Skip to main content

New top story from Time: Vaccine Safety Board Chides AstraZeneca for Using ‘Outdated’ Data in Press Release About its COVID-19 Shot

https://ift.tt/2NJcQ8K

In an unusual move, on March 23 the U.S. National Institute of Allergy and Infectious Diseases (NIAID) issued a strongly worded statement asking AstraZeneca to “ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”

On March 22, AstraZeneca released the results of its long-awaited U.S. trial of its COVID-19 vaccine, developed with scientists from Oxford University’s Jenner Institute. The data showed that the two-dose vaccine was 79% efficacious in protecting people from symptoms of COVID-19, and 100% efficacious in protecting against severe disease.

That data, however, may not have included the most updated information that the independent Data Safety Monitoring Board (DSMB), which reviews U.S. vaccine studies, had shared with the company. U.S. trials of COVID-19 vaccines are conducted under randomized, double blind conditions, which means neither the doctors and staff running the trials nor the participants volunteering in them know whether they are receiving the actual vaccine being tested, or a placebo. Only the DSMB has the authority to unblind the data to determine both efficacy and reveal any safety concerns. The DSMB does periodic unblinding checks to see, for example, if side effects are occurring at higher rates in the vaccinated versus placebo groups. The DSMB also determines if enough cases of COVID-19 have accumulated to provide the statistical power necessary to determine whether a vaccine works.

In all of the U.S. COVID-19 vaccine trials, the same DSMB, made up of about a dozen independent experts, is overseeing data from different vaccine makers, to ensure that the same standards are being used to review the data and that the final results are consistent.

During the evening on March 22, the DSMB grew concerned by the data included in AstraZeneca’s press release, covered extensively by the media, reporting the study results. The board wrote letters to Dr. Anthony Fauci, director of NIAID, who serves as the U.S. government representative for the vaccine trials, as well as the Biomedical Advanced Research and Development Authority, which helped to fund the trial, and AstraZeneca expressing its concern that the company chose to include only older data in its release, which “may have provided an incomplete view of the efficacy data,” NIAID said in a statement.

“The more recent data did not make the data look as good—it wasn’t bad, but it wasn’t as good,” says Fauci. “What concerned the DSMB was that at the time the press release went out, the DSMB knew the company had more recent data, and they chose to report the earlier data which made the data look a little better, that’s what the DSMB is saying.”

In a statement responding to the DSMB’s concern, AstraZeneca said it would “immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”

This is only the latest bump on AstraZeneca’s road to an authorized vaccine in the U.S.. After small numbers of unusual, serious illnesses were reported among study volunteers, the trial was halted in the U.S. and elsewhere last fall; the study was delayed by a month while regulators reviewed the report in the U.S. After the vaccine was authorized in the U.K. and the European Union, concerns about blood clots among people who have been vaccinated emerged in mid-March, prompting a number of countries to halt using the shot until the European Medicines Agency reviewed those cases and determined on March 18 that the benefits of the vaccine still outweighed any risk. AstraZeneca’s U.S. trial also showed that the rate of blood clots among people in the study weren’t any higher than would be expected in that population even if they hadn’t been vaccinated.

In another blow to the vaccine, on March 16 South African researchers reported in a study published in the New England Journal of Medicine that the two-dose regimen was only about 10% efficacious in protecting people from COVID-19 if they were infected with a new variant of the virus known as B.1.351, which was first reported in South Africa and starting to account for more cases around the world.

The company’s decision to report the “outdated” data could further erode confidence in the vaccine, says Fauci. “I look upon this as an unforced error, really,” he says. “There was no need for this to happen.”

It could also raise questions for the U.S. Food and Drug Administration (FDA) scientists who will review AstraZeneca’s request for emergency use authorization, which the company plans to submit in coming weeks. “At the end of the day, the FDA gets all the data and they do a completely independent analysis of all the data,”’ says Fauci. “No matter what went on ahead of time, at the end of the day, the truth will come out.”

AstraZeneca has committed to providing 3 billion doses of its vaccine by the end of 2021, much of it through COVAX, the global vaccine initiative that is procuring and distributing vaccines to lower resource countries.

