A Lawsuit Over Frozen Embryos

When the first letter from Women & Infants Hospital arrived in the mail in July 2017, Elaine Meyer thought perhaps it was a fund-raising solicitation or clerical error. The letter, which included a billing invoice, addressed her as “Dear Patient,” but she had not been a patient at the hospital for nearly two decades. That’s when she and her husband, Barry Prizant, had completed their infertility treatment there.After three miscarriages, they had gone through several rounds of IVF at Women & Infants in Providence, R.I., near their home in Cranston, resulting in the creation of at least 18 test-tube embryos. One of those had become their son, Noah, born in December of 1996, and along with joy there had been a lot of mourning and reckoning with the reality that this would be the sole realization of their efforts.Dr. Meyer mentioned the letter to her husband and stashed it in a filing cabinet of her home office.But then another came the next month. “If you would like WIH to continue to store your embryos/oocytes,” the letter said, “please return a copy of this letter, signed and notarized, along with a check in the amount of $500.”Dr. Meyer, a longtime psychologist at Boston Children’s Hospital and associate professor of psychology at Harvard Medical School, read it with confusion and a growing sense of alarm. Without the payment, the hospital would consider embryos “legally abandoned” and may discard them.“I thought, ‘This can’t be right,’” she said. “We know we went back for all of our embryos.”Those frozen embryos, still in the hospital’s possession, are now at the center of a lawsuit that Dr. Meyer and Dr. Prizant have filed in Rhode Island’s Superior Court, alleging breach of contract, negligence, bailment and intentional infliction of emotional distress — all of which Women & Infants denies in its response. In a statement, a spokeswoman there declined to comment on the case, citing patient confidentiality and federal privacy laws. “We were always coming back for our embryos”: Dr. Meyer and Dr. Prizant.Maddie Malhotra for The New York TimesWhen the letters arrived, Dr. Meyer and Dr. Prizant, a speech and language pathologist and visiting scholar at Brown University, were then fulfilled empty nesters. Noah was in college, a successful student and happy young man that Dr. Meyer, now 63, calls “the light of our lives.”She was ensconced in her work educating students and health care professionals how to have difficult conversations with patients, upholding what she calls an “emotional standard of care.”Dr. Prizant, 69, who specializes in children and adults on the autism spectrum, was training other practitioners and churning out papers and podcasts. He is the author of “Uniquely Human,” a book written with Tom Fields-Meyer. He plays drums in a band and is proud of his roots in the stickball streets of Brooklyn. “Basically, I don’t like to take crap,” he said.He and his wife, a former 4H club member raised in a large working-class family in small-town Connecticut, met in 1985 while attending a conference at a psychiatric hospital. Married two years later, they wanted children but felt it was important for her to finish graduate school first. Dr. Meyer got pregnant at 34, then had a miscarriage. Two more miscarriages followed.The couple first sought treatment from Dr. Gary Frishman at Women & Infants, which is affiliated with Brown’s medical school, in 1995. Dr. Prizant gave his wife daily shots before her eggs were harvested at the clinic and mixed in a petri dish with his sperm to create embryos, some of which were then implanted in Dr. Meyer’s uterus. The first two cycles didn’t work.“It takes something that is supposed to be so private and so intimate and so tender and makes it a whole different affair,” Dr. Meyer said, recalling the experience. “You’re vulnerable and you’re completely dependent on other people. There are so many injections and appointments and disappointments, you put your trust in what the doctors tell you because you are desperate for the process to work.”During a third cycle, Dr. Meyer became pregnant with Noah. After his birth, she and her husband were optimistic they could have another child. There were nine embryos left over from the three cycles, and they signed agreements with the hospital to “cryopreserve” them for implantation in the future.A card made by the couple’s son, Noah.Maddie Malhotra for The New York TimesDr. Meyer felt an acute attachment to the embryos, calling each “a spark of life.” She would drive out of her way to pass by the hospital, stopping in the parking lot to sing lullabies to them while in her car. “We were always coming back for our embryos,” she said. “That was always the plan.”After Noah started preschool, the couple began anew at Women & Infants in August of 2000 with shots and doctor appointments. The hospital would thaw the nine embryos, and those that survived this process would be implanted in Dr. Meyer’s uterus, in the hopes that at least one would develop into a pregnancy.The couple said they were told all the embryos were thawed; they believe three survived the thaw and were implanted. But weeks later, they were called in for “the failure conversation” — what Dr. Meyer called the meetings with doctors to discuss an unsuccessful procedure and possible next steps.This one was with Dr. David Keefe, then the director of the hospital’s division of reproductive medicine. He advised Dr. Meyer that at 43, her and her husband’s most reasonable path to additional children was donor eggs or adoption.Dr. Prizant was done, emotionally exhausted. “It sets you in a constant state of grief,” he said of infertility treatment.Dr. Meyer, a devoted Quaker, needed a little more time and spiritual consultation, but also made peace, grateful for Noah. “We both decided,” Dr. Prizant said, “to look at having just one child as an opportunity to have more resources to serve many more children through our work.”A Crack in the GlassReading the second letter, which like the first one asked for $500, filled Dr. Meyer with dread. She left a voice mail message at the hospital. Days later, she spoke to a person who turned out to be a clerk in the billing department.“I am telling you, there are no embryos,” Dr. Meyer said, asking her to contact the lab itself.For weeks, she waited for a call back. Nothing. She called the clerk again. “I’ve confirmed with the lab, there are two frozen embryos,” the clerk said.Ms. Meyer was stunned, silent. Then she spoke. “Do you understand how serious this is?” she said.A few days later, she was driving back from the family cottage in South Kingstown, when Dr. Ruben Alvero, then the director of the fertility center at Women & Infants, called to confirm. “We have two of your embryos,” he said.She pulled her car to the side of the road.The embryos, Dr. Alvero said, had been found in a glass vial at the bottom of the tank. The vial has a crack in it, he told her, which meant that the embryos had been exposed, possibly for a decade, to the nitrogen cooling agent. They most likely are not viable, he told her, and apologized.Dr. Meyer told Dr. Alvero this was too much to take in from the side of the road. A meeting was arranged for December of that year, between Dr. Meyer, her husband, Dr. Alvero and Richard Hackett, who helped to create and manages the I.V.F. lab at Women & Infants. Dr. Frishman, who had been Dr. Meyer’s main doctor and is still on the staff at Women & Infants, did not attend.The four gathered in a conference room, with Dr. Prizant and his wife on one side, Dr. Alvero and Mr. Hackett on the other.According to the legal complaint, the men representing the hospital apologized for the circumstances that had brought them together and explained to the couple again what had happened. Two of Dr. Meyer and Dr. Prizant’s embryos had disappeared sometime before Dr. Meyer’s procedure in 2000, Dr. Meyer said they told her and her husband. The embryos were located in 2010 when the tank was emptied for cleaning or maintenance and re-entered into the inventory. The vial, as Dr. Alvero had told Dr. Meyer earlier in the fall, had been damaged. When the clinic implemented a new storage fee policy in 2017, the couple received the bills.She asked if the cells of the embryo still physically existed. They did, the men told her. Though likely compromised, the embryos are still intact, in their glass vial with her name on it.Dr. Meyer holds the lid of a petri dish containing embryos that were implanted in her in 2000.Maddie Malhotra for The New York Times“Those are ours!” Dr. Meyer blurted out, and said that she didn’t want the embryos discarded. Dr. Alvero told her that the hospital would continue to store them and that he would waive the $500 fee. He and Mr. Hackett apologized and flipped through pages in her huge medical file, which the men had brought to the meeting. Mr. Hackett stopped on one page, she said, and began tapping his fingers on it: a handwritten note that said “2 missing.”“You knew they were missing” and didn’t tell us, Dr. Meyer asked?No one ever tried to find the embryos, or thought to alert us when they were found years later, Dr. Prizant asked?Perhaps the couple forgot that they had been told that the embryos were missing, they said Dr. Alvero suggested.Dr. Prizant and Dr. Meyer were sure no one had ever told them anything was missing. Why would they have discussed adoption and egg donation if they had known two embryos were lost in the hospital? “That would have set us on a different course of action,” he said.Dr. Keefe, a professor of obstetrics and gynecology and a fertility specialist at New York University Langone Fertility Center, remembered his patients, and expressed surprise to learn of the two long-lost embryos. “Yikes,” he said. “I feel so terribly for this couple.”Dr. Keefe said that he would have only known if embryos were missing if someone from the lab had notified him, and in this case they had not. In the rare instances when embryos are lost or misplaced, he added, the protocol is to notify the patient immediately, apologize and explain in detail what might have happened. “Transparency is the foundation of trust and the essential element of the doctor-patient relationship,” he said.“These are not two cans of peaches on the shelf at a Stop & Shop,” he went on, speaking of the embryos. “They are much more like two kids on a playground. When you’re responsible for them and they’re lost, you notify the people who care about them the most and tell them all you can.”Dr. Meyer, who has devoted a career to speaking up for patients and more recently to studying and writing about bioethics, scoffs at the idea that she would have quietly accepted the news in 2000 that her embryos had been lost. “There is no way on God’s green earth,” she said.Dr. Alvero, now the director of reproductive endocrinology and infertility at the Lucile Packard Children’s Hospital at Stanford University and the president of the Society for Reproductive Endocrinology and Infertility, referred questions to the public relations department of Women & Infants. The hospital’s spokeswoman said Dr. Frishman and Mr. Hackett were not available for comment.‘My Line in the Sand’At the meeting in December 2017, Dr. Prizant and Dr. Meyer said, Dr. Alvero asked what might help them feel resolved about the situation.The couple said they wanted to find something meaningful to come from the careless treatment of their embryos. Perhaps it could provide a learning opportunity, they suggested — proposing, among other ideas, that Dr. Meyer could help train fertility staff at the hospital to interact more compassionately with and informatively to patients in the thicket of family planning.Dr. Meyer and Dr. Prizant on their wedding day.Maddie Malhotra for The New York TimesDr. Alvero and Mr. Hackett said they would consult with the hospital administration and get back in touch after the holidays. But by May 2018, after five months of silence, Dr. Meyer and Dr. Prizant wrote a letter to Dr. Alvero, copying the hospital’s interim president and chief executive, the Rhode Island attorney general and the head of the state’s department of health.“As parents who cherished children, we would NOT have forgotten that our embryos were missing,” they wrote. “We would not have rested until they were found and cared for.”Soon after mailing the letter, they got a phone call from Katherine Wills, the hospital’s director of risk management. “‘This happened a long time ago,’” Dr. Meyer recalled Ms. Wills telling her. Ms. Meyer felt the message was, “Get over it.”Dr. Meyer explained to Ms. Wills that embryos discovered in the bottom of the tank represented to her and her husband potential human beings: children, her and her husband’s children. “I was horrified,” Dr. Meyer said.That conversation, she said, “was my line in the sand.” Hesitant at first, Dr. Meyer and her husband decided to take legal action. “As a woman who had suffered miscarriages and infertility, all the powerful feelings of sadness, shame and grief came crashing back and the knot in my stomach was real.”They are seeking a jury trial and punitive, compensatory, consequential damages. But Dr. Meyer and Dr. Prizant said the real point of the lawsuit is to compel the hospital, and perhaps other infertility treatment providers, to commit to reliable and accountable storage management and patient care practices. (They want to urge vigilance on the increasing number of people freezing eggs and embryos.)In a legal filing, the hospital alleged that Dr. Meyer and Dr. Prizant “were guilty of comparative negligence” but provided no further detail. Angela L. Carr, the hospital’s lawyer, declined to comment.The couple at their cottage in South Kingstown.Maddie Malhotra for The New York Times“I would not be true to myself if I let this be swept under the rug,” Dr. Meyer said. “It is our job as parents to give our children, and in this case embryos, every opportunity for life and for dignity. We were denied our right to fulfill our role as parents.”‘You Assume There is Oversight’Dr. Prizant and Dr. Meyer’s saga is “an interesting story not because it’s unique but because it’s probably not unique,” said Jeffrey Kahn, the director of the Berman Institute of Bioethics at Johns Hopkins University. (He does not know the couple and is not involved in their case.) “There is so little regulation and no accounting of how many embryos there are in storage,” he said.The fertility industry is a lucrative business but operates largely unchecked by regulators, Dr. Kahn said, for several reasons, including federal policies in place since the mid-1980s. The policies bars federal dollars from being used for research that involves the harm or destruction of human embryos.Federal regulation tends to follow federal funding, often leaving privately funded I.V.F. facilities without oversight. Also, most of what takes place in an I.V.F. laboratory falls outside the purview of the Food and Drug Administration. “You assume there is oversight, as there is with most doctors and procedures, but when it comes to infertility, that turns out not to be true,” he said.A study published in 2020 in the journal Fertility & Sterility found that 133 lawsuits were filed in the previous decade over lost, discarded or damaged frozen embryos. That number reflects lawsuits filed, which is likely a fraction of actual occurrences, said Dov Fox, the director of the Center for Health Law Policy and Bioethics at University of San Diego and one of the study’s authors. Dr. Fox also noted that most of these types of suits settled out of court, with undisclosed terms and nondisclosure agreements, making it difficult to know the outcomes.Three lawsuits have been filed against Women & Infants Hospital related to lost embryos, including two in the mid-1990s, when Ms. Meyer was a patient. In 2019, a woman named Marisa Cloutier-Bristol described receiving in 2017 a bill from Women & Infants similar to the ones that Dr. Meyer and Dr. Prizant received, which notified Ms. Cloutier-Bristol that the hospital had a frozen embryo belonging to her and her late husband, despite having been told in 2003 that her I.V.F. cycle had not produced any viable embryos.“I felt like I was now grieving a child I didn’t even know existed, a child I could have had,” she told “Good Morning America” in 2019. She sued the hospital. (The case has since been dismissed. Through her lawyer, Ms. Cloutier-Bristol declined to comment.)As Dr. Meyer and Dr. Prizant’s case winds its way through the pandemic-delayed civil courts system, the couple is also thinking about what to do with their embryos.After seeking spiritual support and guidance at their temple and their Quaker meeting, the couple is leaning toward repossessing their embryos, and burying them in the backyard in Cranston, where her mother’s ashes, and the remains of the family dog, are buried. They also have talked to a rabbi about a cemetery burial.“We need to allow our embryos to finally have some peace and rest,” Dr. Meyer said. “And we need to find some peace and rest ourselves.”

