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: All 53 People Aboard Indonesia Submarine Declared Dead After Vessel’s Wreckage Found

https://ift.tt/3ezrzg5 ANYUWANGI, Indonesia — Indonesia’s military on Sunday officially said all 53 crew members from a submarine that sank and broke apart last week are dead, and that search teams had located the vessel’s wreckage on the ocean floor. The grim announcement comes a day after Indonesia said the submarine was considered sunk, not merely missing , but did not explicitly say whether the crew was dead. Officials had also said the KRI Nanggala 402’s oxygen supply would have run out early Saturday, three days after vessel went missing off the resort island of Bali. “We received underwater pictures that are confirmed as the parts of the submarine, including its rear vertical rudder, anchors, outer pressure body, embossed dive rudder and other ship parts,” military chief Hadi Tjahjanto told reporters in Bali on Sunday. “With this authentic evidence, we can declare that KRI Nanggala 402 has sunk and all the crew members are dead,” Tjahjanto said. An underwater ro...

New top story from Time: ‘One Slip of the Tongue Could Ruin Things.’ Bipartisan Talks on Police Reform Advance—Delicately

https://ift.tt/2ScOdmJ A small bipartisan group of lawmakers in Washington are making an urgent push to get a police reform bill passed in Congress in the wake of a Minneapolis jury finding Derek Chauvin, a white former police officer, guilty of murdering George Floyd, a Black man, last May. Lawmakers on both sides of the aisle say they are optimistic that renewed bipartisan talks will result in a deal that can pass both of the closely split chambers of Congress. President Joe Biden has given lawmakers a deadline to get it done by the anniversary of Floyd’s death on May 25. “Congress should act,” said Biden during his joint address on Wednesday. “We have a giant opportunity to bend the arc of the moral universe toward justice.” The way forward in reforming America’s police force must now be found in a legislative body regularly paralyzed by partisanship and disagreement, on an issue that has become so divisive that compromise can translate to losing support from member...

New top story from Time: Why It’s Crucial to Talk to Kids About Gender Pronouns

https://ift.tt/3fKr8kO It’s only been a week since Katherine Locke’s newest book was published, and they’ve already received messages from parents of trans and nonbinary children saying how much it spoke to them. The book, What Are Your Words? , tells the story of a kid named Ari, who is gender fluid and nonbinary and tries out different pronouns depending on how they feel on different days. Aimed at readers aged 4 to 8, the book follows Ari and his nonbinary uncle Lior as they try to figure out what words fit them. “I certainly didn’t grow up talking about pronouns that weren’t she/her, he/him, and I didn’t know how to have these conversations either,” says Locke, who released their first picture book last November and has previously written novels for young adults and adults. “It’s been really gratifying to see people embrace the book and its concepts.” [time-brightcove not-tgx=”true”] With colorful illustrations by Anne Passchier, the book emphasizes that pronouns are...

New top story from Time: ‘What Will Happen When the World Looks Away?’ An Afghan Teacher on How the World Can Protect Girls From the Taliban

https://ift.tt/3sQiXrP Pashtana Durrani knows that she is on the Taliban’s radar. The 23-year-old teacher has been fiercely advocating for girls’ education since the group started making advances in Afghanistan after the U.S. announced it would withdraw troops from the country by Aug. 31 . But despite being told that she is not safe, Durrani is staying put. “I didn’t leave because I just felt like it’s my responsibility to do right by my people,” she says. “This is not just about me. This is about the girls of Afghanistan.” On Aug. 15, the Taliban took control of Afghanistan’s capital 20 years after being ousted from power, triggering a chaotic rush to the Kabul airport as foreign citizens and many Afghans tried to flee the country. Even though the Taliban has promised to respect the rights of women and religious minorities this time, many remain skeptical given its brutal history of oppression. According to Human Rights Watch, schools have been shut down and women have ...

New top story from Time: Supreme Court Delivers Two Major Voting Victories to Democrats. But the Battle May Not Be Over

https://ift.tt/3ea9ynJ The Supreme Court on Wednesday handed Democrats major victories in election legal battles in two critical swing states, letting extended deadlines for mail-in ballots in North Carolina and Pennsylvania remain in place for now. The Supreme Court declined to expedite a decision on Pennsylvania’s extended deadline for receiving mail-in ballots, virtually guaranteeing it will remain in place through the election, and, in a separate ruling, declined to halt an appeals court ruling that kept the North Carolina deadline in place. Justices Samuel Alito, Neil Gorsuch and Clarence Thomas dissented in both of the rulings. The Court’s newest justice, Amy Coney Barrett, who was confirmed on Monday, did not participate because she did not have adequate time to review the filings, according to the court’s public information officer. As a result of the rulings, mail-in ballots postmarked by Election Day can be received through Nov. 6th in Pennsylvania and Nov. 12 ...

