Tag: Fear

Categories
Politics

Federal Inspectors Worry Extra Vaccines Have been Uncovered to Contamination

Federal Inspectors Fear More Vaccines Were Exposed to Contamination

WASHINGTON – Federal regulators have identified serious defects at the Baltimore plant that resulted in up to 15 million potentially contaminated doses of Johnson & Johnson’s coronavirus vaccine being spilled. This casts doubt on the continued production of a vaccine in the US that the government once considered essential in the fight against the pandemic.

Food and Drug Administration regulators said the company that makes the Emergent BioSolutions vaccine may have contaminated additional doses at the facility. They said the company had not fully investigated the contamination while raising concerns about the disinfection practices, the size and design of the facility, the handling of raw materials and the training of workers.

“There is no guarantee that other lots have not been exposed to cross-contamination,” said the FDA’s 12-page report.

The report was a harsh reprimand for Emergent, who had long downplayed setbacks at the factory, and added to the problems for Johnson & Johnson, whose vaccine was viewed as a game changer because it only takes one shot and is mass-produced can volume and is easy to store.

In the US, production is now ceasing and all vaccines made at the factory have been quarantined. Johnson & Johnson fell far short of its promises to deliver tens of millions of doses to the federal government, partly because concerns about an extremely rare but dangerous blood clotting disorder led federal officials to temporarily suspend distribution last week.

The FDA’s findings, based on an inspection that ended Tuesday, underscore questions raised in New York Times reports about why Emergent didn’t fix issues sooner and why federal officials overseeing their lucrative contracts weren’t demanding better performance .

A series of confidential audits The Times conducted last year warned of the risk of viral and bacterial contamination and a lack of adequate sanitation at the Baltimore plant. Separately, The Times reported, a leading federal manufacturing expert warned last June that Emergent must be “closely monitored.”

Some health officials were surprised by the FDA’s conclusions.

“I’m shocked – I can’t put it any other way,” said Dr. José R. Romero, chairman of a panel that advises the Centers for Disease Control and Prevention and will recommend the use of Johnson & Johnson vaccine later this week. “Inappropriate disinfection, prevention of contamination – these are significant and serious violations.”

In statements on Wednesday, the FDA, Emergent and Johnson & Johnson said they were working to resolve the issues at the factory. There was no indication of how long that would take.

Emergent said, “While we are never satisfied with defects in our manufacturing equipment or processes, they can be corrected and we will take quick action to correct them.”

The FDA has not yet certified the facility in the Bayview neighborhood of Baltimore, and no doses administered there have been released to the public. All Johnson & Johnson recordings made in the United States are from overseas.

In a statement, Dr. Janet Woodcock, Acting Commissioner of the FDA, and Dr. Peter Marks, the top vaccine regulator: “We will only allow the release of products when we are sure that they meet our quality expectations.”

Emergent is a longtime government contractor who has spent much of his time over the past two decades building a market for federal biological defense spending.

Although the Emergent government placed a $ 163 million contract in 2012 to prepare the Baltimore plant for mass production in a pandemic, the site remained largely untested and the company failed to meet the requirement to demonstrate its rapid-reaction capabilities, according to former health officials and contract documents.

Even so, the Emergent government placed a $ 628 million order in June last year, largely to reserve manufacturing space at the plant, and prompted the company to manufacture the Johnson & Johnson shot and a separate vaccine developed by AstraZeneca.

Now Emergent’s dealings with the government are being scrutinized more and more closely. On Tuesday, the House Select Coronavirus Crisis Subcommittee and House Committee on Oversight and Government Reform announced an investigation into the company’s Covid-19 vaccine deal, as well as its long-standing control over an oversized portion of the country’s emergency medicine budget to Reserve, the Strategic National Stockpile.

A Times investigation found that the company’s purchase of the company’s anthrax vaccine over the past decade accounted for nearly half of the reserve’s total annual budget, leaving less cash to spend on critical supplies like masks, which were in short supply last year.

The Bayview facility was supposed to produce most of the Johnson & Johnson vaccine, which received federal emergency approval this year, but only for doses made in the Netherlands. AstraZeneca’s vaccine is not yet approved in the US, regardless of where it is made.

