FDA Approves A Drug For A Rare Disease That Causes Children To Age Quickly : Shots

Sam Berns and Audrey Gordon, executive director of The Progeria Research Foundation and Berns’s aunt, attend The New York Premiere Of HBO’s “Life According To Sam” on October 8, 2013 in New York City.

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Sam Berns and Audrey Gordon, executive director of The Progeria Research Foundation and Berns’s aunt, attend The New York Premiere Of HBO’s “Life According To Sam” on October 8, 2013 in New York City.

Thos Robinson/Getty Images for HBO

The Food and Drug Administration has approved a drug that extends the lives of children with an extremely rare genetic disorder that causes them to grow old before they grow up.

The disorder, progeria, ages cells rapidly and prematurely. As a result, affected children remain small and begin to look frail and old by the time they reach school age. Most die of heart disease in their early teens.

But the drug, Zokinvy, slows down the decline.

“Zokinvy is a treatment. It’s not a cure,” says Dr. Leslie Gordon, an assistant professor of pediatrics at Brown University and medical director of The Progeria Research Foundation. “But what we can say is that, so far, we know that it increases the average lifespan by about two-and-a-half years.”

Gordon and her family played a crucial role in making Zokinvy possible.

Their goal was to find a treatment for Gordon’s son, Sam Berns, who was diagnosed with progeria in 1998 and died in 2014.

“We started this for Sam, and Sam is always here, always,” Gordon says.

Sam Berns gave a TEDx talk about living with progeria.

YouTube

As a teenager, Sam became the public face of progeria. He spoke to NPR and other media about his condition, was the subject of an HBO documentary, and gave a TEDx talk about how to live a happy life that has been viewed more than 40 million times.

Sam was one of the first children with progeria to receive Zokinvy and Gordon says the drug seemed to extend her son’s life.

“I think Sam felt that way,” she says. “And looking at the data, and as parents, we felt that way too.”

Since Sam’s death, his family has continued to operate The Progeria Research Foundation and to search for a cure.

“We make a really great team,” says Audrey Gordon, who is Sam’s aunt and the foundation’s president. “Leslie [is] in charge of the science aspect, I’m in charge of the fundraising and her husband, Scott, is the chairman of the board.”

The approach reflects a philosophy embraced by Sam, who was a big sports fan, Audrey Gordon says.

“Whenever someone asked, who’s your favorite player on your beloved Patriots or your Boston Bruins, he always refused because he felt like it wasn’t any one person who made the team,” she says “It was the team as a whole.”

Team Sam published the first evidence that Zokinvy worked in 2012. But getting FDA approval required a whole new

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Medicaid’s Future As Safety-Net Health Care Hinges On Election : Shots

Health care activists rallied in front of the U.S. Capitol on March 22, 2017, to protest Republican efforts that would have dismantled the Affordable Care Act and capped federal payments for Medicaid patients. The Republican congressional bills, part of the party’s “repeal and replace” push in 2017, were eventually defeated.

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Health care activists rallied in front of the U.S. Capitol on March 22, 2017, to protest Republican efforts that would have dismantled the Affordable Care Act and capped federal payments for Medicaid patients. The Republican congressional bills, part of the party’s “repeal and replace” push in 2017, were eventually defeated.

Alex Wong/Getty Images

It was either put food on the table or drop their health insurance, says Oscar Anchia of Miami. His wife’s coverage was costing $700 a month, and his hours had been cut back because of the coronavirus pandemic. So Anchia made the difficult decision to drop his spouse from his policy, because they needed the money.

Then in October, his love for 40 years fell ill with COVID-19.

“This has been a crazy, crazy nightmare,” he said, after his wife’s first week in the hospital. He kept asking Baptist Health about the bill. He was already at $92,000 from her stay in the intensive care unit.

At this point, Anchia’s best hope is that his wife will be covered by a federal assistance program for uninsured COVID-19 patients. But that’s because he lives in one of the dozen holdout states that hasn’t expanded Medicaid through the Affordable Care Act. That part of the ACA was intended to provide health coverage for adults who are working but who have no insurance through their job — either because it’s not offered or because they can’t afford the premiums.

Medicaid provides health care for millions of low-income Americans. But its future depends very much on politics. Over the past four years, the Trump administration has tried to impose conservative principles on the program and shrink it. A Joe Biden presidency would attempt to go the other way.