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Denmark: Three die of salmonella poisoning linked to herbal remedy

SharecloseShare pageCopy linkAbout sharingimage copyrightOrklaThree people have died in what Danish health authorities say is a large outbreak of salmonella that has left 33 people ill.Nineteen people have been treated in hospital, according to Denmark’s SSI health agency. Those involved in the outbreak are aged between two and 92.All those affected ate Husk brand psyllium husk capsules from batches recalled by manufacturer Orkla Care.Authorities found traces of salmonella in the products at patients’ homes. The herbal products are generally used as a laxative. Luise Müller of Denmark’s Statens Serum Institut said it was the first time the agency had found a herbal medicine to be the cause of a salmonella outbreak.It is not clear which ingredient could have caused the poisoning. Salmonella bacteria can be found in raw or undercooked meat, eggs or other food products. Infection can cause fever, diarrhoea, stomach pain, vomiting and in some cases death. Ms Müller said that while it was not certain that the three deaths were caused by the herbal remedy, this high rate of hospital cases and deaths was unusual. “It’s because this product is taken by people who are already vulnerable and may have stomach problems,” she told the BBC. “And when they are hospitalised or die it’s with the underlying disease as well.”‘Recall of all Husk products’Orkla Care spokesman Hakon Mageli told the BBC that no clear connection had been confirmed between the three deaths and the products. However, as a precaution he said “we have decided right now to recall all Husk products because of the outbreak in Denmark, and also for the Swedish and Norwegian and Finnish market”.Although the main focus of the Danish health investigation had been Husk capsules, Mr Mageli said the recall also applied to Husk powder. The company issued its last recall of a batch of Husk supplements on Monday.Many of those affected by the outbreak became ill in March and the health agency first alerted the public to the outbreak on 9 April. By that time there was no indication of serious illness.Ms Müller said it was possible that some people were unaware they had contracted salmonella as they were already suffering from stomach problems. The three who died are thought to have been ill already but the health agency is unable to give details of their ages.She told the BBC that delays in the surveillance system meant that more cases were likely to arise, especially if people did not see there was a recall.Mr Mageli said Orkla products had been on the Danish market for 35 years and had never had any cases of salmonella. “We don’t know the reason [for the outbreak] but we have now started a full review of the process from the supply of raw materials to the finished product,” he said.

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India's desperate Covid-19 patients turn to black market for drugs

SharecloseShare pageCopy linkAbout sharingimage copyrightReutersAkhilesh Mishra started getting a fever and a cough last Thursday but he initially thought it was just the flu.Akhilesh began to worry the next day, when his father Yogendra developed similar symptoms. The two men decided to get Covid RT-PCR tests done and tried to book a slot online but the next available appointment was three days later.They finally managed to get a slot on Sunday. In the meantime, Yogendra was running a very high fever and his doctor advised him to look for a hospital bed, which turned out to be another daunting task. They were turned away by many private hospitals in the city of Noida and also in the capital, Delhi.The family finally managed to get a bed for him in a private hospital in Delhi and he is now recovering. ‘Covid lockdown will make us beg for food again”Think about ICU workers before you party’Is the world’s vaccine powerhouse running out of doses? Akhilesh had thought he would lose his father.”I felt depressed,” he said. “I feared that he was going to die without getting treatment. No son should have to go through what I went through. Everybody should have equal access to care.”The family’s story is not unique. Accounts of family members struggling to find a bed, or life-saving drugs or oxygen cylinders, are being reported all over India. In some cities, there is a long waiting list at the crematoriums.My otherwise healthy cousin in Ranchi passed away of covid symptoms last night. In his final hours neither could he get a Covid test (for days), nor could he get a hospital bed. Hospital won’t release the body without testing now. He’s not a stat. This is real.— अंशुल (@Ghair_Kanooni) April 15, 2021
The BBC is not responsible for the content of external sites.View original tweet on TwitterMy best friend from school is suffering from #COVID-19, her lungs r failing, the hospital she is currently admitted in not equipped with #ventilator. She needs a ventilator. Please let me know if you have any leads of a hospital+ventilator in #Ahmedabad where she can be treated.— Anjali Jain (@helloanjali) April 15, 2021
The BBC is not responsible for the content of external sites.View original tweet on TwitterBlack-marketing of drugsIn recent days in India, social media has been awash with desperate requests for help finding the drugs remdesivir and tocilizumab. The effectiveness of the two drugs is being debated across the world but some countries, including India, have given emergency use authorisation to both.The antiviral drug remdesivir is being prescribed by doctors across the country, and it is in high demand. India has banned exports, but manufacturers are still struggling to meet the demand. India has reported more than 150,000 Covid cases a day for the past three weeks.This is a call for help. Urgently need #Remdesivir for my mother who’s covid +ive and a chronic patient with Kartagener’s syndrome (a rare, severe lung disease). I am in Jamshedpur with her. She has high fever & her O2 is dropping despite continuous O2 support. Kindly amplify.— Sana Shakil (@sanashakil_TNIE) April 14, 2021
The BBC is not responsible for the content of external sites.View original tweet on TwitterHetero Pharma, one of seven firms manufacturing remdesivir in India, said the company was trying to ramp up production. The BBC has found that the shortage in supply is leading to black marketing of the drug in Delhi and several other cities. At least three agents contacted by the BBC in Delhi agreed to supply each 100mg vial of remdesivir for 24,000 rupees ($320; £232) – five times the official price. India’s health ministry recommends six doses of 100mg vials for a patient for one course of the drug, but doctors say up to eight doses are needed in some cases.That is a lot of money for a middle-class family. “I had to spend so much money to get the drug, said Atul Garg, whose mother was admitted to a private hospital in Delhi. Finding the drug required “hundreds of calls and many anxious hours”, Atul said.Emergency. A friend in Bhopal is looking to hospitalise her Covid+ mother. All hospitals in the city she has reached out to refused bed’s availability. Any lead for bed/oxygen cylinder would be extremely helpful. Please spread the word. DM if you have leads.— Kumar Sambhav (@Kum_Sambhav) April 12, 2021
The BBC is not responsible for the content of external sites.View original tweet on TwitterTocilizumab, a drug normally used to treat arthritis, has been proven to save lives in some clinical trials. But it has almost disappeared from the market in India. Rajiv Singhal, general secretary of the All India Chemists and Druggists Association, said his phone was ringing through the day as people asked him to help find the drugs. “The situation is so bad that I can’t even get the drugs for my own family members,” he said. “We are trying to take action against those who are black marketing, but I admit that there are leakages in the system.”Oxygen, X-rays and Covid testsThe demand for medical oxygen has also soared in several Indian sates. Several hospitals are turning patients away because they lack supplies. Maharashtra state Chief Minister Uddhav Thackeray asked the federal government to send oxygen by army aircraft, as road transportation was taking too long to replenish the supply in hospitals.The situation is much worse in small cities and towns. When patients are not able to find a hospital bed, doctors advise them to arrange oxygen cylinders at home.Nabeel Ahmed’s father was diagnosed with Covid on Friday in a small town in northern India. Five days later, he started having difficulty in breathing. The doctor advised Nabeel to get an oxygen cylinder at home. He had to drive for four hours to another city to pick one up. “It took me eight hours to get a cylinder for my dad while he was struggling to breathe,” he said.Another major problem patients are facing in smaller towns is that private labs are refusing to conduct chest X-rays and CT scans. Doctors often ask for these tests to assess the progress of the disease. Yogesh Kumar, who lives in the northern town of Allahabad, said the only way for him to get an X-ray done was to either get admitted to a hospital or to get the test done at a government-run hospital, where the waiting list was too long.A doctor in Allahabad told the BBC: “It’s unbelievable that I am unable to get X-rays done for my patients. We have to just rely on blood reports to assess the disease in some cases, which is not ideal.”image copyrightReutersBusy crematoriums Crematoriums in many badly affected cities are running day and night. In some cases, families have to wait for several hours to cremate the deceased. A recent report said that the metal structure of the furnaces inside a crematorium in the western Indian city of Surat had started melting because it had been running day and night without any break. A short video clip went viral recently showing dozens of funeral pyres burning in the northern city of Lucknow in the middle of the night.Many staff members at crematoriums are working without a break. They are getting exhausted. Many around India are asking if these situations were avoidable.”We did not learn lessons from the first wave. We were aware that the second wave was coming but we didn’t plan to avoid unfortunate incidences like shortages of drugs, beds and oxygen,” said epidemiologist Dr Lalit Kant.”We didn’t even learn from other countries which faced similar circumstances,” he said.Some names have been changed on request.Read more stories by Vikas Pandey’Think about ICU workers before you party”I have cancer in my 30s, but can’t get a Covid jab’India in ‘delicate phase’ as Covid cases surgeThe vaccine pioneer the world forgot