Comments

Popular posts from this blog

New top story from Time: At the Republican National Convention, You Might Think COVID-19 Was Over

https://ift.tt/2Eo94gy Listening to the speakers at the Republican National Convention, you might be forgiven for thinking that the coronavirus pandemic is over. Many have largely ignored the virus that has killed nearly 180,000 Americans, despite the fact that it continues to seriously disrupt life in the United States, including their own event. Others, like White House economic adviser Larry Kudlow, referred to the pandemic in the past tense: “It was awful,” Kudlow said on August 25. “Health and economic impacts were tragic. Hardship and heartbreak were everywhere. But presidential leadership came swiftly and effectively with an extraordinary rescue for health and safety to successfully fight the COVID virus.” When Vice President Mike Pence took the stage Wednesday night, his speech was a striking example of the Trump Administration’s attempts to reframe the history of the pandemic that has claimed hundreds of thousands of lives worldwide and nearly ground the American

Traffic Collisions have Decreased on San Francisco’s Slow Streets

Traffic Collisions have Decreased on San Francisco’s Slow Streets By Julia Malmo   As a whole, Slow Streets are safer than they were before being designated Slow Streets  Streets that are part of the SFMTA’s  Slow Streets Program have become measurably safer since the program began in 2020, with the number of traffic crashes falling by almost half. On average, these corridors have seen a 48% drop in collisions following their designation as Slow Streets, compared with a 14% drop in collisions citywide over the same period. Slow Streets also are more welcoming for people who walk, bike and roll. Fewer than 1,000 vehicles per day use all but four of the current Slow Streets (20th Street, Minnesota Street, Noe Street, and Page Street).  The goal of the program is to create safe, shared streets that are comfortable and enjoyable for people of all ages and abilities, using any mode of transportation. We now can see how it’s doing in a new evaluation report . When the SFMTA Board appr

New top story from Time: TWICE Delivers Uplifting Performance of ‘DEPEND ON YOU’ at TIME100 Talks

https://ift.tt/3a8KgF0 TWICE delivered a special performance at the TIME100 Talks Friday. For the first time, the South Korean group performed the track “DEPEND ON YOU” from its latest album, Eyes Wide Open . As the coronavirus pandemic continues, members Jihyo, Nayeon, Momo, Sana, Mina, Dahyun, Chaeyoung and Tzuyu offered fans a message of solidarity and gratitude (vocalist Jeongyeon is on hiatus due to health reasons). “ Currently, we are sad to say that we are also aware that all of us are suffering in this situation,” Sana said. “We appreciate all people who are doing their best to return us to our normal lives and to bring back brighter days,” Nayeon continued. “TWICE will diligently keep on carrying out our duty to bring positive energy into the world,” Mina said. In line with these words, the group sang “DEPEND ON YOU”—a breezy, mellow track about steady hands that offer strength and support in the midst of darkness. “DEPEND ON YOU” first appeared on Eyes

New top story from Time: Japan’s Prime Minister Abe Reportedly Stepping Down Over Health Concerns

https://ift.tt/32yNoGh (TOKYO) — Japan’s Prime Minister Shinzo Abe has expressed his intention to step down due to his declining health, according to reports Friday by NHK and other Japanese media. The Prime Minister’s Office said the report could not be immediately confirmed, but that Abe was believed to be meeting top ruling officials at the party headquarters. The Liberal Democratic Party spokesman did not answer the phone. Concerns about Abe’s chronic health issues, simmering since earlier this summer, intensified this month when he visited a Tokyo hospital two weeks in a row for unspecified health checkups. Abe, whose term ends in September 2021, is expected to stay on until a new party leader is elected and formally approved by the parliament. He had abruptly resigned from his first stint in office in 2007 due to his health, which was fueling concerns about his recent condition. Abe on Monday became Japan’s longest serving prime minister by consecutive days in of

In-Person Pride Parade & Celebrations Return This Month!

