New top story from Time: An Astra Zeneca Manufacturing Error Is Clouding Vaccine Study Results

https://ift.tt/363JAQu

LONDON — Astra Zeneca and Oxford University on Wednesday acknowledged a manufacturing error that is raising questions about preliminary results of their experimental COVID-19 vaccine.

A statement describing the error came days after the company and the university described the shots as “highly effective” and made no mention of why some study participants didn’t receive as much vaccine in the first of two shots as expected.

In a surprise, the group of volunteers that got a lower dose seemed to be much better protected than the volunteers who got two full doses. In the low-dose group, Astra Zeneca said, the vaccine appeared to be 90% effective. In the group that got two full doses, the vaccine appeared to be 62% effective. Combined, the drugmakers said the vaccine appeared to be 70% effective. But the way in which the results were arrived at and reported by the companies has led to pointed questions from experts.

The partial results announced Monday are from large ongoing studies in the U.K. and Brazil designed to determine the optimal dose of vaccine, as well as examine safety and effectiveness. Multiple combinations and doses were tried in the volunteers. They were compared to others who were given a meningitis vaccine or a saline shot.

Did researchers mean to give a half dose?

Before they begin their research, scientists spell out all the steps they are taking, and how they will analyze the results. Any deviation from that protocol can put the results in question.

In a statement Wednesday, Oxford University said some of the vials used in the trial didn’t have the right concentration of vaccine so some volunteers got a half dose. The university said that it discussed the problem with regulators, and agreed to complete the late stage trial with two groups. The manufacturing problem has been corrected, according to the statement.

What about the results themselves?

Experts say the relatively small number of people in the low dose group makes it difficult to know if the effectiveness seen in the group is real or a statistical quirk. Some 2,741 people received a half dose of the vaccine followed by a full dose, Astra Zeneca said. A total of 8,895 people received two full doses.

Another factor: none of the people in the low-dose group were over 55 years old. Younger people tend to mount a stronger immune response than older people, so it could be that the youth of the participants in the low-dose group is why it looked more effective, not the size of the dose.

Another point of confusion comes from a decision to pool results from two groups of participants who received different dosing levels to reach an average 70% effectiveness, said David Salisbury, and associate fellow of the global health program at the Chatham House think tank.

“You’ve taken two studies for which different doses were used and come up with a composite that doesn’t represent either of the doses,″ he said of the figure. “I think many people are having trouble with that.″

Why would a smaller first dose be more effective?

Oxford researchers say they aren’t certain and they are working to uncover the reason.

Sarah Gilbert, one of the Oxford scientists leading the research, said the answer is probably related to providing exactly the right amount of vaccine to trigger the best immune response.

“It’s the Goldilocks amount that you want, I think, not too little and not too much. Too much could give you a poor quality response as well,’’ she said. “So you want just the right amount and it’s a bit hit and miss when you’re trying to go quickly to get that perfect first time.”

What are the next steps?

Details of the trial results will be published in medical journals and provided to U.K. regulators so they can decide whether to authorize distribution of the vaccine. Those reports will include a detailed breakdown that includes demographic and other information about who got sick in each group, and give a more complete picture of how effective the vaccine is.

Moncef Slaoui, who leads the U.S. coronavirus vaccine program Operation Warp Speed, said Tuesday in a call with reporters that U.S. officials are trying to determine what immune response the vaccine produced, and may decide to modify the Astra Zeneca study in the U.S. to include a half dose.

“But we want it to be based on data and science,” he said.

Comments

New top story from Time: The Documentary Final Account Is a Rare Trove of Unfiltered Interviews With Former Nazis—Too Unfiltered, Some Historians Say

https://ift.tt/3u2CDYI In 2008, documentary filmmaker Luke Holland was looking for a sense of closure. His Viennese maternal grandparents had perished in the Holocaust and, more than six decades later, he wanted to better understand what had happened. So he decided to ask the people who would know: SS members , Wehrmacht fighters, concentration-camp guards and civilian witnesses. “ At first, I embarked on a project with the completely improbable aim of trying to find the people who had killed [my grandparents]. It was quickly clear that I was not going to achieve that,” Holland wrote in a statement about the project. “But I realized I could actually meet their peers. I could meet people who had also raised their arms and their guns for Hitler , people who had committed atrocious crimes. And maybe through them, I might better understand the context in which the Holocaust played out in the heart of a supposedly civilized Europe.” Holland did more than 250 interviews, bu...