The FDA inspection began after routine checks revealed that Emergent employees had contaminated at least part of a batch of 13-15 million doses of the Johnson & Johnson vaccine with the harmless virus used to make the AstraZeneca shot. Regulators determined that Emergent did not investigate this incident thoroughly and only performed a routine cleanup afterwards. A previous review by Bayview for a pharmaceutical customer found that Emergent glossed over deviations from manufacturing standards without conducting thorough reviews.

The inspectors who examined security recordings as part of their review found that Emergent was not considering whether one or more employees might have been the source of the contamination. Workers are expected to change clothes, ankle boots and showers before moving between the various manufacturing zones for Johnson & Johnson and AstraZeneca.

But regulators said the rule appeared to be routinely violated. In a period of 10 days in February, for example, 13 employees moved from one zone to another on the same day, but only one documented having showered. The inspectors also said Emergent failed to consider whether using common storage containers for raw materials might have caused the contamination. Emergent’s internal audit last July found that the flow of workers and materials through the plant was not adequately controlled “to avoid mix-ups or contamination.”

Federal officials have already insisted on a major change that they believe should significantly limit the risks. This month they instructed Emergent to stop the AstraZeneca shot at the factory and are now trying to help AstraZeneca find a new manufacturing facility.

In another result, the FDA regulators wrote that the Bayview building “is not being kept in a clean and hygienic condition”. Nor is it “of the appropriate size, design and location to facilitate cleaning, maintenance and proper operation,” they said.

They cited peeling paint, damaged walls, improperly trained staff, overcrowded equipment and poor waste disposal. A problem that, in their opinion, could lead to contamination of the warehouse in which raw materials are stored.

The results were released two days prior to the CDC’s scheduled vote to extend, lift, or change the suspension of Johnson & Johnson. Officials recommended the break to investigate eight cases of a rare coagulation disorder in vaccine recipients, one of which was fatal.

Johnson & Johnson resumed its rollout in Europe this week after regulators investigated similar concerns. They recommended putting a warning about the blood clots on the vaccine label, but said the benefits outweighed the risks.

The inspection report comes as a group of shareholders sued Emergent, alleging executives misled investors about the company’s ability to manufacture Covid-19 vaccines in Baltimore.

Emergent’s share price soared following announcements of $ 1.5 billion in deals with the federal government, Johnson & Johnson and AstraZeneca last year. Throughout 2020, its founder and chairman Fuad El-Hibri deposited over $ 42 million in shares and options, and the company’s executive director Robert Kramer recently received a cash bonus of $ 1.2 million.

The lawsuit alleges that the stock price was artificially increased because executives failed to disclose significant quality control issues at the facility. Emergent stocks have been falling in the past few weeks.

Shortly after the Trump administration’s Operation Warp Speed ​​decided to award the $ 628 million contract to Emergent, Carlo de Notaristefani, a manufacturing expert who has been overseeing vaccine production for the federal government since last May, warned the company about his To have to “strengthen” quality controls. requires “significant resources and dedication”.

Dr. Robert Kadlec, the former Trump administration official overseeing the procurement process, said in an interview Tuesday that officials “recognized that there would be inherent risks,” but the government intends “to try to manage those risks consistently.” to reduce. ” . ”

Dr. Romero, the head of the CDC advisory board who is also the Arkansas Secretary of Health, was concerned that the plant’s problems could keep people from getting vaccinated, even though doses from there have not reached the public. Andy Slavitt, a senior health advisor to President Biden, told reporters that the audit “demonstrated a process that is working as it should”.

Johnson & Johnson said it had already increased oversight of Emergent and would “ensure that all FDA observations are promptly and comprehensively addressed”.

The pharmaceutical company is expected to nearly double its supervisors at the Bayview facility to perhaps a dozen, although Emergent will continue to employ around 600 people.

Categories
Health

Well being Care Employees on the Frontline Face a 12 months of Threat, Worry and Loss

Health Care Workers on the Frontline Face a Year of Risk, Fear and Loss

Gabrielle Dawn Luna sees her father with every patient she treats.

