New top story from Time: Pfizer-BioNTech Have Started Testing Their COVID-19 Vaccine in Children Under 12

https://ift.tt/3vWOQjL

Alejandra and Marisol Gerardo are nine years old but already making a little bit of history. The twin sisters are among the first young children to get vaccinated with a COVID-19 shot in Pfizer-BioNTech’s study of its vaccine in kids under age 12.

Alejandra and Marisol had their blood drawn in the morning on March 24, then got their first dose of the two-dose vaccine later that afternoon. “Their primary concern was, ‘is it going to hurt,’” says their father, Dr. Charles Gerardo, chief of emergency medicine at Duke University School of Medicine. “They’re not too worried about the long term side effects; they’re looking at the moment, not the future.”

Testing the vaccine in younger children will answer critical questions about how much immunity the shots can provide, and potentially give parents and education officials more confidence in re-opening schools. While it appears that younger children don’t get as sick with COVID-19 as older teens and adults do, how these children’s immune systems respond to the virus, and to the vaccine, remains a black box. The trial will also help provide some clarity on those questions.

Pfizer-BioNTech says it will test the same vaccine that is currently authorized for emergency use in the U.S. for those 16 years and older, but this time in children aged six months to 11 years. The company is currently wrapping up a study of its two-dose shot in adolescents aged 12 to 15 years in the U.S. and Europe.

The latest pediatric trial will follow the same three-phased approach as the adult study, with Phase 1 involving 144 children aged five to 11 years at Duke, Boston Children’s Hospital, Cincinnati Children’s Hospital and Johns Hopkins, who will all receive the vaccine but be randomly assigned one of three dosages. If the vaccine is safe in this age group, children aged two to four years will be tested, and if safe in that group, the youngest children from six months to two years will get the vaccine. Depending on the immune responses these children generate, the scientists at Pfizer-BioNTech will make a decision about the safest and most effective dose with which to proceed in its Phase 2 and Phase 3 studies.

Those will include a total of about 4,500 children broken down in the same age categories, this time randomly assigned to receive either the vaccine or placebo in a 2:1 ratio. The results will be analyzed after six months to determine if the children receiving the vaccine both generated a stronger immune response than those getting placebo, and that the response was on par with responses in vaccinated adults. If that’s the case, then Pfizer-BioNTech will submit the data to the U.S. Food and Drug Administration to expand authorization to younger children, and hopefully start vaccinating them by early next year.

Dr. Emmanuel Walter, professor of pediatrics and chief medical officer at the Duke Human Vaccine Institute who is overseeing the trial there, says the study will answer important questions about the safety and dosing of the vaccine for children—specifically whether younger children will need a different dose than adolescents and adults. The trial will test a dose about one-third that of the current adult dose, another that is about half of the adult dose, as well as the adult dose. While the Pfizer-BioNTech COVID-19 shot is the first mRNA technology-based vaccine of any kind to gain FDA authorization, Walter says it’s likely to be safe in children. “I don’t think it’s the platform so much that I would worry about for young children—I feel comfortable giving the mRNA to young children. I think the questions of will they have side effects, will the vaccine be tolerable to children, and do we need to use a smaller dose in young kids, are the biggest things.”

So far, Walter says that they have seen an “overwhelming” response to the pediatric trial, with parents like the Gerardos expressing interest in enrolling their children. Both Gerardo and his wife, who is an infectious disease physician at Duke, are vaccinated, and he says before his daughters joined the trial, they discussed volunteering with the girls. “They understand that the results are going to impact other kids, and that’s one of the lessons we wanted to teach them with this experience,” he says. “That this was one of the ways to contribute to help other people.”

Comments

New top story from Time: DOJ Reportedly Investigating Whether New York Gov. Cuomo Manipulated Data on COVID-19 Nursing Home Deaths

https://ift.tt/3u8AJab (ALBANY, N.Y.) — New York Gov. Andrew Cuomo faced mounting challenges to his leadership on the coronavirus pandemic Wednesday as state lawmakers threatened to strip him of the power to issue emergency orders and federal investigators scrutinized his administration’s handling of nursing home data. The U.S. Justice Department has been examining the governor’s coronavirus task force and trying to determine whether the state intentionally manipulated data regarding deaths in nursing homes, two people familiar with the matter told The Associated Press. The people, who weren’t authorized to discuss the investigation and spoke on condition of anonymity, said the Cuomo administration had not been cooperative with prosecutors, especially in the early stages of the probe, and for months had not produced documents and other data the Justice Department had requested. The inquiry began months ago in the Justice Department’s civil division, and parts of it have ...