New top story from Time: The ‘Badass Chief of Staff’ of Turkey’s Opposition Faces Years in Jail After Challenging Erdogan’s Power. She’s Not Backing Down

https://ift.tt/2ZKUTZP Snow brings back memories for Dr. Canan Kaftancioglu. Of recess snowball fights in the Black Sea village where she grew up, of warming her hands at her elementary school’s stove before class — and of discovering a poem by Turkish writer Ataol Behramoglu, a favorite of a beloved uncle who would bring left-wing newspapers to her childhood home and discuss the articles inside. “It is about how the snow brings equality between people,” Kaftancioglu says of the poem. “In the snow, we build a new, more equal world.” The Turkish politician is speaking through an interpreter at her friends’ apartment in Istanbul’s Beyoglu district, seated in an armchair with a beige and brown-spotted dog curled up beside her. In a matter of days or weeks but likely not months, Kaftancioglu expects she will be taken to jail. For now, she’d rather focus on her work: the poverty rate is increasing, and people in her city are suffering. Kaftancioglu represents something unfamil...

New top story from Time: Keeping Up with the Kardashians Is Ending. But Their Exploitation of Black Women’s Aesthetics Continues

https://ift.tt/3gahnMY The inaugural episode of Keeping Up with the Kardashians , which debuted on E! in 2007, begins with an irreverent domestic scene. Kim Kardashian , the undisputed protagonist of the show, rummages through the fridge as she’s teased by her family for the size of her posterior. “I think she’s got a little junk in her trunk,” says Kris Jenner, the family’s matriarch and “momager.” She calls her daughter’s butt “jiggly,” as Kim’s sister Khloé Kardashian chimes in from the kitchen table, “Kim’s always had an ass.” [time-brightcove not-tgx=”true”] That the opener of the watershed reality show—which ends June 10 after 20 seasons—centered on the family’s fixation on Kim’s rear foreshadowed the now-ubiquitous public obsession with her body, and particularly that specific feature of it. This outsize fascination was perhaps best embodied by her controversial 2014 Paper magazine cover, shot by Jean-Paul Goude, where her bare bottom is flanked by the line, “Br...

New top story from Time: City Heat is Worse if You’re Not Rich or White. The World’s First Heat Officer Wants to Change That

https://ift.tt/2Us9kTo Jane Gilbert knows she doesn’t get the worst of the sticky heat and humidity that stifles Miami each summer. She lives in Morningside, a coastal suburb of historically preserved art deco and Mediterranean-style single-family homes. Abundant trees shade the streets and a bay breeze cools residents when they leave their air conditioned cars and homes. “I live in a place of privilege and it’s a beautiful area,” says Gilbert, 58, over Zoom in early June, shortly after beginning her job as the world’s first chief heat officer, in Miami Dade county. “But you don’t have to go far to see the disparity.” [time-brightcove not-tgx=”true”] A mile or two inland, in lower income, mostly Black and Latino neighborhoods like Little Haiti, Little Havana and Liberty City, tree cover can be as little as 10%, compared to around 40% in upscale coastal areas, according to Gilbert. Residents wait for buses on unshaded benches. Many can’t afford to buy or run an AC unit. “You ...

FOX NEWS: Man modeled ex-fiancée's wedding dress to try and sell it: Video Sometimes you’ve got to do a little more to snag that sale.