As a nurse in the emergency room at the same hospital where her father died of Covid in March last year, Ms. Luna knows firsthand what it is like for a family to hold onto any new information. She has become aware of the need to take extra time to explain developments to a patient’s family members who are frequently checking for updates.

And Mrs. Luna was willing to share her personal loss if it helps, as she recently did with a patient whose husband has died. But she also learned to hold it back to respect each person’s grief, as she did when a colleague’s father succumbed to the disease.

It is a challenge to let oneself grieve enough to help patients without feeling overwhelmed.

“Sometimes I think it’s too much of a responsibility,” she said. “But that’s the job I signed up for, isn’t it?”

The Lunas are a foster family. Her father, Tom Omaña Luna, was also a lifeguard and was proud when Mrs. Luna came to him in the field. When he died on April 9, Ms. Luna, who also had mild symptoms of Covid-19, took about a week off. Her mother, a nurse in a long-term care facility, then spent about six weeks at home.

“She didn’t want me to go back to work for fear that something would happen to me too,” said Ms. Luna. “But I had to go back. You needed me “

As her hospital in Teaneck, New Jersey swelled with virus patients, she struggled with stress, burnout, and an excruciating fear that left an open wound on her grief: “Did I give it to him? I don’t want to think about it, but it’s a possibility. “

Like the Lunas, many who treated millions of coronavirus patients in the United States last year come from medically defined families. It is a calling that is passed down through the generations and connects spouses and siblings who are states apart.

It’s a bond that brings the success of shared experiences, but for many, the pandemic has also brought a variety of fears and stresses with it. Many have been concerned about the risks they are taking and those their loved ones are exposed to every day. They worry about the invisible scars they have left.

And for those like Ms. Luna, the care they give coronavirus patients is shaped by the beloved healer they lost to the virus.

For Dr. Nadia Zuabi is so new to the loss that she still refers to her father, another ambulance in the present.

Your father, dr. Shawki Zuabi spent his final days at her UCI Health hospital in Orange County, California before dying of Covid on January 8th. The younger Dr. Zuabi returned to work almost immediately, hoping to carry on with the purpose and camaraderie of her colleagues.

She had expected that working with the people who had cared for her father would deepen her commitment to her own patients, and to some extent, too. Most importantly, she realized how important it is to balance this stressful emotional availability with her own well-being.

“I always try to be as empathic and compassionate as possible,” said Dr. Zuabi. “There is a part of you who may have to build a wall as a survival mechanism because I don’t think it’s sustainable to feel it all the time.”

The work is filled with memories. When she saw the fingertips of a patient, she remembered how her colleagues had also pricked her father’s to check insulin levels.

“He had all these bruises on his fingertips,” she said. “It just broke my heart.”

The two had always been close, but they found a special bond when she went to medical school. Doctors often descend from doctors. About 20 percent in Sweden have parents with medical degrees, and researchers believe the rate is similar in the United States.

The older Dr. Zuabi had a present for conversation and loved talking about medicine with his daughter as he sat in his living room chair with his feet propped up. She is still in her residency training and would reach out to him all last year for advice on the challenging Covid cases she was working on and he would dispel her doubts. “You have to trust yourself,” he told her.

Updated

March 13, 2021, 6:24 p.m. ET

When he caught the virus, she took each day off to be by his bedside and continued their conversations. Even when he was intubated, she pretended they were still talking.

She still does. After difficult shifts, she turns to her memories, the part of him that stays with her. “He really thought I was going to be a great doctor,” she said. “If that’s what my father thought of me, it must be true. I can do it, even if it doesn’t feel like it sometimes. “

Just as medicine is often a passion that arises from a set of values ​​passed down from one generation to the next, so it is also one that is shared by siblings and that brings healers together in marriage.

A quarter of doctors in the US are married to another doctor, according to a study published in the Annals of Internal Medicine. Maria Polyakova, a professor of health policy at Stanford University, said she wouldn’t be surprised if the number of doctors in the U.S. who had siblings with medical degrees was about as high as the Swedish, about 14 percent.