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States Struggle With Vaccine Pause as Federal Officials Reassure Public

Dr. Anthony S. Fauci said he hoped for a decision “quite soon” on the Johnson & Johnson vaccine, as local governments shifted to more complicated two-dose vaccines for marginal populations.Dr. Anthony S. Fauci said on Thursday that he hoped the nation would soon be able to resume use of the Johnson & Johnson vaccine, as a “pause” that now looks indefinite threatened to upend vaccination efforts overseas and in some of the most marginalized communities in the United States.Dr. Fauci, President Biden’s chief medical adviser for the pandemic, made the comment during a hearing of the House Select Subcommittee on the Coronavirus Crisis, where he and other top federal health officials implored Americans to continue to get vaccinated and sought to reassure the nation that all three federally authorized vaccines are safe.“Hopefully we’ll get a decision quite soon, as to whether or not we can get back on track with this very effective vaccine,” Dr. Fauci told the panel. With cases rising in the Midwest, he added, the nation is in a “precarious situation” and it is imperative to vaccinate “as many people as quickly and as expeditiously as we possible can.”But it was increasingly clear that a suspension that initially was to last two to three days would be considerably longer, as officials wrestled with reports of at least six rare cases of blood clotting among women immunized with the Johnson & Johnson shot. Federal health agencies are trying to decide whether to recommend that doctors resume use of the vaccine, possibly with new restrictions.The vaccine has not been a major component of the Biden administration’s vaccination campaign. About 7.7 million Americans have received the Johnson & Johnson shot, accounting for fewer than 4 percent of the more than 198 million doses administered across the country.But while those numbers are small, many of the people the vaccine has been targeted at are vulnerable: homeless people in Baltimore, homebound residents in the District of Columbia, the poor and uninsured in Massachusetts, rural residents in a number of states. All are populations easier to reach with a single dose than the two-dose regimen of the Pfizer and Moderna vaccines.About 10 million doses shipped to the states are now on shelves awaiting a decision. And many people who might not seek out a shot but could have been reached with mobile clinics and concerted outreach may be left behind, at least for now.“There is a great deal of work going on with all of our vaccinators, providers around the state and with our team at the Minnesota Department of Health trying to help plan and shifting things around. It is a series of dominoes, obviously,” said Jan Malcolm, Minnesota’s health commissioner. “We very much regret the clinics that had to be canceled on short notice because of the pause in J&J, and that will continue to be an issue in the coming couple of weeks.”The White House press secretary, Jen Psaki, again calibrated President Biden’s promise that he would secure enough vaccine for all American adults by the end of May. Now, the White House is emphasizing that all adults who want a vaccine will get one.“That means that by the end of May, for about 80 percent of the population, by the end of July about 90 percent of the population,” Ms. Psaki told reporters.In Lexington, Ky., a Johnson & Johnson clinic for Friday was canceled, leaving around 400 people without appointments. All were offered a last-minute option to get a Moderna vaccine, but only about 65 accepted the offer, said Kevin Hall, a spokesman for the Lexington-Fayette County Health Department.“This was a major hit to our planning,” said Mr. Hall, whose agency had already used the Johnson & Johnson vaccine for inmates and homeless people, and had planned to offer neighborhood clinics in the coming weeks. “The logistics of pulling off a first-dose and second-dose clinic become much, much more difficult.”About 7.7 million Americans have received the Johnson & Johnson vaccine, accounting for fewer than 4 percent of the more than 198 million doses administered across the country.Matthew Hatcher/Getty ImagesDr. Letitia Dzirasa, the health commissioner in Baltimore, said the city had received only about 1,400 doses of the Johnson & Johnson vaccine to date, but many were targeted at homeless residents. The city may have to rethink plans it had been making for outdoor pop-up clinics and efforts to reach homebound residents with the one-dose vaccine this summer, she said.“We were thinking the J&J would be the ideal candidate to support that work,” she said.In Washington, D.C., officials are delaying a program to reach homebound residents with Johnson & Johnson shots. The city canceled appointments for about 1,200 people this week, but by now all should have received an invitation for a new appointment for one of the other two federally authorized vaccines, developed by Pfizer-BioNTech and Moderna.Other state and local health officials said they were getting by with those two vaccines. In the Flint, Mich., area, which has some of the country’s highest recent case rates, officials said they had been able to cover all planned clinics even without the Johnson & Johnson vaccine.“It has been smooth so far,” Dr. Pamela Hackert, the medical health officer for the Genesee County Health Department, said in an email.At Des Moines Area Community College in Iowa, administrators have been able to set up three on-campus clinics this month where students will be able to receive a two-dose vaccine. Rob Denson, the college president, said he had been pleased and surprised at his ability to arrange those future clinics so quickly.“I think we’re going to be awash in vaccine within a relatively short amount of time,” he said.But an extended break in Johnson & Johnson availability will begin to pinch, especially in poorer states with harder-to-reach populations. A spokeswoman for Dr. José Romero, the secretary of health in Arkansas, said that “the pause should be a sufficient length to answer safety questions, but not extended any longer than necessary.“His concern is that an overlong pause will increase hesitancy and decrease confidence,” said the spokeswoman, Danyelle McNeill. Dr. Romero leads the advisory committee to the Centers for Disease Control and Prevention that will ultimately recommend how to proceed with the Johnson & Johnson vaccine.The suspension in the United States may have more profound consequences overseas, where only a fraction of the rest of the world has so far been vaccinated. Dr. Luciana Borio, a former acting chief scientist at the Food and Drug Administration who also served on the National Security Council in the Trump White House, said the Johnson & Johnson vaccine was a crucial tool for stopping the spread of the virus around the world.“It’s a vaccine that can be manufactured quickly in very large scale and has much easier distribution procedures,” she said. “The world needs more companies like J&J supplying their vaccine.”Officials were counting on both Johnson & Johnson and another easy-to-distribute vaccine made by AstraZeneca to get inoculations to hard-to-reach parts of the globe. But recent reports of rare blood clots in recipients of the AstraZeneca vaccine have led a number of nations to reconsider its use.Some regions decided to shift to Johnson & Johnson; two weeks ago, the African Union acquired 400 million doses even as wealthier nations have shied away. The European Union said it would not buy more from Johnson & Johnson, and Australia announced it would not purchase any doses.In the United States, members of the C.D.C. advisory panel suggested on Wednesday that it would be a week to 10 days before they had enough information to assess the vaccine’s risks and could make a decision about its future in the United States. Dr. Fauci and two other officials — Dr. Rochelle Walensky, the C.D.C. director, and Dr. David Kessler, who runs the Biden administration’s vaccine effort — urged Americans to continue to get vaccinated.A medical worker giving the Johnson & Johnson vaccine in San Juan, P.R., last month.Ricardo Arduengo/Agence France-Presse — Getty Images“I hope we can all come together and send that message,” especially amid the spread of worrisome variants, Dr. Kessler said, adding that the three federally authorized vaccines have “an excellent safety profile.”.css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-rqynmc{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-rqynmc{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-rqynmc strong{font-weight:600;}.css-rqynmc em{font-style:italic;}.css-yoay6m{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}@media (min-width:740px){.css-yoay6m{font-size:1.25rem;line-height:1.4375rem;}}.css-1dg6kl4{margin-top:5px;margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-1pd7fgo{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-1pd7fgo{padding:20px;width:100%;}}.css-1pd7fgo:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1pd7fgo{border:none;padding:20px 0 0;border-top:1px solid #121212;}.css-1pd7fgo[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-1pd7fgo[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-1pd7fgo[data-truncated] .css-5gimkt:after{content:’See more’;}.css-1pd7fgo[data-truncated] .css-6mllg9{opacity:1;}.css-1rh1sk1{margin:0 auto;overflow:hidden;}.css-1rh1sk1 strong{font-weight:700;}.css-1rh1sk1 em{font-style:italic;}.css-1rh1sk1 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#ccd9e3;text-decoration-color:#ccd9e3;}.css-1rh1sk1 a:visited{color:#333;-webkit-text-decoration-color:#ccc;text-decoration-color:#ccc;}.css-1rh1sk1 a:hover{-webkit-text-decoration:none;text-decoration:none;}The reports of blood clots were the second recent blow to the Johnson & Johnson vaccine. Earlier this month, an ingredient mix-up at a Baltimore manufacturing plant owned by Emergent BioSolutions ruined up to 15 million doses of the vaccine. The F.D.A. is now inspecting the plant to see whether any doses manufactured there can be released to the public.Yet during a hearing that lasted more than two hours, just one lawmaker — Representative Mark E. Green, Republican of Tennessee, who is a doctor — asked about the Johnson & Johnson vaccine. He urged the doctors to be careful when they talked about the investigation, saying he worried that they would stoke fears that would discourage people from getting vaccinated.And there is early evidence that the concern is well taken. A Survey Monkey poll released on Thursday by Boston Children’s Hospital found that a willingness to get the Johnson & Johnson shot dropped 26 percentage points in two days among Americans who wanted to get vaccinated. The drop among women who wanted to get vaccinated was 31 percentage points, according to the survey, a project from the hospital’s Outbreaks Near Me initiative, a crowdsourced infectious disease surveillance system.“Anytime there is a concern or red flag raised at the federal level, that’s going to spark concern for the general public,” Dr. Dzirasa said.Thursday’s session was subtitled “A Science-Driven Approach to Swiftly and Safely Ending the Pandemic.” But whatever science was discussed was overshadowed by partisan posturing and bickering.Democrats worried about the Fox News host Tucker Carlson, who has used his show to wrongly assert that the vaccines do not work.Republicans, fresh off a trip to the nation’s southern border, used the session to attack the Biden administration’s handling of the immigration crisis. They waved photographs of migrants living in crowded conditions, while complaining about testing rules for those entering the country.Representative Jim Jordan, Republican of Ohio, and Dr. Fauci reprised their heated clash from the last time Dr. Fauci testified before the panel in July.“You’re ranting again,” Dr. Fauci said at one point.“I’m not ranting,” Mr. Jordan replied.“Yes, you are,” Dr. Fauci insisted.Representative Maxine Waters, Democrat of California, whose sister died of Covid-19, told Dr. Fauci, “I love you,” and told Mr. Jordan, “Shut your mouth.”Noah Weiland