In-Person Pride Parade & Celebrations Return This Month! By Pamela Johnson The SFMTA is happy to join San Francisco Pride celebrations when they return to in-person events this month as the city continues its recovery from the pandemic. This year’s theme is “Love will Keep Us Together.” The Trans March is happening on Friday, June 24 and the Pride Parade is on Sunday, June 26. SFMTA staff are, of course, an important part of the LGBTQIA+ community that keeps SF moving with Pride. Pride is an opportunity for us to demonstrate our continued support of the LGBTQIA+ community, promoting our core values of respect, inclusivity and integrity.  History/Background of SF Pride   San Francisco had its first Pride celebration in 1970. For more than three decades the LGBTQIA+ community and their allies have been moving San Francisco forward to become a better, safer, and more equitable world for the LGBTQIA+ community and the city a better place for people to live, work and enjoy.    His

New top story from Time: ‘Do Not Hold Grudges.’ Joe Biden’s Notes Reveal Talking Points About Kamala Harris

https://ift.tt/2X4natB (WILMINGTON, Del.) — Joe Biden was uncharacteristically tight-lipped on Tuesday about the final stretch of his search for a vice president. But the presumptive Democratic presidential nominee seemed prepared to talk about at least one leading contender: California Sen. Kamala Harris. As he took questions from reporters on Tuesday, Biden held notes that were captured by an Associated Press photographer. Harris’ name was scrawled across the top, followed by five talking points. “Do not hold grudges.” “Campaigned with me & Jill.” “Talented.” “Great help to campaign.” “Great respect for her.” Those are all observations Biden has made about Harris before. But they take on new significance following a recent Politico report that one of Biden’s closest friends and a co-chair of his vice presidential vetting committee, former Connecticut Sen. Chris Dodd, still harbors concerns about Harris’ tough debate stage performance and that she hasn’t expressed reg

How to inculcate Financial Literacy in your Children

    Many of us may have experienced the kid insisting to get alluring stuff being shown on TV in various ads. The kid may be scrolling through e-commerce websites and finding some attractive clothes, toys or, articles of makeup falsely claiming miraculous results. Are they worth buying? Are their usefulness had proven. In several examples, they end up being useless.                                                 Despite having felt their worthlessness, most parents yield to the pressure of their kids only just to make them happy. The big business houses understand this basic instinct and exploit the parent by pushing ads that might allure children and the parent find no way but to buy those stuff for their kids. Thus making a big profit by leveraging their product to target children and adolescents.           This is why we need to inculcate financial literacy in the children from the beginning so that they may develop a skill to judge the utility versus the price of the products, the

Farmers’ stir: Protesters thinning out at Ghazipur border, NH-24 opened for traffic https://ift.tt/3psgykC

The Ghazipur-Delhi border on the NH-24, one of the protest sites of farmers against the agri laws, was quiet on Wednesday night following fissures emerged among the farm groups. According to reports, almost 50 per cent of the farmers have returned from the border. 

FOX NEWS: Students sing to teacher with stage 4 cancer outside hospital: 'It was overwhelming' In an emotional goodbye visit, 26 children sang worship songs prior to Carol Mack's move to hospice care

Students sing to teacher with stage 4 cancer outside hospital: 'It was overwhelming' In an emotional goodbye visit, 26 children sang worship songs prior to Carol Mack's move to hospice care via FOX NEWS https://ift.tt/3GWyQ6G

New top story from Time: Little Recognition and Less Pay: These Female Healthcare Workers Are Rural India’s First Defense Against COVID-19

https://ift.tt/3mrDgrm Archana Ghugare’s ringtone, a Hindu devotional song, has been the background score of her life since March. By 7 a.m. on a mid-October day, the 41-year-old has already received two calls about suspected COVID-19 cases in Pavnar, her village in the Indian state of Maharashtra. As she gets ready and rushes out the door an hour later, she receives at least four more. “My family jokes that not even Prime Minister Modi gets as many calls as I do,” she says. Ghugare, and nearly a million other Accredited Social Health Activists (ASHAs) assigned to rural villages and small towns across India, are on the front lines of the country’s fight against the coronavirus . Every day, Ghugare goes door to door in search of potential COVID-19 cases, working to get patients tested or to help them find treatment. With 8 million confirmed COVID-19 cases, India has the second-highest tally in the world after the United States and its health infrastructure struggled to co