“For example, me, I always work. I’ve been working 36 years in the same company,” says Anchia, who builds signage for airports. “And now I find myself in this position. Medicaid would be great for regular people. I’m not the only one.”

Anchia’s wife is out of the ICU, but he also expects he’ll need help paying for prescription medication when she’s sent home.

In Florida alone, roughly 1.5 million people would be eligible for coverage under Medicaid expansion, according to estimates by the Florida Health Justice Project. It’s a number that has grown recently because of the economic trouble and job losses triggered by the pandemic.

“The pandemic has really elevated the visibility of the suffering and that it cuts across socioeconomic lines,” says Miriam Harmatz, executive director of the Florida Health Justice Project. “These are folks you wouldn’t have expected to be among the ranks of the uninsured.”

Under a Biden

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In A Small Pennsylvania City, A Mental Crisis Call To 911 Turns Tragic : Shots

Rulennis Munoz (center right) outside Lancaster Courthouse Oct. 14, after learning that the police officer who fatally shot her brother had been cleared of criminal wrongdoing by the Lancaster County District Attorney. Her mother, Miguelina Peña, and her attorney Michael Perna (far right) stood by.

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Rulennis Muñoz remembers the phone ringing on Sept. 13. Her mother was calling from the car, frustrated. Rulennis could also hear her brother Ricardo shouting in the background. Her mom told her that Ricardo, who was 27, wouldn’t take his medication. He had been diagnosed with paranoid schizophrenia five years earlier.

Ricardo lived with his mother in Lancaster, Pa., but earlier that day he had been over at Rulennis’ house across town. Rulennis remembers that her brother had been having what she calls “an episode” that morning. Ricardo had become agitated because his phone charger was missing. When she found it for him, he insisted it wasn’t the same one.

Rulennis knew that her brother was in crisis and that he needed psychiatric care. But she also knew from experience that there were few emergency resources available for Ricardo unless a judge deemed him a threat to himself or others.

After talking with her mom, Rulennis called a county crisis intervention line to see if Ricardo could be committed for inpatient care. It was Sunday afternoon. The crisis worker told her to call the police to see if the officers could petition a judge to force Ricardo to go to the hospital for psychiatric treatment, in what’s called an involuntary commitment. Reluctant to call 911, and wanting more information, Rulennis dialed the non-emergency police number.

Meanwhile, her mother, Miguelina Peña, was back in her own neighborhood. Her other daughter, Deborah, lived only a few doors down. Peña started telling Deborah what was going on. Ricardo was becoming aggressive; he had punched the inside of the car. Back on their block, he was still yelling and upset, and couldn’t be calmed. Deborah called 911 to get help for Ricardo. She didn’t know that her sister was trying the non-emergency line.

The problems and perils of calling 911 for help with mental health

A recording and transcript of the 911 call show that the dispatcher gave Deborah three options: police, fire or ambulance. Deborah wasn’t sure, so she said “police.” Then she went on to explain that Ricardo was being aggressive, had a mental illness and needed to go to the hospital.

Meanwhile, Ricardo had moved on, walking up the street to where he and his mother lived. When the dispatcher questioned Deborah further, she also mentioned that Ricardo was trying “to break into” his mom’s house. She didn’t mention that Ricardo also lived in that house. She did mention that her mother “was afraid” to go back home with him.

The Muñoz family has since emphasized that Ricardo was never a threat to them. However, by the time police got the message, they believed they were responding to

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Doctors urge flu shots in light of COVID-19. Here’s what you need to know.

Health experts have urged Americans to get their flu shots this year to help ward off a “twindemic.”

“There’s considerable concern as we enter the fall and the winter months and into the flu season that we’ll have that dreaded overlap” of COVID-19 and the flu, the nation’s top infectious disease expert, Dr. Anthony Fauci, said earlier this month. 

The U.S. is battling a fresh surge of new coronavirus cases as winter approaches, and hospitals in some western and Midwestern states are filling up with COVID patients. The new rise follows an outbreak of COVID-19 cases that hit the Northeast hard earlier this year, followed by a rise in cases in the South over the summer. 