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Reliable COVID-19 short-term forecasting

A new study by Texas A&M University researchers published in PLOS ONE details a new model for making short-term projections of daily COVID-19 cases that is accurate, reliable and easily used by public health officials and other organizations.
Led by Hongwei Zhao, professor of biostatistics at the Texas A&M School of Public Health, researchers used a method based on the SEIR (susceptible, exposed, infected and recovered states) framework to project COVID-19 incidence in the upcoming two to three weeks based on observed incidence cases only. This model assumes a constant or small change in the transmission rate of the virus that causes COVID-19 over a short period.
The model uses publicly available data on new reported cases of COVID-19 in Texas from the COVID-19 Data Repository by the Center for Systems Science and Engineering at Johns Hopkins University. Texas A&M researchers used this data on disease incidence for Texas and a selection of counties that included the Texas A&M campus to estimate the COVID-19 transmission rate.
“The results indicate that this model can be used to reasonably predict COVID-19 cases two to three weeks in advance using only current incidence numbers,” Zhao said. “The simplicity of this model is one of its greatest strengths as it can be easily implemented by organizations with few resources. Forecasts from this model can help health care organizations prepare for surges and help public health officials determine whether mask mandates or other policies will be needed.”
They forecasted future infections under three possible scenarios: a sustained, constant rate of transmission; one where the transmission rate is five percent higher than current levels, reflecting a decrease in practices to prevent transmission or an increase in conditions that promote transmission; and one where transmission is five percent lower.
Estimating the current effective transmission rate can be tricky, since day-to-day variations in both infections and reporting can dramatically influence this estimate. Thus, the researchers smoothed daily reporting variations using a three-day weighted average and performed additional smoothing to account for data anomalies such as counties reporting several months of cases all at once.
The researchers compared their projections with reported incidence in Texas through four periods in 2020: April 15, June 15, August 15 and October 15. The number of new daily COVID-19 cases reported were relatively low in mid-April, when many businesses were shut down, and then started to increase in early May after phased re-openings began in Texas. The numbers increased sharply after Memorial Day, and then trended downward after a statewide mask mandate was enacted during the summer. Infections increased again after Labor Day, but then seemed to plateau until the middle of October, when the transmission rate was observed again to increase dramatically.
The statewide application of the model showed that it performed reasonably well, with only the second period forecast deviating from the actual recorded incidence, perhaps due to the dramatically changing numbers at the time when a great wave of COVID-19 occurred around the Memorial Day holiday. The model performed similarly well at the county level, though the smaller population and changes in population, such as students moving in and out of the area during the school year, influenced reporting of new cases.
However, the model is limited by the data it uses. Local testing and reporting policies and resources can affect data accuracy, and assumptions about transmission rate based on current incidence are less likely to be accurate further into the future. And as more people contract COVID-19 and recover, or are vaccinated, the susceptible population will change, possibly affecting transmission.
Despite these limitations, the researchers said the model can be a valuable tool for health care facilities and public health officials, especially when combined with other sources of information. The COVID-19 pandemic is not yet over, so having a tool that can determine when and where another surge might occur is important. Similarly, researchers hope to use these new tools at their disposal for future infectious disease needs.
Additionally, the model has been used to create a dashboard that provides real-time data on the spread of COVID-19 state-wide. It has been used locally by university administrators and public health officials.
Other School of Public health researchers involved in this study included Marcia Ory, Tiffany Radcliff, Murray Côté, Rebecca Fischer and Alyssa McNulty, along with Department of Statistics researchers Huiyan Sangand and Naveed Merchant.
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Materials provided by Texas A&M University. Original written by Rae Lynn Mitchell. Note: Content may be edited for style and length.

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Can financial stress lead to physical pain in later years?

