencing “mild” symptoms and would stick to prearranged plans to travel to his home in Rehoboth Beach, where he would isolate.
Biden’s physician, Dr. Kevin O’Connor, said in a separate statement that Biden had a runny nose, dry cough and a feeling of “general malaise.” He said Biden was being treated with the drug Paxlovid “and will be self-isolating in accordance with CDC guidance for symptomatic individuals.”
What the CDC says
The Centers for Disease Control and Prevention encourages people recovering from COVID-19 or any other respiratory illness to wear masks as part of an overall strategy to reduce transmission, but masks are not mandated.
The CDC recommends that people “stay home and away from others” if they’re feeling sick. They say people can resume normal activities when symptoms have started to improve and the person no longer has a fever.
The CDC describes masks as an “additional strategy” for preventing disease spread, but it generally leaves it up to individuals to decide whether to use them. It calls masks “especially helpful” when someone is sick and suggests they be used as a precaution during recovery.
What the White House says
The White House has not responded to an emailed request for comment about why Biden chose not to wear a mask.
How is Biden doing?
O’Connor said Thursday that Biden is still experiencing mild upper respiratory symptoms from COVID-19,. The president does not have a fever and his vital signs remained normal. He’s being treated with the drug Paxlovid.
Quentin Fulks, the principal deputy manager of Biden’s reelection campaign, said Thursday that Biden was “feeling fine” and was making calls and doing work. Fulks spoke at a news conference on the sidelines of the Republican National Convention in Milwaukee.
White House national security spokesperson John Kirby told reporters during a separate Zoom briefing that Biden was “being kept up to speed as appropriate by his leadership team, and certainly that includes on the national security front.”
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Associated Press writers Mike Stobbe in New York and Will Weissert in Washington contributed to this report.