“We far surpassed what we’re used to with the flu with COVID this spring,” said Dr. Stephanie Sterling, chief of infectious disease at NYU Langone Hospital–Brooklyn, in New York. “And to consider COVID plus flu together, this kind of pandemic would be devastating for communities and for healthcare systems.” 

She said we need to do everything we can to prevent the flu. 

“We don’t want a bad influenza season coinciding with a second wave of COVID,” Sterling said. “Flu shots are safe. They do help prevent illness.”

Why is getting a flu shot so important this year? 

“One is to prevent flu illnesses and it’s complications, but the benefit in this current season are resources that would otherwise be needed to care for patients with the flu that would become scarce, could be directed toward the pandemic,” said Dr. Ram Koppaka, a medical officer for the CDC’s National Center for Immunization and Respiratory Diseases.

The CDC estimates that last flu season, there were 38 million flu illnesses, 400,000 flu hospitalizations and 22,000 flu deaths. Koppaka said there were also 188 pediatric deaths from influenza. 

An estimated 48% of U.S. adults and 64% of children received a flu vaccine during the same season. Koppaka said the number of flu vaccinations had been increasing prior to COVID-19, but there was still a need for improvement. 

Sterling said that despite communities having a good amount of flu vaccinations, emergency rooms and hospital beds are often overwhelmed during a normal flu season.

This could be a great concern for hospitals in rural areas. Many rural hospitals have limited beds and ventilators, and rural Americans may be at higher risk of getting severely ill from COVID-19 due to a range of factors, according to the CDC.

Additionally, the body does not do well fighting two infections at the same time, according to Dr. Jacqueline P. Cooke, a hospitalist at Jefferson Health in New Jersey. 

“The danger with COVID-19 is that the viral infection leads to overwhelming pneumonia and that type of viral pneumonia is what is causing the vast majority of people to need respiratory assistance and ventilation,” she said. 

Who should get a flu shot?

The CDC encourages people six months of age and older to get an annual flu shot. There are different types of vaccines that

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Fighting A High Medical Bill Takes Tenacity And Health Insurance Know-How : Shots

When Tiffany Qiu found herself on the hook for her usual 30% Blue Shield of California coinsurance after the hospital quoted 20%, she pushed back.

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Shelby Knowles for KHN

When Tiffany Qiu found herself on the hook for her usual 30% Blue Shield of California coinsurance after the hospital quoted 20%, she pushed back.

Shelby Knowles for KHN

When Tiffany Qiu heard how much her surgery was going to cost her, she was sure the hospital’s financial department had made a mistake. Qiu already knew from a breast cancer scare earlier that year that her plan required a 30% coinsurance payment on operations, so she pressed the person on the phone several times to make sure she had heard correctly: Her coinsurance payment would be only 20% if she had the procedure at Palomar Medical Center in Poway, California, about 38 miles south of where Qiu lives.

“I was kind of in doubt, so I called them a second time,” said Qiu. “They gave me the exact same amount.”

Qiu had been diagnosed with uterine polyps, a benign condition that was making her periods heavier and more unpredictable. Her OB-GYN proposed removing them but said it was safe to wait. Qiu said that she asked about the possibility of doing it in the doctor’s office under local anesthesia to make the procedure cheaper, but that her doctor rebuffed her suggestion.

Because Qiu thought she was getting a deal on her usual 30% share of the bill, she decided to go ahead with the polyp removal on Nov. 5, 2019. As she sat in the waiting room filling out forms, staffers let her know she needed to pay in full before the surgery.

Unease set in. The hospital asked for the 20% coinsurance — $1,656.10 — that she had been quoted over the phone, but Qiu hadn’t been told she needed to pay on the day of the procedure. As she handed over her credit card, she confirmed one more time that this would be her total patient responsibility, barring complications.

The surgery was over in less than 30 minutes, and she walked out of the hospital with her husband, feeling perfectly fine.

Then the bill came.

Patient: Tiffany Qiu is a 49-year-old real estate agent and mother of two who lives in Temecula, California. Her family of four is covered by a Blue Shield of California policy that she and her husband purchased on the marketplace. Last year, they paid a $1,455 monthly premium, with an individual annual $1,850 deductible and an individual out-of-pocket maximum of $7,550.