In interviews with a dozen doctors and nurses, they described how helpful it has long been to have a loved one who knows the rigors of the job. But the pandemic has also shown how frightening it can be to put a loved one at risk.

A nurse’s brother took care of her when she had the virus before volunteering at another virus hotspot. A doctor chatted with her children about what would happen if she and her husband both died from the virus. And others described crying softly during a will talk after putting their children to bed.

Dr. Fred E. Kency Jr., a doctor at two emergency rooms in Jackson, Miss., Understood that he was surrounded by danger while serving in the Navy. He never expected that he would face such a threat in civil life or that his wife, an internist and pediatrician, would face the same dangers.

“It’s scary to know that my wife has to go to the rooms of patients with Covid every day,” said Dr. Kency before he and his wife were vaccinated. “But it is a reward to know that not just one of us, the two of us, are doing everything we can to save lives in this pandemic.”

The vaccine has eliminated fears of being vaccinated at work among vaccinated medical professionals, but some express deep concern at the toll that working in a year of horror has left their closest relatives.

“I am concerned about the amount of suffering and death she sees,” said Dr. Adesuwa I. Akhetuamhen, an emergency physician at Northwestern Medicine in Chicago, about her sister, the doctor at the Mayo Clinic in Rochester, Minn. I feel like I learned to deal with this while working in the emergency room before Covid started, but it’s not something that should be happening in her specialty as a neurologist. “

She and her sister, Dr. Eseosa T. Ighodaro, have been on the phone regularly to compare notes on the precautions they have taken, to update their families, and to support one another. “She totally understands what I’m going through and encourages me,” said Dr. Ighodaro.

The seemingly endless intensity of work, increasing deaths, and the careless attitudes of some Americans about safety precautions have caused anxiety, fatigue, and burnout in a growing number of healthcare workers. Almost 25 percent of them are most likely to have PTSD, according to a survey published by the Yale School of Medicine in February. And many have left the field or are considering doing so.

Donna Quinn, a midwife at NYU Health in Manhattan, has feared that her son’s experience as an ambulance doctor in Chicago will cause him to leave the field he recently came to. He was in his final year of residence when the pandemic started and he volunteered on the intubation team.

“I’m concerned about the toll he’s taking emotionally,” she said. “There were nights when we tearfully talked about what happened to us.”

She still has nightmares that are sometimes so terrible that she falls out of bed. Some are about her son or about patients she cannot help. In one, a patient’s bed linen is transformed into a towering monster that chases her out of the room.

When Ms. Luna first returned to her emergency room at Holy Name Medical Center in Teaneck, New Jersey after her father’s death, she felt that something was missing. She had got used to having him there. It had been nerve-wracking when she was asked, “Is that my father?” On every urgent intercom call after a resuscitation. But at least she could stop by now and then to see how he was doing.

Furthermore, she had never known what it was like to be a nurse without him. She remembered going to elementary school to step into the field and using a yellow highlighter to paint over almost every line in his large textbooks.

During breakfast last March, Ms. Luna told her father how upset she was after holding an iPad for a dying patient to say goodbye to a family who couldn’t go to the hospital.

“This is our job,” she recalled Mr. Luna. “We’re here to act as a family when the family can’t be there. It’s a difficult role. It will be difficult, and there will be more times that you have to do it. “

Kitty Bennett contributed to the research.

Categories
World News

To Battle or Cover: Worry Grips Myanmar With Navy Again in Cost

To Fight or Hide: Fear Grips Myanmar With Military Back in Charge

The red balloons rose over a frightened city. Hundreds of them hovered over the golden tower of Sule Pagoda in Yangon, the commercial capital of Myanmar, and drifted along an avenue where more than a dozen years ago soldiers shot dead citizens marching peacefully for democracy.

The balloons hovering over Yangon were released by activists, expressing their hope that elected leaders, detained in a military coup, would be free again. The color – later pink after red balloons sold out – symbolized the party of the National League for Democracy, which until Monday led the civilian government headed by Daw Aung San Suu Kyi.

On Saturday, balloons weren’t enough and the protesters’ familiar footsteps rang out in the city. When armed policemen stood behind protective shields, the demonstrators demanded “democracy rise, the military dictatorship fall” and sang protest anthems that once brought prison sentences.