Financial stress can have an immediate impact on well-being, but can it lead to physical pain nearly 30 years later? The answer is yes, according to new research from University of Georgia scientists.
The study, published in Stress & Health, reveals that family financial stress in midlife is associated with a depleted sense of control, which is related to increased physical pain in later years.
“Physical pain is considered an illness on its own with three major components: biological, psychological and social,” said Kandauda A.S. Wickrama, first author and professor in the College of Family and Consumer Sciences. “In older adults, it co-occurs with other health problems like limited physical functioning, loneliness and cardiovascular disease.”
Most pain research is neurological, but it’s important to also connect it to stressful family experiences, according to the researchers.
“Dr. Wickrama and I are both interested in the context surrounding families and how that context impacts the relational, physical and mental health of the individuals in the family,” said lead author Catherine Walker O’Neal, associate research scientist in the College of Family and Consumer Sciences. “Finances are an important component of our work because it’s such a relevant contextual stressor families face.”
The authors used data from the Iowa Youth and Family Project, a longitudinal study that provides 27 years of data on rural families from a cluster of eight counties in north-central Iowa. The data was collected in real time from husbands and wives in 500 families who experienced financial problems associated with the late 1980s farm crisis. Most of the individuals are now over 65 years old, and the couples are in enduring marriages — some as long as 45 years.
Even after the researchers controlled for concurrent physical illnesses, family income and age, they found a connection between family financial hardship in the early 1990s and physical pain nearly three decades later. Additional findings from their study show it’s more likely that financial strain influences physical pain, though physical pain can in turn influence financial strain through additional health care costs.
Physical pain is a biopsychosocial phenomenon, according to Wickrama. The research suggests that stressful experiences like financial strain erode psychological resources like a sense of control. This depletion of resources activates brain regions that are sensitive to stress, launching pathological, physiological and neurological processes that lead to health conditions like physical pain, physical limitations, loneliness and cardiovascular disease.
“In their later years, many complain about memory loss, bodily pain and lack of social connections,” he said. “Nearly two-thirds of adults complain of some type of bodily pain, and nearly that many complain of loneliness. That percentage is going up, and the health cost for that is going up. That is a public health concern.”
Eric T. Klopack, who recently graduated from UGA and is currently a postdoctoral fellow at University of Southern California, is also co-author on this paper.
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Materials provided by University of Georgia. Original written by Allyson Mann. Note: Content may be edited for style and length.

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Human cells grown in monkey embryos spark ethical debate

SharecloseShare pageCopy linkAbout sharingimage copyrightWeizhi Ji/Kunming Univ of Science and TechnologyMonkey embryos containing human cells have been made in a laboratory, a study has confirmed.The research, by a US-Chinese team, has sparked fresh debate into the ethics of such experiments. The scientists injected human stem cells – cells that have the ability to develop into many different body tissues – into macaque embryos.The developing embryos were studied for up to 20 days.Other so-called mixed-species embryos, or chimeras, have been produced in the past, with human cells implanted into sheep and pig embryos.The scientists were led by Prof Juan Carlos Izpisua Belmonte of the Salk Institute in the US, who, in 2017, helped make the first human-pig hybrid.Human-pig ‘chimera embryos’ detailedFirst ‘mixed embryo’ monkeys bornTheir work could pave the way in addressing the severe shortage in transplantable organs as well as help understand more about early human development, disease progression and ageing, he said. “These chimeric approaches could be really very useful for advancing biomedical research not just at the very earliest stage of life, but also the latest stage of life.”He maintained that the study, published in the journal Cell, had met the current ethical and legal guidelines.”Ultimately, we conduct these studies to understand and improve human health,” he said.’Ethical challenges’Some scientists have, however, raised concerns about the experiment, arguing that while the embryos in this case were destroyed at 20 days, others could try to take the work further. They are calling for public debate over the implications of creating part human/part nonhuman chimeras.Commenting on the research, Dr Anna Smajdor, lecturer and researcher in biomedical ethics at the University of East Anglia’s Norwich Medical School, said it posed “significant ethical and legal challenges”.She added: “The scientists behind this research state that these chimeric embryos offer new opportunities, because ‘we are unable to conduct certain types of experiments in humans’. But whether these embryos are human or not is open to question.”Prof Julian Savulescu, director of the Oxford Uehiro Centre for Practical Ethics and co-director of the Wellcome Centre for Ethics and Humanities, University of Oxford, said the research “opens Pandora’s box to human-nonhuman chimeras”.He added: “These embryos were destroyed at 20 days of development but it is only a matter of time before human-nonhuman chimeras are successfully developed, perhaps as a source of organs for humans. That is one of the long-term goals of this research.”Sarah Norcross, director of the Progress Educational Trust, said that while “substantial advances” are being made in embryo and stem cell research, which could bring equally substantial benefits, “there is a clear need for public discussion and debate about the ethical and regulatory challenges raised”. Follow Helen on Twitter.

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Can the Covid Vaccine Protect Me Against Virus Variants?