Total Bill: Palomar Health billed Blue Shield $22,219.64 for the polyp removal, which the insurer negotiated down to $8,576.79. Blue Shield paid $5,769.72 and stated in an explanation of benefits document that Qiu was responsible for a $334.32 deductible and $2,472.75 coinsurance.

Because Qiu had already paid $1,873.20 on the day of surgery, the hospital billed her an additional $933.87, which meant Qiu was on

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Washington Offering Free Flu Shots To Uninsured Adults

WASHINGTON — This year’s flu season has been very mild, and state health officials would like to keep it that way.

The Washington State Department of Health has announced a new program, offering free flu shots to uninsured adults at 23 participating Albertsons and Safeway pharmacies across the state.

To qualify for a free shot, patients must be over 18 and uninsured. No proof of residency or immigration status will be required. Flu vaccines are already being offered and the program will run through June of 2021.

Participating Pharmacies in Western Washington

Location

Address

Phone Number

Safeway Pharmacy (Store #1546)

221 West Heron Street
Aberdeen, WA 98520

(360) 532-8743

Safeway Pharmacy (Store #0531)

101 Auburn Way S
Auburn, WA 98002

(253) 735-4404

Safeway Pharmacy (Store #3285)

1275 E Sunset Drive
Bellingham, WA 98226

(360) 650-1537

Safeway Pharmacy (Store #1467)

900 N Callow
Bremerton, WA 98312

(360) 792-9262

Safeway Pharmacy (Store #0474)

1715 Broadway
Everett, WA 98201

(425) 339-9448

Safeway Pharmacy (Store #1484)

4128 Rucker Ave
Everett, WA 98203

(425) 258-3552

Safeway Pharmacy (Store #1294)

210 Washington Ave S
Kent, WA 98032

(253) 852-5115

Safeway Pharmacy (Store #1464)

3215 Harrison Avenue NW
Olympia, WA 98502

(360) 956-3827

Safeway Pharmacy (Store #1492)

110 East 3rd Street
Port Angeles, WA 98362

(360) 457-0599

Safeway Pharmacy (Store #1563)

200 S 3rd Street
Renton, WA 98057

(425) 226-0325

Safeway Pharmacy (Store #1508)

3820 Rainier Avenue South
Seattle, WA 98118

(206) 725-9887

Safeway Pharmacy (Store #3213)

15332 Aurora Ave N
Shoreline, WA 98133

(206) 539-5500

Safeway Pharmacy (Store #0329)

1112 South M Street
Tacoma, WA 98405

(253) 627-8840

Safeway Pharmacy (Store #1437)

1302 E 38th Street
Tacoma, WA 98418

(253) 471-1630

Learn more about the program from the Washington State Department of Health’s website.

Washington’s top health officials say, in the middle of a pandemic, the last thing our medical system needs is an influx of flu patients.

“The potential for a severe influenza season, or even an average influenza season, compounding the COVID outbreak is very, very disturbing and worrisome,” said King County Health Officer Dr. Jeff Duchin.

Read more: Health Experts: Now ‘More Important Than Ever’ To Get Flu Vaccine

The flu shot is recommended for everyone six months old or older. Patients over 65 should consult with their doctor first.

The Washington State Department of Health says there are several changes patients should be aware of for the 2020-2021 flu season:

  • All children under 19 can now receive flu vaccines and other recommended vaccines for free.

  • Most insurance plan cover the cost of the flu vaccine for adults.

  • Adults without insurance may qualify to recieve the vaccine at no cost. Find more information on free vaccination from your local health department.

Guidance from the Center for Disease Control and Prevention shows the best time to get vaccinated is between September and October, though if the flu season persists past October it’s never too late to get the vaccine. Receiving a vaccine too early, like in August or July, can leave it

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Trump vs. Biden On Health Care: Compare Their Platforms : Shots

President Trump and former Vice President Joe Biden have widely divergent views on health care issues.

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President Trump and former Vice President Joe Biden have widely divergent views on health care issues.

Patrick Semansky/AP

Health care was going to be the defining issue of the 2020 election before a pandemic and economic upheaval eclipsed pretty much everything else. But of course, the pandemic has highlighted many health policy issues.

With a highly contagious virus spreading around the world, “you might be thinking more about the importance of health insurance, or you may be worried about losing your job, which is where you get your health insurance,” says Sabrina Corlette, co-director of the Center on Health Insurance Reforms at Georgetown University. “The COVID pandemic and health policy are intertwined.”