With the abrupt takeover of power by the generals, the people of Myanmar are back in the crosshairs of the military – and increasingly cut off from the world. Although the coup led by Lieutenant General Min Aung Hlaing, the army chief, was bloodless itself, the military has resorted to familiar tactics in recent days: dozens of arrests, strikes by mysterious thugs, telecommunications outages, and this time social media bans on Facebook, Twitter and Instagram . A whole class of people – including poets, painters, reporters, and rap artists – have gone into hiding.

When officers of the special department, the fearsome secret service, knocked on the doors, the muscular memory of living under almost half a century of direct military rule had – look to the left, look to the right, don’t linger too long – people who had resorted to both camouflage and Cunning. The reflexes may have been rusty, but they have set in quickly in this new, uncertain era of terror.

The balloons and marches were among hundreds of acts of defiance by a population whose DNA is encoded with both resistance and vigilance. Every day brings growing disagreements on the street as well as moments of civil disobedience that are as subtle as they are powerful. People test the limits of what can be done and said.

On Saturday, thousands of people wearing hard hats and face masks marched in Yangon for the largest rally since the coup. But the world couldn’t watch. Live social media feeds of the protests were abruptly shut down as mobile internet, and then broadband services across the country were cut, just as they were during the coup.

Around the same time, in Mandalay, a convoy of hundreds of cars and motorcycles circled the iconic moat around the city’s old palace, honking their support for the protest movement. Soldiers and policemen stood with guns drawn.

Since the coup, cities across Myanmar have rang with the din of clinking pots, pans, gongs and empty water jugs, a traditional farewell for the devil, who in this case wears army green.

The generals have been busy this week. More than 130 officials and lawmakers and 14 civil society figures were arrested in the early hours of the coup, according to the Assistance Association for Political Prisoners, a group that focuses on political prisoners in Myanmar.

“I will do this until the dwarf Min Aung Hlaing dies,” said Daw Marlar, a participant in the protests. “I will fight until I die.”

On an offshore natural gas platform, workers in orange overalls waved red ribbons to support the National League for Democracy. More than 500 instructors at Yangon University also wanted to join the campaign, but activists had only prepared 200 tapes. The doctors posed with three fingers in a rebellious gesture from the “Hunger Games” films. The entire staff of the Ministry of Social Affairs resigned.

On Monday, the day of the coup, a daughter of Dr. Si Thu Kyaw, a surgeon at Mandalay General Hospital, was born. The 34-year-old doctor greeted his newborn baby and then led a campaign against civil disobedience among medical professionals.

“We went through life in fear under the military junta, but we will not let it happen to the next generation,” he said. “We are not afraid of the military. We are not afraid of their weapons. If we agree, it’s like we’re in the morgue. We have to fight back. “

The generals may have ruled Myanmar for nearly 50 years, but they are taking over a country that has changed remarkably over the past decade. In 2007, in downtown Yangon, invisible blood seeped into the burgundy robes of Buddhist monks who were shot by soldiers in yet another downcast protest movement. Discarded flip-flops indicated panicked feet fleeing bullets. The nation was largely unplugged at the time, and cell phone cards were only available to those who could pay $ 3,000. News whispered in tea shops.

Today there are skyscrapers and shopping malls, billboards for iPhones and cafes suitable for Instagram in the same streets. It often feels like all of Myanmar is on Facebook. Shortly after the Department of Transportation and Communications blocked the social media site, the use of virtual private networks to circumvent the ban rose 6,700 percent, according to a technology research firm. Twitter and Instagram bans followed.

By Friday, the campaign against civil disobedience had harnessed the energy of students and even some soldiers. Satirical memes and protest art have increased. A national association representing the interests of Nats and Weizzas, the various ghosts and wizards believed to live in the country, said it would cast a spell over the coup plotters. The organization was created after the military takeover on Monday.

Some young people defiantly bow to the light of their phones and remain defiant. The generation with the panda eyes, as they call themselves, mounts vigils night after night.