Vaccines do a good job of protecting us from coronavirus, but fear and confusion about the rise of variants have muddled the message. Here are answers to common questions.The news about coronavirus variants can sound like a horror movie, with references to a “double-mutant” virus, “vaccine-evading” variants and even an “Eek” mutation. One headline warned ominously: “The devil is already here.”While it’s true that the virus variants are a significant public health concern, the unrelenting focus on each new variant has created undue alarm and a false impression that vaccines don’t protect us against the various variants that continue to emerge.“I use the term ‘scariants,’” said Dr. Eric Topol, professor of molecular medicine at Scripps Research in La Jolla, Calif., referring to much of the media coverage of the variants. “Even my wife was saying, ‘What about this double mutant?’ It drives me nuts. People are scared unnecessarily. If you’re fully vaccinated, two weeks post dose, you shouldn’t have to worry about variants at all.”Viruses are constantly changing, and new variants have been emerging and circulating around the world throughout the pandemic. Some mutations don’t matter, but others can make things much worse by creating a variant that spreads faster or makes people sicker. While the rise of more infectious variants has caused cases of Covid-19 to surge around the world, the risk is primarily to the unvaccinated, for whom there is great concern. While vaccination efforts are well underway in the United States and many other developed countries, huge swaths of the world’s population remain vulnerable, with some countries yet to report having administered a single dose.But for the vaccinated, the outlook is much more hopeful. While it’s true that the vaccines have different success rates against different variants, the perception that they don’t work against variants at all is incorrect. In fact, the available vaccines have worked remarkably well so far, not just at preventing infection but, most important, at preventing serious illness and hospitalization, even as new variants circulate around the globe.The variants are “all the more reason to get vaccinated,” said Dr. Anthony S. Fauci, the nation’s top infectious disease specialist. “The bottom line is the vaccines we are using very well protect against the most dominant variant we have right now, and to varying degrees protect against serious disease among several of the other variants.”Part of the confusion stems from what vaccine efficacy really means and the use of terms like “vaccine evasion,” which sounds a lot scarier than it is. In addition, the fact that two vaccines have achieved about 95 percent efficacy has created unrealistic expectations about what it takes for a vaccine to perform well. Here are answers to common questions about the variants and the vaccines being used to stop Covid-19.Which variant am I most likely to encounter in the United States?The variant called B.1.1.7, which was first identified in Britain, is now the most common source of new infections in the United States. This highly contagious variant is also fueling the spread of the virus in Europe and has been found in 114 countries. A mutation allows this version of the virus to more effectively attach to cells. Carriers may also shed much higher levels of virus and stay infectious longer.The main concern about B.1.1.7 is that it is highly infectious and spreads quickly among the unvaccinated, potentially overwhelming hospitals in areas where cases are surging.Do the vaccines work against B.1.1.7?All of the major vaccines in use — Pfizer-BioNTech, Moderna, Johnson & Johnson, AstraZeneca, Sputnik and Novavax — have been shown to be effective against B.1.1.7. We know this from a variety of studies and indicators. First, scientists have used the blood of vaccinated patients to study how well vaccine antibodies bind to a variant in a test tube. The vaccines have all performed relatively well against B.1.1.7. There’s also clinical trial data, particularly from Johnson & Johnson and AstraZeneca (which is the most widely used vaccine around the world), that shows they are highly effective against both preventing infection and serious illness in areas where B.1.1.7 is circulating. And in Israel, for instance, where 80 percent of the eligible population is vaccinated (all with the Pfizer shot), case counts are plummeting, even as schools, restaurants and workplaces open up, suggesting that vaccines are tamping down new infections, including those caused by variants.If the vaccines are working, why do I keep hearing about “breakthrough” cases?No vaccine is foolproof, and even though the Covid vaccines are highly protective, sometimes vaccinated people still get infected. But breakthrough cases of vaccinated people are very rare, even as variants are fueling a surge in case counts. And the vaccines clearly prevent severe illness and hospitalization in the few vaccinated patients who do get infected.So what’s the risk of getting infected after vaccination? Nobody knows for sure, but we have some clues. During the Moderna trial, for instance, only 11 patients out of 15,210 who were vaccinated got infected. Both Pfizer and Moderna now are doing more detailed studies of breakthrough cases among vaccinated trial participants, and should be releasing that data soon.Two real-world studies of vaccinated health care workers, who have a much higher risk of virus exposure than the rest of us, offer hopeful signs. One study found that just four out of 8,121 fully vaccinated employees at the University of Texas Southwestern Medical Center in Dallas became infected. The other found that only seven out of 14,990 workers at UC San Diego Health and the David Geffen School of Medicine at the University of California, Los Angeles, tested positive two or more weeks after receiving a second dose of either the Pfizer-BioNTech or Moderna vaccines. Both reports were published in the New England Journal of Medicine, and are a sign that even as cases were surging in the United States, breakthrough cases were uncommon, even among individuals who were often exposed to sick patients. Most important, patients who were infected after vaccination had mild symptoms. Some people had no symptoms at all, and were discovered only through testing in studies or as part of their unrelated medical care.Researchers are still studying whether the variants eventually might increase the number of breakthrough cases or if vaccine antibodies begin to wane over time. So far, data from Moderna show the vaccine still remains 90 percent effective after at least six months. Pfizer has reported similar results. A recent study of 149 people in Israel who became infected after vaccination with the Pfizer vaccine suggested that a variant first identified in South Africa was more likely to cause breakthrough infections. However, those eight infections occurred between days seven and 13 following the second dose. “We didn’t see any South Africa variant 14 days after the second dose,” said Adi Stern, the study’s senior author, a professor at the Shmunis School of Biomedicine and Cancer Research, Tel Aviv University. “It was a small sample size, but it’s very possible that two weeks after the second dose, maybe the protection level goes up and that blocks the South Africa variant completely. It gives us more room for optimism.”For now, the variants don’t appear to be increasing the rate of infection in vaccinated people, but that could change as more data are collected. Read more about breakthrough cases here.Are there other variants we should be worried about?The C.D.C. is tracking more than a dozen variants, but only a few qualify as “variants of concern,” which is a public health designation to identify variants that could be more transmissible or have other qualities that make them more of a risk. The main additional variants everyone is talking about right now are the B.1.351, which was first detected in South Africa, and the P.1, which was first identified in Brazil. While there are other variants (including two “California” variants, B.1.427 and B.1.429, and a New York variant, B.1.526) for now, it seems, that the South Africa and Brazil variants (which as of late March together accounted for about 2 percent of cases in the United States) are causing the most concern. While a new variant can emerge at any time, existing variants also compete with each other for dominance. One interesting new development: In countries like the United States where B.1.1.7 is dominant, some of the other variants seem to be getting crowded out, making them less of a worry.Is it true that the variants first identified in South Africa and