New top story from Time: Blast Outside Kabul Airport Kills 2, Wounds 15, Russia Says

https://ift.tt/3yjY6hU KABUL, Afghanistan — A suicide attack outside Kabul’s airport Thursday killed at least 2 people and wounded 15, Russian officials said. Large crowds of people have massed outside the airport as they try to flee the Taliban takeover of Afghanistan. Western nations had warned earlier in the day of a possible attack at the airport in the waning days of a massive airlift. Suspicion for any attack targeting the crowds would likely fall on the Islamic State group and not the Taliban, who have been deployed at the airport’s gates trying to control the mass of people. [time-brightcove not-tgx=”true”] The Pentagon confirmed the blast, and Russian Foreign Ministry gave the official casualty count. The explosion went off in a crowd of people waiting to enter the airport, according to Adam Khan, an Afghan waiting nearby. He said several people appeared to have been killed or wounded, including some who lost body parts. Several countries urged people to avoid t...

New top story from Time: Summer Tutoring Is Not the Solution to a Lost Year of Schooling. It Might Hurt Kids More Than It Helps Them

https://ift.tt/2Wpnci1 Summer tutoring has become the rallying cry by politicians and pundits as a way to address the learning loss from months of remote and hybrid learning. A frightening number of students did not show up to class last school year, including up to 15% of kindergarteners in some school districts. But tutoring is the not the easy solution many think it is. Before parents sign up their children, they need to do their own homework and, except under specific conditions, they should not pursue tutoring. Simply put, most children do not benefit long term from standard tutoring. Moreover, current trends in supplemental education can end up hurting children. [time-brightcove not-tgx=”true”] Tutoring can work well under certain conditions for children. Unfortunately, those conditions are quite strict. First, tutors should have a strong command of the content and must find ways to connect it to the student’s interests. Second, tutoring is more effective when ...

New top story from Time: The Capital Gazette Found Justice. But Can the Newspaper Survive?

https://ift.tt/3l5r0iS I sat 10 feet behind the man who plotted to murder me. It was the final day of his sanity trial, giving a jury power to decide if he understood what he was doing three years ago when he the illusion of safety created by the glass doors of our Annapolis newsroom . Among the evidence were two years spent stockpiling weapons, identifying targets while sitting in the office parking lot with a camera, statements that he hoped to appear insane, letters taking responsibility for his attack and a revelation that after murdering four people, he put down his shotgun to surrender. Then he spotted a survivor under a desk, picked up the weapon and obliterated one more life. [time-brightcove not-tgx=”true”] That was Gerald Fischman, a brilliant opinion page editor and my friend for 25 years. He died during minutes of carnage on June 28, 2018 along with Rob Hiaasen, Wendi Winters, John McNamara and Rebecca Smith. I listened to the man’s public defender offer a ...

New top story from Time: Facebook’s Market Value Climbs Over $1 Trillion as Judge Dismisses Antitrust Suits Against the Social Network

https://ift.tt/3hirG0C Facebook Inc. won a court ruling dismissing two monopoly lawsuits filed by the U.S. government and a coalition of states that sought to break up the company, dealing a blow to the effort of antitrust officials to take on the biggest tech platforms. The decision by U.S. District Judge James Boasberg in Washington on Monday sent Facebook shares soaring, pushing the company’s market value to more than $1 trillion. Boasberg granted the company’s request to dismiss the complaints filed last year by the U.S. Federal Trade Commission and state attorneys general led by New York, saying in his opinion that the FTC failed to meet the burden for establishing that Facebook has a monopoly in social networking. [time-brightcove not-tgx=”true”] The judge said the FTC failed to clearly define the market and said its assertion about Facebook’s share of the market was “too speculative and conclusory to go forward.” He said the agency could refile the complaint within ...

New top story from Time: As Myanmar’s Junta Intensifies Its Crackdown, Pro-Democracy Protesters Prepare for Civil War

https://ift.tt/3cUWeEQ Before the Feb. 1 coup, Zarni Win* worked for a United Nations-funded committee that monitored a ceasefire between Myanmar’s junta and ethnic armed groups. Today, the 27-year-old from Yangon, the country’s largest city, is getting ready to enlist in one of those groups herself. “Now is the time to start preparing to eliminate the terrorist military,” she tells TIME. “I am ready to join the armed revolution.” Myanmar is veering dangerously toward all-out civil war as the military, known as the Tatmadaw, terrorizes the public , and attacks restive ethnic territories. The U.N. special envoy for Myanmar, Christine Schraner Burgener, warned on Mar. 31 that “a bloodbath is imminent.” In an online presentation cited by the Associated Press, she said civil war “at an unprecedented scale” was a possibility and spoke of Myanmar’s deterioration into a “failed state.” Protesters in Myanmar have maintained a largely peaceful resistance to dictatorship since ...

My precise view

Search This Blog