On Facebook, a grandson of a former junta leader, retired Lieutenant General Than Shwe, posted a sticker with bouncing teddy bear bottoms to aid someone deciphering the coup. “Stay strong,” he wrote along with emojis with a heart and muscular arms. “You will never go alone.”

Tens of thousands of people liked Facebook campaigns to boycott a beer company and cellular operator that are part of the military’s immense business empire. Another embargo is on a member of the new military cabinet who owns gold and diamond businesses.

The hashtag #savemyanmar has attracted tens of millions of supporters, and even Rihanna, the pop singer, sent her prayers to the citizens of the country.

But when the resistance has become sharper and more refined, the military still shows its strength. 21 people were picked up by police on Thursday evening, banging pots and pans in Mandalay. Activists and reporters were shadowed again. The generals transferred power to the National League for Democracy in 2015 after the party won elections in a landslide, but they did not dismantle the vast security apparatus that had locked the country in place for decades.

In the elections last November, the National League for Democracy received an even more crucial mandate. But the army, whose proxy party did terribly, claimed that the election was tarnished by fraud.

It did not help that, even in the years of hybrid military-civil governance, the number of political prisoners grew larger than in the previous era of transitional military rule. The Relief Society for Political Prisoners says that before the coup, more than 700 people were either in jail or tried for crimes of conscience.

The army, which has vowed to rule for at least a year with a board of 15 member states reporting to General Min Aung Hlaing, has shown that it will use any legal pretext to imprison people.

A court document surfaced Wednesday confirming that Ms. Aung San Suu Kyi, a Nobel Peace Prize winner who had been under house arrest for 15 years, was charged with an arcane violation related to walkie-talkies and other imported equipment in her mansion was Naypyidaw, the capital. President U Win Myint, who was also detained Monday, faces separate charges of violating coronavirus regulations by welcoming supporters in last year’s election campaign.

The charges against the two civilian leaders may seem absurd, but they could jail anyone for up to three years, which is a reminder that Myanmar can be run like a penal state. In 2016, a poet who wrote about a former president’s tattoo on his penis was sentenced to six months in prison for online defamation. During the years of direct military rule, critics of the army were imprisoned for holding foreign currency and reversing on motorcycles, among other things.

The coup on Monday took place before daybreak, when the taps were not overcrowded and the monks had not gone barefoot to their morning pastures. As dusk falls every night after the army is taken over, the national mood is desperate. Who will be taken tonight?

Since little information is known about the fate of those still in custody – some have been released and placed under house arrest – people again rely on “oral radio”, as rumors are called.

“We know that protesting on the street is very risky, but we have to do it,” said Ko Ye Win Aung, a protest organizer. “We cannot let democracy go backwards.”

If there is one constant, as Myanmar’s military is called, in the history of the Tatmadaw, it is a willingness to shed blood. The military put down tens of thousands of protests in 1988 and 2007. When Ms. Aung San Suu Kyi was under house arrest in 2003, generals sent thugs into her convoy and killed dozen.

And in the border areas of the nation the Tatmadaw has killed, raped and burned. According to United Nations investigators, a genocide was committed against the Rohingya, which culminated in an exodus of the Muslim minority in 2017.

As protests intensify, some fear that bloody crackdown will be inevitable. U Tun Shein, a trishaw driver, said he peeled a photo of Ms. Aung San Suu Kyi from his vehicle.

“She will still be in my heart,” he said.

On Thursday, U Win Htein, an elder from the National League for Democracy, sat in his home awaiting arrest.

Win Htein, a former army captain who joined the opposition movement and became one of Ms. Aung San Suu Kyi’s closest advisers, spent about 20 years in prison. In the notorious Insein Prison, he read international business papers and wrote love letters to his wife.

When he was released in 2010, the same year as Ms. Aung San Suu Kyi, he joked that he was “out for the time being” and made fun of others in the National League for Democracy who had served shorter sentences. Mr. Win Htein became a legislator in the civil government.

Around midnight, in the shade between Thursday and Friday, soldiers and men from Special Branch came for him. Win Htein, 79, was charged with criticizing the coup.

“I’m back,” Win Htein said hours earlier, short for imprisonment. “But do not worry. My heart is free “