Brazil can “evade” the vaccines?There is a concern that the B.1.351 and the P.1 are better at dodging vaccine antibodies than other variants. But that doesn’t mean the vaccines don’t work at all. It just means the level of protection you get from the vaccines against these variants could be lower than when the shots were studied against early forms of the virus. Among the variants, the B.1.351 may pose the biggest challenge so far. It has a key mutation — called E484K, and often shortened to “Eek” — that can help the virus evade some, but probably not all, antibodies.Remember that there’s a lot of “cushion” provided by this current crop of vaccines, so even if a vaccine is less effective against a variant, it appears that it’s still going to do a good job of protecting you from serious illness.How much protection will the vaccines give me against the variant first seen in South Africa?We don’t yet have precise estimates of vaccine effectiveness against B.1.351, which may be the most challenging variant so far. But studies show that the various vaccines still lower overall risk for infection and help prevent severe disease. A large study of Johnson & Johnson’s one-dose vaccine in South Africa found it was about 85 percent effective at preventing severe disease, and lowered risk for mild to moderate disease by 64 percent. (Distribution of the Johnson & Johnson vaccine has been paused as health officials investigate safety concerns.) There’s less definitive research for the Pfizer and Moderna vaccines against the variant, but it’s believed that these two-dose vaccines still reduce risk of infection against the variant by about 60 percent to 70 percent and still are highly effective at preventing severe disease and hospitalization..css-1xzcza9{list-style-type:disc;padding-inline-start:1em;}.css-rqynmc{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.9375rem;line-height:1.25rem;color:#333;margin-bottom:0.78125rem;}@media (min-width:740px){.css-rqynmc{font-size:1.0625rem;line-height:1.5rem;margin-bottom:0.9375rem;}}.css-rqynmc strong{font-weight:600;}.css-rqynmc em{font-style:italic;}.css-yoay6m{margin:0 auto 5px;font-family:nyt-franklin,helvetica,arial,sans-serif;font-weight:700;font-size:1.125rem;line-height:1.3125rem;color:#121212;}@media (min-width:740px){.css-yoay6m{font-size:1.25rem;line-height:1.4375rem;}}.css-1dg6kl4{margin-top:5px;margin-bottom:15px;}.css-16ed7iq{width:100%;display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;-webkit-box-pack:center;-webkit-justify-content:center;-ms-flex-pack:center;justify-content:center;padding:10px 0;background-color:white;}.css-pmm6ed{display:-webkit-box;display:-webkit-flex;display:-ms-flexbox;display:flex;-webkit-align-items:center;-webkit-box-align:center;-ms-flex-align:center;align-items:center;}.css-pmm6ed > :not(:first-child){margin-left:5px;}.css-5gimkt{font-family:nyt-franklin,helvetica,arial,sans-serif;font-size:0.8125rem;font-weight:700;-webkit-letter-spacing:0.03em;-moz-letter-spacing:0.03em;-ms-letter-spacing:0.03em;letter-spacing:0.03em;text-transform:uppercase;color:#333;}.css-5gimkt:after{content:’Collapse’;}.css-rdoyk0{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;-webkit-transform:rotate(180deg);-ms-transform:rotate(180deg);transform:rotate(180deg);}.css-eb027h{max-height:5000px;-webkit-transition:max-height 0.5s ease;transition:max-height 0.5s ease;}.css-6mllg9{-webkit-transition:all 0.5s ease;transition:all 0.5s ease;position:relative;opacity:0;}.css-6mllg9:before{content:”;background-image:linear-gradient(180deg,transparent,#ffffff);background-image:-webkit-linear-gradient(270deg,rgba(255,255,255,0),#ffffff);height:80px;width:100%;position:absolute;bottom:0px;pointer-events:none;}#masthead-bar-one{display:none;}#masthead-bar-one{display:none;}.css-1pd7fgo{background-color:white;border:1px solid #e2e2e2;width:calc(100% – 40px);max-width:600px;margin:1.5rem auto 1.9rem;padding:15px;box-sizing:border-box;}@media (min-width:740px){.css-1pd7fgo{padding:20px;width:100%;}}.css-1pd7fgo:focus{outline:1px solid #e2e2e2;}#NYT_BELOW_MAIN_CONTENT_REGION .css-1pd7fgo{border:none;padding:20px 0 0;border-top:1px solid #121212;}.css-1pd7fgo[data-truncated] .css-rdoyk0{-webkit-transform:rotate(0deg);-ms-transform:rotate(0deg);transform:rotate(0deg);}.css-1pd7fgo[data-truncated] .css-eb027h{max-height:300px;overflow:hidden;-webkit-transition:none;transition:none;}.css-1pd7fgo[data-truncated] .css-5gimkt:after{content:’See more’;}.css-1pd7fgo[data-truncated] .css-6mllg9{opacity:1;}.css-1rh1sk1{margin:0 auto;overflow:hidden;}.css-1rh1sk1 strong{font-weight:700;}.css-1rh1sk1 em{font-style:italic;}.css-1rh1sk1 a{color:#326891;-webkit-text-decoration:underline;text-decoration:underline;text-underline-offset:1px;-webkit-text-decoration-thickness:1px;text-decoration-thickness:1px;-webkit-text-decoration-color:#ccd9e3;text-decoration-color:#ccd9e3;}.css-1rh1sk1 a:visited{color:#333;-webkit-text-decoration-color:#ccc;text-decoration-color:#ccc;}.css-1rh1sk1 a:hover{-webkit-text-decoration:none;text-decoration:none;}“From everything we know today, there is still protection from the vaccines against the South Africa variant,” said Dr. Stern.Should I still worry that the vaccines are less effective against some variants?Part of the problem is that we misinterpret what efficacy really means. When someone hears the term “70 percent efficacy,” for instance, they might wrongly conclude that it means 30 percent of vaccinated people would get sick. That’s not the case. Even if a vaccine loses some ground to a variant, a large portion of people are still protected, and only a fraction of vaccinated people will get infected. Here’s why.To understand efficacy, consider the data from the Pfizer clinical trials. In the unvaccinated group of 21,728, a total of 162 people got infected. But in the vaccinated group of 21,720, only eight people became infected. That’s what is referred to as 95 percent efficacy. It doesn’t mean that 5 percent of the participants (or 1,086 of them) got sick. It means 95 percent fewer vaccinated people got infected compared to the unvaccinated group.Now imagine a hypothetical scenario with a vaccine that is 70 percent effective against a more challenging variant. Under the same conditions of the clinical trial, vaccination would still protect 21,672 people in the group, and just 48 vaccinated people — less than one percent — would become infected, compared to 162 in the unvaccinated group. Even though overall efficacy was lower, only a fraction of vaccinated people in this scenario would get infected, most likely with only mild illness.While far more research is needed to fully understand how variants might dodge some (but not all) vaccine antibodies, public health experts note that an estimate of 50 percent to 70 percent efficacy against a challenging variant would still be considered an adequate level of protection.“Seventy percent is extremely high,” said Dr. Stern. “Basically what this means is that it’s even more important to get vaccinated. If you have 95 percent efficacy, you can create some form of herd immunity with less people. With 70 percent efficacy, it’s even more important to get vaccinated to protect others.”Am I going to need a booster shot?Vaccine makers already are working on developing booster shots that will target the variants, but it’s not clear how soon they might be needed. “In time, you’re going to see a recommendation for a booster,” said Dr. Peter J. Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston. “That booster will elevate everybody’s antibodies and increase durability. The booster will probably be configured to target the South African and Brazil variants.”Given all these unknowns about the variants, shouldn’t I just stay home even after I’m vaccinated?Even amid the rise of variants, vaccines will significantly lower your risk for infection and will protect you from serious illness and hospitalization.People who are vaccinated can socialize, unmasked, with other vaccinated people. While vaccinated people still need to follow local health guidelines about wearing a mask and gathering in groups to protect the unvaccinated, vaccinated people can travel, get their hair and nails done, or go to work without worrying. And vaccinated grandparents can hug their unvaccinated grandchildren. Because there are still some outstanding questions about the risk of vaccinated people carrying the virus, a vaccinated person is still advised to wear a mask in public to protect the unvaccinated — although those guidelines may be updated soon.“The vaccines protect you, so go get vaccinated — that’s the message,” said Dr. Fauci. “If you’re around other vaccinated people, you shouldn’t worry about it at all. Zero.”