Man modeled ex-fiancée's wedding dress to try and sell it: Video Sometimes you’ve got to do a little more to snag that sale. via FOX NEWS https://ift.tt/3iwCTgo

New top story from Time: We’re in the Third Quarter of the Pandemic. Antarctic Researchers, Mars Simulation Scientists and Navy Submarine Officers Have Advice For How to Get Through It

https://ift.tt/2MtohAV McMurdo Station, an Antarctic research base 2,415 miles south of Christchurch, New Zealand, is a strange place to ride out the COVID-19 pandemic. But it’s been a home of sorts for Pedro Salom since he took a dishwashing job there in 2001, when he was 24. Now an assistant area manager with more than a dozen Antarctic deployments behind him, Salom has grown accustomed to the ebb and flow of life on the ice. There’s the surge of excitement when new arrivals join the camp, the feeling of isolation from the rest of the world when earth and sea disappear in the endless night from April to August; and the joy when the sun finally appears behind the mountains once again. He’s also been around long enough to know that, as people reach the end of their deployments, many begin to struggle—whether they’ve been at McMurdo for over a year, or even just a few months. “One of the things I look for is dramatic changes in people’s habits,” says Salom. “If somebody has...

New top story from Time: China Says It Will Provide COVID-19 Vaccines to Almost 40 African States

https://ift.tt/3f34nYP BEIJING — China said Thursday it is providing COVID-19 vaccines to nearly 40 African countries, describing its actions as purely altruistic in an apparent intensification of what has been described as “vaccine diplomacy.” The vaccines were donated or sold at “favorable prices,” Foreign Ministry official Wu Peng told reporters. Wu compared China’s outreach to the actions of “some countries that have said they have to wait for their own people to finish the vaccination before they could supply the vaccines to foreign countries,” in an apparent dig at the United States. “We believe that it is, of course, necessary to ensure that the Chinese people get vaccinated as soon as possible, but for other countries in need, we also try our best to provide vaccine help,” said Wu, who is director of the ministry’s Africa department. While the U.S. has been accused by some of hoarding vaccines, President Joe Biden on Monday pledged to share an additional 20 mi...

FOX NEWS: Alligator invades Florida post office This gator needs to say later to the post office.

Alligator invades Florida post office This gator needs to say later to the post office. via FOX NEWS https://ift.tt/3gdiGdY

New top story from Time: House Democrats Pass Sweeping Voting Rights Bill Over GOP Opposition

https://ift.tt/3bVXJAY (WASHINGTON) — House Democrats passed sweeping voting and ethics legislation over unanimous Republican opposition, advancing to the Senate what would be the largest overhaul of the U.S. election law in at least a generation. House Resolution 1, which touches on virtually every aspect of the electoral process, was approved Wednesday night on a near party-line 220-210 vote. It would restrict partisan gerrymandering of congressional districts, strike down hurdles to voting and bring transparency to a murky campaign finance system that allows wealthy donors to anonymously bankroll political causes. The bill is a powerful counterweight to voting rights restrictions advancing in Republican-controlled statehouses across the country in the wake of Donald Trump’s repeated false claims of a stolen 2020 election. Yet it faces an uncertain fate in the Democratic-controlled Senate, where it has little chance of passing without changes to procedural rules that curr...

New top story from Time: How Spirited Away Changed Animation Forever

https://ift.tt/3xVoGP5 Twenty years ago, on July 20, 2001, a film that would become one of the most celebrated animated movies of all time hit theaters in Japan. Directed by Hayao Miyazaki and produced by Studio Ghibli, Sen to Chihiro no Kamikakushi, titled Spirited Away in English, would leave an indelible mark on animation in the 21st century. The movie arrived at a time when animation was widely perceived as a genre solely for children, and when cultural differences often became barriers to the global distribution of animated works. Spirited Away shattered preconceived notions about the art form and also proved that, as a film created in Japanese with elements of Japanese folklore central to its core, it could resonate deeply with audiences around the world. [time-brightcove not-tgx=”true”] The story follows an ordinary 10-year-old girl, Chihiro, as she arrives at a deserted theme park that turns out to be a realm of gods and spirits. After an overeating incident ...

My precise view

Search This Blog