Meanwhile, the choice between the two major presidential candidates on health policy could not be more stark. Drawing from President Trump’s record on health care and former Vice President Joe Biden’s policy proposals, here’s a guide to where they stand.

The Affordable Care Act

The candidates’ visions differ radically on the Affordable Care Act, President Barack Obama’s signature health care law, which was enacted in 2010.

“President Trump has — from Day 1 — pushed for repealing or overturning the ACA, and Joe Biden is pushing to build and expand on it,” says Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation.

The Supreme Court is slated to hear arguments on the latest challenge to the ACA on Nov. 10. If the court does overturn the law, the president and Congress will have to work quickly to address the possibility of tens of millions becoming uninsured.

One of the ACA’s most popular provisions is protection for people with preexisting conditions from being denied coverage or charged higher premiums. Trump has promised to keep this part of the law but hasn’t offered specifics on how, and policy experts warn it’s harder than it sounds.

Medicare and Medicaid

When it comes to Medicare and Medicaid, the federal health programs that together provide coverage to 115 million people, Trump has promoted the private market and given states control, while Biden wants to expand eligibility to both programs.

Trump has sought to bring drug costs down and provide more private plan options for beneficiaries in Medicare — the federal program for people over 65 — while supporting spending caps and work requirements for Medicaid — the state-run program for low-income adults, children, pregnant women and people with disabilities.

Biden would allow people to enroll in Medicare at age 60 and would also try to create a new federal health program similar to Medicare, which he calls a public option.

COVID-19 pandemic

Biden has remarked often that he would “listen to science” in handling the pandemic, drawing a contrast with Trump, who has repeatedly contradicted his top health officials.

Biden’s proposals emphasize the role of the federal government leading the response, while Trump has delegated

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European Cities Plead for More Flu Shots as Winter Looms, Pandemic Rages | Top News

By Alicja Ptak, Emilio Parodi and Francois Murphy

WARSAW/MILAN/VIENNA (Reuters) – A surge in demand for vaccines to ward off the winter flu has led to shortages in some European cities, raising the risk of a potentially lethal “twindemic” as COVID-19 cases spike.

Many governments boosted vaccine orders this year and launched campaigns to encourage citizens to get shots.

The aim was to inoculate earlier than usual and cover a bigger portion of the continent’s 450 million population to reduce the burden on health services.

Top manufacturers such as GlaxoSmithKline

, Sanofi

, Abbott

and Seqirus have boosted supplies to the region by an average of 30% in anticipation of higher demand. But they are operating at full capacity and cannot meet all the late extra demand, Vaccines Europe, which represents the producers, said in a statement on Wednesday.

Interviews with at least 10 city and government officials, as well as medical experts, also show systems in major cities such as Warsaw are struggling with the strong early demand, causing delays and temporary shortages.

“This year, patients come all the time and ask about vaccines, more than 10 people every day,” said Grazyna Lenkowska-Mielniczuk, manager at Apteka Non Stop pharmacy in Warsaw’s Wola district.

“The wholesalers tell us the same thing as we tell patients: that there are no vaccines and we have to wait.”

Europe’s flu season begins in October and infections typically pick up between mid-November and the start of December, according to data from the European Centre for Disease Prevention and Control.

Seasonal flu viruses cause between 4 and 50 million infections each year and up to 70,000 Europeans die each year of causes linked to flu, particularly among older adults and at-risk groups.

Precautionary measures to curb COVID-19 transmission such as social distancing, mask wearing and hand washing may help curb infections this season.

There was “very limited” flu transmission in the southern hemisphere this year for that reason, Sylvie Briand, director of Global Infectious Hazard Preparedness at the World Health Organization said in a briefing last week.

Even so, surging coronavirus infections across the continent prompted EU Health Commissioner Stella Kyriakides to warn last month of the risk of a “twindemic of COVID-19 and the flu”.

Medical experts are urging more people get inoculated to prevent a deeper crisis.

“There is a need to prevent a double wave of influenza plus COVID-19,” said Clemens Wendtner, chief physician of infectiology and tropical medicine at the Munich Schwabing Clinic, who recommends people younger than 60 get the jab this year.