New top story from Time: Environmental Crises Are Forcing Millions Into Cities. Can Countries Turn Climate Migrants Into an Asset?

https://ift.tt/3sEUWCv When he was a child, James Owuor loved hearing the elders talk about the way life used to be. So it comes as something of a surprise that at 38, he is now the one tasked with the job of describing the Before Times in Kenya’s Rift Valley. Before Lake Baringo started to rise, before it flooded and stole everything he knew. “At the beginning, we just thought it was a bad rainy season, that the water would recede when the dry season came. It didn’t,” he says ruefully, peering over the edge of his motorized canoe at what used to be houses below the milky brown waters. Over the past decade, an unprecedented increase in annual rainfall—widely attributed to climate change —has raised the lake by 40 ft. (12 m), inundating nearly 22,000 acres and destroying homes, businesses and Roberts Camp, the lakeside resort where Owuor has worked for most of his adult life. In 2014, he watched the waters overtake the two-story-tall shorefront lodge. The restaurant went next...

New top story from Time: What Women Owe One Another on Black Women’s Equal Pay Day

https://ift.tt/2Vlj9D9 Given the durability of the so-called “ glass ceiling ,” it is apt that, when the U.S. government brought its first gender pay discrimination lawsuit, in the late 1960s, the company at the center of the case was a large New Jersy glassmaking facility . The company had been founded in the late 1880s , but by 1956 ran headlong into what it described in court documents as a shortage of male workers . The situation prompted the company, in an agreement with a union representing its workers, to hire women as “selector-packers,” forbidden from lifting items over 35 lbs. Beyond that one limitation, many men and women inside the company did the same work and were responsible for almost all the same tasks. And yet, they did not take home the same salaries—until the government’s lawyers ultimately prevailed at the U.S. Supreme Court in January 1970 , winning wage equality (and back pay) for the women. [time-brightcove not-tgx=”true”] The case established a cor...

New top story from Time: China Calls U.S. Policy ‘Misguided’ in High-Level Talks

https://ift.tt/3iPgwS0 TIANJIN, China — China came out swinging at high-level face-to-face talks with the United States on Monday, blaming the U.S. for a “stalemate” in bilateral relations and calling on America to change “its highly misguided mindset and dangerous policy.” Vice Foreign Minister Xie Feng accused the administration of President Joe Biden of trying to contain and suppress China’s development, according to an official summary of his remarks in talks with visiting U.S. Deputy Secretary of State Wendy Sherman. The fundamental reason why relations between the two face serious difficulties is because some Americans portray China as an “imagined enemy,” the Foreign Ministry quoted Xie as saying. [time-brightcove not-tgx=”true”] Sherman, America’s No. 2 diplomat, is the highest-ranking U.S. official to visit China since Biden took office six months ago. She was having separate meetings with Xie, who is in charge of U.S.-China relations, and Foreign Minister Wang Y...

New top story from Time: To Vaccinate U.S. Veterans, Health Care Workers Must Cross Mountains, Plains and Tundra

https://ift.tt/3uavmaw A Learjet 31 took off before daybreak from Helena Regional Airport in Montana in late January, carrying six Veterans Affairs medical providers and 250 doses of historic cargo cradled in a plug-in cooler designed to minimize breakage. Even in a state where 80-mph speed limits are normal, ground transportation across long distances is risky for the Moderna mRNA-1273 vaccine, which must be used within 12 hours of thawing. The group’s destination was Havre, Mont., 30 miles from the Canadian border. About 500 military veterans live in and around this small town of roughly 9,800, and millions more reside in similarly rural, hard-to-reach areas across the United States. About 2.7 million veterans who use the VA health system are classified as “rural” or “highly rural” patients, residing in communities or on land with fewer services and less access to health care than those in densely populated towns and cities. An additional 2 million veterans live in remote ...

New top story from Time: Many U.S. At-Home COVID-19 Test Results Could Be Going Unreported

https://ift.tt/3jdyI9f Popular at-home COVID-19 tests from Abbott Laboratories and Quidel Corp., available without a prescription, were launched without a mechanism for reporting results to health officials, potentially leaving many cases uncounted by authorities as the delta variant spreads around the U.S. How many of the products have been sold in pharmacies and online and used isn’t clear. When Abbott’s BinaxNOW Self Test became available through retail stores in late April, the company said it planned to make at least tens of millions each month. The company last month said a group of COVID tests including BinaxNOW brought in $1 billion in global sales. [time-brightcove not-tgx=”true”] While COVID testing sites and labs are required to report their findings, the Food and Drug Administration relaxed requirements for some at-home tests to speed their path to market. Abbott said customers are encouraged to report results of its tests, while Quidel didn’t respond to a req...

