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

Mumbai terror attack 12 years on: Remembering the heroes of 26/11 https://ift.tt/2J9bWA8

Floral tributes were paid on Thursday to the martyrs who laid down their lives while fighting terrorists who attacked Mumbai on November 26, 2008. "Their sacrifice will never be erased from the memory of time and history. Today, we pay tribute to our saviours #2611Attack #2611Martyrs," Mumbai Police tweeted.

More trouble for Chinese cos as India changes trade rules in public procurement https://ift.tt/2EeBklg

Amid the border tension with China, the government has changed trade rules imposing restrictions on public procurement from China and other countries with the common border. According to the changed rules, the government has imposed restrictions on firms, companies from countries which share common land border after it amended the General Financial Rules 2017. An official statement on Modi government latest move said that this has been done on the grounds of defence of India, or matters directly or indirectly related thereto including national security. The Department of Expenditure has, under the said Rules, issued a detailed order on public procurement to strengthen the defence of India and national security, it said. Here what the order says: As per the order, it said, any bidder from such countries sharing a land border with India will be eligible to bid in any procurement whether of goods, services (including consultancy services and non-consultancy services) or works (...

New top story from Time: Bomb Targeting Mosque in Kabul Kills a ‘Number of Civilians’

https://ift.tt/3Fg5SxS KABUL, Afghanistan — A bomb exploded in the entrance of a mosque in the Afghan capital on Sunday leaving a “number of civilians dead,” a Taliban spokesman said. The bomb targeted the sprawling Eidgah Mosque in Kabul, where a memorial service was being held for the mother of Taliban spokesman Zabihullah Mujahid, who later tweeted the attack had claimed civilian lives. Taliban fighters were not been harmed in the attack, Taliban spokesman Bilal Karimi told the Associated Press. Those killed in the attack were civilians outside the mosque gate. He did not provide a figure for the number killed and said an investigation was ongoing. [time-brightcove not-tgx=”true”] Emergency NGO, an Italian-funded hospital in Kabul, tweeted it had received four people wounded in the blast. The area around the mosque was cordoned off by the Taliban, who maintained a heavy security presence. No one immediately claimed responsibility for the attack. However, since the Tal...

Biking by the Numbers: San Francisco’s 2019 Biking Statistics

Biking by the Numbers: San Francisco’s 2019 Biking Statistics By Bradley Dunn Bicycling moves people around San Francisco using less space per person than when people go by driving. The SFMTA encourages bicycling and makes yearly ridership and trend data public. While Bike-to-Work day has moved to September this year due to the ongoing pandemic, we are excited to share San Francisco’s 2019 citywide bicycling data that we usually release in May. The SFMTA uses a variety of bicycle infrastructure and data metrics as indicators of a healthy and growing bicycle network. In 2019, the Agency prioritized the development of a robust data management system, improving high-quality bikeway infrastructure to make bicycling less stressful and more appealing, and expanding access to bikeshare services across the city. As in past years, 2019 data is pulled from the SFMTA’s automated bike counters, annual manual count data, operator-provided bikeshare data, and the US Census. Here are some key fin...

New top story from Time: Facebook’s Ties to India’s Ruling Party Complicate Its Fight Against Hate Speech

https://ift.tt/3b0vAI8 In July 2019, Alaphia Zoyab was on a video call with Facebook employees in India , discussing some 180 posts by users in the country that Avaaz, the watchdog group where she worked, said violated Facebook’s hate speech rules. But half way through the hour-long meeting, Shivnath Thukral, the most senior Facebook official on the call, got up and walked out of the room, Zoyab says, saying he had other important things to do. Among the posts was one by Shiladitya Dev, a lawmaker in the state of Assam for Prime Minister Narendra Modi’s Hindu nationalist Bharatiya Janata Party (BJP). He had shared a news report about a girl being allegedly drugged and raped by a Muslim man, and added his own comment: “This is how Bangladeshi Muslims target our [native people] in 2019.” But rather than removing it, Facebook allowed the post to remain online for more than a year after the meeting, until TIME contacted Facebook to ask about it on Aug. 21. “We looked into ...