Poland’s Ministry of Health said it bought 3 million doses this year and will buy more if needed – as of Tuesday it had received 1.6 million shots.

But Mylan’s Influvac Tetra and Sanofi’s Vaxigrip Tetra vaccines are available in only 1% of pharmacies in Poland, according to gdziepolek.pl, a Polish website that helps patients find the nearest pharmacy with a drug they are seeking.

GSK’s Fluarix Tetra is not available and AstraZeneca’s

Fluenz Tetra is available

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The most advanced Covid-19 vaccine trials won’t tell us if the shots save lives, expert notes

The most advanced trials for coronavirus vaccines cannot tell researchers if the shots will save lives, or even if they’ll prevent serious disease, a drug development expert pointed out Wednesday.



a woman smiling for the camera


© Reuters / University of Oxford


The ongoing trials are only designed to show if the vaccines prevent infection — and most infections are mild infections, Peter Doshi, an associate editor at the BMJ medical journal and a drug development specialist at the University of Maryland’s school of pharmacy, said.

“I think there are some pretty widely held assumptions about what we are getting out of Phase 3 studies,” Doshi told CNN.

“None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus,” Doshi wrote in the BMJ.

“Hospital admissions and deaths from Covid-19 are simply too uncommon in the population being studied for an effective vaccine to demonstrate statistically significant differences in a trial of 30,000 people. The same is true of its ability to save lives or prevent transmission: the trials are not designed to find out.”

Four vaccines being developed in the US are in the most advanced, Phase 3 stage of development: those being made by Moderna, Pfizer, AstraZeneca and Johnson & Johnson. They’re “event-driven” trials, meaning that the goal is to keep them going until a certain number of volunteers become infected. If more infections are seen among people who got placebo, or dummy shots, it’s an indication the vaccines prevented infection.

But that doesn’t mean the vaccines saved people from serious disease or death, Doshi argued.

“Severe illness requiring hospital admission, which happens in only a small fraction of symptomatic Covid-19 cases, would be unlikely to occur in significant numbers in trials,” he wrote.

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee meets Thursday to discuss the ongoing coronavirus vaccine trials and what members would like the FDA to consider when reviewing any applications for either emergency use authorization for a vaccine, or full approval.

Doshi said they should consider asking the companies to reconfigure their trials to include data on preventing severe illness and death.

“People expect that the most severe part of the Covid iceberg — the ICU admissions and hospitalizations and deaths — that’s what a vaccine would put an end to,” he said.

But the current trials will just look for early infections. It’s possible to keep these current trials going and add onto them so that they will, eventually, answer the question of whether Covid vaccines save lives and prevent severe disease.

“The trials are ongoing,” he told CNN. “There’s a chance for that. It’s not too late.”

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South Korea Tries to Quell Anxiety Over Flu Shots After 13 Unexplained Deaths

Then, earlier this month, 615,000 doses of a flu vaccine​ shipped by another company were also recalled after some of them were found to contain white particles, which the government described as being a harmless protein. Almost 18,000 people had received doses before they were recalled.

No serious harm had been reported from either those lots, though dozens of people who received those doses reported fevers or other minor complaints — which are common reactions to flu shots, officials said. None of nine people who died had received vaccines from those that had been recalled, they added.

After suspending the vaccination program for teenagers for three weeks, it resumed on Oct. 13. Three days later, a 17-year-old boy in Incheon, just west of Seoul, died after receiving his shot. On Tuesday, a 77-year-old woman was found dead at her home in Gochang, south of Seoul, after being vaccinated a day earlier. On the same day, an 82-year-old man who had also been inoculated died in the central city of Daejeon.

Four of the five people who died on Wednesday ranged in age from 53 to 89. Information about the two other people who died, one on Tuesday and one on Wednesday, has not been released.

Nine of those who died, all of whom had received flu shots in the past, received vaccines supplied by several different local drugmakers, officials said.

“Since most people who got flu shots with the same vaccines reported no major problems, we concluded that those vaccines do not contain toxic materials,” said Kim Joong-gon, ​a professor of medicine at Seoul National University who led a team of investigators. “We​ concluded that we can exclude ​the vaccine ​as a problem.”​

In general, flu vaccines have a good safety record. In the United States, the Centers for Disease Control and Prevention say that the body of scientific evidence over decades “overwhelmingly” supports their safety.

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