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Scientists generate human-monkey chimeric embryos

Investigators in China and the United States have injected human stem cells into primate embryos and were able to grow chimeric embryos for a significant period of time — up to 20 days. The research, despite its ethical concerns, has the potential to provide new insights into developmental biology and evolution. It also has implications for developing new models of human biology and disease. The work appears April 15 in the journal Cell.
“As we are unable to conduct certain types of experiments in humans, it is essential that we have better models to more accurately study and understand human biology and disease,” says senior author Juan Carlos Izpisua Belmonte, a professor in the Gene Expression Laboratory at the Salk Institute for Biological Sciences. “An important goal of experimental biology is the development of model systems that allow for the study of human diseases under in vivo conditions.”
Interspecies chimeras in mammals have been made since the 1970s, when they were generated in rodents and used to study early developmental processes. The advance that made the current study possible came last year when this study’s collaborating team — led by Weizhi Ji of Kunming University of Science and Technology in Yunnan, China — generated technology that allowed monkey embryos to stay alive and grow outside the body for an extended period of time.
In the current study, six days after the monkey embryos had been created, each one was injected with 25 human cells. The cells were from an induced pluripotent cell line known as extended pluripotent stem cells, which have the potential to contribute to both embryonic and extra-embryonic tissues. After one day, human cells were detected in 132 embryos. After 10 days, 103 of the chimeric embryos were still developing. Survival soon began declining, and by day 19, only three chimeras were still alive. Importantly, though, the percentage of human cells in the embryos remained high throughout the time they continued to grow.
“Historically, the generation of human-animal chimeras has suffered from low efficiency and integration of human cells into the host species,” Izpisua Belmonte says. “Generation of a chimera between human and non-human primate, a species more closely related to humans along the evolutionary timeline than all previously used species, will allow us to gain better insight into whether there are evolutionarily imposed barriers to chimera generation and if there are any means by which we can overcome them.”
The investigators performed transcriptome analysis on both the human and monkey cells from the embryos. “From these analyses, several communication pathways that were either novel or strengthened in the chimeric cells were identified,” Izpisua Belmonte explains. “Understanding which pathways are involved in chimeric cell communication will allow us to possibly enhance this communication and increase the efficiency of chimerism in a host species that’s more evolutionarily distant to humans.”
An important next step for this research is to evaluate in more detail all the molecular pathways that are involved in this interspecies communication, with the immediate goal of finding which pathways are vital to the developmental process. Longer term, the researchers hope to use the chimeras not only to study early human development and to model disease, but to develop new approaches for drug screening, as well as potentially generating transplantable cells, tissues, or organs.
An accompanying Preview in Cell outlines potential ethical considerations surrounding the generation of human/non-human primate chimeras. Izpisua Belmonte also notes that “it is our responsibility as scientists to conduct our research thoughtfully, following all the ethical, legal, and social guidelines in place.” He adds that before beginning this work, “ethical consultations and reviews were performed both at the institutional level and via outreach to non-affiliated bioethicists. This thorough and detailed process helped guide our experiments.”
This work was supported by the National Key Research and Development Program, the National Natural Science Foundation of China, Major Basic Research Project of Science and Technology of Yunnan, Key Projects of Basic Research Program in Yunnan Province, High-level Talent Cultivation Support Plan of Yunnan Province and Yunnan Fundamental Research Projects, UCAM, and the Moxie Foundation.
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