New top story from Time: Thousands of People Are Fleeing Into Thailand Following Air Strikes in Myanmar

https://ift.tt/3u7UFJB YANGON, Myanmar — Thai authorities along the country’s border with Myanmar are bracing Monday for a possible influx of more ethnic Karen villagers fleeing new airstrikes by the Myanmar military. Myanmar aircraft carried out three strikes overnight Sunday, according to Free Burma Rangers, a humanitarian relief agency that delivers medical and other assistance to villagers. The strikes severely injured one child but caused no apparent fatalities, a member of the agency said. Thai Prime Minister Prayut Chan-ocha on Monday acknowledged the problems across his country’s western border and said his government is preparing for a possible influx of people. “We don’t want to have mass migration into our territory, but we will consider human rights, too,” Prayut said. Asked about people who have already fled into Thailand, Prayut said, “We have prepared some places, but we don’t want to talk about the preparation of refugee centers at the moment. We won’t ...

New top story from Time: The Fight for a $15 Minimum Wage Is Our Selma

https://ift.tt/37oF2Ez After the public lynching of George Floyd last summer, his cry of “I can’t breathe” galvanized a movement for Black lives that won majority support among Americans . Floyd wasn’t the only one gasping for breath. While Americans watched a police officer choke the life out of Floyd, we also witnessed Black Americans contracting a deadly respiratory disease at three times the rate of our white neighbors , according to an August report from the National Urban League. The growing public consensus that we as a nation must address systemic racism has led to serious soul-searching in families, churches, universities, corporations and political life. But just as the Selma campaign became a symbol during the civil rights movement of the need for legislation to expand voting rights, the $15 an hour minimum wage proposal in Joe Biden’s American Rescue Plan represents the possibility that our government can take decisive action to make racial justice real tod...

1st reported US case of COVID-19 variant found in Colorado https://ift.tt/38DY5uc

The first reported U.S. case of the COVID-19 variant that’s been seen in the United Kingdom has been discovered in Colorado, Gov. Jared Polis announced Tuesday, adding urgency to efforts to vaccinate Americans.

New top story from Time: Cleveland Baseball Team Reportedly Dropping Indians Name After 105 Years

https://ift.tt/2LpSBeG (CLEVELAND) — The Cleveland Indians are changing their name after 105 years. Citing three people familiar with the decision, The New York Times reported Sunday night that the team is moving away from a name considered racist for decades. The Indians have been internally discussing a potential name change for months. A team spokesman told The Associated Press the franchise has no immediate comment on the report. The Times said the team could make a formal announcement later this week. It’s not known when the name change will take affect or if the team has settled on a new moniker. Cleveland’s move away from Indians follows a similar decision earlier this year by the NFL’s Washington Football Team, which was previously known as the Redskins. For years, Native American groups and others have protested against Cleveland’s use of Indians as its name as well as other imagery used by the American League charter franchise founded in 1901. Last year, the ...

Meet the People who Keep You Safe on Muni

Meet the People who Keep You Safe on Muni By Mariana Maguire Next time you ride Muni or see a Muni vehicle, keep an eye out for the faces of some of the people of the SFMTA working to keep customers and fellow staff safe on Muni, day to day. They include members of our Muni Transit Assistance Program , Proof of Purchase team, our Muni operators, as well as our head of Safety, Security and Investigations. Staff in our Muni Transit Assistance Program ride Muni \ to help address conflicts.Our Proof of Purchase team, Station Agents and Transit Inspectors support customer safety by providing an extra presence on Muni vehicles, at stops and in stations and assistance if issues arise. And our Muni operators provide the first line of safety for customers. While their primary responsibility is to operate their vehicles safely, they can also help address conflicts onboard when necessary and when it is safe for them to do so. In the case that it’s not possible or safe for an operator to...

My precise view

Search This Blog