Coronavirus Vaccine in China Shows Promising Results on People, Immune Cells Developed in 2 Weeks “This is promising data, but it’s early data,” said Dr. Daniel Barouch, director of vaccine research at Beth Israel Deaconess Medical Center in Boston, who was not involved in the work. “Overall, I would say this is good news.” “This is promising data, but it’s early data,” said Dr. Daniel Barouch, director of vaccine research at Beth Israel Deaconess Medical Center in Boston, who was not involved in the work. “Overall, I would say this is good news.”

“This is promising data, but it’s early data,” said Dr. Daniel Barouch, director of vaccine research at Beth Israel Deaconess Medical Center in Boston, who was not involved in the work. “Overall, I would say this is good news.” from Top World News- News18.com https://ift.tt/2LRebpt https://ift.tt/3aYjmyk “This is promising data, but it’s early data,” said Dr. Daniel Barouch, director of vaccine research at Beth Israel Deaconess Medical Center in Boston, who was not involved in the work. “Overall, I would say this is good news.”

New top story from Time: The Green Knight Is an Extravagant Unicorn Tapestry of a Movie

https://ift.tt/2UHqxst In a guttural growl, as if possessed by a demon, a medieval queen reads aloud a threatening letter that has just been delivered by a gargantuan bark-covered warrior on an equally imposing steed. She faints as she reaches the letter’s final line; the paper drops to the floor and bursts into flames. Cinema! There’s nothing more ridiculous, or more awesome. There is no lettre flambée, specifically, in the late 14th century poem Sir Gawain and the Green Knight. But it’s part of the embroidery writer-director David Lowery uses to fill out his extravagant unicorn tapestry of a movie, The Green Knight, a detail that makes this ambitious adaptation feel both lived-in and magickal, with all the self-aware grandiosity that superfluous ancient k implies. [time-brightcove not-tgx=”true”] Dev Patel stars as the aimless yet mildly arrogant young knight-to-be Gawain, who, as the movie opens, still lives with his mother (Sarita Choudhury) and isn’t quite sure h...

New top story from Time: Why Lorde’s Solar Power Is a Pop Oddity

https://ift.tt/3DdBK5t As a pop star, Lorde stands out for many reasons: her reclusiveness on social media , her emotional acuity , her idiosyncratic dancing . But one of the key elements that makes her so distinctive from her peers is more theoretical: her use of the mixolydian mode. Without getting too technical, the mixolydian is a type of major scale in which the leading tone—used relentlessly in pop music to build tension and yearning—is replaced by a flat seven. The mixolydian is a primary part of blues music as well as much of early rock: think the Beatles’ “Norwegian Wood” or the Doors’ “L.A. Woman.” But it’s much less common in modern pop music, to the point that it was nearly nonexistent in charting songs when Lorde brought it back to the top with the foreboding “Royals” in 2013. (You can read a more granular, precise definition of mixolydian on Stereogum .) [time-brightcove not-tgx=”true”] Four years after “Royals,” Lorde achieved similarly huge success with the ...

New top story from Time: Sunisa Lee Is Representing America in the Tokyo Olympics—and a Community America Left Behind

https://ift.tt/3zIdc1R In March 2019, a day before her 16th birthday and just over a year before the Olympic Trials were supposed to begin, Sunisa “Suni” Lee appeared on 3 Hmong TV , one of the most popular Hmong-language news shows in the Twin Cities. Cushioned between her parents, John Lee and Yee Thoj, wearing her Team USA jacket, the newscaster asked, “Do you feel you have high potential to go to the Olympics?” “Um, I think. I’m not really sure,” Lee says. Her father interrupts, “The important thing is that she has as much potential as anyone on the team.” [time-brightcove not-tgx=”true”] Now, two years later, Suni Lee is a singular talent in the world of gymnastics—poised to carry both the hopes of the United States and a community that has not always felt a part of it. Lee is the youngest of six gymnasts representing the U.S. in Tokyo and the first Hmong-American to compete for Team USA. She has advanced to the finals in the all-around, beam and uneven bars events...

My precise view

Search This Blog